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USER MANUAL - World Health Organization

1. Chapter 5 Catalogues Sy 5 9 Dispensing Categories These distribution categories are normally provided for in the statutes of each country and are part of the conditions for issuing a product licence Examples of these include OTC for over the counter preparations POM for prescription only preparations and prescription for narcotic drugs DISPENSING CATEGORY Code N Description Prescription for narcotics Notes lt Replace Delete gt lt Figure 5 10 Dispensing Categories screen Code This is a unique code used to identify the dispensing category Description This field displays the full meaning of the code Notes Use this text field to add any additional information World Health Organization 1998 57 SIAMED User Manual 5 10 Rejection Cancellation Causes Reasons for rejecting applications and for cancelling licences can be predefined Rejection is reversible through a specific menu option The voluntary withdrawal of product applications or the abandonment of applications by applicants should be given ad hoc rejection cause codes Cancellation is reversible and is performed through the Renewal menu option Suspension of licences is performed through the Cancellation menu option REJECT I ON CANCELLATION CAUSES Classification CANCELLAT I ON REJECTION Code AR Description Unacceptable Adverse Reactions Notes 4 Replace Delete gt lt Figure 5 11 Rejection Cancellation scree
2. World Health Organization 1998 95 Company Activities Item Group State owned Private All Handles Psychotropic Narcotic Drugs Not Authorized or All Name Full Name SIAMED User Manual You can select any number of company activities such as manufacturer pharmaceutical or distributor If you do not select anything the system disregards this selection criterion and lists companies regardless of their licenced activity ies If you select activities A B and C the system lists companies that are licenced for ALL three activities If acompany is not listed for all three activities it will not be included You can select any number of item groups If you do not select anything the system disregards this selection criterion and lists companies regardless of their licenced item group s If you select item groups A Band C the system lists companies that are licenced for ALL three item groups If acompany is not listed for all three groups it will not be included The radio buttons permit you to select whether you want to list private or state owned companies or either If you do not select anything the system assumes you selected all Select whether you want to list companies authorized to handle psychotropic and narcotic drugs or not authorized or either If you do not select anything the system assumes you selected all Use these fields to limit the search range to companies whose name or full name
3. Human Drugs New Revalidation Minor Variation and Major Variation Veterinary Drugs New Revalidation Minor Variation and Major Variation Biological Drugs New Revalidation and Variation Special Procedures Users that wish to implement this option should enter as many steps as appropriate in the catalogue When entering steps users are prompted to decide whether a positive conclusion of a given step is necessary to permit the approval of an application This distinction becomes useful when you want to enter steps that are only required for selected applications Users can change the entries in this catalogue add new steps remove steps edit duration change between necessary and non necessary as required at any moment during the routine use of the system The system will take care of making the necessary changes to all applications that had been entered prior to the changes made in this catalogue More precisely a if you remove a step from the catalogue all pending applications will disregard any decision made at that step if any and will not accept or require entry of data World Health Organization 1998 59 SIAMED User Manual regarding that step b if you add a new step all pending applications will accept entry of decisions made at that step and will require a positive decision if the new step has been marked necessary c if you change the necessary mark all existing applications will require
4. gt Valid licences Cancelled licences Expired licences 0k lt Exit Ty e Figure 8 54 Retrieval of Ingredient Frequency To generate this report complete the following steps 1 Select whether the search should include active excipients or other ingredients 2 Specify ifthe search should include pending applications rejected applications valid licences cancelled licences or expired licences 3 Specify the date range from to to be included in the report 4 To conduct the search press lt lt Ok gt gt or lt Exit gt to return to the Main Menu 194 World Health Organization 1998 Chapter 8 Drugs WEE 8 14 17 Generic Name Frequency This option permits you to retrieve information on the frequency of a generic name appear in drug applications licences GENERIC NAME FREQUENCY Search all Ce Pending applications gt Rejected applications Valid licences Cancelled licences Expired licences From 7 To Figure 8 55 Retrieval by Generic Name Frequency To generate this report complete the following steps 1 Specify if the search should include pending applications rejected applications valid licences cancelled licences or expired licences 2 Specify the date range to be included in the report 3 To conduct the search press lt lt Ok gt gt or lt Exit gt to return to the Main Menu World Health Organization 1998 195 SIAMED User Manu
5. This step National Version allows each facility to accommodate alternative expressions which they as users can define at set up or when the need arises This option allows you to locate the text you want to change and permits you to edit it regardless of caps status i e whether text is lower or upper case lettering or both and the position of the word in the string In this way you may replace any text string thus producing screens and printouts which are more meaningful to your specific context while reflecting the language and or spoken of your facility and the country in which it operates See Section 10 1 4 for details on customizing the system using the option National Version Retrieval Although is not a formal step in the quick start process the ability to retrieve information is a pivotal component of the entire system The SIAMED system allows you to retrieve and print information through the Retrieval option associated with the primary operations Catalogue Company Drug Inspections etc under the Licensing module Selecting the retrieval feature under any operation displays a list of choices from which you can select the report that best meets your need If needed and requested the printouts can be adapted to the local needs See the Retrieval section of each licensing option Chapters 5 through 9 for details on using the retrieval system 42 World Health Organization 1998 Chapter 5 Catalogues SE 5 CATALOGUE
6. Strength 24 mg Generic nane lt Data on application Similar formula Licence 2 Approval date 62 06 1998 Expiry date lt Licensing fees Limit marketing date 0k lt Exit Figure 8 22 Marketing Authorization The following is a description of each field listed on the Issue of Licences screen Application Type in the application number and press lt Enter gt You can also Number press lt F2 gt or click the right mouse button to view the list showing only applications that have not been rejected or approved and that have completed at least the compulsory processing steps If you do not find the application you are looking for it means that this has been rejected has already been approved or has not completed at least the compulsory processing steps When you have selected the application summary information such as applicant drug name strength and generic name will be displayed If there are any pending Reminders the system will prompt you Then if there are any fees that have not been paid the system will display a message where you can select lt Yes gt or lt No gt Choosing lt Yes gt allows you to continue to update the record Data on This button when selected displays an additional screen that Application provides detailed information on the drug in the application Information in this screen is for display purposes only No editing functions can be performed in this screen 150 World Health O
7. active ingredients 7178 Licences with Psychotropics 55 6 Licences with Narcotics 2778 Figure 8 46 Sample of Predefined Statistic report 186 World Health Organization 1998 Chapter 8 Drugs WEY 8 14 10 Price Related Retrieval This retrieval option allows you retrieve information based on price data e g all items with retail price lower than a given value PRICE RELATED RETRIEVAL All Received applications 09 23 98 _ Rejected applications 4 7 Pending applications Issued licences Expired licences Cancelled licences Valid licences NAMA IN es es se se gt HUMAN gt VETERINARY gt ALL Figure 8 47 Price Related Retrieval screen To implement price related retrieval complete the following steps 1 Define the scope of the data The options you are offered on the screen are All Received Applications Rejected Applications Pending Applications Issued Licences Expired Licences Canceled Licences and Valid Licences These available options are described in Section 8 14 6 2 Select whether Human Veterinary Both drugs are to be included in the printout Note You will also be able to change this setting after having selected the searching price 3 Press lt lt Ok gt gt to continue then see the specific help screen or lt Exit gt to return to the Main Menu World Health Organization 1998 187 SIAMED User Manual 8 14 11 Variations This option permits you to print a list
8. authorities After selecting this option you will be prompted to indicate what kind of data is being imported and the source drive A or B After making your selections click the lt lt Ok gt gt button to begin the restoration process 10 1 10 Troubleshooting Steps For any Notes fields displayed if the entry indicates MEMO in upper case letters this means that the system contains information that can be viewed by pressing either lt Ctrl gt lt Page Down gt or double clicking on the memo field To return to the list simply press lt Esc gt You may also continuously press lt Esc gt until you are returned to the main processing duration screen At that point you must select lt Exit gt to return to the main menu Pulled from ch 8 drugs Section 8 14 15 Processing Duration World Health Organization 1998 221 SIAMED User Manual 224 World Health Organization 1998 Chapter 11 WHO National WEE 11 WHO NATIONAL This chapter combines information on the menu options under WHO and National 11 1 WHO The WHO menu screen is composed of three sections WHO Scheme s Certificate WHO Documents and UN Consolidated List of Products The functions under this menu option permit you to access various types of information and or organisational documents WHO Edit National a Print WHO Scheme s certificate Pharmaceutical newsletter Model Prescribing Multisource products GCP WHO Dru
9. enter a separate date if necessary The system automatically enters an expiry date of five years after the approval date This date however can be changed Selecting this option causes an additional window where you may enter any additional licensing fees that may apply to the licence if necessary See Section 8 1 13 for details on adding licensing fees Use this field to specify a deadline date by which the applicant must begin marketing the product After completing the approval screen select lt lt Ok gt gt and the system will prompt you to indicate whether or not you want to print an approval letter See Section 12 10 for details on how to generate a letter Press lt Exit gt to return to the main menu World Health Organization 1998 151 SIAMED User Manual 8 6 Post marketing Follow up This option allows you to record any summary data that has been collected on marketed products You may also use this same option to retrieve any marketing information on the same product POST REGISTRATION FOLLOW UP Licence 137 1996 Licensed 13 07 1996 Status VALID Expiry date 13 07 2861 Licence Holder DRUG COMPANY JJJ Drug name ADACARD Strength 26 MG CTD TAB Generic name NICARDIPINE Limit marketing date First marketing date Date marketing suspended Date marketing resumed Summary Stability data Postmarketing Surveillance Other notes Ok Figure 8 23 Post marketing Follow up screen Licence This fie
10. in your country and make them more easily identifiable See Section 5 3 for more details Identifies the type of container that is in direct contact with the dosage form Used to build a database that defines the form in which the products are dispensed such as tablets capsule or liquid Used to build a database that defines the various ways a drug or product may be administered e g orally In this context licence means marketing authorization The menu label and the screens use Licence only to make it fit in the available space In some countries it is a requirement to specify whether a marketing authorization is to import and sell to manufacture and sell to import complete manufacture and sell etc This catalogue is there for those countries that may require it This option builds a database that is used to indicate whether a druf product enters the general distribution system or is available only at special sites or through special mechanisms Restrictions are based on decisions of the drug regulatory authorities to prevent a particular drug from entering the general distribution system This option will be used to build a list of dispensing categories which will be used to determine how the item can be dispensed i e OTC for over the counter preparations POM for prescription only preparations etc These distribution categories are normally provided for in the statutes of each country and are part of the conditions of iss
11. that is applicable to you and then click lt lt Ok gt gt If you do not find your printer in the list try first to use one of those listed and look at the quality of the printouts If no acceptable solution is found please get in contact with us Four fields have been prepared in the system to be defined by the end user to store additional information related to applications licences If necessary you may include up to four additional entries from here If you are unable to use this option alone WHO PAHO can provide assistance Additional fields applications 1 2 3 4 Two fields have been prepared in the system to be defined by the end user to store additional information related to companies If necessary you may include up to 2 additional entries from here If you are unable to use this option alone WHO PAHO can provide assistance Additional fields companies 1 2 When the button lt More gt is selected a new pop up window appears which provides the user with the following screen options 216 World Health Organization 1998 Chapter 10 Maintenance Authorization Additional Configuration Options Automatic or Manual Numbering Application Automatic or Manual Numbering Licence Justification of Application Numbers Automatic Correspondence Prompt Market Limit Up to three different fields have been added to the system to accommodate identification
12. 154 249 SIAMED User Manual Risk Inspection 111 Routes of Administration 48 54 237 Application 131 Security 6 select i 237 Select Printer 206 Shelf Life 125 Similar Formula Drugs 138 Similar Names Drugs 138 SOP 238 Source Catalogue 65 Special Characters 205 Starting SIAMED 23 Storage Conditions 126 Strength 238 Substance Monographs 68 substance names 13 69 Substance Names Dictionary 49 62 Synonyms 63 System Update 22 SYSTEM REQUIREMENTS iii Network Support iii Recommended Hardware iii TAG Technical Advisory Group 7 Term to Comply 89 Therapeutic Groups 132 Town Geographical Code 50 Troubleshooting 216 Types of Licence 48 Catalogue 55 Types of Price 49 Types of Relation 49 User Manual 205 Users Log 209 Variation 238 Variations 158 licence 156 Veterinary Data 136 WHO 219 Drug Information 222 WHO Scheme s Certificate 219 Year end Optimization 215 250 World Health Organization 1998
13. 1998 Applicant COMPANY BBB Drug name aaadruname Strength 24 my Generic name Rejection cause IC Irrational Combination Rejection date 82 86 1998 0k Figure 8 21 Recover rejected application screen Application Nr Type in the application number and press lt Enter gt You can also press lt F2 gt or click the right mouse button to select from the list showing only applications that have been rejected Thus if you do not find the application you are looking for it means that this has not been rejected When you have selected the application number summary information such as date received applicant drug name strength generic name rejection cause and rejections date are displayed When you have selected the application summary information is shown and you can press lt lt Ok gt gt to recover your entry If lt lt Ok gt gt is selected the system will prompt you as to whether or not you wish to print a letter to send to the applicant indicating that the application has been recovered from rejection See Section 12 10 for details on how to prepare a letter Press lt Exit gt to return to the main menu World Health Organization 1998 149 SIAMED User Manual 8 5 Issue Marketing Authorization This option permits you to record the decision to approve an application making it a marketing authorization ISSUE OF LICENCES Application nr 5 Received 18 03 1998 Applicant COMPANY BBB Drug name aaadrunane
14. 8 Received 27702719978 Applicant SELECT DATA TO BE VARIED lt Licence holder lt gt Internal decision PRIORITY LICENCE HOLDER REPRESENTATIVE DRUG NAME STRENGTH GENERIC NAME ae AGE FORM PRIMARY CONTAINER Figure 8 29 Variations to Application screen Data entry is carried out in two or three steps First a variation application number needs to be generated by the computer Second the variation application can be retrieved though the above mentioned number to record decisions made at the different processing steps This is not compulsory Finally the decision to record the variation s to the licence is recorded The procedures for recording variations to application are as follows 1 Type in the licence number and press lt Enter gt You can also press lt F2 gt or click the right mouse button to get a list of file contents This list of file contents will show valid licences only If you do not find the licence you are looking for it means that this has never been entered has been removed from the system has been cancelled or is expired 2 After you have selected the licence summary information such as licence holder drug name strength is shown together with a computer generated variation application number This number is a unique identifier for the variation application It serves as a reference tool via which users can record information related to the processing steps as well as the final dec
15. AGENTS SODIUM FLUORIDE SODIUMMONOFLUOROPHOS PHATE OLAFLUR ANTIINFECTIVES FOR LOCAL ORAL TREATMENT HYDROGENPEROK I DE CHLORHEX I DINE AMPHOTERICIN SU NE POLYNOXYLIN lt lt lt Press ESC to exit gt gt gt Figure 5 15 Sample of the ATC Classification List Code This is a unique code used to identify the ATC classification level Description This field gives the description World Health Organization 1998 65 SIAMED User Manual 5 13 3 Source This option provides pop up window with an alphabetical search list indicating the literature sources of the listed substance names synonyms SOURCES LIST Type characters Locate matching data PgUp PgDn t Move Bar Enter or Click Rigth Mouse Select Order by Description Code Description ADUERSE REACTIONS KARTOTEKA NEZADOUCICH UCINKU LEKU SUKL ARZNEIBUCH DER DDR 2 AUSGABE 1975 BRITISH APPROUED NAMES 1981 AND SUPPLEMENTS BRITISH PHARMACEUTICAL CODEX 1949 BRITISH PHARMACEUTICAL CODEX 1954 BRITISH PHARMACEUTICAL CODEX 1959 BRITISH PHARMACEUTICAL CODEX 1963 AND SUPPL 1966 BRITISH PHARMACEUTICAL CODEX 1968 BRITISH PHARMACOPOEIA 1948 BRITISH PHARMACOPOEIA 1953 BRITISH PHARMACOPOEIA 1958 BRITISH PHARMACOPOEIA 1963 Press lt lt lt Esc gt gt gt to exit Figure 5 16 Sample of Source List Code A unique code used to identify the source of the literature Description This field gives the full name of the literature source 66 World Health Orga
16. Application for Revalidation Renewal of Marketing Authorization Application for Variation to Marketing Authorizations This refers to an application for a new marketing authorization Each application for marketing authorization is characterized by a number called application number It is also characterized by the following elements a company responsible before the authorities for all the implications that can arise from product marketing marketing authorization holder or licence holder a product name be it a generic name or a trade mark a dosage form a strength and a primary container A change in one of these elements implies a different application number In this system the application number can be automatically generated by the computer or can be entered by a user having the appropriate type of password The maximum length of the application number is fifteen 15 digits characters or a mixture of the two This refers to an application for extending the period of validity of an existing marketing authorization Application numbers for this type of applications can only be computer generated This refers to an application for changing selected information related to an existing valid marketing authorization Application numbers for this type of applications can only be computer generated Depending on established regulations the type and extent of variations permitted vary from country to country Variations admit
17. Application nr 8152795 Received 84 86 1995 PROGESSING STEPS Step Reception of applications Expert Step date 21 06 1998 Decision date APPROUED Similar formula gt lt gt PENDING lt gt REJECTED Letter Notes lt Enlarge text 0k Delete Exit Figure 8 16 Secondary Processing Steps screen For each step in the process a detailed window is be displayed All entries can be edited at any time provided the application has not been rejected or approved The following information is displayed in the detailed processing steps screen Step This field displays the name or description of the step Expert This button gives access to an additional window which list any experts or sub steps that have been assigned to the step in its catalogue Step Date The starting date for this particular step Decision Date The date a decision was made regarding the status of the application as it pertains to this processing step Approved These options are meant to summarize the outcome or decision Pending Rejected made at the step Similar Formula This button allows you to carry out two types of search The first is aimed at retrieving and displaying all drug item regardless of their status as application and or licence having at least one active ingredient in common with the item being entered The second will retrieve and display all items having at least one active ingredient in common with and the same dosage form as th
18. Hospital price Price 16 332666 Currency NEW NEW POUND Exchange rate 1 66666 Valid on 64 766 1998 Notes lt Enlarge text Description Valid on Hospital price 16 332 NEW 16 332 NEW 14 18 1996 Maximum Retail price 26 644 NEU 26 644 NEW 14 10 1996 Wholesale price 14 847 NEW 14 847 NEW 14 18 1996 Figure 8 11 Application Drug Price screen Description This field describes the price type Hospital price maximum retail price and wholesale price description are examples of price descriptions This field is linked to the types of price catalogue therefore pressing lt F2 gt will allow you to select a price description from the available entries in the catalogue Price Use this field to enter the price of the drug for this particular description Currency This field displays the currency in which the above price is quoted This field is linked to the currency catalogue therefore selecting lt F2 gt will provide you with a list of currencies that have been entered in the original catalogue system Exchange Rate The currencies exchange rate for the item will be automatically displayed in this field if acurrency was selected from the currency catalogue Valid On This field displays the date on which the exchange rate is valid This date will automatically be displayed if a selection is made from the currency catalogue Notes This is a free text field that allows you to enter any additional information relating to the prici
19. Licence Licence Press lt F2 gt to select a valid licence number This screen will only show a list of all licences that have NOT been cancelled nor expired After selecting the licence the specific information relating to the application number will be displayed This information includes the date the application was received the applicant the drug name the strength and if applicable the generic name lt Similar Formula gt is an additional option that can be selected from this screen Selecting the lt Similar Formula gt button causes the system to find and retrieve all drugs having at least one active ingredient in common with the item on the licence which you want to cancel After reviewing the information you may then select lt Print gt to print the report or select lt Exit gt At this point the system will retrieve and display all drug items with similar ingredients and the same dosage form as the drug listed on the licence which you wish to cancel After reviewing this information you may again then select lt Print gt to print the results of the search or select lt Exit gt return to the previous screen At this point selecting lt lt Ok gt gt would indicate that the application has been cancelled The system will then prompt you to indicate whether you want to print a cancellation letter See Section 12 10 Simply select lt lt YES gt gt or lt NO gt After a selection is made you will be returned to the previ
20. Move Bar Enter or Glick Rigth Mouse Select Order by Substance Substance ABSINTHII HERBA Narcotic Psychotr Preferred national nane Group A T C V1188 Source PHARMACOPOEA HUNGARICA VI 1978 Substance ABSINTHIUM Narcotic Psychotr Preferred national nane Group A T C 1188 Source MARTINDALE THE EXTRA PHARMACOPOEIA 29TH ED 198 Y Press lt lt lt Esc gt gt gt to exit Figure 5 14 Sample of Substance Name Dictionary Substance This field displays the name for which a synonym is being sought Narcotic Psychotr Displays the narcotic psychotropic drug code for the substance A label N1 N2 N3 P1 P2 P3 or P4 has been added to indicate that the substance is listed in tables 1 through 3 of the 1961 Convention on Narcotic Drugs or in tables 1 through 4 of the 1971 Convention on Psychotropic Drugs If the substance is not under international control there will be no label displayed Preferred National Displays a P if this synonym has been selected as the Preferred Name National Name of the substance The preferred national name serves as a system default so that the same item isn t referred to by several different names within the system To assure consistency in data display and retrieval each regulatory authority should select one synonym for each substance the first time the substance is used to record data in an application After this is done every time you select a synonym the system will a
21. Route of Administration screen Routes of This field is linked to the Route of Administration catalogue Type Administration in acode and press lt F2 gt to obtain a list of the items in the routes of administration catalogue file Press lt lt Ok gt gt to save your entry and it will appear in a window in the lower part of the screen Selecting an item listed in the bottom portion of the screen and double clicking on it reveals a window option to lt Delete gt the entry or lt Go Back gt one step Items listed in the Routes of Administration window can be deleted by double clicking on any item and selecting lt Delete gt When all information has been entered press lt Exit gt to return to the main application entry screen World Health Organization 1998 133 SIAMED User Manual 8 1 5 Status In Other Countries This option offers free text fields where users can record notes about the regulatory status in other countries or any other information drawn from authorities of other countries which is considered relevant for decision making in the drug registration process An unlimited number of references about regulatory status of the drug in other countries can be entered for each application This is an optional field to be set at configuration Country This field is linked to the countries catalogue Press lt F2 gt to obtain a listing of countries and select the desired country Date Type in the date on which such
22. SIAMED User Manual Opens a submenu which allows you to generate reports on inspections This information can be shown on the screen or printed This option opens a submenu permitting access to operations on applications and marketing authorizations licences Opens a submenu which allows you to generate reports on applications and marketing authorizations licences This information can be shown on the screen or printed Gives access to management of fees related to applications and marketing authorizations licences Opens a submenu which allows you to generate reports and print information on payment and validity of fees In this chapter we shall present details on the information that can be entered under the Catalogues menu options and specify where additional information may be found within the manual 46 World Health Organization 1998 Chapter 5 Catalogues SE 5 2 Catalogues The Catalogues menu option gives access to all the files containing descriptive data that will be used throughout the system This option allows you to build standard abbreviations or codes to ensure that all staff members use the same terms when entering data in the system There are 21 different types of catalogues ranging from Geographical Code to Type of Price To access the Catalogue menu options select Catalogue on the Licensing main menu and then select the desired option Geographical codes Primary containers Dosage forms R
23. Selecting the lt Geographical codes gt button will allow you to Codes limit the selection of companies to one specific geographical area If no selection 1s made all companies based in the country of installation will be included if they match the other criteria established under activities and item group Check Boxes These fields are used to further narrow the search criteria Checking any or all of the following boxes results in the following Inspector s Geographical Code Criterion limit the selection of inspectors only to those of the geographical area selected Exclude Last Inspector excludes those who last visited the company from the list of proposed inspectors Match Inspector with Activity limits the selection of inspectors only to those qualified for the activity ies selected and Match Inspector with Item Group to limit the selection of inspectors to only those qualified for the item group s selected Press lt lt Ok gt gt for the computer to generate the list of companies and proposed inspectors In generating the list of companies and proposed inspectors based on the criteria you have entered the computer considers the following elements Y date proposed for next inspection at the time of last inspection Y date of last inspection degree of risk assigned to each company These three elements are taken into account as follows 4 for each company the computer seeks the last inspection informatio
24. Transfer lt Paste gt functions World Health Organization 1998 233 SIAMED User Manual 12 6 Find This option allows you to search various fields for specific information To use this option you must be in a search field Select the Search option and another window will be displayed with the following information Look for Enter the information you want to search for Replace with Leave this option blank You are provided with several option that you can select as desired Ignore Case Match Words Wrap Around Search Forward and Search Backward After all entries have been selected click lt Find gt The system will then find references matching the information text you typed into the Look for field 12 7 Find Again This option allows you to repeat your last Find procedure using the search parameters previously established when the initial Find data was entered 12 8 Replace and Find Again This option allows you to replace and find data When selected the Replace and Find Again option will display another window with the following descriptions Look for Enter the information you want replaced Replace with Enter the data that is to replace the existing word or phrase Whatever information you enter in this field the system will replace the data you want replaced with the new information just entered The system will look for the next option occurrence where this replacement can be implemented again 234 World
25. Type of Relation Information Valid on Notes Company Type of Relation RELATED COMPANIES Related to COMPANY JJJ Type of relation MARC Manufacturing of raw materials Information valid on 18 86 1998 lt Enlarge text gt Type of relation DRUG COMPANY EEE Holding Company 61 85 1997 lt Figure 6 3 Related Companies screen Selecting lt F2 gt in this field allows you to select the name of a company you want to indicate as related to the company for which you are entering data Note Both companies must exist or be created in the system before they can be related Once the data has been entered to specify the relationship the change will automatically take effect in both companies entries Selecting lt F2 gt in this field allows you to specify what type of relationship exists between both companies These options are available based on information entered in the Types of Relation catalogue Indicates the date on which this information was valid Free text field to enter information the better explain the relationship between the companies This part of the screen displays which relationships of the company for which you are entering data have already been recorded An arrow on one line indicates that the information displayed in the upper part of the screen is referred to that specific relation When all entries are completed and saved by pressing lt lt Ok gt gt you can return to the main entry
26. all system facilities A Limited password only has access to menu entries selected at the time the password was established See Figure 10 World Health Organization O 1998 211 SIAMED User Manual 212 World Health Organization 1998 Licensing a Catalogues a Geographical codes a Country b Region c District d Town e Currencies Primary containers Dosage forms Routes of administration Types of licence Availability restrictions Dispensing categories ENTER OR DOURLE CLICK LEFT MONSE TO SELECT Figure 10 4 Limited Access assignment screen The system is preset with REG as unlimited access password Using this you can create any number of user passwords All user passwords can be deleted but there must always be a valid unlimited access password in place to be able to use the system Below is a description of the fields used to assign user passwords Name This field is used to indicate the user name to which a password is to be assigned To create a new entry type in the user name and press lt Enter gt To edit an existing entry press lt F2 gt or click the right mouse button Password This field is used to indicate the password for the assigned user Enter the password you want to create it must be a minimum of 2 characters and a maximum of 10 characters Users will be able to change the assigned password anytime but those with access to the password assignment option will be able to see what
27. applicable This field permits to link the drug registration database with another database such as procurement or reimbursement list Location of File Used to indicate where the physical file s can be found The optional fields set at configuration would also appear in this screen The contents of any of these fields are defined by the user The system is set up to allow retrieval of information using these fields as searching criteria Once all data is entered press lt lt Ok gt gt to return to the main entry screen World Health Organization 1998 129 SIAMED User Manual 8 1 2 Manufacturers This option is used to provide detailed information about any and all manufacturer s of the drug item that has been identified for this application APPLICATION ANUFACTURERS Manufacturer COMPANY UUU Contact person Mrs Rachel Orchid Company Manufacturer Contact Person Role Notes Role FO Formulation only Notes Count Activity NEW Formulation only APPROVED Figure 8 6 Application Manufacturer s screen This field is for the name of any company that is involved in the manufacturing process of the drug listed on the application Press lt F2 gt or click the right mouse button to get a list and select the desired item This can be chosen only from those companies for which the activity manufacturer has been selected during data entry for companies and whose status is different than cancelled Users ma
28. complement these administrative instruments WHO has developed a Model System for Computer Assisted Drug Registration which is now available after consultation and field testing in several countries The acronym for the WHO model system is SIAMED The main objective of the model system is to improve the efficiency of drug regulatory authorities enabling them to assure that marketing authorizations are consistent with their national drug policy This is to be achieved through the provision of technical advice a specifically designed locally adaptable computer system and assistance to make effective use of the system SIAMED has been developed by the World Health Organization and the Pan American Health Organization with technical and financial support from GTZ and DSE both international cooperation agencies of Germany and Direzione Generale per la Cooperazione allo Sviluppo the official development agency of Italy Further technical input has been provided by the Institut Universitaire de M decine Sociale et Pr ventive of the University of Lausanne Switzerland by the State Institute for Drug Control of Prague Czech Republic by CHD Amsterdam the Netherlands and by HS Programar Medellin Colombia However the development of this software package has been made possible only by the invaluable support and technical inputs provided by the officials of the Drug Regulatory Authorities of all the countries where field tests and development work
29. complete the following steps 1 Enter either an application or licence number as appropriate In the case where both application and licence numbers are retrieval options the system will automatically distinguish among the two types of numbers However if the same number exists for both an application and a licence only the application will be retrieved 2 Move to the appropriate field and select the item 3 Press lt lt Ok gt gt to get access to the correspondence 4 In the correspondence list double click on the Memo label to see the full text of the correspondence 190 World Health Organization 1998 Chapter 8 Drugs IF 8 14 14 New Substances This retrieval option permits you to search and list the substances that for the first time have been included in an application or licence received issued within a given date range NEWLY LICENSED SUBSTANCES Substance X Active X Excipients X Other X Received applications From 89 23 97 To 777 X Issued licences From 7 To 4 42 Figure 8 51 Retrieval of New Substances screen To generate this report complete the following steps 1 Select whether the search should include substances entered as active excipient and or other 2 Indicate whether the search should include applications received within a given date range 3 Indicate whether the search should include licences issued within a given date range 4 To conduct the search pr
30. creates a basis for developing a rigorous internationally accepted technical mechanism for admitting new products into national markets and for monitoring their subsequent performance and it provides a means of rationalizing expediting and reducing the costs of developing products that are offered to a wide spectrum of national markets A scheme for harmonizing and integrating national drug monitoring programmes directed primarily at creating an international data base of reports of suspected adverse drug reactions was first developed under the Press lt lt lt Esc gt gt gt to exit Figure 11 7 Drug Information screen Regulation of Biological Products This displays a text screen of a WHO guideline on biological products REGULATION OF BIOLOGICAL PRODUCTS Press lt lt lt Esc gt gt gt to exit Figure 11 8 Regulation of Biological Products screen World Health Organization 1998 229 SIAMED User Manual 11 1 3 UN Consolidated List of Products The final section under the WHO menu enables the user to consult the UN Consolidated List of Products whose Consumption and or Sale have been Banned Withdrawn Severely Restricted or not Approved by Governments The screen displayed with this option requests a substance name which you can enter manually or select from the pop up which appears when you press lt F2 gt Once a selection is made additional information provided by the UN is displayed about the pr
31. displays the code and the corresponding name of the classified drug This field is linked to the Class code Group Code Defines what group this item should be assigned to This field is linked to the subclass code Subgroup Code Provides a more specific category to which the item should be assigned This field is linked to the group code Description This field displays the full name of the classification level Notes Use this field to add any additional information or notes about the classification level Each screen class subclass group and subgroup displays a different level of classification where the user can enter a code with their description and notes As each successive level is chosen classification fields from the previous levels will be displayed Thus at the subgroup level all 3 previous levels are shown 62 World Health Organization 1998 Chapter 5 Catalogues IE 5 13 Substance Names Dictionary This is a database with over 80 000 non proprietary names of active principles and excipients Users can enter additional names to keep the dictionary up to date and to accommodate specific national names e g traditional remedies It is important to check before adding a new entry whether the file contains any synonym of the name users wish to add Adding new names without linking them to existing synonyms reduces the efficiency of the dictionary It increases the probability of licensing drugs with the same ingredi
32. for details on assigning passwords Step 3 Catalogues Catalogues are any files that contain an abbreviation or code and its description For example there is a catalogue of countries where all country codes and their descriptions are stored for example AFG is the code for Afghanistan and ZIM is the code for Zimbabwe This step requires that you begin to create or modify any catalogue files so that they apply to the needs of your system and or facility To assure consistency and avoid redundancy it is important that the definition of codes be completed during your initial setup There are 21 different types of catalogues ranging from Geographical Codes to Types of Price Many catalogues have already been filled with examples to make familiarization with the system easier See Chapter 5 for more details on Catalogues Step 4 Companies This step requires that you begin to create or modify any company files so that they apply to the needs of your system and or facility The Companies database permits you to enter detailed information about a company that your facility utilizes associates with in connection with the drug registration process To assure consistency and avoid redundancy it is important that the bulk of this information be updated during your initial setup See Chapter 6 for detailed information on Companies Step 5 Inspections The Inspections step of the SIAMED Quick Start process requires that you begin to create or mo
33. gt lt Figure 5 8 Type of Licence screen Code This is a unique code used to identify how a licence is classified For example I to import and sell S to import for clinical study only M to manufacture and sell or A to import complete manufacture and sell Description This field displays the full meaning of the code Notes Use this text field to add any additional information regarding the type of licence World Health Organization 1998 55 SIAMED User Manual 5 8 Availability Restrictions This option is used to specify any decisions of the drug regulatory authorities to prevent a particular drug from entering the general distribution system For example Drugs available only for clinical studies drug available only at poisoning treatment centres or drug available only through designated institutions e g for TB drugs VAILABILITY RESTRICTIONS Code C Description Use restricted to clinical studies Notes lt Replace Delete gt lt Figure 5 9 Availability Restrictions screen Code This is a unique code used to identify restrictions of drug availability Description This field displays the full meaning of the code Notes Use this text field to add any additional information regarding the restriction NOTE Availability Restrictions is a provision over and above the normal statutory dispensing modalities or categories for distribution 56 World Health Organization 1998
34. identifying number which is given to each professional Enter the name of the professional This field indicates the unique number assigned to each professional document Indicates the date the professional document was issued This field specifies who issued the professional documents This push button 1f selected specifies that the current professional documents have an expiration date This push button if selected indicates that the current professional documents have no expiration date World Health Organization O 1998 81 SIAMED User Manual Geographical This field identifies the primary geographical area i e country Codes region district or town where this professional conducts business Profession This field specifies what this individual s profession is Responsible This field indicates whether or not this professional is a primary Professional contact within their organization company Related This field indicates other related companies with which this Companies professional might be associated Address Indicates the address where the professional can be contacted Phone Indicates the telephone number where the professional can be contacted 5 22 Type of Relation The Type of Relation catalogue is for storing abbreviations of the relations that can be established between companies such as holding company subsidiary packaging unit QC lab exclusive distributor or marketing agent TYPES OF RE
35. information on companies that participate in the Drug Registration program Information includes the company s name addresses contacts activity profile history of inspections and relation with other companies Information on each application and licensed product is stored within these consolidated files This includes information on approved indications dosage and administration precautions contraindications adverse effects use in pregnancy and lactation interactions treatment of over dosage and storage conditions This main file is linked to related files holding information on ingredients manufacturers regulatory status in other countries distributors prices fees etc Any variations to licensed products are also recorded here World Health Organization 1998 5 SIAMED User Manual 1 2 The System 1 2 1 Overview of Use The system is intended to improve management of information on companies and drug items at a Drug Regulatory authority This is to be achieved through five different types of operations prepare and keep the catalogues up to date i e tables of abbreviations substance names application processing steps correspondence formats develop and maintain company file information on company data activity profile history of inspections develop and maintain drug item file detailed information on item data application authorization status history of variations use system options
36. information was valid Notes Free text field for additional information Press lt lt Ok gt gt to save your entry and it will appear in a window in the lower part of the screen Selecting an item listed in the bottom portion of the screen and double clicking on it reveals a window option to lt Change gt or lt Delete gt the entry or lt Go Back gt one step Items listed in the Status in Other Countries window can be deleted by double clicking on them and selecting lt Delete gt When all information has been entered press lt Exit gt to return to the main application entry screen 8 1 6 Therapeutic Groups This option is used to specify the various therapeutic classes under which a drug may fall based on its clinical use An unlimited number of therapeutic groups can be entered for each application Group This code specifies the therapeutic group in which the drug item submitted on the current application can be categorized Press lt F2 gt or click the right mouse button to get a list and select the desired item Press lt lt Ok gt gt to save your entry and it will appear in a window in the lower part of the screen Selecting an item listed in the bottom portion of the screen and double clicking on it reveals a window option to lt Delete gt the entry or lt Go Back gt one step Items listed in the Therapeutic Groups window can be deleted by double clicking on them and selecting lt Delete gt or lt Tab gt a
37. institution such as street number street name city and country as you would want it to appear on an envelope The physical location of the organization s operating plant If a company has several plants in the same country separate company entries should be made to enable inspection to be referred to each specific unit The name of the person primarily responsible for managing all company activities The numerical prefix for the organisation s telephone number s The organization s telephone number Telex communication number Telephone number used to send a facsimile fax transmission to the organization Used to provide additional information on the company s activities Click the check box next to each activity that the company has been authorized to perform For manufacturer distributor pharmacy and other additional screens will appear requesting more information see below The other options are simple check boxes and do not require any additional information Used to specify a company name and its relationship to the company for which you are entering this data See below for more details This field is used to enter any additional information about a company These fields are established during the configuration process See Chapter 10 for additional information on Configuration World Health Organization 1998 Chapter 6 Companies WEE Selecting the check boxes for manufacturer distributor or ph
38. mouse button on the little double arrow to the left of any step and moving while the mouse button is still pressed the selected step up or down the line The sequence shown does not impose that users start or complete any given step before entering information on a subsequent one Click lt lt Ok gt gt to save your changes 60 World Health Organization 1998 Chapter 5 Catalogues WEY Data entry update and retrieval is identical for all processing steps You may add as many steps as you wish to each path in this catalogue World Health Organization 1998 61 SIAMED User Manual 5 12 Drug Classification This catalogue permits you to enter and update information regarding the classification for all drugs if national classification or national classification from the Anatomical Therapeutic Chemical A T C classification system has been selected If the ATC classification system has been chosen at configuration this option will be faded The number of levels of the national classification 1s set using the configuration option SUBGROUPS Class AD ANTIMIGRAINE DRUGS Subc lass ND Non Drowsy Group 0M Oral Medication Subgroup PR Description Prescription Medication Notes lt Replace Delete gt lt Figure 5 12 Drug Classification screen Class Code A two character field that displays the code and the corresponding description of where this drug should be classified Subclass Code This field
39. of their name in common SOP An acronym for Standard Operating Procedures Strength Defines how strong the drug dosage is Strength is always indicated on the product label Substance Names Dictionary A file that contains over 80 000 different non proprietary names of pharmaceutical substances cross related synonyms and their anatomical therapeutic classification Synonyms Provides a list of substance names and possible alternate names that may refer to the same item Variation Refers to the process of recording to a specific file any changes alterations made to an application This enables the user to retrieve a history of any and all variations associated with an application 244 World Health Organization 1998 Marketing Authorization Approval Date 148 Issuing 147 Licensing Fees 148 Stability Data 149 lt lt Ok gt gt 30 lt Exit gt 31 lt Replace Delete gt 30 A T C Catalogue 64 A T C 49 61 A T C 210 233 Group 63 About the System 205 Accessing WHO Documents 220 Active Ingredient 13 70 122 233 235 Active User 206 Change 206 Activity Company 90 ADD Application 120 Additional Fields Configuration 211 Alphabetical Search 233 Alphabetical Search Window 32 To exit without selecting an item 33 To locate and point to an item 33 To select an item 33 Applicant Change 159 Application 11 for Variation 11 Marketing Authorization 11 Recove
40. or another governmental body may employ such professionals regularly while elsewhere it may be difficult for the drug regulatory authority to obtain the services of programmers Therefore this matter will need to be tackled case by case staff commitment The package has been conceived to be used directly by professionals Data entry has been limited as much as possible Most information can be selected from lists with a simple click of a mouse button to eliminate tedious retyping of data and permit standardization of terms In addition generation of correspondence and certificates is by simple selection of items the computer automatically places the specific variable information in the right place This reduces the clerical work to a minimum Thus it is vital that professionals be willing to work directly with a computer and receive ad hoc training 2 3 days for this In addition the introduction of computer assisted drug licensing is a major undertaking for any drug regulatory authority It often entails revision of the existing working procedures and habits and the establishment of new ones It also entails reviewing existing files and information to assure completeness and consistency For these reasons staff at the decision making level needs to be substantially involved in all the activities which will eventually lead to a fully functioning computer assisted drug licensing programme World Health Organization 1998 9 SIAMED Us
41. overview of drug regulatory decisions made by the national regulatory authorities PHARMACEUTICAL NEWSLETTER Bharmaceuticals Newsletter No 18 October 1993 Regulatory actions Antifungal agents not acceptable for fungal scalp and nail infections United States of America e Food and Drug Administration has prohibited claims that nonprescription topical antifungal agents effectively treat fungal infections of the scalp and fingernails Scalp and nail fungal infections are difficult to treat because of the thickness of the nails and the depth of the hair roots The FDA asked manufacturers who make such claims to demonstrate the effectiveness of their products Based on a review of the submitted clinical data the FDA concluded that the available data do not support these indications and that the products have not been proven effective roducts affected include Fungi Naill Pro Clearzi and Lee s Ant Fungal Nail Treatment Reference FDA Talk Paper T93 42 dated 3 September 1993 Diazepam revised data sheet interactions Press lt lt lt Esc gt gt gt to exit Figure 11 3 Sample of Newsletter screen World Health Organization 1998 227 SIAMED User Manual Model Prescribing Provides an example of the WHO series model prescribing information which provides information n drug use MODEL PRESCRIBING I ral rehydration salts g litre of clean water sodium chloride trisodium citrate dihydrate potassium chlor
42. record of application licence retention fees 4 information to carry out data searches and produce reports on the basis of multiple searching criteria encompassing all the pieces of information mentioned above 4 information on national databases to create expand keep up to date and make automatic or on line use of stored information on substances whose use is restricted and excipients admitted uses limitations etc 4 export reports and correspondence to user selected external word processors in order to issue printouts in any format 18 World Health Organization O 1998 Chapter 2 Installation 2 INSTALLATION This chapter outlines the requirements for installing and configuring SIAMED Your computer uses a system configuration file CONFIG SYS to load any necessary system configuration parameters This file can be viewed or changed using a simple text editor programme such as MS DOS EDIT or Windows Notepad For SIAMED to run properly make sure that in the root directory of your computer there is a CONFIG SYS file containing the following statement FILES 160 The parameter entered in the CONFIG SYS file controls how many files SIAMED and other programmes can have open at one time SIAMED uses many database files and needs to have enough room available to open all necessary files If the settings are incorrect the programme may halt After making any changes to the CONFIG SYS file reboot the computer turn if of
43. screen This option allows you to record the decision to reject one or more applications Rejection Cause Rejection Date Notes This field should display the code and description of the rejection This field is linked to the Rejection Causes catalogue therefore pressing lt F2 gt will allow you to select a code from this option Records the date the application was rejected By default the system enters the current date However if the rejection date is different you may change the date Free text field for additional information Select whether this rejection refers to one specific application or is common to a number of them A specific screen will appear for each option 146 World Health Organization 1998 Chapter 8 Drugs 8 3 1 One Application Select this option if you wish to specify a single application which should be rejected Selecting this option displays the screen below REJECTING APPLICATIONS Rejection cause IG Irrational Combination Rejection date 1128621998 Application nr 0289N79 Received M3 10 1995 Applicant DRUG COMPANY JJJ Drug name ADANITRA 48 Strength 48 MG TAB Generic name ISOSORBIDE DINITRATE lt Similar formula Exit gt Figure 8 19 Rejecting One application screen Application Type the application number which you want to record the Number rejection or press lt F2 gt to obtain a list of applications which have not been rejected or approved After select
44. starts with a string of characters Enter the appropriate characters in the proper field For example If you want to limit your search to companies with the name Roche simply enter Roche in the name field If you want to limit your search to that particular company enter Hoffman La Roche Press lt lt Ok gt gt to execute If at least one company matches the selection criteria you are shown an additional window to select display options as described in Section 6 2 Retrieval Companies 96 World Health Organization 1998 Chapter 6 Companies WEE 6 2 3 Expiry of Operating Licence This option permits you to see or print company operating licence expiry dates COMPANY OPERATING LICENCE EXPIRY DATE Company TAMI From 95 21 96 Ce Screen AA lt gt Printer APPROUED g To Figure 6 7 Expiry of Operating Licence screen Company Use this to retrieve information on a given company simply by typing its name or selecting a name from the pop up window list provided when you press lt F2 gt or click the left mouse button If you want to list all companies just leave this field blank From To Use this field to specify the range of dates from which you want to retrieve data regarding expiring licences If you leave blank the From date the system assumes 11th November 1111 i e much before you started your licensing activities If you leave blank the To date the system assumes 31st December 99
45. the Licensing menu from the menu bar at the top of the screen Then you select catalogues and the company activity Enter the necessary data and then click lt Ok gt to save and on lt Exit gt to return to the operation you where performing Date Reference This text field displays notes as to the date reference and activity Activity associated with the referenced document as described above for manufacturers distributors and pharmacies After completing the entry of information related to an activity you press the lt lt Ok gt gt button and summary information about your entry will appear in the large window placed in the lower part of the screen Clicking on any line of this latter window will give access to the entry for editing Selecting the button lt Related Companies gt reveals a window which allows you to relate one company to another When entering related companies it must be remembered that these must be companies already existing in the computer for it to accept them In other words 92 World Health Organization 1998 Chapter 6 Companies when you start using the system and you enter the first company you will not click the lt Related companies gt button even if you know that you want to enter one You will then enter the second company as the second entry and relate it to the first company the change will automatically take effect in both company s entries Notes Company Related to
46. the right mouse button or the lt F2 gt key GENERAL RULES FOR SEARCH FIELDS If you select the same field more than once the occurrences will be grouped and related with OR e g priority 1 OR priority essential drugs OR etc If you select a field in connection with another the two will be related with AND e g priority essential drugs AND licence holder Bayer If you select fields in disordered order the system will take care of grouping them as appropriate Thus if you first select dosage form tablet then licence holder Bayer then dosage form capsule the system will build the following relation dosage form table OR dosage form capsule AND licence holder Bayer Some items do not follow the general rule This is the case with fixed dose combinations combinations of therapeutic groups and items that can be logically chosen only once e g human veterinary generic brand Further details are offered here below ____ World Health Organization O 1998 173 SIAMED User Manual Priority Licence Holder Representative Drug Name Strength Generic Name Permits you to search by priority degree e g list all items with priority EQUAL 1 list all items with priority NOT EQUAL essential drugs etc Follows the general rule Applicable operators are EQUAL and NOT EQUAL List is available through right mouse button or lt F2 gt key Permits you to search by applicant licence holder Th
47. to speed up the system s performance If you select the year end optimization option you must confirm if you want to proceed with the optimization process by selecting lt lt Ok gt gt A warning message is then displayed asking you to confirm lt lt YES gt gt or go back lt NO gt If you select lt lt YES gt gt the system will begin optimizing files You will then be prompted to Press Any Key when completed which will return you to the main Menu If you select lt NO gt you will be returned to the previous screen 10 1 8 Back Up This option is used to back up information to diskettes Follow the instructions you have been given when the system was installed or those appearing on the screen Selecting this option requires that you have up to 8 formatted diskettes All information on the diskettes will be deleted in order to facilitate the back up process The Copy To option requires that you select the destination drive A or B containing the diskettes Click the lt lt Ok gt gt button to begin the back up process IMPORTANT Database files do get corrupted and selected information may become 220 World Health Organization 1998 Chapter 10 Maintenance unusable Making daily backups means that at most you can lose one 1 day of work Backing up on a weekly basis means that you may lose up to a week of work 10 1 9 Restore This option is used to restore information from back up diskettes prepared by the regulatory
48. window by pressing lt Exit gt World Health Organization 1998 93 SIAMED User Manual 6 2 Retrieval Companies Licensing Mainte a Catalogues b Companies c Retrieval Companies Multiple searching criteria Expiry of operating licence ha companiei PR P ompanies by geographical code g Retrieval Companies by activity geograph code Companies with no activity h Fees gt on il Retrieval lt URBAN ses with one activity d Inspections e Retrieval f Drugs Figure 6 4 Companies Retrieval main menu This Retrieval Companies option permits retrieval of information from the Company file 6 2 1 Companies The screen for the retrieval option Companies reveals a series of radio buttons By selecting the radio button options that best suit your needs you specify how the data is to be formatted and displayed LIST OF COMPANIES Ce Screen Ce Full gt Printer gt Brief Ce Partial gt Total Ce Code gt Description Figure 6 5 Retrieval Company screen Screen Printer Specifies where you want the data sent 94 World Health Organization 1998 Chapter 6 Companies Full Brief Partial Total Ordered by Code Description Selecting Full will include ALL data entered into the system about your selected company Brief will provide a synopsis of the company such as code name address and licenced activities Selecting Total means
49. 22 12 1996 Licence Licensed 28 81 1996 Licence Holder COMPANY GGG Representative COMPANY GGG BRAND Drug name A D C FLOR Strength Generic name MULTIUITAMIN PREPARATION DOMESTIC Presentations CARTON BOX WITH 7207 OR 588 TAB BLISTER AND 5 OR Dosage form CHTA Chewable Tablet Primary container BLIS Blister Specifications Type of licence M To manufacture and sell a MANUFACTURE Restrictions N None Dispensing categ P Prescription only Shelf life months 8 lt Storage cond National formulary P 287 R Additional information Location of file Similar formula lt Similar names Ok lt Reject application gt lt Exit F2 RIGHT MOUSE LIST FILTERED DATA F3 LIST ALL DATA N Vv YYYY Figure 8 30 Record Variations screen Once the relevant data has been entered press lt lt Ok gt gt a red window will appear asking to indicate whether all variations regarding this variation application have been recorded or if a decision is still pending regarding further variations If you select the first option the variation application will be removed from the list and no further variations can be recorded unless a new application for variation is entered through step one of the variation process If you select the second option the variation application will be accessible for recording further variations In any case each individual variation recorded takes immediate effect At this point the system will then prompt you t
50. 6 World Health Organization 1998 Chapter 4 Quick Start I 4 QUICK START The Quick Start chapter is designed to provide the beginner with a schematic overview for configuring and using the SIAMED system If you have just received the diskettes and no one is assisting you with the installation or introduction on how to the use of the system follow the primary steps shown here Configuration Password Assignment Catalogues Companies Fees Application for Marketing Authorization National Version Each step will refer you to a section in the remainder of this manual that contains detailed instructions for editing or adding data to the specific menu option See diagram You should also make use of the lt F1 gt key to access the Help database which provides additional information on the function of each feature under the various menu options of the SIAMED system See also the Flowcharts appendix at the end of this manual for a simple graphical presentation of the menu options permitting to implement the different operations of the drug registration process World Health Organization 1998 39 SIAMED User Manual Overview of SIAMED Process Chapter 10 Chapter 10 Chapter 10 Update National Configure Version for your SIAMED Fe nn facility System asswords Chapter 5 Data Modify
51. 99 i e much beyond the scope of your licensing activities Although leaving dates blank does not result in any error message it may give meaningless output For example From 01 01 1994 To blank lists all licences expiring anytime after 01 01 1994 which practically means that all company licence will be shown as expired Approved Use this field to determine if you want the search to be restricted to Cancelled Term companies currently operational cancelled or with term to comply to Comply All with inspection recommendations Screen Printer Select where output should go Press lt lt Ok gt gt to execute lt Exit gt to return to main menu The output lists all activities of each company with the indication of the operating licence expiry date World Health Organization 1998 97 SIAMED User Manual 6 2 4 Related Companies This option enables you to retrieve information on the types of relationships exist between companies To relate companies to each other you must press the lt Related companies gt button of the company data entry screen RELATED COMPANIES Company TAMI COMPANY BBB Country NEW DEMOLAND Town TWN3 Town 3 Type of relation Ce Screen Holding Company gt Printer Manufacturing of raw materials Subsidiary Ok Under licence lt Exit Select all lt Deselect all Figure 6 8 Used to establish relationship between companies Company Indicate the name of the company you want fo
52. CONTAINS then enter the string dark glass and press lt lt Ok gt gt and lt lt Execute gt gt The retrieved items will include dark glass dark glass bottle dark glass ampule 5 dark glass ampules Permits you to search by type of licence Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by availability restrictions Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by marketing conditions Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by national formulary code Follows the general rule Applicable operators are EQUAL and NOT EQUAL Field not related to catalogue no list available Permits you to search by location of file Follows the general rule Applicable operators are EQUAL and NOT EQUAL Field not related to catalogue no list available Permits you to search by shelf life Follows the general rule Applicable operators are EQUAL and NOT EQUAL Field not related to catalogue no list available Permits you to search by withdrawal period Follows the general tule Applicable operators are EQUAL and NOT EQUAL Field not related to catalogue no list available Permits you to limit the search to either brand or generic items It does not follow the general rule because it can be selected only once If it is not selected both branded and generic items are retrieved World Health Or
53. Catalogues to __ Save RETRIEVAL correspond with your for facility Catalogues Chapter 7 Chapter 6 Companies Enter modify E Enter data on vsaig Inspections Inspection j Companies Inspector Programmes and associated with your we Inspectors database program Applications Fees A Chapter 8 Yes H Save Enter Update Chapter 9 Applications for drug licensing and marketing ET Request amp Record Fee authorization a Payments u Le Application Licence Fee Processing Steps Renewal Fee Variation Fee NO REJECTED Application CANCELLED Licence APPROVED Application Licence Submission Terminated Authorized to do business market drug product 40 World Health Organization 1998 Chapter 4 Quick Stan SEW Step 1 Configuration The first step in setting up the SIAMED program is to configure the system and edit the preset options to meet the specifications of your SIAMED facility See Section 10 1 3 for detailed information on configuring your system Step 2 Assign User Passwords Passwords are assigned to users by accessing Maintenance Tools under the Maintenance menu tab and then selecting Password Assignment from the list Passwords are used to determine the level of access limited access and unlimited access that a user has to menu entries Any entry in the SIAMED program can be assigned a password access in the Maintenance Password Assignment option See Section 10 1 1
54. ED specifications ONFIGURATION OF DRUG LICENSING MODULE Classification Additional fields applications Ce A T C C 1 gt National 1 2 lt gt Use ATC as basis for national cl 3 Level 4 Ce Class gt Subclass Additional fields companies gt Group 1 gt Subgroup 1 2 Country of installation USA UNITED STATES OF AMERICA Level X Country lt More gt X Region X District lt Selection of processing steps gt X Town Currency lt Select printer gt Selected printer Epson E F J RX LQ 8 5 x 11 Figure 10 6 Sample of Configuration screen Classification You may choose to adopt the A T C classification as it is use it as the basis to prepare your national classification or establish your national drug classification If you choose the last two options you will be prompted to indicate the number of levels of such classification The maximum number of levels of the classification is four Indicatively they have been named CLASS SUBCLASS GROUP SUBGROUP These labels may be changed using the National Version option See Section 10 1 4 for details Country of The country of installation of the system is preset and cannot be Installation and edited You can select which levels of geographical codes you will Levels of use Indicatively the levels have been called COUNTRY REGION DISTRICT TOWN These labels may be changed using the National Version option See Se
55. Health Organization 1998 Chapter 12 Edit SZ 12 9 Print This option allows you to print the information displayed in the text field 12 10 Print Edit Letter This option allows you to print a letter or edit the text before printing When this option is first selected you are prompted to enter an application or licence number Press lt F2 gt to obtain a list of available applications or licences and then select lt Print gt The subsequent screen allows you to retrieve a standard letter or certificate format and have it automatically filled with the specific of the application or licence on which you are working You may then format and print the correspondence directly or you may save the text for later printing In addition the system also allows you to export the text under the form of an ASCII file which can then be formatted and printed using an external word processor The lower portion of the screen contains six 6 options which allows you to do the following Formats This option permits to select the required format from the list of available correspondence forms When you select a letter format the system will then replace all variables in that letter format with the data from the application or licence which you selected in the previous step A letter will then be displayed in the large gray window If there is any additional information which you would like to add you may do so here The text in the gray window ca
56. INATION or MULTIPLE in this field In this context generic name is meant as a name by which all drug items generally only drugs with one or two active ingredients with the same or equivalent active ingredient can be identified as a group See Glossary for additional details on Generic Name For example ERYTHROMYCIN can be chosen as generic name for all drugs containing any salt of erythromycin This would permit you to retrieve all these drugs as a group using the generic name as a single searching criterion In addition combining generic name with strength and dosage form as searching criteria would permit you to retrieve all drug items that in principle should be therapeutically equivalent In the case of fixed dose combinations where stating the generic name of each individual active principle would be confusing it is suggested to leave the field blank or enter general labels Example multivitamin minerals see formula etc as appropriate See notes on Generic Names catalogue To enter a generic name you may type in the generic name of the drug press lt F2 gt or click the right mouse button to see a list of existing generic names You can also press lt F3 gt to see the substance names file from where a name can be selected and then edited if necessary to be used as the drug generic name Unlike other catalogues new generic names can be created during drug application data entry with the system adding them automaticall
57. LATION Code MARC Description Manufacturing of raw materials Notes lt Replace Delete gt lt Figure 5 30 Sample of Types of Relation screen Code This is a unique code used to identify the type of relation Description This field displays the description of the code Notes Use this text field to add any additional information 82 World Health Organization 1998 Chapter 5 Catalogues SE 5 23 Type of Price The Type of Price catalogue permits you to establish abbreviations for the different types of prices that may be applied to medicinal products TYPES OF PRICE Code RP Description Maximum Retail price Notes lt Replace Delete gt lt Figure 5 31 Sample of Types of Price screen Code This is a unique code used to identify the type of price applied to a product Description This field displays the description of the code Notes Use this text field to add any additional information World Health Organization O 1998 83 SIAMED User Manual 5 24 Retrieval Catalogues Licensing Maintenance WHO National Edit a Catalogues HIE h Companies c Retrieval Catalogues Substance names dictionary d Inspections F Generic names e Retrieval F fnmnanies Figure 5 32 Catalogues Retrieval main menu This options allows you to print or view on the screen the contents of the catalogues ordered either by code or description BO Se Ph D un D Ce Code LIST
58. LED Phone 111 333 lt Activities X MOH staff lt Item group 0k lt Replace Delete gt lt Exit Figure 7 2 Inspectors sample screen Below is a description of this screen World Health Organization 1998 105 Personal Identification Number Name Professional Document Number Geographical Codes Profession Address Phone Status Activities Item Group MOH Staff SIAMED User Manual This is a unique identifying number which is given to each inspector Enter the name of the inspector By pressing lt F2 gt you can also make a selection using the professionals file Please note There is no compulsory relation between the inspectors file and the professionals file i e an inspector may or may not be included in the professionals file If the inspector s name does not appear continue to enter data into the fields indicated below This field indicates the unique licence number assigned to each inspector This field identifies the primary geographical area 1 e country region district or town where the inspector is authorized to conduct business Select the profession for the inspector you are entering using the list of options provided when you press lt F2 gt Type in the mailing address as it will appear on envelope labels The telephone number of the inspector This field is used to indicate the status of the inspector Approved means that he she will be considered
59. Manual 8 3 2 Several Applications Select this option if you wish to specify several applications which should be rejected Selecting this option displays the screen below Criteria By licence holder applicant By manufacturer By ingredient Figure 8 20 Rejecting Multiple Applications screen Criteria This pop up field displays 3 criteria which you can use for rejecting applications Select one of the following criteria By licence holder applicant by manufacturer or by ingredient Name This field will be dependent upon the criterion selected name of applicant licence holder manufacturer or ingredient Once you have entered the appropriate item press lt lt Ok gt gt This option confirms that you wish to reject all applications that have been submitted based on the criterion selected The system will prompt you to confirm your action or go back The system will them ask you whether or not you wish to print the rejection letter If you select lt lt YES gt gt the system will generate rejection letters for all applications based on your criteria selected See Section 12 10 for details on how to prepare a letter You can select lt Exit gt to return to the previous Rejection Application menu 148 World Health Organization 1998 Chapter 8 Drugs 8 4 Recover Rejected This option permits you to recover an application that has been rejected RECOUER REJECTED APPLICATIONS Application nr Received 18 83
60. OS filename select lt lt Ok gt gt when done Press lt Exit gt to return to the main menu 236 World Health Organization 1998 N Glossary GLOSSARY Active Ingredient That portion of a drug which produces the intended therapeutic effect Alphabetical Search Window A screen that lists file contents of your database in alphabetical order ASCII an output mode that allows information to be converted into a text file that is useable by virtually all word processing packages A T C Anatomical Therapeutic Chemical Classification An international coding system maintained by the WHO that provides a common basis for drug classification to facilitate comparative data for drug consumption between different countries Authorization refers to the issuing agency giving a company organization the go ahead to operate or market a product in the host country There are three basic forms of authorization marketing company operating and Company related See Section 1 3 1 for details Back up A process initiated by the user to copy information stored in the computer onto a diskette or tape drive to insure that if the computer should malfunction the data will still be available In essence when you perform a back up you are creating a duplicate of the data in your computer Catalogues Catalogue Files a set of files containing codes abbreviations and descriptive data used throughout the QCL system These codes are us
61. PUNCUOUS a asus ee ee here 36 4 QUICK START 26 cidee0n0s 480 354 0 re ideen 39 Step l Commer soii as a des E 41 Step 2 Assign User Passwords u essa 20 200002 near 41 Step 3 Calalogues ur el 41 Step 4 COMPa es zer ss riet 41 Step gt ISSUES A 41 SEPO ST SEEN A ESTER RR ee 42 Step 7 Applications for Marketing Authorization 42 Step 8 National Version zu hes Se nes che 42 ROSES eur use nes eier 42 3 CATALOGUES ip a a 45 5 1 Licensing Menu Option z2r 5u 240 4u 20 1 1 a ae 45 5 27 Calo ses y evoca pesitos near an ee 47 5 3 Geographical Codes erosiones li es 50 5 4 Primary Containers sacarina ec ie al 52 39 Dosage Forms s4 csdexnsnce cdeuesds den saberssdiantessteasenus 53 5 6 Routes of Administration us a4 eat 54 3 1 Types OF Licence oras aiei ada eea es 55 5 8 Availability Restrictions voomccrorinrrcrira nac HR aaa 56 5 9 Dispensing Categories dr caen user ensure GE ee eee when es 57 5 10 Rejection Cancellation Causes 58 5 11 Processing MEPS i nn sd ann ud kueni su EREN aaa ie 59 5 12 Drug Classification Lazare dite bars a a eed 61 5 13 Substance Names Dictionary sauna acc 62 3 1 Priority ss ne ind nas eRe she Diseases 71 World Health Organization 1998 5 SIAMED User Manual SAS PCS a ata Ri eG Ree eS AS AS wee ee 72 3 16 Company Activities lt 0 4 o0c lt dsSeuweed led eveeSu ia 74 5 17 Manufacturer s Roles 2 4204 He la 75 5 18 Corr
62. Quit Figure 10 1 Main Maintenance menu To activate these options either press the letter indicating the option move the bar to the option to be selected using the keyboard arrow keys and press lt Enter gt or just point and click using the mouse The following is a discussion of all available options in the Maintenance label Aboutthe System User Manual Calculator Special Characters Displays a series of screens with credits and general information on the system The information displayed when this option is selected includes contact numbers phone and fax for assistance when using SIAMED This option gives access to the context sensitive help screens These screens are also shown when pressing the lt F1 gt key from any window while using the system This option activates a pull down calculator that can be used at any time while operating the system Pressing the lt F12 gt key will activate the calculator while in any screen in the system This option activates a pull down window from where users may select and use characters not always available on all keyboards Pressing the lt Alt gt lt S gt keys will activate this window while anywhere in the system World Health Organization O 1998 209 ASCII Chart Change Foremost Window Select Printer Maintenance Tools Chek Validities Change Password Change Active User Quit 210 SIAMED User Manual Selecting this option will cause
63. RIXEN 256 MG CAP Capsule Licence Holder DRUG COMPANY NNN Pres CARTON BOX WITH 26 CAP BLISTE v Press lt lt lt Esc gt gt gt to exit Figure 8 40 Data Output screen 180 World Health Organization O 1998 Chapter 8 Drugs WEY World Health Organization 1998 181 SIAMED User Manual Selecting Output Destination The options you are offered here are to send the output either to the screen to the printer or to MULTIPLE SEARCHING CRITERIA Printout Ce Brief gt Full Select Ce Partial gt Total Figure 8 41 Selecting Destination for multiple search print out a file Screen lt gt Printer lt gt File File name Screen Printer File 182 After selecting screen press lt lt Ok gt gt and you will be shown data on the screen After viewing data you are sent back to this screen and you will then be able to select printer or file If you select printer you are offered two additional options First you can choose between brief and full printout The extent of information to be printed in these printouts is decided by the user at the time of customizing the system for routine use Second you can choose between partial or total printing Total means that all the items retrieved will be printed without further prompt Partial means that the items retrieved will be shown in a window from where the user can select those to be printed clicking on them one by one You c
64. Replace Delete gt lt Figure 5 28 Sample of Item Groups screen Code A unique code used to identify the item group for the activities of a given company Description This field displays the description of the code Notes Use this text field to add any additional information 80 World Health Organization 1998 Chapter 5 Catalogues IE 5 21 Professionals The Professionals catalogue permits you to store information on professionals associated with the SIAMED process Responsible professionals of manufacturing units need to be entered here before you can enter them in the company file This permits you to have control on who is engaged where and avoid if required double assignments PROFESS I ONALS Personal identification number 2 Name M me Sazan Abri Professional document number 444 666 Date professional document issued 12 84 1988 Issueing authority PHARMACIST SINDACATE gt Professional document valid until f A Ce Without limit lt Geographical codes gt DEMOLAND Toun 1 Profession PHAR Pharmacist X Responsible professional Address Lilly Road 444 Town 2 555666 0k Personal Identification Number Name Professional Document Number Date Professional Document Issued Issuing Authority Professional Document Valid Until Without Limit Related companies Phone 00999 11 444555 Replace Delete gt lt Figure 5 29 Sample of Professionals screen This is a unique
65. S 5 1 Licensing Menu Option The Licensing menu option gives access to all operations related to drug licensing This menu is divided into four distinct function areas catalogues and company inspections drugs and fees Cataloques Companies Retrieual Inspections Retrieval Drugs Retrieval Fees Retrieval Figure 5 1 Licensing Menu The following is a brief description of the primary operations under the Licensing menu Catalogues These are the files where all the abbreviations used in the system are stored Abbreviations must be stored in catalogues for the system to work properly Entry of abbreviations in catalogues is done directly using the catalogue menu option which is accessible to those with the appropriate password even while performing other operations such as entering company or drug data See help screens and manual entries of individual Catalogues for more details Companies Gives access to the file holding information on company name address activities and operating licence status Retrieval Opens a submenu which allows you to generate reports on catalogues and companies This information can be shown on the screen or printed Inspections Gives access to files where users can store information on inspectors prepare inspection programmes and enter summary information about company inspection results World Health Organization 1998 45 Retrieval Drugs Retrieval Fees Retrieval
66. S FROM CATALOGUES Primary containers Dosage forms Routes of administration Types of licence Availability restrictions Dispensing categories Rejection Cancellation causes Processing steps Drug classification Priority Fees Ce Screen gt Description gt Printer Catalogues Code Description Screen Printer 84 Figure 5 33 Retrieval Catalogues screen Displays a list of all available catalogue options Select the catalogue for which you wish to retrieve a report Selecting this radio button will sort the output by order of code Selecting this radio button will sort the output by alphabetical order of description Specifies where you want the output sent As a default all output goes to the screen World Health Organization O 1998 Chapter 5 Catalogues YS 5 24 1 Substance Name Dictionary This option permits you to print all the content of the substance names file or to print the synonyms of any selected name in alphabetical order SUBSTANCE NAME DICTIONARY Select Alphabetic gt Synonyms of Substance Print Figure 5 34 Substance Name Dictionary screen WARNING The substance names files is hundreds of pages Think carefully before you try to print it Select Specifies if you want the data printed in alphabetical order or if Alphabetic you only want the synonyms of a selected name printed Synonyms of Substance This field is only ava
67. SIAMED directory If the computer will ask for confirmation for overwriting any existing file answer YES to overwriting Go to the directory to which you copied the diskettes type INSTALL and press lt Enter gt Choose the appropriate option from the installation menu Disregard any File not found messages that may appear on the screen during installation The system will unpack in a minute or two From the SIAMED directory type REGX and press lt Enter gt Use REG as both name and password to start using the system Wait about five minutes until the system completes the creation of its indexes IMPORTANT If you are upgrading from a previous installation remember that all established passwords should be revalidated through the Password Assignment menu option before they can be used to their full extent with the new menu 22 World Health Organization 1998 Chapter 2 Installation 2 3 Starting SIAMED The first time you run SIAMED the system will create its own indexes This process may take up to 10 minutes depending on the computer being used When indexing has been completed the system will display the login screen See Figure 2 1 This login screen requires that you enter your user name and password If this is the first time logging into the system if this is after first installation of update type REG for the name and press the lt Tab gt key Next enter REG as your password The system will not display your p
68. STER DOMESTIC Dosage form COTA Coated Tablet Primary container BLIS Blister Specifications Type of licence M To manufacture and sell Restrictions N None a MANUFACTURE Dispensing categ P Prescription only Shelf life months 48 lt Storage cond gt Location of file lt Additional information gt lt Similar formula gt Print Exit gt Figure 8 34 Retrieval by Application Licence Number To do this report complete the following steps 1 Type in the application or licence number or press lt F2 gt to select from the file contents list which shows you ALL applications and licences that have been entered into the system 2 Once selection is made press lt Enter gt to reveal information on the chosen item in the retrieval window To review information on manufacturers ingredients routes of administration status in other countries therapeutic groups data sheets prices distributors veterinary data manufacturing process general appearance and analytical information fees and Reminders relating to the particular application or licence selected use the highlighted pop up window in the lower right corner of your screen You can also select any of the push buttons lt Storage Cond gt lt Additional information gt or lt Similar formula gt in the lower right corner of the screen to review information notes relating to the selected application or licence If the lt Similar formula gt button is selected th
69. Thus searches can be based on either the generic name of the drug product or the individual substance names of the ingredients Drug Products In this case the generic name is the name of the base that with Two Active constitutes the two active ingredients regardless of the molecular Ingredients form used in the formulation unless a specific salt has unique therapeutic uses unrelated to those of the base These two names are entered in the same field It is recommended that to avoid repetitions a fixed format is used to enter them For example one could use a plus sign to separate the two names and enter them only in alphabetical order e g amoxycillin clavulanic acid instead of clavulanic acid amoxycillin Drug Products Building a generic name by adding those of the individual with More Than components is not practical In addition it is uncommon that a Two Active rational drug has three or more active ingredients The proposed Ingredients approaches are these a enter the same predefined term for all drugs e g combination see formula or b enter an arbitrary term to indicate a loosely homogeneous group and use a predefined term for those drugs for which an homogeneous group is not easily identified e g multivitamin minerals minerals multivitamin electrolytes electrolytes glucose cold preparation combination see formula The use of these arbitrary generic names does not limit search on the basis of an individual ingredie
70. WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE ORGANIZACION MUNDIAL DE LA SALUD ORGANIZAGAO MUNDIAL DA SAUDE Model System for Computer Assisted Drug Registration SLAMED USER MANUAL June 1998 For more detailed information please contact HTP TCM World Health Organization Avenue Appia 20 1211 Geneva Switzerland email tcminfo who int or mednet who int Technical and financial support has been provided by Direzione Generale per la Cooperazione allo Sviluppo Rome Italy TABLE OF CONTENTS ABOUT THISMANUAL Sue roer ects eye seul eee en re Ses 1 SYSTEM REQUIREMENTS jesnesssesanerdotiancurautasersateinoeseragerts 111 1 INTRODUCTION TO SIAMED 5 44223242322 24 222 ds rr 3 1 1 Background 202324224 4 ra ac 3 1 2 Th System sent teen Petare rara res 6 13 Keyt Se E etweee eee dea ye pee 10 1 4 What This Software Package Does 16 2 INSTALLATION serum rra eS Se en SEEK ORE ba 21 2 1 Installation Procedures soso partners ads sat thetades eee es 21 22 Updating Procedures ess Li dann liess eS 22 Zo Starting SIAMED seine an a reset 23 2 4 Troubleshooting Steps zu32 43u 454 ch 3 Rene are 23 3 COMMANDS AND FUNCTIONS suce aumeduhesvetiesebusrduihenneetetet 21 3 1 SIAMED Main Menu sus ss tassbereasdehd duwathsedagas h s 27 3 2 SIAMED Window Objects e oocrinorrre dead eaves ea x4 29 3 3 Standard Keyboard Commands 34 34 Mouse
71. a chart of ASCII characters to be displayed Pressing the lt Alt gt lt I gt keys will activate this window while anywhere in the system From the list users can identify codes for special functions e g Inserting a page break in a text Selecting this option brings to the front one after the other all windows open at a given moment It is used to bring to the front an active window that because of its size is hidden by larger windows You will rarely need to use this feature however if needed the option is also available by pressing the lt Ctrl gt lt F1 gt keys See Section 3 2 Working with Multiple Windows When selected this option opens a window that permits you to select among a number of printers If your printer is not listed please try each one of the available options If none meets your requirements please get in touch with us This window can also be activated by pressing lt Alt gt lt D gt When selected displays options to access password assignment user log configuration national version initialization indexation year end optimization backup and restore See Section 9 1 for details Checks for expired company operating licences and drug licences and permits to make a report This option allows you to change your existing user password The password screen requires that you enter previous data your existing password and current data your new password This option permits you to swap
72. a sheet Drug prices u Distrihutors Veterinary data Manufacturing process General appearance Lab testing Licensing fees Reminders Similar names Similar formula NAANANAN YYYYYYYY ANANANAN VVVVVV VY Figure 8 4 Drug Application screen Below is a description of each field on the screen Application Nr A number unique to a particular product This number can be a maximum of 15 numbers or characters and can not be duplicated within the system in the Add mode You will be warned if the number already exists in the system If you have selected automatic application numbering in the configuration a computer generated number will appear and you will not be able to enter anything in this field Received The date on which the application has been received By default the system proposes today s date Applicant The name of the company submitting the application You can press lt Enter gt lt F2 gt or click the right mouse button to get a list and select the desired item Drug Name The label name of the product which may be the generic name The name can be a maximum length of 70 numbers and or characters 124 World Health Organization 1998 Chapter 8 Drugs WEY Strength Generic Name Describes the strength of the product as per label Description can not exceed 20 characters In the case of fixed dose combinations where stating each individual strength would be confusing it is suggested that you type COMB
73. aa ra aa ee ee era 195 9 1 Payments by Application Licence 196 92 Payments by Licence Holder 2 2 2 u these 197 03 Receipt Text A ae Dr ea ee oases 198 Of RETRIEVAL Fees il 199 10 MAINTENANCE 53 24444 oR ed GRPEG RTE ke RES 205 10 1 Maintenance Tools 42 222 432 280124 282 eed Ge weer Nee see enters 207 Il WHO NATIONAL eredet somes Sues ee aa en 219 6 World Health Organization 1998 A ER EEE ER ER eee eG 219 National 22 uk 223 EI E EIS N 227 Undo CHANGES reed 227 A aaa a a a T AR aa 227 COPE Re a OER de E du dou AAA 227 Transfer segs sauna ec rer 227 Select All Text 4c stern srno Arae es as le cad ae ae ENE 227 Find anis dr drain een ie initie 228 Fin Od s rie atteste II 228 Replace and Find Again ade esla 228 A den ee ara eed Oey ie 229 Pint Edit letter 2c nie bncdcktadueratarabaracktabasacheweacacaes 229 Se ee ee ee Ter ee eer ey ee E re 233 Ze 241 World Health Organization 1998 7 About This Manual ABOUT THIS MANUAL This manual is designed to serve as a training guide and a reference manual for anyone using SIAMED the WHO Model System for Computer assisted Drug Registration For the learner the basic commands and procedures for each option are explained step by step For the experienced user the manual has bold headings for referencing the SIAMED procedures or commands discussed within each section Answers to specific questions or steps for a particular proc
74. act as if that licence never existed even as an application This makes it possible to use its number again unless automatic numbering is used Utilize the function for deleting licences very carefully since there is no possibility to recover deleted information This option has been added only to permit you to remove a licence and free up its number after a data entry mistake DELETE LICENCES Licence 29 1998 Licensed 64 61 1998 Licence Holder DRUG cr 955 Drug name ACTIDINE Strength 2 MG 5 ML Generic name TRIPROLIDINE HCL 0k Figure 8 32 Deleting Licence screen The process for deleting licences is as follows 1 Type in the licence number and press lt Enter gt You can also press lt F2 gt or click the right mouse button to access a list from which you can select a licence If you do not find the licence you are looking for it means that this has already been removed from the system 2 After you have selected the licence summary information such as licence licensed licence holder drug name strength and generic name is displayed 3 Press lt lt Ok gt gt to confirm deletion You must then again confirm the operation 4 Press lt Exit gt to return to the Main Menu 164 World Health Organization 1998 Chapter 8 Drugs WEY 8 14 RETRIEVAL Drugs The Retrieval option permits you to retrieve information as outlined here below By Application Licence number Application status Application
75. al 8 14 18 Ingredients by Classification This option permits you to retrieve information on ingredients sorted by their classification INGREDIENT FREQUENCY BY THERAPEUTIC GROUP pe Search all gt Active Ce Pending applications gt Excipients gt Rejected applications gt Other lt gt Valid licences gt Cancelled licences gt Expired licences 0k lt Exit Ty Ce Figure 8 56 Retrieval of Ingredient by Classification To generate this report complete the following steps 1 Select whether the search should include active excipients or other 2 Specify if the search should include pending applications rejected applications valid licences cancelled licences or expired licences 3 Specify the date range to be included in the report 4 To conduct the search press lt lt Ok gt gt or lt Exit gt to return to the Main Menu 196 World Health Organization 1998 Chapter 9 Fees WEY 9 FEES The SIAMED process utilizes different types of fees For example there can be application fees licence fees for imported products licence fees for domestic products and QC laboratory fees Licensing Maintenance WHO Edit National a Catalogues b Companies c Retrieval d Inspections e Retrieval f Drugs g Retrieval h Fees k a Payments by application licence i Retrieval b Payments by licence holder c Receipt text Figure 9 1 Fees main
76. al 8 14 3 Applications at a Step The Applications at a Step option permits you to display applications that are pending at a given step This information can be viewed on the screen or printed Applications that have not yet started a step or have completed it are not shown APPLICATION BY PROCESSING STEP NEW DRUG APPLICATIONS PROCESSING STEPS HUMAN Step 3 Pharmacy amp Therapeutics Committee Expert gt Expert three Ce Screen gt Printer Figure 8 36 Retrieval of Application by Processing Step To generate this report complete the following steps 1 Select the appropriate type of processing 2 Specify how you want the information retrieved 4 To retrieve by step type in the step number or press lt F2 gt to select the step from the revealed list If you do not select a step you will be shown pending applications at all steps grouped in step order To retrieve by an assigned expert click on lt Expert gt and select from the file content 3 Select where the output should go and press lt lt Ok gt gt or lt Exit gt to return to the Main Menu 168 World Health Organization O 1998 Chapter 8 Drugs WEE 8 14 4 Delayed Applications This option permits you to display all the applications that have been pending at a given step for longer than the period established by the user when creating the step entry in the appropriate catalogue This information can be viewed on the screen
77. also open these text files simultaneously while you work on a data sheet You have the flexibility of selecting and transferring parts of the file to the data sheet The documents that have been included are there only to provide an example of this option Users can add their own reference documents to be used for reference or for copying text when working on licences To copy selected parts of the available document into an application licence data sheet 1 Click on WHO on the upper menu bar to pull down the WHO Menu 2 Select a document The document opens on the screen Select the text you want to transfer by clicking and dragging with the mouse Click on Edit on the upper menu bar to pull down the Edit Menu Select Copy The selected text is now in memory DN EN Click on the small box on the upper left corner of the window in front of you to make it disappear You are now back to your data sheet a Move the cursor to the position where you want the text to be transferred 8 Click on Edit on the upper menu bar 9 Select Transfer The text is transferred In this example we have used a WHO document as source of text to be copied However at the time of installation any other national document can be linked to the system This would permit you to standardize parts of your data sheets and save time The examples of selected documents which can be viewed under this menu option are Pharmaceutical Newsletter Provides an informational
78. alth Organization 1998 23 PAIN PROG MOG MY NDS N D Ft ee AN N CZ Chapter 3 Commands And Functions er 3 COMMANDS AND FUNCTIONS 3 1 SIAMED Main Menu To start the SIAMED programme in DOS change the root directory by typing CD SIAMED At the prompt C SIAMED type REG The Password Checking window will appear Type your name and press the lt Enter gt key Next enter your password and press lt Enter gt If this is the first time starting the programme enter REG for both the Name and Password entries The SIAMED Main Menu will appear The SIAMED software system has five primary labels that are displayed on the Main Menu when you activate the program These options cover all the principal SIAMED functions needed to conduct drug registration procedures This is the Main Menu of SIAMED It consists of five primary labels as described below Licensing Maintenance WHO Edit National 16 48 15 pm 4 66 14 666 e 1 ve 40006000 oo oo SOFTWARE PACKAGE FOR DRUG REGISTRATION Technical and financial support has been provided by Direzione Generale per la Cooperazione allo Sviluppo Rome Italy Figure 3 1 SIAMED Main Menu LICENSING The Licensing label gives access to management of abbreviations company information inspections fees and all operations related to drug licensing This is the p
79. ame reflects the name of the base that constitutes the with Two Active two active ingredients regardless of the molecular form used in the Ingredients formulation unless a specific salt has unique therapeutic uses unrelated to those of the base These two names are entered in the same field It is recommended that to avoid repetitions a fixed format is used to enter them For example one could use a plus sign to separate the two names and enter them only in alphabetical order such as amoxycillin clavulanic acid instead of clavulanic acid amoxycillin Drug Products Building a generic name by adding those of the individual with More Than components is not practical In addition it is infrequent that a Two Active rational drug has three or more active ingredients The proposed approaches are these a enter in the generic name field the same predefined term for all drugs e g combination See formula composition or b enter an arbitrary term to indicate a loosely homogeneous group and use a predefined term for those drugs as in example a for those drugs for which an homogeneous group is not easily identified e g multivitamin minerals minerals multivitamin electrolytes electrolytes glucose cold preparation combination See formula Ingredients The use of these arbitrary generic names does not limit search on the basis of an individual ingredient name On the other hand it contributes to establishing searching criteria tha
80. ame then you should rather use the list to get the name you need to retrieve Ingredients Permits you to search by fixed dose ingredients combination It Combination does not follow the general rule Applicable operators are EQUAL and CONTAINS See here above under INGREDIENT for the use of CONTAINS to search by part of the ingredient name You can use in the same search both the EQUAL and CONTAINS operators Example To list all items containing any chloroquine salt and starch and tartrazine select ingredients combination from the fields list then the operator CONTAINS then enter the string CHLOROQUINE and press lt lt Ok gt gt then select the operator EQUAL and enter STARCH or get it from the list and press lt lt Ok gt gt then enter TARTRAZINE or get it from the list and press lt lt Ok gt gt and lt lt Execute gt gt World Health Organization 1998 177 Active Excipient Other Quantity of Ingredient Route of Administration Therapeutic Group Combination of Therapeutic Groups Distributor Distributor s Country of Origin Data Sheet 178 SIAMED User Manual The maximum number of ingredients in combination that you can search for is five Note If you enter an ingredient name and press lt Enter gt the system will search exactly for the name you have entered Thus if you are not sure about the spelling or about the preferred national name then you should rather use the li
81. an send the subset of data resulting from your search to a file You can then use that file to prepare specific reports using the report generator provided with this system You can choose a file name up to 50 characters long World Health Organization 1998 Chapter 8 Drugs IF 8 14 7 Report Generator This tool permits you to prepare printouts containing only user defined information Users can select the report title the fields that should be shown in each column their width and the set of data to be shown To print information referred to a specific set of data users should carry out a multiple searching criteria retrieval save the set of data matching such criteria to a file and finally use that file as source of data for the report generator REPORT GENERATOR Paper e Wide Character e Normal gt Narrow lt gt Compressed No of columns 132 Report title _ Used columns 8 Free columns 132 APPLICATION LICENCE LICENCE HOLDER REPRESENTATIUE DRUG NAME STRENGTH GENERIC NAME DOSAGE FORM Figure 8 42 Report Generator screen To utilize the report generator complete the following steps 1 Select paper width and normal or compressed characters narrow paper permits a maximum of 80 normal or 132 compressed characters per line wide paper permits a maximum of 132 normal or 217 compressed characters per line The maximum number of characters is shown on the screen as maximum number of columns 2 Type the re
82. antity of the active substance s in the ingredient fields Thus searches can be based on either the generic name or the individual full substance names of the ingredients In this case the generic name reflects the names of the base that constitutes the two active ingredients regardless of the form used in the formulation unless a specific salt has unique therapeutic uses unrelated to those of the base These two names need to be entered in the same field Itis therefore recommended that to avoid repetitions a fixed format is used to enter them For example one could use a plus sign to separate the two names and enter them only in alphabetical order e g amoxycillin clavulanic acid instead of clavulanic acid amoxycillin Building a generic name by adding those of the individual components is not practical In addition it is infrequent that a rational drug has three or more active ingredients The proposed approaches are these 1 enter in the generic name field the same predefined term for all drugs e g combination see composition or 2 enter an arbitrary term to indicate a loosely homogeneous group and use a predefined term for those drugs for which an homogeneous group is not easily identified e g multivitamin minerals minerals multivitamin electrolytes electrolytes glucose cold preparation combination see conposition The use of these arbitrary generic names does not limit search on the basis of an individual ing
83. arching criterion add another searching criterion If you were searching by ingredients combination of ingredients or combination of therapeutic groups after you pressed lt lt Ok gt gt the cursor stays in the upper right side of the screen to permit you to enter additional data related to the same field e g other ingredient names to complete the fixed dose combination In these cases press lt Exit gt to leave the upper right side of the screen Select one of the three buttons on the lower right side of the screen that is most appropriate for your task The lt See searching criteria gt button opens a window showing all the criteria you have entered so far The lt lt Execute gt gt button executes the search using the selected searching criteria The lt Exit gt button permits you to quit the search World Health Organization 1998 171 SIAMED User Manual 8 14 6 1 Multiple Search Criteria Inclusion Options As indicated above the first step in establishing a multiple search criteria is to define the scope of the search MULTIPLE SEARCHING CRITERIA All Received applications Rejected applications Pending applications Issued licences Expired licences Cancelled licences Valid licences www eee 0k Figure 8 8 Multiple Searching Criteria screen Below is a description of what those choices are All Includes the entire file i e both applications and licences regard
84. armaceutical sciences and clinical medicine The group or theme specific subgroups could meet once or twice a month to provide advice on specific issues The group could also define a list of basic criteria e g which fixed dose combinations are acceptable a common basic data sheet for drugs of the same profile as in the WHO Model Prescribing Information the British National Formulary the Guide National de Prescription the American Medical Association s World Health Organization 1998 7 SIAMED User Manual Drug Evaluations and other publications labelling criteria a positive list of active principles e g all accepted benzodiazepines systemic corticosteroids etc or acceptable excipients On the basis of these documents the regulatory authority will be able to process registration applications for widely used drugs more expeditiously without submitting them to the TAG effective and meaningful communication with other regulatory authorities Regulatory Authorities with limited resources both human and material may wish to proceed cautiously in licensing drugs containing active ingredients that have not been widely used When facilities or resources do not allow for analysing a large amount of technical documentation or for conducting appropriate studies e g sufficiently large clinical trials and post marketing surveillance ad hoc connections with more advanced regulatory authorities in other countries could be esta
85. armacy reveals the following screen ANU FACTURER Reference document 41 24 91 VALID UNTIL 31 12 1999 APPROVED Responsible professional Ms Nancy Missor lt Item group lt See all notes Professional document nr 8887999 lt Role Responsible for lot release Notes of last inspection lt Information on other company lt Delete 2 Figure 6 2 Screen displayed when the Check Boxes for Manufacturer Distributor Pharmacy or Other are selected Approved Cancelled Term to Comply Reference Document Responsible Professional Professional Document Number Role Item Group Select the appropriate option to indicate the status of the company as Approved Cancelled or given a Term to Comply with inspector s recommendations Enter a reference number i e licence number file number etc that is unique to document related to the above mentioned status and a date as appropriate Press lt F2 gt to reveal the list of responsible professionals and select the contact person who is associated with this activity This is a read only field that displays a unique licence number that identifies the professional Specify what the professional s responsibility or title is for this activity The button reveals an additional screen which allows you to select the item groups to be associated with this activity such as Controlled Substances Injectables Semisolid etc Simply click the lef
86. assword but instead will display an asterisk in place of each character typed Press lt Enter gt after typing in your password PASSWORD CHECKING Password eek AR AAA Exit Figure 2 1 Initial Password screen If the system displays a message that says data not found this indicated that the name entered is not in the system Be sure to type REG If you get a message that displays Wrong password this indicates that you have mistyped your password In either case press the lt Esc gt key and retype your name and password correctly After pressing lt Enter gt the main menu will be displayed After password checking you are shown the MAIN MENU Before discussing the features of the Main Menu please read the sections in Chapter 3 on Mouse amp Keyboard use After reviewing the necessary sections see Chapter 4 for an overview of the features of the Main Menu Then choose Configuration and attune the system to your requirements 2 4 Troubleshooting Steps For any Notes fields displayed if the entry indicates MEMO in upper case letters this means that the system contains information that can be viewed by pressing either lt Ctrl gt lt Page Down gt or double clicking on the memo field To return to the list simply press lt Esc gt You may also continuously press lt Esc gt until you are returned to the main processing duration screen At that point you must select lt Exit gt to return to the main menu World He
87. ate on which the note has been entered the date if any on which the note has been deactivated and the status sign means active note means deactivated note 2 Mark the deactivate check box to prevent the notes from popping up automatically at the time of issuance of the marketing authorization To complete the entry press lt lt Ok gt gt or lt Tab gt as many times as is necessary Summary information on reminders will appears in a Reminders window placed in the lower part of the screen Double click on an item to lt Change gt lt Delete gt or lt Go Back gt on the option window When all information has been entered press lt Exit gt to return to the main application screen 8 1 15 Similar Names Selecting this button makes the system search for drug names starting with the same five first letters If data is found a list is shown with all matches This retrieval option allows you to verify whether the same brand name has already been used by another applicant 8 1 16 Similar Formula Selecting this button causes the system carry out tow simultaneous searches The first reveal search is aimed at retrieving and displaying all drug items having at least one active ingredient Similar Ingredient in common with the item being used You may then select lt Print gt to print the results of the search or after viewing select lt Exit gt When you click lt Exit gt the other search is revealed which displays all
88. ating basic application information and reception date and number We shall call the reception of an application a processing step World Health Organization 1998 13 SIAMED User Manual 2 It is assumed that a coordinating person or group assigns the application or parts of it to those in charge of its assessment These assignments should also be entered into the computer system This distribution of work is a second processing step The third box on the left side of the diagram indicates that the conclusions reached assessing each individual part of the application can also be entered in the computer Each of these assessment operations are a different processing step This set of operations leads to a final decision about an application This decision should be entered into the computer system This is the last step in the processing of applications On the basis of the above schematic presentation a processing step is defined as any event in the processing of an application characterized by a date on which the event starts or is expected to start a technical or operational decision and a date on which such decision is taken The system is designed to permit users to define as many different steps and sub steps as required By making proper use of this feature users will be able to trace applications and know their status at any given moment during processing They will also be able to produce statistics on duration of assessme
89. ay to move within menus and screens is using a mouse The best way to move without the mouse is the lt Tab gt key To move using the mouse it is sufficient to move the pointer to the desired location and then click the left mouse button Unless otherwise specified to click the mouse should be understood as to click the left button of a two button mouse set for right handed use Pressing the lt Tab gt key moves the cursor from field to field to move backward hold down the shift key and press lt Tab gt Gives access to context sensitive help This means that if you press the lt F1 gt key while in the catalogue country option you will see help information regarding that option Gives access to a window displaying a list of selectable items This is active only when the cursor is in a field where the user should enter an item drawn from an existing file e g acompany name an application number for an existing application an abbreviation or code See the subsection Alphabetical search earlier in this section for further information Used to carry out special actions These key functions are available only under special circumstances all indicated by a specific message appearing at the bottom of the screen Used to quit the program Activates the menu bar at the top of the screen Pulls down a calculator Used to select a printer Activates the ASCI chart Activates the Special Characters screen World Health Organizatio
90. b etc 4 information on drug items for which an application and or a licence has been received issued This includes data on application number generic name dosage strength dosage form linkage code with social security or other system prices distributors importers regulatory situation in other countries etc 4 information on status and decisions made at the different steps of the evaluation process Up to twelve different paths of evaluation can be used Drug licence application for A new human drug A new veterinary drug A new biological drug Drug licence renewal for A new human drug A new veterinary drug A new biological drug Minor Variation for A human drug A veterinary drug Major Variation for A human drug A veterinary drug Variation for A biological drug Special Procedures at each step any number of sub steps or responsible officials experts can be indicated to help keep track of the documentation under evaluation 4 information on decisions like rejecting applications recovering rejected applications issuing licences canceling licences and revalidating licences World Health Organization 1998 17 SIAMED User Manual 4 information on variations to valid licences which automatically keeps history of all variations made to a licence 4 information to automatically issue correspondence and certificates based on user defined standard models and keep record of the issued documentation 4
91. be defined by the user and changed any time The option National Version allows you to locate the text you want to change and permits you to edit it regardless of caps status i e whether text is lower or upper case lettering or both and to the position of the word in the string In this way you may replace any text string and produce screens and printouts which are more meaningful to your specific context For the changes to take effect you may have to Exit the system and start up again NATIONAL VERSION All lt Selecting text Text Figure 10 7 National Version selection screen Below is a brief description of the fields used to locate and edit text All Selecting All indicates that you wish to be shown all text messages existing in the system Selecting Text This option allows you to define the specific text string you wish to see Selecting this latter option activates the Text field Text This field is used to enter the words phrases or sentences that you want the system to locate for editing purposes Once selections are made press lt lt Ok gt gt when done and a new screen will appear displaying the text strings you requested or press lt Exit gt to return to the Main Menu 218 World Health Organization 1998 Chapter 10 Maintenance Selecting Text to Translate Select the text to edit by clicking on it or pressing lt Enter gt when the bar is on it Y After the text has been selected yo
92. blished in order to learn from each other s experience and to give as solid a basis as possible to a decision about licensing active ingredients for which there is limited experience of use A simplified approach which regulatory authorities with limited resources may adopt is to establish continuous working relations with two or three highly evolved drug regulatory authorities of countries with a sizeable pharmaceutical market and to exclude from registration all active ingredients not registered in at least one of the reference countries unless exceptional circumstances demonstrate a need In addition the evaluation of manufacturers based abroad for registration purposes is not an easy task for many regulatory authorities Foreign manufacturers premises can be visited only sporadically if at all and such visits may not be enough to express sound judgement nor have any legal significance The most practical approach seems to be to establish connections with the regulatory authorities of the countries where manufacturers are based This would ascertain whether a regulatory authority is in place what task it performs and on the basis of which criteria it grants manufacturing licences and monitors production meant for national use and for export The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce is an administrative tool for the exchange of information among regulatory authorities Its regular an
93. button on the double arrow sign at the left of any item and keeping the button pressed move the mouse up or down The item will change its position in the window This will be reflected in its position on the printout the first item on top of the list will appear as the first column on the left of the printout and so on Select the source of data from the two available options entire registration file includes all data as selected in the previous screen or user defined files files generated by the user as a result of a multiple searching criteria retrieval In the latter case a report could be generated to include for example only licences valid on 31 December 1993 for imported tablets or capsules containing salbutamol as the sole active ingredient or licences approved between 1 January 1993 and 31 December 1993 for veterinary tablets or capsules containing either sulphamethoxazole plus trimethoprim or chloramphenicol involving a manufacturer based in Switzerland and a distributor based in Liechtenstein etc Select destination of output If you chose to output to a file you will be able to pick up the table with a wordprocessor and further edit format it before printing Press lt lt Ok gt gt to print or lt Exit gt to return backwards 8 14 8 Predefined Reports The Predefined Reports option permits you to prepare standard reports grouped or ordered by a number of preset criteria PREDEFINED REPORTS MYYVVvwwuw all Receive
94. cess to that operation or in that specific occasion that operation cannot be carried out e g trying to open the company s file while already working on it trying to use the editing functions when the cursor is not in a text field Some menu entries are faded because the related software needs to be finalized after the first installation EDIT The Edit label is used to access text editing options The options listed under this label are available when entering data in other label screens Chapter 12 describes all the information necessary to properly edit data using the Edit label 28 World Health Organization 1998 Chapter 3 Commands And Functions er 3 2 SIAMED Window Objects This system is operated successfully by activating various window objects The window system is easy to use and instructions about each window are clearly indicated on each screen However if this type of system is new to you the following is a description of the various window objects that are used in this system Standard Form Windows A form window is a screen version of a form containing the information that you need to manage such as data on companies drug applications and inspections There are various type of data fields on a form window In some data fields information is entered by you the user while in others the programme automatically enters data based on information gathered from other data fields PPLICATION Application nr 1 Ad
95. cific information on selected substances particularly excipients and items of natural origin The information stored in this file is meant to be used to guide decision making by all staff in the licensing process UBSTANCE MONOGRAPHS Substance Last update DEXEPHEDRIN HEMIHYDRAT 21 06 1998 Print list Print text Figure 5 19 Substance Monograph screen For example When a technical decision on the admissible levels of an excipient is reached after consulting several sources it may be desirable to record such a conclusion in order to be able to retrieve it and avoid having to redo all the work next time that the same issue arises At the same time this helps to assure consistency of technical decisions among different staff members World Health Organization 1998 69 SIAMED User Manual 5 13 7 Restricted Substances The Restricted Substances feature is meant to prepare a national list of substances whose consumption is banned restricted or not approved in the country of installation RESTRICTED SUBSTANCES Subst Last update PHENDIMETRAZINE 21 66 1998 Print list Print text Figure 5 20 Restricted Substance screen When a substance has been entered here a warning appears automatically to alert the user who is recording information on applications or licences involving such substance This feature is similar to that used for the substances listed in the UN Consolidated List 5 13 8 Generic Names In this sys
96. composition We shall call these fields ingredient name fields In these fields substance names are entered specifying the exact form e g chloroquine phosphate and b a field indicating only the active part of the molecule used to prepare the dosage form e g chloroquine This field will contain chloroquine for all products containing any salt of chloroquine regardless of dosage form or strength We shall call this field generic name field referring to the active component Two drug products may have the same generic name but have different ingredient names and dosage form and strength To use this concept of generic name in the context of computer assisted drug registration we propose the following principles 240 World Health Organization 1998 N Glossary Drug Products with Only One Active Ingredient Drug Products with Two Active Ingredients Drug Products with More Than Two Active Ingredients In this case the generic name is the name of the base that constitutes the active ingredient regardless of the form used in the formulation unless a specific salt has unique therapeutic uses unrelated to those of the base For example The generic name ampicillin applies to all drugs containing either ampicillin trihydrate ampicillin sodium ampicillin hydrochloride etc This simplification applies only to the generic name field of an application It does not limit the possibility for users to record the full name and qu
97. ction by clicking lt Go back gt If you select lt lt Ok gt gt the system will begin initializing company and application licence files You will then be prompted to Press Any Key when completed This will return you to the main Menu If you select lt NO gt you will be returned to the previous screen Contact WHO for additional information on how to implement this process World Health Organization 1998 219 SIAMED User Manual before proceeding 10 1 6 Indexation The indexation option permits you to regenerate all system indexes This feature 1s utilized only when so instructed by a system message that may appear when you cannot locate information that you know is there or when the alphabetical search windows do not seem to work properly INDEX ING This procedure creates necessary index files Select lt gt All files Only the missing ones lt Figure 10 8 Indexation screen You may choose to rebuild all files or only the files that are missing After making your selection press lt lt Ok gt gt The system will begin regenerating the indexes and will prompt you to Press Any Key when completed You Will probably never need to use this option 10 1 7 Year end Optimization This option allows to remove only the useless information that you have deleted during the routine use of the system Optimization may be carried out once a year It is useful to reduce the use of disk space and may help
98. ction 10 1 4 for details Geographical Classification You cannot change the COUNTRY level If you choose any of the three lower levels you will have to enter all the relevant data regarding the country of installation of the system in the appropriate catalogues If for example you select all four levels World Health Organization 1998 215 Currency Printer Additional Fields SIAMED User Manual then you should enter all Regions all Districts and all Towns of your country before entering any domestic company or institution If you do not enter such geographical details you will still be able to use the system with the following limitations you will not be able to programme company inspections on a town or district or region specific way and you will not be able to retrieve information using town district or region as searching criterion You may of course configure the system to use only country and town in which case you do not need to define regions or districts The use of this type of detail is particularly important for those who will use the system to monitor national companies at a high degree of geographical administrative detail Type the name of your national currency as you want it to appear on printouts Note Do not forget that several countries use the same name and or symbol for their currency try to be sure to avoid confusion Press this button to be shown a set of printers Click on the one
99. d Received 12 B2 1998 Applicant Drug name GENERIC Strength Generic name Presentations Dosage form Primary container DOMESTIC Specifications Additional information Manufacturers Ingredients Routes of administration Status in others countries Therapeutic groups Data sheet Drug prices Ok W Distributors Veterinary data Manufacturing process General appearance Lab testing Licensing fees Reminders Similar names Similar formula YYYYYYYY lt lt lt lt lt lt lt lt YYYYYYYY A AAAAANAN Exit gt M Figure 3 2 Sample of a Standard Form Window Pop Up Windows Pop up windows provide you with a list of specific data to be selected For example in the Geographical Codes menu option Licensing menu selecting Country displays the Countries screen The Continent option is a Pop up field If you click the right mouse button or press the lt Enter gt key a list of continents will appear You need only to highlight the desired continent to continue with your data entry In certain occasions some of the listed items are faded Faded items cannot be selected The screen below is an example of a pop up screen World Health Organization 1998 29 SIAMED User Manual COUNTRIES Continent AMERICA EUROPE Country U ASIA AFRICA AUS ASIA Description UNITED STATES OF AMERICA Notes lt Replace Delete gt lt Figure 3 3 Sample of Pop up Window P
100. d additional free notes screen below to enter or edit the data sheet Import from File If this option is selected you will need to specify the drive the path and the file name Keep in mind that this file should be an ASCII or text file Press lt F3 gt to view new listing of files in directories Use copy lt Ctrl gt lt C gt and paste lt Ctrl gt lt V gt to import the data Data Sheet You may use this free text box to enter any detailed information regarding indications contradictions known reactions or any other pertinent information relating to the drug specified in this application Additional Notes This free text field may be used to provide any additional information not listed in the data sheet section The information here commonly refers to any information that the licensing authority may wish to link to an application or licence without having it to appear on licence certificates or data sheets World Health Organization 1998 135 SIAMED User Manual For additional information on using the data sheet see the Appendix 136 World Health Organization 1998 Chapter 8 Drugs WEY 8 1 8 Drug Prices Drug Prices allows you to record several different types of prices for each application if applicable in your national context This permits you to link a variety of prices to each application e g price at importation maximum retail price hospital price maximum wholesale price etc PRICE Description
101. d applications Rejected applications 99 22 98 Pending applications 2 Issued licences Expired licences Cancelled licences Valid licences lt vey AAN HUMAN VETERINARY a By drug name BOTH Figure 8 43 Predefined Reports 184 World Health Organization 1998 Chapter 8 Drugs WEY To generate a predefined report complete the following steps 1 Define the scope of the search using the available options All Received Applications Rejected Applications Pending Applications Issued Licences Expired Licences Canceled Licences and Valid Licences These available options are described in Section 8 14 6 N Select whether Human Veterinary Both drugs are to be included in the printout R Select the printing order criterion from the following list By drug name By ingredient By licence holder applicant By manufacturer By representative By number of active ingredients By dosage form By dispensing modalities By availability restrictions By therapeutic classification by product origin With narcotic ingredients By licence type By generic name by priority By application licence number By distributor a b c d e f g h i j k L m n O p q Figure 8 44 Pre defined Report options 4 Select whether you want to print the entire file or only a specific item For example After selecting drug name as printing order criter
102. d proper utilization may contribute to reduce significantly the risk of being confronted with substandard or spurious drugs simplified and meaningful procedures and documentation analysis may significantly contribute to the efficiency and the reliability of the evaluation of licence applications In all cases where the safety and efficacy profile of the active ingredient strength and dosage form of a drug submitted for registration is well established and the licencing authority is satisfied with the available information showing that this item is relevant to meet recognized therapeutic needs quality becomes the most important concern in evaluating an application If regulatory authorities counting on limited human and material resources limit most of their licensing activities to well established drugs they will be in a better position to concentrate on evaluating those parts of the applications that describe the manufacturing process and its controls the specifications of the proposed product and its regulatory status in other countries and the GMP profile of the manufacturer WHO has developed guidelines on assessing bio equivalence and stability data A simplified model application form based on World Health Organization 1998 Chapter 1 Introduction To SIAMED WEL these considerations is under development adaptation and use of the software The present software package is provided by WHO free of charge and of copyright to all int
103. d separately A situation can therefore arise where a company is permitted to continue with one activity e g wholesale dealing but not permitted to manufacture as a result of an inspection INSPECT I ONS Company code SHAH Description COMPANY NNN Full name Mailing address P 0 BOX 5689 Beautiful Town Plant address GOMPANY IN FULL NNN Ph Yan Yellow Area code 80999 Phone 219949 Contact person Telex Fax 56558 Inspection of Manufacturer APPROUED Figure 7 4 Inspections screen The primary Inspections screen consists of the following data entry fields Company Code A code that is uniquely assigned to each entity associated with the drug regulatory authority Name Gives the name by which the company is referred e g Roche Full Name Displays the full name of the company institution or entity to which the code has been assigned e g Hoffman La Roche Pharmaceuticals Inc 110 World Health Organization 1998 Chapter 7 Inspections IF Mailing Address Pertinent information regarding the location of the company institution such as street number street name city country etc as you would want it to appear on an envelope Plant Address Pertinent data regarding the physical location of the organisation s operating plant Contact Person Name of the person primarily responsible for managing all company activities Phone The organization s telephone number Telex Number utilized to se
104. data as appropriate Users that prefer not to take this option should simply ensure that the Processing Steps catalogue is empty The following is a description of each field displayed on the Processing Steps screen Since the screens are the same for all twelve paths this discussion will apply to all paths Code The unique code for this step To simplify the process you may wish to use sequential numbers which indicate the step level For example if this were the first step in the process you would enter 1 for the code All additional steps would follow as 2 3 4 and so on Description The name or description for the processing step Examples include Reception of application Pricing Committee and QCL Duration days This value represents the number of days that is considered normal for the duration of the step Necessary This field indicates whether this specific step is necessary to permit licence approval Experts This option when selected displays a text box which can be used to enter expert names or sub steps for the purposes of tracking applications that must be sent for expert opinion or assigned to different members of a panel Notes This field displays any additional information relating to the specific processing step Steps Selecting this button results in a window displaying all steps entered for the specific processing path If you wish you may change the order in which each step appears by pressing the left
105. dify data regarding your facility s inspection criteria and programmes and the inspectors who will conduct the inspections Once you begin to conduct actual inspections you will begin to utilize the Inspections component which allows you to enter detailed information about the individual inspections To assure consistency it is important that the definition of codes be completed during your initial setup See Chapter 7 for detailed information on World Health Organization 1998 41 SIAMED User Manual Inspections Step 6 Fees This step creates and or modifies the Fee database which established the standard prices to be charged to applicants for different activities application renewal etc within the drug licensing and marketing authorization process To assure consistency and avoid redundancy it is important that the bulk of this information be entered during your initial setup if available See Chapter 9 for detailed information on Fees Step 7 Applications for Marketing Authorization The step gives access to all operations related to drug licensing including management of abbreviations catalogues company information inspections and fees Once data has been entered using Steps 3 to 6 the preparatory work has been completed Now you can begin to enter information regarding the drugs to be registered See Chapter 8 Drugs for detailed information on Applications for Marketing Authorization Step 8 National Version
106. e PRINT Prints in draft form all information entered regarding an application Data can not be edited in this mode EXIT Returns you to the main menu All of these functions utilize the same screen However in the case of the Copy option the screen shown below appears prior to the standard drug screen Application nr 18 Copy of Figure 8 3 Screen used to initiate the Copy process Application Nr Enter the application number that you will use for your new entry Copy of Enter the application number that you wish copy in order to add a new entry and press lt F2 gt to select the application or licence from the list World Health Organization 1998 123 SIAMED User Manual Below is the standard drug screen which appears when you add a new entry Add add a new entry by copying an existing application licence Copy update Change delete or print an existing application In all cases the mode Add Copy Change Delete or Print is always shown on the upper right hand corner of the screen PPLICATION Application nr 82894 95 Received 63 18 1995 Applicant DRUG COMPANY JJJ Drug name ADANITRA 48 Strength 48 MG TAB Generic name ISOSORBIDE DINITRATE Presentations CARTON BOX WITH 58 TAB BLISTER Dosage form TABL Tablet Primary container BLIS Blister DOMESTIC Specifications Additional information Manufacturers Ingredients Routes of administration Status in others countries Therapeutic groups Dat
107. e 236 Other Countries Status In 132 Password 206 Assignment 207 Change 206 entering 23 Peripherals 236 Personal Identification Number Inspectors 104 Pharmaceutical Newsletter 220 Pop up Window 236 Pop Up Windows 29 defined 29 Post Marketing Surveillance 150 Pre Defined Reports 236 Preferred National Name 62 63 236 Changing 67 Presentations 237 World Health Organization 1998 Primary Container 237 Primary Containers 48 52 PRINT Application 120 Printer Configuration 211 Priority Catalogue 49 Priority levels Catalogue 71 Processing Steps 12 59 237 Catalogue 48 Configuration 213 Recording by Application 140 Recording By Step 142 Product Information Application 133 Product Licence 237 Professionals 49 Professions 49 78 Push Buttons 30 237 lt lt Ok gt gt 30 lt Exit gt 31 lt Replace Delete gt 30 defined 30 Quit 206 Radio Buttons 32 237 RAM iii 237 Read only 237 Reagents 237 Reference Substances 237 Region 50 REGX 21 Rejection Cause Application 143 Rejection Causes 58 Related Companies 88 Reminders 138 Restore 216 Restricted Substances 69 Result Inspection 110 Retrieval Catalogues 83 Company 92 description 45 Output Destination 177 Predefined Reports 179 Predefined Statistics 181 Price Related Retrieval 182 Query 184 Report Generator 178 step 42 Revalidation licence
108. e because it can be selected only once Applicable operators are EQUAL GREATER THAN SMALLER THAN NOT EQUAL RANGE See General Rule for Dates Permits you to search by number of active ingredients Follows the general rule Applicable operators are EQUAL GREATER THAN SMALLER THAN NOT EQUAL RANGE Permits you to limit search to items containing internationally controlled substances It does not follow the general rule because it can be selected only once If it is not selected both items containing and not containing internationally controlled substances are retrieved Permits you to retrieve selectively items containing substances listed in tables 1 2 or 3 of the narcotics convention or in tables 1 2 3 or 4 of the psychotropics convention Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to retrieve selectively multiple formula preparations It does not follow the general rule because it can be selected only once If it is not selected both standard and multiple formula preparations are retrieved World Health Organization 1998 Chapter 8 Drugs WEE Manufacturer Permits you to search by manufacturer Follows the general rule Applicable operators are EQUAL and NOT EQUAL Manufacturer s Permits you to search by manufacturer s country of origin Follows Country of Origin the general rule Applicable operators are EQUAL and NOT EQUAL All manufacturers matching the country criterion
109. e holder drug name and strength is shown together with a computer generated renewal application number This number is a unique identifier for the renewal application It serves as a reference tool via which users can record information related to the processing steps as well as the final decision Enter the date on which the renewal application was received Press lt lt Ok gt gt to record the entry The system prompts you to select whether or not you wish to have a letter printed Section 12 10 Press lt Exit gt to return to the previous screen For Processing Steps see Section 8 2 This option is virtually identical to the processing steps described in section 8 2 Please refer to Section 8 2 for details on using this feature World Health Organization 1998 157 SIAMED User Manual 8 9 Record Revalidation This feature is used to record the decision to extend the validity of licence or to revalidate a suspended licence LICENCE REVALIDATION Renewal application nr 93 Received 24 66 1998 Licence 16 1996 Licensed 28 B1 1996 Licence Holder COMPANY GGG Drug name A D C FLOR Strength Generic name MULTIUITAMIN PREPARATION Expiry date 27 1 20 81 Similar formula Renewal date 24 8671998 Expiry date 7 Licensing fees lt Reject application gt lt Exit Figure 8 28 Record Revalidation Renewal screen To record revalidation complete the following steps S Press lt F2 gt or click th
110. e item being entered Letter This button allows you to prepare and print a letter to advise the applicant or another addressee about the decisions taken at this step See Section 12 10 for details on how to prepare a letter 144 World Health Organization 1998 Chapter 8 Drugs Notes This text field can be used to provide any additional information relative to the decision made in the step 8 2 2 Recording Processing Steps By Step This feature allows you to assign any number of pending applications to a given step This is particularly useful when preparing for committee meetings where several applications are reviewed on the same date When this option is selected a search screen will be displayed listing all the processing steps defined in the processing steps catalogue Select the desired step and a new screen will be displayed see below PROCESSING STEPS Step Ministry of Agriculture Clearen Type NEW DRUG APPLICATIONS PROCESS ING STEPS UETERINARY Date in 31 85 1997 Application nr Description lt Pending applications gt Results lt Print gt Exit Figure 8 17 Application Processing Steps by Step The screen displays the Step and the processing step type The following is a description of all additional data fields displayed on this screen Date in This field requires that you enter a date corresponding to a time period that an application has entered a particular processing step If no applicat
111. e of several signs such as plus sign indicates that payment has been made minus sign indicates that payment is still pending A letter A indicates that this fee was cancelled If you select an item with any of the signs indicated under Status your actions will be limited as follows plus sign you will only be permitted to cancel the fee or print a letter related to the application or licence to which the fee refers minus sign a window will be revealed where you can record information on payment A you can make no changes to this item You can however utilize the lt lt Add gt gt key to add a new fee or lt Exit gt to return to the main menu 9 2 Payments by Licence Holder This fee option permits you to record information about fee payments by licence holder It is intended for managing any type of fee such as an application fee QC laboratory testing fee licence fee retention fee certificate fee etc In order to function this feature requires that fees and their date due have been previously recorded FEES Applicant DIMA COMPANY CCC Payment due 82 15797 Select all Deselect all Payment received Ok Receipt nr Exit Figure 9 2 Payment of Fees by Licence Holder World Health Organization 1998 201 Applicant Payment Due date Select All Deselect All Payment Received Receipt Nr SIAMED User Manual Enter the name of the ap
112. e right mouse button to select from a list of pending renewal applications the one you want to work on Summary information such as date received licence licensed licence holder drug name strength generic name and expiry date are revealed S Select lt Similar formula gt if you wish to check which other products share at least one active ingredient with the one you are entering S Select lt Licensing fees gt to check or add the fees associated with this licence S Enter the revalidation date and the new expiry date S Press lt lt Ok gt gt to record the decision The system will then prompt you to indicate if you wish to print the letter of revalidation Section 12 10 select lt lt Yes gt gt or lt No gt From this screen you may also reject the application i e no extension of validity granted Selecting the lt Reject Application gt button displays an additional screen in which you may choose a rejection cause linked to the Rejection Cause database and the rejection date Select lt Exit gt to return to the main menu 158 World Health Organization 1998 Chapter 8 Drugs WEL 8 10 Variation Application Variations to licences differ from changes to applications in that all variations are recorded to specific file where the history of all variations are kept and from where it can be retrieved LICENCE VARIATION APPLICATIONS Licence _ Licensed 7 Licence Holder Drug name Strength Variation application nr
113. e system will interpret licence holder if you restrict the search to licences It will interpret applicant in all other cases Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by representative Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by drug name or part of it Follows the general rule Applicable operators are EQUAL NOT EQUAL and CONTAINS Use Contains to search by part of the drug name Example To list all items where the drug name contains the string DOLDOL select drug name from the fields list then the operator CONTAINS then enter the string DOLDOL and press lt lt Ok gt gt and lt lt Execute gt gt The retrieved items will include DOLDOL DOLDOL PAEDIATRIC DOLDOL FORTE EXTRA STRENGTH DOLDOL NEO DOLDOL Permits you to search by strength or part of the strength definition string Follows the general rule Applicable operators are EQUAL NOT EQUAL and CONTAINS Use Contains to search by part of the strength definition string Example To list all items where the strength definition string contains the wording 25 mg select strength from the fields list then the operator Contains then enter the string 25 mg and press lt lt Ok gt gt and lt lt Execute gt gt Obviously the search is more meaningful when the strength field is used in conjunction with other fields Pe
114. ed Hardware 486 or Pentium personal computer 4 MB of RAM DOS 8 MB required if changes to the source code are to be made 32 MB if using Windows 95 or Windows NT 100 MB Hard Disk space Colour monitor Mouse Network Support LANtastic 6 0 Windows NT 4 0 Novell DOS 7 Novell NetWare 3 11 Memory requirements are much higher if using a Windows based operating system For specific instructions and assistance when performing a network installation contact the World Health Organization World Health Organization 1998 jii Chapter 1 Introduction To SIAMED WEY 1 INTRODUCTION TO SIAMED 1 1 Background The recommendations of the Conference of Experts on the Rational Use of Drugs held in Nairobi Kenya in November 1985 are the basis of the WHO Revised Drug Strategy as endorsed by different subsequent resolutions of the World Health Assembly Within the context of these resolutions WHO is requested to prepare guidelines for a simple drug regulatory authority and to support governments in setting up or strengthening drug regulatory authorities In response to this WHO has developed Guiding Principles for Small Drug Regulatory Authorities which have been endorsed by the WHO Expert Committees on Specifications for Pharmaceutical Preparations and on the Use of Essential Drugs In addition WHO has updated the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce To
115. ed for describing data relating to equipment reagents reference materials type purpose of analysis procedures tests and standard operating procedures Check Boxes Screen objects used for data that can have only two values like YES NO or very specific choices Unlike radio buttons many boxes can be checked at the same time Classification The structure used to designate where a drug should be classified The designations include class subclass group and sub group Company Files Files that contain information on the companies that participate in the drug registration programme Configuration A configuration of a computer is used to set the parameters in which the software will operate and establishes the default settings for the system Currency A medium of fiscal exchange including coins bank notes government notes etc DMP Drug Management Policies A division of the World Health Organization that is primarily responsible for the creation and development of the Quality Control Laboratory prototype system World Health Organization 1998 239 SIAMED User Manual Dispensing Categories Used to indicate how drugs are dispensed to consumers i e over the counter prescription only medication etc Drop Down List See pop up window Equipment Instruments used in the laboratory Error Message A notice that the computer displays on screen to let the user know that something is wrong with an action th
116. ed on the initial criteria entered and allows you to view any detailed information available 192 World Health Organization 1998 Chapter 8 Drugs WEE For any Notes fields displayed if the entry indicates MEMO in upper case letters this means that the system contains information that can be viewed by pressing either lt Ctrl gt lt Page Down gt or double clicking on the memo field To return to the list simply press lt Esc gt You may also continuously press lt Esc gt until you are returned to the main processing duration screen At that point you must select lt Exit gt to return to the main menu Below is a sample of the report using From Reception to Issue of Licence criteria Application nr Description Duration days 47 1997 ETHAMBUTOL 26 1997 UITADYN 49 1997 ECONAZOL 58 1 1997 BESCORAZE 281 1996 LAXADYL 18 279 1996 LAXADYL 5 182 1996 LINCOPH 588P 24871996 E VITE 190 249 1996 E VITE FORT 26 1996 PANTHON 160 1996 ESCONAD Total 1 678 Average days 276 ENTER OR DOUBLE CLICK LEFT MOUSE TO SELECT Figure 8 53 Processing Duration output screen World Health Organization 1998 193 SIAMED User Manual 8 14 16 Ingredient Frequency This option permits you to retrieve information on the frequency of ingredients in drug applications licences INGREDIENT FREQUENCY pe Search all gt Active Pending applications gt Excipients gt Rejected applications gt Other
117. edure can easily be located by looking up the key word in the index Concepts unique to SIAMED and instructions on data interpretation are presented throughout the manual and can also be found in the Glossary Important SIAMED features are covered in summary sections 1 key SIAMED concepts and design in Chapter 1 2 command keys in Chapter 3 3 a step by step quick start tutorial in Chapter 4 In each chapter on SIAMED options all data entry information is described in detail Throughout the manual arrow brackets are used to indicate computer keystrokes For example lt Enter gt means you should press the Return or lt Enter gt key on your keyboard lt PgDn gt refers to the Page Down key The key names that are used correspond to those printed on your keyboard To activate some SIAMED functions or options you may if using a mouse click on the function highlight the function and press lt Enter gt or type the letter that corresponds to the desired function Since any one of these actions can be used to access the function the term select will be used throughout the manual to indicate that any one of the above actions may be performed Whenever possible the manual has used SIAMED notations so that what you see in the manual corresponds to what you see on your screen See Chapter 3 for more details on key commands World Health Organization 1998 i SAY System Requirements IE SYSTEM REQUIREMENTS Recommend
118. eived Applications Rejected Applications Pending Applications Issued Licences Expired Licences Canceled Licences and Valid Licences These available options are described in Section 8 14 6 2 Select between applicant licence holders manufacturers and distributors as appropriate 3 Select one or more searching criteria If you select more than one the search will yield all items that match either one of the searching criteria indicated Example If you choose as a searching criteria the product name DRUGGOLINE and generic name PARACETAMOL all items with generic name PARACETAMOL will be included even if their name is not DRUGGOLINE In addition all items named DRUGGOLINE will be included even if their generic name is not PARACETAMOL 4 Press lt lt Ok gt gt to get the list of companies matching the searching criteria or lt Exit gt to return to the main menu World Health Organization 1998 189 SIAMED User Manual 8 14 13 Correspondence This option permits you to retrieve all the correspondence issued for a given application or licence CORRESPONDENCE Application nr 8111 95 Received 84 04 1995 Licence 294 95 Licensed 21 12 1995 Expiry date 28 12 2888 Applicant COMPANY GGG Drug name A D C BAL Strength g Generic name MULTIVITAMIN PREPARATION Status VALID Expiry date 20 12 2008 Figure 8 50 Correspondence format screen To retrieve correspondence
119. elds are used to establish the range of dates to be included in the search User This field is used to limit the search to one particular user If you leave this option blank the search will include all users Users Currently Selecting these radio buttons help to further establish the search Logged In Users criteria for generating a user log The options allow you to display Currently data regarding users currently logged in users currently logged off Logged Off Or or both which will cause the system to include all users If no radio button is selected the option of including both logged in and logged off users is used as the system default Both Logged in and Logged Off Once all criteria have been established select where the output should go and press lt lt Ok gt gt to complete the search Pressing lt Delete gt will clear the user log If both logged in and logged off users are selected delete will end your current sessions as well Press lt Exit gt to return to the Main Menu 214 World Health Organization 1998 Chapter 10 Maintenance 10 1 3 Configuration This option allows you to configure the system to better suit user requirements Use the main menu option Maintenance select Maintenance Tools followed by Configuration to access the Configuration of Drug Licensing Module screen This screen shows the preset configuration options The following information may be edited as it applies to your SIAM
120. ences Search is limited to licences expired within a date range that you are prompted to specify If you do not specify an end date you run the risk of getting meaningless results because the system includes the oldest expired licences and or those that will be expired on 31 December 9999 as applicable Cancelled Search is limited to licences cancelled within a date range that you licences are prompted to specify If you do not specify an end date the system includes the oldest cancelled licences and or the most recently cancelled as appropriate Valid Licences Search is limited to applications valid on a specific date that you are prompted to specify If you leave the date field blank the system will give meaningless results Licences cannot be valid within a date range IMPORTANT When range is selected two dates should be entered in all other cases only one If you enter no date the system uses 11 November 1111 to carry out the search with EQUAL GREATER THAN SMALLER THAN NOT EQUAL It uses 11 November 1111 as the from date and 31 December 9999 as the to date when RANGE is selected This in many cases would result in meaningless data if any being retrieved Fields You Can Use To Search The fields that appear in the left side of the window are discussed here below In all cases where company names or data of a catalogue are involved e g dosage form primary container etc a list is available as usual by clicking
121. ences of the old entry with the new one Example You realize that your catalogue has a double abbreviation for the same item say US and USA for United States of America You decide you want to use only USA and want to clean your data assuring that only USA is present You do the following access the country catalogue and select US press lt Replace Delete gt enter USA as new entry and press Replace then press Delete to remove from the catalogue the entry US Now all your data will contain USA where there was US before lt Exit gt This button is used to leave the screen and return to the main menu When the Exit button is pressed any information shown on the screen is ignored This means that you can use the Exit button as an escape button when you do not want to write to disk an entry you are creating or the changes you made to an existing entry i e the existing entry remains recorded as it was before Push buttons that have double delimiters like lt lt Ok gt gt can be activated regardless of the position of the cursor in the screen by pressing lt Ctrl gt lt Enter gt keys Check Box Check boxes are screen objects used for data that can have only two values like YES NO or very specific choices Leaving the check box untouched means you do not wish to select or choose the option Checking the box means YES you do mean to select that specific option To check the box click on it with the mouse or press lt Enter
122. ent under different names Licensing Maintenance WHO Edit National a Catalogues Geographical codes b Companies Primary containers c Retrieval gt Dosage forms Routes of administration d Inspections Types of licence e Retrieval gt Availability restrictions Dispensing categories f Drugs gt h Rejection Gancellation causes g Retrieval gt i Processing steps fication a Synonyms s dictionary c Sources ities roles e Change preferred natl name formats f Substance monographs g Restricted substances h Generic names Figure 5 13 Substance Names Dictionary menu options The first three options of the Substance Names Dictionary submenu permit you to see the list of synonyms ATC codes and the literature sources of the listed substance names synonyms respectively The Update option permits you to add entries to the Substance Names Dictionary The Change Preferred National Name Substance Monographs Restricted Substances and Generic Names options are described in further detail below World Health Organization 1998 63 SIAMED User Manual 5 13 1 Synonyms Provides a listing of substances cross referenced with the possible synonyms associated with each item and their sources Select a substance name and press lt Enter gt to display a listing of possible synonyms associated with the selected name SUBSTANCE NAME DICTIONARY Type characters Locate matching data gUp PgDn t 4
123. entered by a user having the appropriate type of password The maximum length of the registration number is twenty 20 digits characters or a mixture of the two To make it fit in screens the term most commonly used in this system is licence Company This refers to an authorization given to company to exert a given Operating activity falling under the control of the drug regulatory authority It Authorization is also known as an operating licence or permit If a company carries out more than one activity it may have a separate operating licence for each individual activity The maximum length of the operating licence number is ten 10 digits characters or a mixture of the two 10 World Health Organization 1998 Chapter 1 Introduction To SIAMED WEY Other Types of Company related Authorization 1 3 2 Application In several countries the regulatory authority needs to store information linking companies with other institutions e g Ministry of Industry Ministry of Finance Customs In these situations this form of authorization is used These pieces of information are called in several different ways e g Ministry of Industry Number Customs Number etc when they are used The present system permits you to store up to five 5 different items of this type with user defined field labels In this system the term application is used in the following different situations Application for Marketing Authorization
124. er accepted for carrying out business in your country Term To Comply This result indicates that following the results of an inspection a delay has been given to comply with recommendations Once you have selected the criteria you want to apply select where the output should go and press lt lt Ok gt gt and the report will be generated 7 4 3 Inspections by Inspector This retrieval option permits you to retrieve information on which inspectors performed which inspections INSPECTIONS BY INSPECTOR Country AFG AFGHANISTAN Toun Inspection carried out by 1 A Dr John Smith Activity From 83 23 97 To finother activity Distributor Ce Screen Hospital Pharmacy lt gt Printer Importer Licence Holder only Ok lt Exit Figure 7 9 Inspections by Inspectors screen Below is a description of the fields associated with this screen Country Region District Town Inspection Carried Out By Activity From To 116 Specify the geographical area to be included in the retrieval process Gives the code assigned to the Inspector who conducted the inspection Specify what activity area should be included i e manufacturer distribution etc Specify the date range in which the inspections were performed World Health Organization 1998 Chapter 7 Inspections ILE Once you have selected the criteria you want to apply select where the output should go and press lt lt Ok
125. er window to be shown more detailed information LICENCE STATUS Licence 294 95 Licensed 21 12 1995 Applicant COMPANY GGG Drug name A D C BAL Strength Generic name MULTIUITAMIN PREPARATION Application nr Status UARIATION 78 10 03 1996 INCOMPLETE PROCESSING Figure 8 38 Retrieval by Licence Status 8 14 6 Multiple Searching Criteria This is a powerful information retrieval option that permits you to search data using a variable number of searching criteria MULTIPLE SEARCHING CRITERIA Ce All Received applications Rejected applications Pending applications r gt Issued licences Expired licences Cancelled licences gt Valid licences Figure 8 39 Multiple Search Criteria screen To generate a report using multiple searching criteria complete the following steps 1 Define the scope of the search using the available options All Received Applications Rejected Applications Pending Applications Issued Licences Expired Licences Canceled Licences and Valid Licences 2 Press lt lt Ok gt gt to be shown the second searching criteria window or lt Exit gt to return to the menu 170 World Health Organization 1998 Chapter 8 Drugs WEY In the second window the following steps must be taken 1 Select the search field double clicking on it This will activate the box in the upper right portion of your screen This upper right side when active consists o
126. er Manual 1 3 Key Concepts In the design of computer applications a number of assumptions and choices need to be made with regard to terminology and format of information The following definitions are those that have been used in this model system and this manual The choice of terms is to a large extent arbitrary and should not be seen as a recommendation to adopt them These concepts are presented only for the sake of clarity and with the understanding that terms routinely used by national regulatory authorities have considerably different meanings in different parts of the world 1 3 1 Authorization In this system the term authorization is used in the following different situations Marketing This refers to an authorization for a product to be marketed In Authorization some countries it is called product licence Each marketing authorization is characterized by a number called registration number licence number or marketing authorization number It is also characterized by the following elements a company responsible before the authorities for all the implications that can arise from product marketing marketing authorization holder or licence holder a product name be it a generic name or a trade mark a dosage form a strength and a primary container A change in one of these elements implies a different registration number In this system the registration number can be automatically generated by the computer or can be
127. erested drug regulatory authorities Subject to availability of funds installation of the package and training in its use as well as its adaptation when necessary to meet national requirements will be undertaken by WHO National authorities will also receive a separate set of instructions giving full details of the software structure in order to enable local professionals familiar with database management systems to correct any inaccuracies that may become evident after several months of use or to introduce additional functions or options Whenever feasible a short period of training for local programmers will be organized to make the manipulation of the software easier WHO is ready in all circumstances to provide further assistance as well as updated versions of the software as need arises Commercially available database management systems necessary to introduce changes into or to run the un compiled version of the WHO model software cost less than US 500 The computer equipment of the suggested configuration is generally available for less than US 3 000 costs vary considerably in different parts of the world Consumables and running costs paper diskettes ribbons power etc depend on use and can be estimated at no more than US 1 500 per year The cost of professional programmer assistance for local maintenance or adaptation of software varies considerably in different parts of the world In fact in some countries the Ministry of Health
128. ery Low Risk Low Risk Moderate Risk High Risk and a blank field to indicate no risk Use the Notes on risk field to provide any details on the risks associated with conduction the inspection For example if the inspection includes a high risk of exposure to a carcinogen select the High Risk level and enter any notes and precautions necessary in the text box to the right This button provides access to a text window that displays all related inspection information pertaining to the selected company All notes are stored in the same text file so that it is easy to make reference to results of previous inspections and to notes written while entering company data in the company file This text box may be used to type in any free notes to give more details of the results of the inspection Select lt lt Ok gt gt to save your data and return to the previous Inspections screen lt Exit gt will return you to the Inspections screen without saving any changes World Health Organization 1998 113 SIAMED User Manual 7 4 RETRIEVAL Inspections The Retrieval feature under the Inspections menu option gives access to submenu entries permitting you to produce a list of inspectors retrieve inspection information and to produce a list of companies that have never been inspected Licensing Maintenance WHO Edit National a Catalogues gt b Companies c Retrieval d Inspections gt e Retrieval a Inspectors b Inspec
129. espondence Formats 500 bes aan 76 5 19 Professins 9c 4 00400 asus bit nantaise te ie a a eo a aw tit 78 520 Tom Groups anne dede en Cae ads oleh eee 79 5 21 Professionals sr an A a TEES tenseur 80 5 23 Type of Pace a a Suk eke a ne Swe eed eo een 82 5 24 Belnieval Calalo pues Sebas a a aise 83 6 COMPANIES 4 42 4424 a a CES 87 L COMPANES SH sexe een A las de rare 87 6 2 Beirieval Companies semestre po has dde tea ee 92 Ta INSPECTIONS ii a nina desert 103 Ll JIISPEGIO S 2ecay enaceuand coder adepte aan rante 103 7 2 Inspection Programmes are era la 106 Tede ANSPOCHOUS Le ee dra ee a iris ii 108 7 4 RETRIEVAL Inspections vaceosicisiscin caras a aa 112 A NI 119 8 1 Entry Update Applications ss 00000 sa san 119 8 2 Processing Steps casses super ened bees u a ea EES 139 8 3 Rejecting Applications wsscksesuns ech ech achte 143 S4 Recover Rejected aan essen 146 8 5 Issue Marketing Authorization 147 8 6 Post marketing Follow up 149 8 7 Cancellation Le Seat 000 een era 151 8 8 Revalidation Applications 4eme sjssssieameessestide a a aa 154 8 9 Record Revalidation 242 2 204 05224 voii rr lt aa 155 8 10 Variation Application 156 8 11 Record Vanalion 2icecss eadereves bernardo 158 8 12 Change Applicant Holder search aan os 159 8 13 Deleting lines nl lle dr 160 8 14 RETRIEVAL Drugs lt suisses is ra 161 A a
130. ess lt lt Ok gt gt or lt Exit gt to return to the main menu If lt lt Ok gt gt is selected a second screen is revealed that provides a summary of the result of the search 5 To see list of substances meeting the searching criteria press the lt List substances gt button You may then select a substance to see a list of applications licences that contain it At this stage you may press lt Enter gt on a specific application or licence to view detailed information Press lt Esc gt or lt Exit gt to return to the previous screen 6 To print the list press lt Print gt or lt Exit gt to return to the previous screen World Health Organization 1998 191 SIAMED User Manual 8 14 15 Processing Duration This option permits you to retrieve information on drug licence applications based on their processing duration PROCESSING DURATION Search all e New drug product applications gt Revalidation applications gt Variation applications gt From reception to issue of licence Type NEW DRUG APPLICATIONS PROCESSING STEPS HUMAN Initial step Pricing Committee Date started 4 23 97 Final step Decision date 7 Ok Figure 8 52 Retrieval of Processing Duration To generate this report complete the following steps 1 A PR pP a Select whether the search should include new drug product applications revalidation applications variation application substances or all app
131. etrieval h Fees i Retrieval a Fees due b By type of fee c By licence holder Figure 9 4 Retrieval Fees menu screen 9 4 1 Fees Due This feature allows you to display and print a list of fees due before a given date The printout can be used as an invoice or aide memoire reminder to be sent to companies before payments are due FEES DUE Applicant DIMA COMPANY CCC Payment due 87 17798 _ Screen lt gt Printer 1 On separate pages Exit Figure 9 5 Fees Due screen Applicant Use lt F2 gt to select the company for which the listing should be done If you choose to leave this field blank the computer will list all fees due for all companies by company name Payment Due Enter the date on which the payment is due Once data is entered select where the output should go If you are printing information on multiple companies you can select the check box On Separate Paper to specify that the fees of each company should be listed on separate pages Press lt lt Ok gt gt to execute or lt Exit gt to return to the main menu World Health Organization 1998 203 SIAMED User Manual 9 4 2 By Type of Fee This option permits you to print a list of all fees grouped by type of fee LICENCE FEES BY FEE TYPE Fee type APF Application Fee Payment due Screen Fron 88 23 98 gt Printer To Figure 9 6 Sample of Licence Fees by Fee Type screen Fee Type Specify the fee type or
132. ey are trying to perform Exchange Rate The rate at which currency of one country is exchanged for the currency of another country Fields Refer to the rectangular boxes on the screen where information is entered by the user or displays data that the user had entered previously In some cases the data that appears in a field may have been generated automatically by the QCL system Foremost Window The current active window displayed on screen If working with multiple windows the window on top is the foremost window Form Window A screen version of an actual form containing the information that you need to manage such as data on companies items to be tested and samples Formulary National A list of approved and recommended drugs compiled by an individual practitioner or a group of medical and scientific professionals for the purpose of a specific medical practice or supply system Frozen Refers to a situation where the system does not seem to be working i e you type or click the mouse but nothing happens Often occurs when working with multiple windows To resolve this situation see Working with Multiple Windows in chapter 3 Generic Name Generic Names are also called common names for pharmaceutical substances or when available International Non proprietary Name INN or modified INNs In a computerized system information on substance names needs to be entered in two separate database fields a fields describing the
133. f manufacture import export distribution including promotion prescription and dispensation and in some cases pricing This central body should also have access to an independent quality control laboratory either in the country or by arrangement with 6 World Health Organization 1998 Chapter 1 Introduction To SIAMED WEL a foreign partner availability of adequate resources for the efficient functioning of the drug regulatory authority In several countries the imposition of application licence and annual retention fees provides a practical way to help meet the running costs of the drug regulatory authority of inspections and other regulation enforcement activities and to filter out superfluous and irrelevant applications If a decision is made in favour of establishing fees consideration should be given to the following points fees should be high enough to contribute significantly to the efficient and effective functioning of the national drug regulatory system i e registration inspectorate and quality control in relation to its market size appropriate mechanisms need to exist within the government administration to ensure that funds collected as fees are made available to the drug regulatory authority for use in ensuring that pharmaceuticals on the market are acceptable in terms of quality safety efficacy and are rationally used Y provisions for fee reduction or exemption should be made in order to ensure t
134. f a pop up box that permits you to select a relational operator The relational operators are equal greater than smaller than not equal range and contains This latter operator is to be used for text search e g to search for a specific word or group of words within a given field or text For example operators will be active or not depending on the type of field you want to use as a searching criterion e g if you want to search on the basis of dosage form you will be able to select only equal or not equal Choose a desired search field from the list on the left side of the screen The fields are not in alphabetical order so you can view the list by scrolling typing the first letter in the name of the field or clicking on the desired field A description of the fields by which you can search is provided below 8 14 6 1 Fields You Can Use to Search Below the pop up box enter the data that the system will use to carry out the search Example If you want to search all items available as tablet you will select Dosage form from the list that appears on the left side of the screen then you will select equal from the operators pop up window then you will enter tablet in the field below the operator box either directly or drawing it from a list as usual Press lt lt Ok gt gt to save your completed entry After you have done that in most cases the cursor goes back to the upper left side of the screen to select additional se
135. f and back on again before continuing the installation process so that your changes will be effective Repeat this for all workstations if you are installing on a network 2 1 Installation Procedures To install or update the system 1 If it is a first installation create a directory called SIAMED Ze Copy disks 1 and 2 to the directory SIAMED 3 Go to the directory to which you copied the diskettes type INSTALL and press lt Enter gt 4 Choose the appropriate option from the installation menu Disregard any File not found messages that may appear on the screen during installation The system will expand the necessary program files 5 From the directory which contains the file REGX EXE type REGX and press lt Enter gt Use REG as both name and password to start using the system Wait about five minutes until the system completes the creation of its indexes World Health Organization 1998 21 SIAMED User Manual 2 2 Updating Procedures To update the system 1 2 Make a back up copy of the existing data Make sure that you begin at the DOS prompt C gt on the hard drive of your computer For simplicity the following discussion assumes that the C drive is being used and that the system was installed in a directory called SIAMED At C gt type CD SIAMED and press lt Enter gt The computer will give you a prompt C SIAMED Place the SIAMED Disk 1 into your floppy drive Copy disks 1 and 2 to the
136. f terms used in data entry to get meaningful retrieval 8 1 12 General Appearance Laboratory Testing This option permits you to enter critical information if any regarding the general appearance of the drug its organoleptic characteristics and analytical methods for quality control purposes Information is entered as free text Retrieval of general appearance lab testing information is performed by searching words in the entire text Thus it is important to assure consistency of terms used in data entry to get meaningful retrieval World Health Organization 1998 139 SIAMED User Manual 8 1 13 Licensing Fees This option allows you to list the various licensing fees that are related to the specific application An unlimited number of fees can be entered for each application APP 1 1 CA 1 IN FEES Code APF Application Fee lt Enlarge text gt Amount 300 00 NEW Exchange rate 1 8668 Exempt Description Exempt Application Fee 300 00 NEW NO Figure 8 13 Application Licence Fees screen Code The unique code for the fees This option is linked to the Fees catalogue therefor pressing lt F2 gt will reveal all options listed in this catalogue and you can select the desired fee Once selected information on the amount of the fee and the exchange rate will be displayed Notes This is a free text field which allows you to enter any additional information relating to the selected fee for this par
137. g information Regulation of biological products United Nations consolidated list Figure 11 1 Who Main menu 11 1 1 Print WHO Scheme s Certificate The first section is Print WHO Scheme s Certificate This option enables you to print a product certificate for licenced products containing all the information required by the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce The certificate provides detailed information regarding the drug s name application number strength presentations specifications type of licence drug restrictions shelf life etc World Health Organization 1998 225 SIAMED User Manual CERTIFICATE OF PHARMACEUTICAL PRODUCT Drug name Application nr Priority Applicant Representative Strength Generic name Presentations Dosage form Primary container Specifications Type of licence Restrictions Dispensing categ Shelf life months Received National formulary Location of file Received 7 GENERIC DOMESTIC a MANUFACTURE Storage cond Additional information Ok lt Exit Figure 11 2 Sample of Scheme s Certificate 226 World Health Organization 1998 Chapter 11 WHO National 52 11 1 2 Accessing WHO Documents The second section of the WHO menu provides you with several options for accessing select WHO documents This information can be read on screen or printed You can
138. ganization 1998 Chapter 8 Drugs 8 2 1 Recording Processing Steps by Application PROCESSING STEPS Application nr 8289A 95 Received 83 18 1995 Applicant DRUG COMPANY JJJ Drug name ADANITRA 48 Strength 46 MG TAB Generic name Reception of applications YES Quality assessment NO 63 18 1995 Pricing Committee N0 7 7 Q C L NO Pharmacy amp Therapeutics Commit NO 7 Figure 8 15 Processing Steps by Application The following is a discussion of all fields found in the Processing Steps screen Application Nr The unique number that identifies the specific application being reviewed Type in the application number and press lt Enter gt You can also press lt F2 gt or click the right mouse button to reveal a list of choices The list will show only applications that have not been rejected or approved Thus if you do not find the application you are looking for it means that this has been rejected or it has become a marketing authorization When you have selected the application number summary information such as applicant drug name strength generic name and processing steps are displayed After a processing procedure is assigned all processing steps appear in the window below At this point you may click on any step to enter detailed information relating to the step A new screen will appear World Health Organization 1998 143 SIAMED User Manual PROCESSING STEPS
139. ganization 1998 175 SIAMED User Manual Domestic Imported Both Human Veterinary Reception Date Cancellation Date Expiry Date Renewal Date Number of Active Ingredients Narcotic Non Narcotic Classification N1 N3 P1 P4 Multiple Formula Preparation 176 Permits you to limit the search to either option It does not follow the general rule because it can be selected only once If it is not selected items are retrieved regardless of their origin Permits you to limit the search to either option It does not follow the general rule because it can be selected only once If it is not selected both human and veterinary items are retrieved Permits you to search by application reception date It does not follow the general rule because it can be selected only once Applicable operators are EQUAL GREATER THAN SMALLER THAN NOT EQUAL RANGE See General Rule for Dates Permits you to search by licence cancellation date It does not follow the general rule because it can be selected only once Applicable operators are EQUAL GREATER THAN SMALLER THAN NOT EQUAL RANGE See General Rule for Dates Permits you to search by licence expiry date It does not follow the general rule because it can be selected only once Applicable operators are EQUAL GREATER THAN SMALLER THAN NOT EQUAL RANGE See General Rule for Dates Permits you to search by licence renewal date It does not follow the general rul
140. gt gt and the report will be generated 7 4 4 Inspection Outcome This retrieval option permits you to retrieve information on the outcome of various inspections It also allows you to limit the search to a given geographical area INSPECTION OUTCOME Country NEW DEMOLAND Town TWN2 Town 2 Activity an o Another activity Distributor Screen Hospital Pharmacy gt Printer Importer Licence Holder only 0k lt Exit Figure 7 10 Retrieval of Inspection Outcome The data to be entered is as follows Country Region Specify the geographical area to be included in the retrieval District Town process Activity Specify what activity area should be included i e manufacturer distribution etc From To Specify the date range in which the inspections were performed Once you have selected the criteria you want to apply select where the output should go and press lt lt Ok gt gt and the report will be generated World Health Organization 1998 117 SIAMED User Manual 7 4 5 Companies with No Inspection This retrieval option permits you to retrieve information on the companies that have not been inspected It also allows you to limit the search to a given geographical area and specify which activities should be included COMPANIES WITH NO INSPECTION RECORDED Country NEW DEMOLAND Town TWN4 Town 4 Activity Screen Another activity lt gt Printer Distributor Hospital Pharmacy I
141. gt when the cursor is on it 1 e when it is highlighted Multiple boxes can be checked at the same time To uncheck a box just click on it again Manufacturer X Distributor Pharmacy X Other World Health Organization 1998 31 SIAMED User Manual Radio Buttons Radio Buttons are used to indicate reciprocally excluding options To check the button click on it with the mouse or press lt Enter gt when the cursor is on it i e when it is highlighted Unlike check boxes only one radio button can be selected of a list NOTE One button must be selected With limit Without limit Working With Multiple Windows When entering data users type information in fields that are placed in windows like when filling rectangular boxes drawn on paper forms In many cases while working on one window the system may need you to enter information into fields that are placed in other windows When this happens the new window will appear automatically on top of the former one To return to the previous window you must complete the entry in the current window If you click on a window placed in the background before completing your data entry the background window will become the foremost window but the other one is still open active and waiting for your entry If you have not closed it and you try to type information on the foremost window you will get the impression that the system is frozen i e y
142. h Organization 1998 67 SIAMED User Manual 5 13 5 Change Preferred National Name Synonyms in the substance names file are cross referenced to help ensure consistency in the substance names used Consistency is made possible by the use of preferred national name Users are prompted to select a preferred national substance name among a number of synonyms After such a selection is done the system will convert any synonym entered to the preferred national name and prevent licensing drugs with the same substance recorded under different names The preferred national name status can be changed from one name to another as many times as is necessary The computer will automatically change a previously selected name to the new preferred name throughout the system HANGE PREFERRED NATIONAL NAME Current preferred _ New preferred name Figure 5 18 Change Preferred National Name screen Current Enter the name currently used as the preferred national name to Preferred identify the substance or press lt F2 gt to select it from the list of preferred names New Preferred You can now change the preferred national name previously Name selected by entering the new preferred name or by pressing lt F2 gt to select it from the list of synonyms 68 World Health Organization 1998 Chapter 5 Catalogues WEL 5 13 6 Substance Monographs This feature has been developed for those licensing authorities who desire to record spe
143. h of them which role they play e g source of starting materials preparation of semifinished product formulation labelling repackaging etc This field accommodates the requirement of some countries which have regulations to establish that importation or wholesale of a given drug product can be done only by selected companies Up to fifty 50 different distributors can be related to each individual drug product World Health Organization 1998 Chapter 1 Introduction To SIAMED WEY 1 4 What This Software Package Does SIAMED is designed to aid users in the process of collecting and tracking all data related to the drug registration process This software package organizes all required data into structured databases and produces the required reports and licences SIAMED is intended to improve the registration and licencing process by allowing the user to properly record keep up to date and retrieve 4 information on companies including name mailing address premises address phone fax telex e mail numbers contact responsible officials activity 1es operating licences and their validity authorization to act as applicant licence holder for drug licensing purposes authorization to handle psychotropic narcotic drugs 4 summary information on inspections carried out at company premises keeping separate records for each individual activity that a company is or has been carrying out manufacturer wholesaler importer QC la
144. h town you add is specific to a district If there are multiple districts then you must specify the towns in each district Description This field displays the full name of the country region district or town for which you entered an abbreviation Notes Use this text field to add any additional descriptive information or notes about the country 5 3 1 Currencies Currencies and exchange rates can be entered here to permit comparison between prices when these are not expressed in the national currency Currencies take the same code as the country to which they belong DOLLAR AAA 365 Ba 365 6666 1 8888 ANNNNNN ANNNNNN Country Currency 6 6666 Exch rate date 11 6271998 lt Exit Figure 5 4 Sample of Currencies screen Country Select the country for which you wish to enter currency exchange information A selection list is provided by pressing lt F2 gt or the right mouse button Currency Enter the name of the currency used in the selected country For example the United States uses the dollar as currency and Switzerland uses the franc as currency Exchange Rate Enter or edit the date on which the exhange rate was established Date Click lt lt OK gt gt to add the entry to the catalogue Additional entries can be added by inputting information into the data fields provided on the screen NOTE Do not forget that several countries use the same name and or symbol for their currency try to avoid confu
145. hat vital drugs with a limited market are reliably available Such provisions may also be needed for other purposes e g to privilege nationally manufactured drugs On the other hand fees may be higher for very popular drugs with a sizeable market if these can be identified the risk that the collection of fees may induce approval of a greater number of applications can be contained by appropriate mechanisms such as transparency of the evaluation process setting no relation between fees and evaluation results and the involvement of institutions external to the drug regulatory authority in decision making adequate staff and technical support from national experts Initially the introduction of computer based drug registration will put an additional burden on staff especially when existing information needs to be revised and for validating data entry This phase can take more than one year in countries where three to five thousand drug products are marketed However once the system is operational staff will face less routine and clerical work and will have more time available for technical and professional work None the less staff will need technical support from other institutions and individuals In several countries a Technical Advisory Group TAG or committee has been established to provide technical advice to the drug regulatory authority A TAG may consist of national experts in clinical pharmacology pharmacology pharmacy ph
146. have been carried out Software and guidelines will be continually field tested and where necessary and feasible adapted to meet specific national requirements The development of SIAMED has been undertaken with the realization that the introduction of desktop computers and ad hoc software alone are not enough to ensure efficient drug registration The provision of this software package and its guidelines are therefore intended World Health Organization 1998 3 SIAMED User Manual as a component of a broader national programme aimed at efficient drug registration and encompassing legislation regulations human resources and appropriate facilities Thus the implementation of the WHO model software requires a feasibility study to define local specifications the establishment of an appropriate organizational structure the establishment of reliable working procedures the appointment of competent staff allocation of resources the adaptation of the software to meet local needs and data entry and validation Support 1f required can be provided by WHO for these activities System Design SIAMED has been developed in FoxPro 2 6 DOS It is a user friendly system that provides for entering updating retrieving and printing information which is stored in a relational database A relational database can be schematically defined as a system of files linked to each other by means of key words This perm
147. hoose tablet from the list Press lt lt Ok gt gt Repeat the step 3 to choose capsule gt pS Select the number of active ingredients from the field list select EQUAL and type 1 press lt lt Ok gt gt un Select ingredient from the field list select EQUAL and press lt F2 gt or the right mouse button Select salbutamol from the list press lt lt Ok gt gt then press lt Exit gt Select Imported Domestic Both from the field list by double clicking on it Select Imported from the pop up window press lt lt Ok gt gt ee A ee Press the lt See searching criteria gt button to check your entry 10 Press lt lt Execute gt gt If data is found that matches the entered searching criteria a red window appears prompting you to select where the output should go Specific help is available by pressing lt F1 gt when that window is on the screen LIST OF DATA PgUp PgDn t Move Bar Enter or Click Rigth Mouse Select TOTAL Application nr 8220 95 BRAND HUM PENDING ALTIAZEM 188 MG CAP Capsule Applicant COMPANY XXX Pres CARTON BOX WITH 18 CAP BLISTE Licence 168 1996 BRAND HUM CANCELLED 22 18 1997 AMOXI PEN 258 MG 258 MG CAP Capsule Licence Holder COMPANY III Pres CARTON BOX WITH 20 CAP BLISTE Licence 189 1996 HUM CANCELLED 22 18 1997 AMPIXIN 258 MG 258 MG CAP apsule Licence Holder COMPANY GGG Pres CARTON BOX WITH 2 CAP AND 5 Licence 91 284 BRAND HUM EXPIRED 38 12 1996 AM
148. ication 135 District Geographical Code 50 DMP 233 Dosage Forms 48 53 Drug Classification 48 Drug Name 121 Drug Prices 134 DRUG REGISTRATION 3 Background and General Design 3 INTRODUCTION 3 Key Concepts 10 System Design 4 What Does the Software Package Do 16 Drugs 119 description 46 EDIT 227 Copy 227 Cut 227 Find 228 Find Again 228 Print 229 Print Edit Letter 229 Replace and Find Again 228 Select All Text 227 Transfer lt Paste gt 227 Undo Changes 227 Equipment 234 Exchange Rate 51 234 Expiry Operating Licence 95 Fees 195 Catalogue 49 72 description 46 Establishing 73 Payments by Application 196 Payments by Licence Holder 197 Relating Applications to 195 step 42 Fields 234 Files Catalogue 4 Company 4 Foremost Window 206 Change 206 Form window 29 234 Form Windows 29 fields 29 Standard 29 Formulary National 234 248 Frozen 234 GCP 221 General Appearance 136 GENERAL RULES 169 Generic Name 13 234 description 122 Generic Names 69 Geographical Codes 48 GLOSSARY 233 Hard Drive 235 Hardware Requirements iii Inactive Ingredient 236 Indexation 215 Initialization 214 Inspection Details 109 Inspections 103 description 45 step 41 INSTALL 21 INSTALLATION 21 INSTALLATION AND SET UP Installation Procedures 21 Updating Procedures 22 Issu
149. ide r glucose Canhydrous gt 2 8 Oral rehydration solution is optimally constituted to correct the fluid and electrolyte loss which results from acute diarrhoea in infants older children and adults When glucose and trisodium citrate are not avail able these ingredients may be replaced respectively by g litre sucrose common sugar 18 88 Press lt lt lt Esc gt gt gt to exit Figure 11 4 Model Prescribing screen Multisource Products This is a consultative document pharmaceutical products from multiple sources which may or may not be therapeutically equivalent drug products Multisouce Pharmaceutical are also referred to as generics MULTISOURCE PRODUCTS a CONSULTATIVE DOCUMENT December 199 INTERCHANGEABLE MULTI SOURCE PHARMACEUTICAL PRODUCTS WHO DRAFT GUIDELINE ON MARKETING AUTHORIZATION REQUIREMENTS I INTRODUCTION The competitive pricing that results from the marketing of generic versions of of f patent pharmaceutical products significantly reduces drug costs Before issuing a marketing authorization for a multi source generic pharmaceutical product the national regulatory authority has to assess if it is therapeutically equivalent and interchangeable with the brand product marketed by the innovator Press lt lt lt Esc gt gt gt to exit Figure 11 5 Multisource Products screen GCP This is a detailed guideline of Good Clinical Practice GCP for trials on pharmaceutical products desig
150. ilable if Synonyms of is selected first Once selection is made clicking lt F2 gt here reveals a pop window listing all substance names available in the SIAMED programme Simply select the desired substance name 5 24 2 Generic Names This option allows you to retrieve the generic names of the drug products contained in both application and in marketing authorization LIST OF GENERIC NAMES Screen Printer Figure 5 35 Generic Names Screen Printer Select whether you want the report to be displayed on the screen or to be sent directly to the printer World Health Organization 1998 85 Chapter 6 Companies WEE 6 COMPANIES 6 1 Companies The Companies database is intended for storing information about all companies institutions and any other entity having relevance for the work of the drug regulatory authority OMPANI ES Company code KANA Name COMPANY EEE Full name COMPANY IN FULL EEE lt Geographical codes gt NEW ZEALAND Mailing address Welcome Street 122 Auckland Contact person Dr Jane Maggy Area code Plant address Phone 330565 Telex Fax 1 Manufacturer X Can act as applicant licence holder Distributor State owned X Handles Psychotropic Narcotics 1 Can be inspected Related companies gt lt Additional information gt lt 0k lt Delete gt lt Exit Figure 6 1 Companies primary screen Users are expected to enter pertinent info
151. in computer generated inspection programmes Cancelled means he she will not be considered Selecting this button enables you to select the company activities e g manufacturer warehouse distributor etc that this inspector is qualified to inspect You have the option of selecting all or deselecting all activities Selecting this button enables you to select the item groups e g biologicals injectable etc that this inspector is qualified to inspect Checking the MOH staff box indicates that this individual is a central level inspector A non checked box indicates that the inspector is a peripheral administration inspector Check the box as appropriate Press the lt lt Ok gt gt button to add this entry to the catalogue To enter additional inspectors 106 World Health Organization 1998 Chapter 7 Inspections WEE repeat the data entry process or press lt Exit gt to return to the main menu World Health Organization 1998 107 SIAMED User Manual 7 2 Inspection Programmes This option permits you to generate a list of companies to be inspected You also have the option of generating a list of proposed inspectors to conduct the inspection PROGRAMMING INSPECTIONS Programme number 1 1 A Description End programme date M1 05 1997 First term inspection lt Activities Item group lt Geographical codes gt DEMOLAND Toun 4 1 Inspector s geogr code criterion X Exclude last
152. ing Invoices 73 Issuing Receipts 73 Item Groups 49 Keyboard Commands 34 lt lt Ok gt gt 30 lt Alt gt lt D gt 34 lt Alt gt lt I gt 34 lt Alt gt lt S gt 34 lt Alt gt lt U gt 35 lt Alt gt lt X gt 35 lt F1 gt 34 lt F10 gt 34 lt F12 gt 34 lt F2 gt 34 lt F3 gt 34 lt F7 gt 34 lt Shift gt lt Tab gt 35 lt Tab gt 35 Moving From Field to Field 34 Labels Company 99 Laboratory Testing 136 Licence Holder 14 Licensing Fees Application 137 List of Products UN Consolidated 223 Main Menu 23 EDIT 28 LICENSING 27 MAINTENANCE 28 World Health Organization 1998 NATIONAL 28 WHO 28 Maintenance 205 Chek Validities 206 Maintenance Tools 206 Users Log 209 Manual Numbering Application 212 licence 212 Manufacturer 15 Manufacturers Roles 49 Manufacturing Process 136 Market Limit 212 Marketing Authorization 10 Model Prescribing 221 Mouse Buttons 236 Mouse Functions 36 MS DOS EDIT 21 Multiple Formula Preparation 236 Multiple Formula Preparations 130 Multiple Searching Criteria 93 236 General Rules 169 Inclusion Options 168 Retrieval Tool 176 Multiple Windows 32 foremost window 32 frozen 32 Multisource Products 221 National 223 National Formulary 126 National Version 213 236 Configuration 213 step 42 Network 111 236 non proprietary names 62 Operating licenc
153. ing the application the specific information relating to the application number will be displayed This information includes the date the application was received the applicant the drug name the strength and if applicable the generic name lt Similar Formula gt is an additional option that can be selected from this screen Selecting the lt Similar Formula gt button causes the system to find and retrieve all drugs having at least one active ingredient in common with the item on the application which you want to reject After reviewing the information you may then select lt Print gt to print the report or select lt Exit gt At this point the system will retrieve and display all drug items with similar ingredients and the same dosage form as the drug listed on the application which you wish to reject After reviewing this information you may again then select lt Print gt to print the results of the search or select lt Exit gt return to the previous screen At this point selecting lt lt Ok gt gt would indicate that the application has been rejected The system will then prompt you to indicate whether you want to print a rejection letter See Section 12 10 for details on how to prepare a letter Simply select lt lt YES gt gt or lt NO gt After a selection is made you will be returned to the previous screen Press lt Exit gt return to the rejection application screen World Health Organization 1998 147 SIAMED User
154. inspector X Match inspector with activity X Match inspector with item group Figure 7 3 Programming Inspections screen When you select Inspection Programmes the screen Programming Inspections appears requesting the following data Programme Number Description End programme Date Activities 108 A unique number used to identify each programme If creating a brand new program enter the program number If reviewing a predefined inspection program press lt F2 gt to select the programme In this latter case an additional option box will be displayed giving you the following 3 choices lt See Data gt If you wish to see existing data relating to this programme that was previously defined lt Delete gt If you wish to delete the option lt Go Back gt functions like the lt Esc gt escape key A descriptive name for the inspection programme e g Insp manufacturers of injectables 1st quarter 1997 Enter the date on which the programme will end The computer will use today as the starting date This option is linked to the Company Activities database Selecting the lt Activities gt button allows you to limit the selection of companies to one or more specific activity ies World Health Organization O 1998 Chapter 7 Inspections ILE Item Group Selecting the lt Item Group gt button allows you to limit the selection of companies to one or more specific item group s Geographical
155. ion the user can decide to print all items alphabetically ordered by drug name or only the items with a drug name entered by the user In the same way only drugs of one licence holder or manufacturer or dosage form etc can be printed 5 Press lt lt Ok gt gt to print or lt Exit gt to return to the Main Menu World Health Organization O 1998 185 SIAMED User Manual 8 14 9 Predefined Statistics The Predefined Statistics option permits you to display and print a set of predefined statistics Data concerning drug items will show separate figures for human and veterinary items as well as a total PREDEFINED STATISTICS Figure 8 45 Predefined Statistics screen For company data separate figures will be shown for the statuses Approved Cancelled and Term to Comply as well as for the total To begin generating this report you must enter the date range i e begin date From and the end date To that you want to include The system will retrieve predefined statistics limited to the specified time periods SeeSample Report below From 11 11 1111 To add de Received applications 2115 2115 Rejected applications 81 81 Approved licences 1676 1678 Pending applications 364 364 Valid licences 6 8 Cancelled licences 145 145 Expired licences 1522 1522 Renewed licences 71771 Licences with 1 active ingredient 1694 8 Licences with 2 active ingredients 268 8 Licences with 3 active ingredients 7978 Licences with 4 or
156. ion had previously been put in relation with that step and date The screen will remain empty otherwise it will show those applications already related to the selected step and date Pending Press the lt Pending applications gt button The system will show Applications a list of pending applications that have not started nor completed the selected step Select one by one those you want to relate to the step and date Then press lt lt Ok gt gt The screen will show all applications that have an established relation with the step and date you are working on World Health Organization 1998 145 SIAMED User Manual Results Print This button allows you to enter information on decisions made for this particular step All applications that have been previously assigned to this particular step will be listed allowing you to enter decisions for multiple applications at once Enter a decision date and result Additional notes can be entered in the Notes text box After completing the results information press lt lt Ok gt gt to save your changes or lt Exit gt to return to the previous screen Select this option if you wish to have detailed information printed to your local printer 8 3 Rejecting Applications REJECTING APPLICATIONS Rejection cause IG Irrational Combination Rejection date 2 06 1998 Notes lt Enlarge text gt One application Several applications Figure 8 18 Rejecting Application
157. ion is used to prepare standard formats of letters and certificates which can be automatically filled and printed automatically by the computer system Used in conjunction with the Professionals catalogue to allow more flexibility and consistency in defining professions relating to the management of inspections Used to further specify the activities of a given company Used to build and maintain a database of responsible professionals within manufacturing units or other activities requiring exclusive engagement of professionals Used to build a database of abbreviations for the various relationships that can be established between companies Used to build a database of abbreviations for the various types of prices applied to medicinal products World Health Organization 1998 49 SIAMED User Manual 5 3 Geographical Codes These are the codes assigned to countries regions districts and or towns in your country The level s you have access to will depend on which levels have been selected during configuration of the system The screen below shows an example in which only country and town have been selected at the time of setting the configuration Continent AMERICA EUROPE Country U ASIA TES OF AMERICA AFRICA AUS ASIA Town P Descript ion PHILADELPHIA Central Phila and surrounding cities in Philadelphia lt Replace Delete Figure 5 3 Geographical Code screen For each option you mus
158. is empty However users that wish to implement this option should enter all steps in the catalogu and then record dates and decisions related to each individual processing step APPLICATION STATUS Application nr 5 Rece ived 18 63 71998 Licence Licensed 7 Applicant COMPANY BBB Drug name aaadruname Strength 24 mg Generic name GENERIC Quality assessment NO 18 03 1998 Pharmacy Therapeutics Commit NO 18 03 1998 Q C L NO 18 03 1998 7 Reception of applications YES 18 03 1998 17 64 1998 APPROUED Figure 8 35 Retrieval by Application Status screen To find out about application status complete the following steps 1 Type in the application licence number or press lt F2 gt to select from the file contents list 2 Once selection is made summary information is shown indicating at which steps the application is pending For more details on each step click on any step or sub step This will give you detailed information about the situation at such step In addition you will be able to send data to the printer or to the screen 3 Press lt Exit gt to return to the Main Menu To see information on another item just click in the application number field and repeat all steps If you do not find the application you are looking for it could mean that the application has completed its processing has been rejected or has been approved World Health Organization 1998 167 SIAMED User Manu
159. is is a unique code used to identify the various manufacturers roles Description This field displays the description of the code Notes Use this text field to add any additional information 76 World Health Organization 1998 Chapter 5 Catalogues SS 5 18 Correspondence Formats Correspondence Format is used to prepare the standard format of letters or certificates to be filled automatically by the system when the need arises On the screens you will see the word Letter but this is to be understood as any type of pre formatted print out To utilize this menu option simply enter the Letter Title and click you mouse in the gray portion of the screen to be able to access the list of variables lt Ctrl gt lt L gt and edit the appearance of the document s text lt Ctrl gt lt O gt LETTER FORMATS Letter title APPLICATION RECEPTION Last update 22 84 1997 L NEWLAND REPUBLIC MINISTRY OF HEALTH PHARMACETICAL DIRECTORATE DRUG REGISTRATION DEPARTMENT Town 1 lt SYSTEM DATE _DIARYDATE gt eft margin 12 Application Nr lt APPLICATION RO_SOL gt 1 Dear LICENCE HOLDER RO_TIT gt 1 RO_SOL gt we are glad to inform you you that we received your licence application concerning Figure 5 26 Sample of Correspondence Format screen Letter Title Specifies the title of the letter The title can be selected by pressing lt F2 gt or clicking the right mouse button to select from the available
160. is will initiate a search for items with at least one active ingredient in common with the selected application licence followed by a search of items with at least one active ingredient in common with and the same dosage form as the retrieved item See Section 8 1 16 Similar formula for details 3 Select lt lt Print gt gt if you wish to print the data or lt Exit gt to return to the Main Menu 4 If lt lt Print gt gt is selected the system will prompt you to indicate if you first wish to print a letter Section 12 10 and then a licence To see information on another item just click in the application number field and repeat all steps If you do not find the licence you are looking for it means that it has been removed from the system 166 World Health Organization 1998 Chapter 8 Drugs IF 8 14 2 Application Status This option if properly used permits you to find out the status of applications at each processing step and to locate applications that have been forgotten in the processing path It is important to remember that you can only retrieve information that has been entered Therefore users are expected to enter the necessary data at each step about whether a decision has been made and if necessary to type a brief explanation for the decision taken or not taken The use of this option is not compulsory Users that prefer not to take this option should simply ensure that the Processing Steps catalogue
161. ision 3 Enter the date on which the variation application was received 4 Indicate whether the request for variation has been submitted by an applicant usually the licence holder or is an internal decision of the licensing authority World Health Organization 1998 159 SIAMED User Manual 5 Indicate which piece s of information may be varied You can select lt All gt by pressing the appropriate button or double click on individual items to select them you can select any number of them Note Only the items selected here will be editable when using the facility to record variations 6 Press lt lt Ok gt gt to save your changes The system will then prompt you to indicate if you wish to print the letter of variation See Section 12 10 select lt lt Yes gt gt or lt No gt Select lt Exit gt to return to the Main Menu For Processing Steps see Section 8 2 This option is virtually identical to the processing steps described in section 8 2 Please refer to Section 8 2 for details on using this feature 160 World Health Organization 1998 Chapter 8 Drugs IF 8 11 Record Variation Variations entered into the system are recorded here The process of entering data is similar to that of entering or updating an application for a new licence Only the fields that have been selected for variation at the first step of the variation process are editable LICENCE VARIATIONS Variation application nr _ 641
162. items that have the Same Ingredient and Dosage Form You may again select lt Print gt to print the results of the search or after viewing select lt Exit gt return to the main application entry screen NOTE If you press lt Exit gt before you saved your entry you will be warned that all your entry will be lost unless you save it World Health Organization 1998 141 SIAMED User Manual 8 2 Processing Steps a Entry lpdate applications Ne c Rejection h By step d Recover rejection e Issue marketing authorization Figure 8 14 Processing Steps menu This option if properly used allows you to track the status of applications at each processing step and to locate applications that have been forgotten in the processing path Users that wish to implement this option should have entered as many steps as appropriate in the Processing Steps catalogue Only steps entered in such a catalogue can be used in this feature It is important to remember that you can only retrieve information that has been entered Thus users are expected to enter the necessary data at each step about whether a decision has been made and what action has been taken If necessary you can also type a brief explanation for the actions that have or have not been taken NOTE The processing steps detailed in 8 2 1 and 8 2 2 also apply to the processing steps for Revalidation Applications and Variation Applications 142 World Health Or
163. its the user to access several different files at the same time making use only of selected information from each However users do not need to know which programme or which file is active at any given moment to be able to use the system A system of menus messages and instructions leads users through all the options of the package In order to standardize information in a way that assures meaningful retrieval of information several abbreviations and codes should be used All abbreviations and codes are entered updated and printed using specific menu entries The definition and compilation of these abbreviations and codes are key activities which demands careful preparatory work by professional staff within each regulatory authority As is the case with any computer application the efficiency of the system depends on the accuracy with which this work is undertaken The main files within this system are Catalogue Files A set of files containing codes used throughout the SIAMED system These codes are used for dosage forms primary containers country names drug classification the ATC Classification is included but a different one can be accepted sale dispensing modalities etc The information in these files is linked to a number of related screens requiring information stored in the catalogue files 4 World Health Organization 1998 Chapter 1 Introduction To SIAMED NZ Company File Main Register File These files contain
164. ld displays the licence number for the application Press lt F2 gt to obtain a list of all marketing authorizations Once a licence number has been selected the following predefined information is displayed on screen the date the licence was issued the licence holder the drug name the strength of the drug and the generic name if applicable These fields are for display purposed only and no information can be changed Limit Marketing Use this field to specify a deadline date by which the applicant Date must begin marketing the product If no date has previously been defined you may enter one here First Marketing This field should display the first date the licence holder began Date marketing the product Date Marketing This field is used to display the date on which marketing for this Suspended product has been suspended A marketing suspension can either be issued by the licensing authority or by the licence holder Date Marketing This field is used to display the date on which marketing has been Resumed resumed This date should always be a date after the suspension date 152 World Health Organization 1998 Chapter 8 Drugs WEY Stability Data Selecting this option displays a free text window in which any data relating to updates of stability information can be entered Adjacent to this field a summary field exists in which up to 20 characters can be entered that can be used to summarize the contents of this window P
165. less of their validity status Received Search is limited to applications received within a date range that Applications you are prompted to specify If you do not specify an end date the system includes the oldest received application and or the most recently received as applicable Please note the searching criterion is the date of reception not the fate of applications Thus applications are included even if they have later been rejected or approved Rejected Search is limited to applications rejected within a date range that Applications you are prompted to specify If you do not specify an end date the system includes the oldest rejected application and or the most recently rejected as applicable Pending Search is limited to applications pending on a specific date that you Applications are prompted to specify If you leave the date field blank the system will give meaningless results Applications cannot be pending within a date range Issued Licences Search is limited to licences issued within a date range that you are prompted to specify If you do not specify an end date the system includes the oldest issued licences and or the most recently issued as applicable Please note the searching criterion is the date of approval not the fate of licences Thus licences that have later been cancelled or are expired fall within the searching criteria 172 World Health Organization 1998 Chapter 8 Drugs WEE Expired Lic
166. lications from reception to licence issue If the option From Reception to Issue of Licence is selected then you will not have the option to enter initial step and final step If the other 3 options new drug product applications revalidation applications variation application substances are selected you must enter what the initial step is and the date on which the initial step began and you must also enter the final step and the decision date for the final step Select the type of processing Select a priority level optional Type in the initial step or press lt F2 gt to select from the file content list In the date started field enter the date on which the initial step began i e the search will include all applications that have started that step on or after that date Type in the final step or press lt F2 gt to select from the file content list In the decision date field enter the date on which the final step ended i e the search will include all applications that have started that step on or after that date To conduct the search press lt lt Ok gt gt or lt Exit gt to return to the Main Menu If lt lt Ok gt gt is selected the system will then display all the applications that fit the criteria and display the duration in days for each application The bottom portion of the screen displays the average duration in days Selecting a specific application by double clicking on it displays all steps bas
167. licences Licence 94 131 Licensed 21 08 1994 Licence Holder DRUG COMPANY GGG Drug name ACNASOL S Strength 4 y Generic name ERYTHROMYCIN Similar formula Exit gt Figure 8 24 Licence Cancellation screens Cancellation This field requires that you enter the code that corresponds to the Cause cause of cancelling the licence This field is linked to the Cancellation Causes database Therefore pressing lt F2 gt will display a list of causes from which you can select Cancellation By default the system enters the current date today s date as the Date cancellation date You may accept this value or change it 1f the cancellation date 1s Notes Any specific information relating to the cancellation cause can be entered in the notes field This is a text field that can contain unlimited data Select whether this cancellation refers to one specific licence or is common to a number of them A specific screen will appear for each option 154 World Health Organization O 1998 Chapter 8 Drugs WEL 8 7 1 One Licence Select this option if you wish to specify a single licence which should be cancelled Selecting this option displays the screen below CANCELLING LICENCES Cancellation cause AR Unacceptable Adverse Reactions Cancellation date 1170671998 Licence 2 Licensed 11 86 1998 Licence Holder COMPANY BBB Drug name aaadruname Strength 24 mg Generic name Similar formula Exit Figure 8 25 Cancelling One
168. list of options Last Update Indicates when this letter format was last updated Left Margin Use this field to specify the distance from the left margin where the letter is to begin A standard format serves as a mask which contains both text and variables The text will be printed as it has been written in the format while the variables indicated by will be replaced by their actual value The value of each variable depends on the context application or licence where the user has requested that this information be retrieved from The user determines which variable to use by clicking lt Ctrl gt lt L gt and selecting from the pop up list World Health Organization 1998 77 SIAMED User Manual The following format is prepared as an example of the correspondence format Dear Mr LICENCE HOLDER S CONTACT CP_BOSI wish to refer to your application APPLICATION NUMBER RO_SOL etc When this format is retrieved while entering data of application number 1234567890 submitted by COMPANY ABC whose contact person is Mr REDWHITE the screen will show the following Dear Mr REDWHITE wish to refer to your application 1234567890 etc If that format is retrieved from another application or licence the appropriate data reflecting that application or licence will appear To enter special marks or set text appearance click lt Ctrl gt lt O gt and chose the desired text option such as system date ne
169. ltiple Formula Preparations If you selected multiple formula preparations you do not need to enter anything in the field labeled Formula referred to placed at the left upper corner of the screen After selecting multiple formula preparation enter in the substance field as is done for normal formulations all ingredients regardless of their presence in all units of the preparation example for a preparation of 7 tablets with ingredients A and B and 7 tablets with ingredients A and C enter ingredients as if all tablets contained A B and C without specifying quantity When entry of ingredients is completed a field will appear where in an unlimited size free text form you can type the exact formulae with number of units etc as you want it to appear on the printouts It is probably better to format your text so as to get a nicer presentation of the formula The requirement to enter ingredients in the ingredient field as it is done for normal formulations has been set to enable the system to search by ingredient s although the formula is displayed as entered in the free text field 132 World Health Organization 1998 Chapter 8 Drugs WEE 8 1 4 Routes of Administration An unlimited number of routes of administration can be entered for each application PPLICATION Application nr 70152795 Change ROUTES OF ADMINISTRATION Route of administration TRAD Transdermal Code Description TOPI Topical Figure 8 9 Application
170. menu The system uses the following processes to function effectively Defining Fees Fees used within the system are defined through the Fees catalogues Relating Users then establish a relationship between fees and applications Applications licences This is not done automatically by the system By Licences to Fees establishing the relation the system is then able to tell the user when a fee is due for a given application or licence A relation can be set in three ways leading to the same results a by selecting the relevant fee s while entering application data b when issuing a marketing authorization or c from the fees submenu option shown above Payments by application licence Issuing Invoices This feature is used to print invoices to applicants licence holders remind them of payments due or simply to issue lists of fees due Issuing Invoices is done through the Retrieval Fees submenu options World Health Organization 1998 199 Recording Payments amp Issuing Receipts SIAMED User Manual This feature is used to record payments through the Fees submenu options After recording a payment a receipt is automatically numbered and printed This can be done either for each individual application licence through Fees Payments by application licence or for all fees of a given company using Fees Payments by licence holder 9 1 Payments by Application Licence This option permits to establish a link be
171. mporter Licence Holder only Figure 7 11 Companies without Inspection screen Country Region Specify the geographical area to be included in the retrieval District Town process Activity Specify what activity area should be included i e manufacturer distribution etc From To Specify the date range in which the inspections were performed Once you have selected the criteria you want to apply select where the output should go and press lt lt Ok gt gt and the report will be generated 118 World Health Organization 1998 Chapter 8 Drugs WEE 8 DRUGS The Drugs menu is divided into 5 basic functional sections that handle entry and updating of applications for new marketing authorizations issue of new marketing authorization revalidation renewal of existing marketing authorization variations to existing marketing authorizations and two miscellaneous actions changing applicant holder or manufacturer name in all drug screens and deleting licences These functional areas are detailed in this section b Processing steps c Rejection Recover rejection Issue marketing authorization Post marketing follow up Cancellation Revalidation applications Processing steps Record revalidation Variation applications Procesing steps Record variation n Change applicant holder o Delete a licence Figure 8 1 Drugs main menu 8 1 Entry Update Applications This option is the key part of SIAMED It is f
172. n 1998 Chapter 3 Commands And Functions NZ lt Alt gt lt U gt lt Alt gt lt X gt lt Tab gt lt Shift gt lt Tab gt lt Enter gt Used to switch control to another password user This key combination can also be used to quit the system Used to move forward from one field to another Used to move backward from one field to another Used to execute a command entered from the keyboard World Health Organization 1998 35 SIAMED User Manual 3 4 Mouse Functions De Click Quickly press and release the mouse button Left Clicking the left mouse button S In any field of a record in the form window will select that field for editing S Anywhere in the title line of the form window will allow you to adjust the position of the window on your screen S On the tiny triangle in the upper or lower right side of the Alphabetical search window will allow you to scroll through the list of items in the window S On the tiny triangle in the lower left or right corner of the Alphabetical search window will allow you to scroll from left to right to view more information about a particular item Right Clicking the right mouse button S On an item in the Alphabetical search window will cause the item to be selected and entered in the original field on the form window The Alphabetical search window will automatically close S Ona pop up field will cause the field to display all options for that field 3
173. n Classification Use this field to specify if the reason for the action being taken is rejection or cancellation Code This is a unique code used to identify the cause of the rejection or cancellation This field can contain up to two characters Description This field displays the full meaning of the code Notes Use this text field to add any additional information about the reasons for rejection or cancellation 58 World Health Organization 1998 Chapter 5 Catalogues SE 5 11 Processing Steps This menu option allows users to define the processing steps for applications and indicate their expected duration It is not compulsory that this feature be used but once chosen it has to be complied with otherwise you may not be able to issue marketing authorizations or record revalidations variations Making use of the processing steps feature prevents issuing licences with incomplete processing and enables you to trace licences forgotten in process 5 11 1 Defining Processing Steps EW DRUG APPLICATIONS PROGESSING STEPS HUMAN Code 3 Description Pharmacy amp Therapeutics Committee Duration days 38 Necessary lt Experts Notes lt De lete Figure 5 12 Sample of Processing Steps screen Users can define processing steps for drug licence applications with their expected duration Up to twelve different paths for processing applications can be defined These paths are divided into four categories
174. n Y if this is found it checks whether a date was proposed for the next inspection If one was proposed and falls before the end of the programming period the company is included in the list If no date was proposed the computer checks what degree of risk is assigned to this company If the company has been assigned Low risk the computer checks whether date of last inspection plus 720 days falls before the end of the programming period if so the company is included The other degrees of risk are treated the same way substituting 540 360 or 180 days for 720 as appropriate 4 1f no information on a previous inspection is found the company is included World Health Organization O 1998 109 SIAMED User Manual 7 3 Inspections The purpose of this catalogue option is to allow you to record the key outcome of inspections which can be important for drug licensing work The system allows you to enter notes that may arise from inspections or any particular decisions made during discussions following inspections Data entry involves selecting first the company and then the activity for which you wish to enter data To guide in selecting the activities for which the company is licensed are listed in the lower portion of the screen Selecting a valid activity results in the appearance of a subsequent window where data can be entered SIAMED also permits the inspection results of the different company roles or activities to be entere
175. n be edited and formatted as required NOTE When adding a new letter you will be prompted to add another application This prompt only occurs if using automatic numbering F6 Select If you wish to add information related to one or more processing Steps steps select this option and a list of steps appears You may then select a step Upon such a selection the following information will be transferred automatically to your letter Step Initial and Decision Date Conclusion Approved Pending Rejected and any notes written in the column window Use Old Letter This option permits to allow one to pick up a letter that had been generated in an earlier session and needs revision or you simply wish to copy it World Health Organization 1998 235 F5 Print Save Letter SIAMED User Manual This option allows you to print your letter Selecting this option permits to save a letter generated by the computer This can be done in one or both ways 1 Recorded As Is i e in the format as it appeared in the previous screen In this way it is retrievable within the system To save AS IS simply type under Letter Title the name under which you would like to save this file 2 Copied in ASCII format In this way it is retrievable through an external word processor for editing formatting and printing like any other document To copy this file to an ASCII format file first select the destination drive then type in a valid D
176. nce the computer loses power Read only Indicates that the data displayed on screen can only be viewed by the user The data can not be altered in anyway Reagents Chemicals used to carry out the analysis of a sample An example of a reagent is calcium carbonate Reference Substances Details the substances that are used during the performance of analyses Restricted Substances A substance whose consumption has been banned restricted or not approved in the country of installation Routes of Administration Defines the various routes via which an item or drug product can be administered e g oral topical etc Secondary Form Windows An additional window or screen version of an actual form that is accessed from the form window The secondary form window may allow the user to enter additional information or it may be a read only screen Select Used throughout the manual to indicate which action to use to activate a QCL function such as clicking a mouse or typing the letter that corresponds to the desired World Health Organization 1998 243 SIAMED User Manual function The word press may sometimes be used in place of select but the function is the same Similar Formula A search criteria that retrieves information based on drugs with at least one active ingredient and or dosage form in common Similar Name A search criteria that retrieves information on drugs that have the same first five letters
177. nd a telex communication to the organization Fax Telephone number used to send a facsimile fax transmission to the organization Inspection of This screen displays the current status of each activity defined for the selected company Selecting the desired activity displays a new window which allows you to retrieve or record information on inspections See Section 7 3 1 for more details 7 3 1 Inspection Details Through this option you can enter data concerning inspections for each given company activity The criterion to distinguish between different inspections for the same activity 1s the date of inspection ANUFACTURER Reference document 82 26 92 VALID UNTIL 31 12 1999 lt History Date of this inspection 7 7 FAUNE Report date 7 Next inspection expected 7 Inspectors gt Result Reference document 82726792 APPROVED VALID UNTIL 31 12 1999 Notes on risk lt See all notes gt lt Enlarge text Notes on this inspection Ok Exit gt Figure 7 5 Inspection Details sample screen World Health Organization 1998 111 SIAMED User Manual The following is a discussion of all data entry fields in this screen Reference Document Valid Until History Date Of This Inspection Report Date Next Inspection Expected Inspectors Result 112 This field displays the reference document number which was entered when creating the company entry This field is display only and can
178. ned to set globally applicable standards for the conduct of biomedical research on human subjects GCP DRAFT GCP GUIDELINES CONTENTS INTRODUCT I ON DEFINITION OF TERMS PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL 1 1 Justification for the triali 1 2 Ethical principlesi 1 3 Supporting data for the investigational producti 1 4 Investigator and site s of investigationi 1 5 Regulatory requirementsi THE PROTOCOL1 PROTECTION OF TRIAL SUBJECTS 3 1 Declaration of Helsinki2 3 2 Independent ethics review hoard committee2 Press lt lt lt Esc gt gt gt to exit Figure 11 6 GCP screen 228 World Health Organization 1998 Chapter 11 WHO National 52 WHO Drug Information Provides an example of the quarterly WHO publication WHO Drug Information WHO DRUG INFORMATION fidverse drug related events need for increased efficiency in international transfer of information ep iil Multilateral harmonization of the controls applied to the registration and marketing of pharmaceutical products has been given impetus in recent years both as a result of a broad political commitment throughout the world to free trading policies and the development of single markets between close trading partners notably among the Member States of the European Union International alignment of technical requirements for assessing and monitor ing pharmaceutical products advances public health interests as well as economic objectives it
179. ng standards for this particular drug World Health Organization 1998 137 SIAMED User Manual Press lt lt Ok gt gt to save your entry and it will appear in a window in the lower part of the screen Selecting an item listed in the bottom portion of the screen and double clicking on it reveals a window option to lt Change gt or lt Delete gt the entry or lt Go Back gt one step Items listed in the Drug Prices window can be deleted by double clicking on them and selecting lt Delete gt or lt Tab gt as many times as is necessary to highlight the drug price s window and move to the item you want with the arrow keys When all information has been entered press lt Exit gt to return to the main application entry screen 8 1 9 Distributors Distributors can be chosen only from those companies for which the activity distributor has been selected during data entry for companies Users may enter any number of distributors for each application PPLICATION Application nr 8152 95 DISTRIBUTORS Distributor DRUG COMPANY WW Notes lt Enlarge text Company Country DRUG COMPANY Wilt Figure 8 12 Application Distributor screen Distributors To enter the full name of the company you can either type it in press lt F2 gt or click the right mouse button to get a list and select the desired item Note Free text field for additional information To complete the entry press lt lt Ok gt gt Summa
180. nization 1998 Chapter 5 Catalogues SE 5 13 4 Update Allows for the entry of additional substance names with the possibility to relate them to existing synonyms It is important to check before adding a new entry whether the file contains any synonym of the name users wish to add Adding new names without linking them to existing synonyms reduces the efficiency of the dictionary It increases the probability of licensing drugs with the same ingredient under different names PDATING SUBSTANGE NAMES Description 4 4 PROPYLENEDI 2 6 PIPERAZINEDIONE Synonym of Type CN1 N2 N3 P1 P2 P3 P4 Therapeutic groups LOLXX OTHER CYTOSTATICS Delete Figure 5 17 Sample of Update screen Description Enter the name you wish to add Synonym of Type the name of its synonym or press lt F2 gt to select an item from the search window It is very important that users try as much as they can to identify synonyms in the file Type Enter the type N1 N3 P1 P4 for the new name If you related the new name to an existing synonym this field will be filled automatically with the information belonging to the synonym Classification Select the classification for the new name Pressing lt F2 gt in the classification option will give you a list of items according to their ATC codes If you related the new name to an existing synonym this field will be filled automatically with the information belonging to the synonym World Healt
181. nly 0k Manufacturer Figure 6 12 Companies with No Activities retrieval screen 6 2 9 Labels The ability to retrieve labels from the system must be developed at the time of installation 100 World Health Organization 1998 Chapter 6 Companies ILE World Health Organization 1998 101 SIAMED User Manual 102 World Health Organization 1998 Chapter 7 Inspections IF 7 INSPECTIONS The purpose of this menu option is to allow you to record the key outcome of inspections which can be important for drug licensing work The Inspections menu option consists of four components Inspectors Inspection Programmes Inspection and Retrieval Licensing Maintenance WHO Edit Nat ional a Catalogues PF b Companies c Retrieval d Inspections a Inspectors e Retrieval r b Inspection programmes c Inspections f Drugs g Retrieval h Fees i Retrieval Figure 7 1 Inspections main menu 7 1 Inspectors This relates to the inspectors and the type of activities and item groups they can inspect In order to effectively utilize this feature to programme inspections relevant data must first be entered into the system using the following screen INSPECTORS Personal identification number 1 A Name Dr John Smith Professional document number 1 4 97 3 97 Geographical codes gt DEMOLAND Toun 2 Profession ANAL Analyst Address washington Road 41 Status Toun 2 gt APPROVED Ce CANCEL
182. not be edited here This field displays the date of validity of the authorization given for the activity you are working on see Company data entry screen for more details This field is display only and cannot be edited here This button provides access to information on dates and results of all previous inspections ordered by the inspection date The date or dates of the current inspection Enter valid dates for which the current inspection has been carried out This date indicates the date on which the report is being completed The date on which the next inspection should occur This button provides access to the list of authorized inspectors and can be used to assign inspectors for this inspection You may select one or all inspectors After making your selection press lt Exit gt and the selected inspector s will be displayed in the adjacent text field This pop up field provides three choices for a summary result Approved This result indicates the company has a valid operating licence or if based abroad is accepted by implication Cancelled This result indicates the company does not have a valid operating licence or if based abroad is not or no longer accepted for carrying out business in your country Term To Comply This result indicates that following the results of an inspection a delay has been given to comply with recommendations If this result is selected the Valid Until field becomes Must Comply Befo
183. nt as a whole or by step However the use of this feature is not obligatory Regulatory authorities with very limited staff do not usually have difficulty in tracing pending applications They can use the system disregarding this option 1 3 4 Generic Name In this system the names of the individual ingredients constituting the formula of a drug are called substance names The term generic name is used as follows Drug Products The generic name is the name of the base that constitutes the active with Only One ingredient regardless of the form used in the formulation unless a Active Ingredient specific salt has unique therapeutic uses unrelated to those of the base For example the generic name ampicillin applies to all drugs containing either ampicillin trihydrate ampicillin sodium ampicillin hydrochloride etc In this way a search based on the generic name ampicillin would permit the user to retrieve all products containing any form of ampicillin irrespective of the dosage form This simplification applies only to the generic name field of an application It does not limit the possibility for users to record the full name and quantity of the active substance s in the ingredient fields Thus searches can be based on either the generic name of the drug product or the individual full substance names of the ingredients 14 World Health Organization 1998 Chapter 1 Introduction To SIAMED WEY Drug Products The generic n
184. nt name On the other hand it contributes to establishing searching criteria that permit you to group together drugs that have the unusually large number of active ingredients in common World Health Organization 1998 71 SIAMED User Manual 5 14 Priority Priority levels can be allocated to drug items or to applications Examples are drugs listed in the national essential drug list drugs that are not listed PRIORITY Code El Description In Essential Drug List Notes lt Replace Delete gt lt Figure 5 22 Sample of Priority screen Code This is a unique code used to identify the priority level that can be assigned to an application Description This field displays the description of the code Notes Use this text field to add any additional information 72 World Health Organization 1998 Chapter 5 Catalogues SE 5 15 Fees Different type of fees such as application fee licence fee for imported products licence fee for domestic products QC laboratory fee and others may need to be used in the company and drug licensing process This catalogue permits you to define these fees record payments and to check expiry of payment validity where applicable Code LIF Description Licence Fee Amount 1 600 00 Currency CAE Annual fee lt Replace Delete gt lt Figure 5 23 Sample of Fees screen Code This is a unique code used to identify the fee types Description This field di
185. numbers given to companies in several countries You can decide here whether or not you will use any of them Click on the to mark it as X for each field you need to use You will then be able to change the field label from Authorization 1 2 or 3 to any appropriate one using the National Version facility see the National Version help topic Some fields can be switched on and off and not used during routine system operation These include X Priorities X Data sheet X Notes X National formulary code X Location of file X Drug prices X Licensing fees Use the radio buttons listed on the screen to specify whether you wish to have the system automatically generate application numbers or if you wish to manually enter them If selected to have the system automatically generate the numbers please enter in the field to the right the number you want the system to begin using Use the radio buttons listed on the screen to specify whether you wish to have the system automatically generate licence numbers or if you wish to manually enter them If selected to have the system automatically generate the numbers please enter in the field to the right the number you want the system to begin using If your system will use numerical application numbers only specify whether you want the system to right justify these numbers This means that all numbers will be aligned on the right margin of the application This radio button req
186. o indicate if you want to have a letter printed now The following example should clarify this process You have received an application for varying two excipients and the commercial presentations of a product with a valid licence You must enter this application as step one of the variation process When you come to a final decision regarding one excipient i e you decide to accept the variation you may record that decision i e you record the variation of one excipient and exit the data entry screen telling the computer that further variations may be recorded At this point if you print or display licence information that one variation made will be reflected even if the other two are still pending World Health Organization 1998 161 SIAMED User Manual 162 World Health Organization 1998 Chapter 8 Drugs IF 8 12 Change Applicant Holder This option permits you to automatically change the name of the applicant licence holder representative manufacturer distributor in all applications and licences This feature is available to save time in those cases where companies change name or change their proprietary status HANGE LICENCE HOLDER REPRESENTAT IVE MANUFACTURER DISTRIBUTOR Current company DIMA COMPANY CCC New company BIO DRUG COMPANY KKK Change X Licence holders X4 Manufacturers Representatives Distributors Ok Exit Figure 8 31 Change Applicant Holder screen Curren
187. oduct aintenance WHO Nat ional Edit 16 62 23 am SUBSTANCE NOT IN UN LIST J IN UN CONSOLIDATED LIST Substance 1 1 OXYBIS ETHENE Exit Figure 11 8 UN Consolidated List screen 11 2 National This option is there for facilities meeting specific national requirements These requirements will be developed after installation 230 World Health Organization 1998 Chapter 12 Edit SZ 12 EDIT The EDIT menu option gives access to some text editing functions These features are accessible only when the user is editing a text such as recording inspections results and entering drug data sheets National Undo changes Cut Copy Transfer Paste Select all text Find Find again Replace and find again Frint ALT F Figure 12 1 Edit menu 12 1 Undo Changes This option allows you to Undo your last changes 12 2 Cut This option allows you to cut a word phrase or entire section of text and move it to another location or to simply delete it 12 3 Copy This option allows you to copy a word phrase or entire section of text and move it to another location 12 4 Transfer lt Paste gt This option allows you to transfer a previously cut or copied word phrase or section transfer it to a new area and paste it into that area 12 5 Select All Text This option allows you to select all text information on a screen and then move it elsewhere using the Cut Copy and
188. of all variations recorded for a given licence LIST OF VARIATIONS Licence 16 1996 Licensed 28 01 1996 Licence Holder COMPANY GGG Drug name A D C FLOR Strength Generic nane MULTIUITAMIN PREPARATION From 09 12 98_ Ce Screen To gt Printer 0k Exit Figure 8 48 Retrieval by Variations screen To generate this report complete the following steps 1 Select the licence whose variations you wish to print 2 Setan optional date range to limit the printout only to variations made within that date range If no dates are entered the printout will include all variations 3 Press lt lt Ok gt gt to print 188 World Health Organization 1998 Chapter 8 Drugs 8 14 12 Company Drug orientated Query This query option allows you to retrieve data on all licence holders manufacturers or distributors of a given group of drug products The drug product groups can be identified by their product name generic name or ingredient name QUERIES REGARDING COMPANY ROLES IN DRUGS To Search all gt Applicants licence holders Ce Screen lt gt Manufacturers gt Printer lt e Distributors 8 By a Mes D C X By generic na ACEFYLLINE PIPERAZINE X1 By elle GEPEFR Figure 8 49 Query screen used to retrieve Company Drug information To generate this report complete the following steps 1 Define the scope of the data The options you are offered on the screen are All Rec
189. or printed DELAYED APPLICATIONS NEW DRUG APPLICATIONS PROCESSING STEPS HUMAN Step 4 Q C L As of 22 66 1998 lt Expert gt Ce Screen gt Printer Figure 8 37 Retrieval of Delayed Applications screen To generate the delayed applications report complete the following steps 1 Select the appropriate type of processing 2 Specify how you want the information retrieved To retrieve by step type in the step number or press lt F2 gt to select the step from the revealed list If you do not select a step you will be shown pending applications at all steps grouped in step order To retrieve by an assigned expert click on lt Expert gt and select from the file content list NOTE If you do not select any step the report will display information on ALL steps giving a global overview of delayed applications 3 The system will automatically enter the current date for the As of date To specify a different date simply type in the new date 4 Select where the output should go and press lt lt Ok gt gt or lt Exit gt to return to the Main Menu World Health Organization 1998 169 SIAMED User Manual 8 14 5 Licence Status This retrieval option allows you to see the status of a licence including any renewals variations or cancellations Typing in the licence number will display data regarding the applicant drug name strength and generic name Click on any line that appears in the low
190. orted Both The screen also displays 16 additional options that allow you to provide more detailed information about the current application Each of these options when selected gives access to an additional window that contains more data field To select an option simply click the desired screen button and enter the data requested The following is a description of the subsequent screens that appears when a selection is made World Health Organization 1998 127 SIAMED User Manual 8 1 1 Additional Information m ne Application nr 8289N 95 Representative DRUG COMPANY JJJ Type of licence To manufacture and sell Restrictions N None Dispensing categ P Prescription only Shelf life SRE B lt Storage cond National formulary P 5 Location of file Representative Type of Licence Restrictions Dispensing Category 128 APPLICAT ION DDITIONAL INFORMATION Figure 8 5 Additional Information screen This field may be left blank if it is the same as the company on the original application screen if the company submitting the application is being represented by a separate company enter the other company s name here You can press lt Enter gt lt F2 gt or click the right mouse button to get a list and select the desired item If the concept representative is irrelevant to your national context you can ignore this field or simply assign it whatever function that is meaningful to you It i
191. ost Marketing This field is used to enter any information relating to post Surveillance marketing surveillance studies Adjacent to this field a summary field exists in which up to 20 characters can be entered that can be used to summarize the contents of this window such as a rare adverse reactions to a drug Other Notes This is field gives access to a free text window where additional information regarding the marketing performance of the product can be entered here Adjacent to this field a summary field exists in which up to 20 characters can be entered that can be used to summarize the contents of this window Once you ve completed entering this information press lt lt Ok gt gt to save your entry If you wish you may also select a print option to provide a hard copy output of the information entered in the Post registration Follow up screen World Health Organization 1998 153 SIAMED User Manual 8 7 Cancellation This option permits you to record the decision to cancel or suspend one or more licences Cancelled licences can be validated again using the Revalidation menu option This procedure is also used to reactivate suspended licences The distinction between cancelled and suspended licences can be entered as a specific cancellation cause or as free notes ANCELLING LICENCES Cancellation cause IC Irrational Combination Cancellation date B2 06 1998 lt Enlarge text gt lt One licence lt Several
192. other activity Distributor Hospital Pharmacy Screen lt Select all gt lt Deselect all lt gt Printer Item group Controlled Substances Cosmetics Injectables lt Select all gt lt Deselect all Figure 6 10 Retrieval of Companies by Activity and Geographical Code Country Region Specify the country region district or town that serve as the District Town primary criteria for sorting companies Activi Specify the activities with which the companies are involved World Health Organization 1998 99 SIAMED User Manual Item Group Specify which item groups the companies are involved with Select All Choosing Select All or Deselect All either selects all activities Deselect All or item groups listed in the respective boxes or deselects them 6 2 7 Companies with No Activities This retrieval option identifies companies by geographical code for which no activity has been recorded in the computer system COMPANIES WITH NO ACTIVITY ASSIGNED Country HUN HUNGARY Town e Screen gt Printer Figure 6 11 Companies with No Activities retrieval screen 6 2 8 Companies with One Activity This retrieval option will list companies for which no other activity than the one selected has been recorded COMPANIES WITH ONE ACTIVITY Country LUX LUXEMBOURG Town Activity Another activity Screen Distributor lt gt Printer Hospital Pharmacy Importer Licence Holder o
193. ottles with 30 50 and 100 tablets etc NOTE Assigning separate application and licence numbers to each individual presentation of the same product is technically more rigorous and offers the obvious advantage of making much simpler drug utilization and consumption studies On the other hand it requires a little more work in the drug registration process The choice between one option and the other is left with the licensing authority Dosage Form Enter the code of the dosage form or either press lt F2 gt or click the right mouse button to get a list and select the desired item Primary Type in the code of primary container or either press lt F2 gt or click Containers the right mouse button to get a list and select the desired item Specifications Refers to characteristics of primary container Example dark glass scored ampule etc Maximum length 70 characters The screen also displays three pop up boxes which perform the following functions Generic Brand Displays a pop up menu which allows you to specify whether the product is a generic product or a brand name Branded generic products would fall either under brand because they are not labeled with the generic name only or under generic depending on national regulations Human Select the option that is appropriate to describe whether the drug is Veterinary for human use or veterinary use Domestic Select the option that is applicable in your national context Imp
194. ou type or click the mouse but nothing happens If you look at the extreme right or left of the foremost window you may see a small part of the one that has disappeared behind it If you see it just click on it and the hidden window will return to the front of the screen If you cannot see the background window use the Change foremost window option on the Maintenance label or press lt Ctrl gt lt F1 gt The hidden window will come to the front and you will be able to continue working Alphabetical Search Window At different stages in the SIAMED system you will need to enter information from your Catalogue files such as Geographical Codes or Companies just to name a few The alphabetical search window lists file contents contained in your database file inn alphabetical order This window is activated by clicking the right mouse button or pressing lt F2 gt when your cursor is in a field that requires data from a catalogue file As you type each letter of the item name the system will automatically search the list for that item 32 World Health Organization 1998 Chapter 3 Commands And Functions NZ COUNTRIES I Find gt BE Type characters Locate matching data PgUp PgDn t Move Bar Enter or Click Rigth Mouse Select Order by Description Description ANGUILLA ARGENTINA BAHAMAS BARBADOS BELIZE BERMUDA BOLIVIA BRAZIL BRITISH VIRGIN ISLANDS CANADA CHILE Press lt lt lt Esc gt gt gt to exit Fig
195. ous screen Press lt Exit gt return to the cancellation licence screen World Health Organization 1998 155 SIAMED User Manual 8 7 2 Several Licences Select this option if you wish to specify several licences which should be cancelled Selecting this option displays the screen below Criteria By licence holder applicant By manufacturer By ingredient Nane Figure 8 26 Cancelling Multiple Licences screen Criteria This pop up field displays 3 criteria by which you use for cancelling licences Select one of the following criterion By licence holder applicant by manufacturer or by ingredient Name This field will be dependent upon the criterion selected name of licence holder applicant manufacturer or ingredient Once you have entered the appropriate item press lt lt Ok gt gt This option confirms that you wish to cancel all licences that have been submitted based on the criterion selected The system will prompt you to confirm your action or go back The system will them ask you whether or not you wish to print the cancellation letter If you select lt lt YES gt gt the system will generate cancellation letters for all licences based on your criteria selected See Section 12 10 for details on generating a letter You can select lt Exit gt to return to the previous Cancellation Licence menu 156 World Health Organization 1998 Chapter 8 Drugs WEY 8 8 Revalidation Application
196. outes of administration Types of licence Availability restrictions Dispensing categories Rejection Cancellation causes Processing steps Drug classification Substance names dictionary Priority Fees Company activities Manufacturers roles Correspondence formats Professions Item groups Professionals Types of relation Types of price Figure 5 2 Catalogue Menu Abbreviations must be stored in catalogues for the system to work properly Entry of abbreviations in catalogues is done directly using the Catalogue menu options which are accessible even while performing other operations such as entering company or drug data Some catalogues are already filled with examples to make familiarization with the system easier others must be completed by the SIAMED user based on their working procedures This section is designed to act as a reference guide The following is a discussion that presents all catalogue options and their uses This discussion is followed by detailed information on each option World Health Organization 1998 47 Geographical Codes Primary Containers Dosage Forms Routes of Administration Types of Licence Availability Restrictions Dispensing Categories Rejection Cancellation Causes Processing Steps Drug Classification 48 SIAMED User Manual The Geographical Codes catalogue contains a database listing of codes assigned to define countries regions districts and or towns
197. plicant company You can also press lt F2 gt to select from a list of applicants Use this field to enter a date which the computer will use to generate a list of all fees due from the licence holder by the date indicated If information on fees or payments has been entered into the system the generated list will display payments status Use these push buttons to select from the list of items generated Selecting an item includes it in the list of items for which payment has been received on a given date and for which the same receipt number will be used Enter the date on which payment was received Type the receipt number Once data entry has been completed press lt lt Ok gt gt to save your entry The system will automatically print a payment receipt for all selected items if a payment has been recorded Press lt Exit gt to return to the main menu 9 3 Receipt Text The Receipt Text function allows you to prepare and edit the text that will accompany the list of items for which fee payment has been received RECEIPT TEXT 202 Figure 9 3 Receipt Text screen World Health Organization 1998 Chapter 9 Fees WEE 9 4 RETRIEVAL Fees The Retrieval section under the Fees menu option consist of three sub menus Fees Due By Type of Fee and By Licence Holder Licensing Maintenance WHO Edit Nat i a Catalogues b Companies c Retrieval gt d Inspections e Retrieval f Drugs g R
198. port title and press lt Enter gt 3 Select from the list of fields that appears in the lower left side of the screen the fields you wish to see printed You can select them either with the light bar and lt Enter gt key or by clicking on the field with the mouse 4 Type in the width for these data 5 To remove a selected item just select it again and or set field width to 0 zero Selected items are 1dentified by a number indicating width and an arrow sign The remaining number of columns is shown on the screen after each item selection Some items indicated by the absence of the column width number do not use up column space because they are printed on separate lines 6 Click lt lt OK gt gt after completing the selection of columns 7 On the new screen click the Order by pop up window This pop up window shows all items that you selected to appear in columns Any of them can be chosen to define the order in which data are printed World Health Organization 1998 183 8 10 11 12 13 SIAMED User Manual You can now restrict the range of items to be printed to Human Veterinary Both and to a variety of application licence statuses This is done selecting as appropriate from the respective lists Press lt lt Ok gt gt to continue or lt Exit gt to return to the Main Menu The left side of the screen lists all the items you have selected in the previous screen Click the left mouse
199. r Rejected 146 Revalidation Renewal 11 Application Nr 120 Applications step 42 Approved Company 89 ASCI 233 ASCI Chart 205 ASCII format 133 Assign User Passwords step 41 Authorization 10 233 Company Operating 10 Marketing 10 Other Types 10 Automatic Numbering Application 212 World Health Organization 1998 INDEX licence 212 Availability Restrictions 48 56 Back Up 215 233 Calculator 205 Cancellation licence 151 Cancellation Causes 48 58 Cancelled Company 89 Catalogue defined 4 Catalogue Files 233 Catalogues 233 description 45 step 41 Catalogues menu 47 CHANGE Application 120 Check Box 31 Check Boxes 233 Classification 233 Companies 87 description 45 step 41 Company defined 4 Representative 14 Company Activities 49 Catalogue 74 Company Files 233 CONFIG SYS 21 CONFIG SYS file 21 Configuration 210 233 step 41 Configuring during installation 21 Continent 50 COPY Application 120 Correspondence Format 76 Correspondence Formats 49 Correspondence Prompt 212 Country Geographical Code 50 COUNTRY level 210 Currencies 51 Currency 211 233 Data Sheet Application 133 Defining Fees 195 Issuing Invoices 195 DELETE Application 120 247 SIAMED User Manual Deleting Licences 160 Dispensing Categories 48 57 234 Distributor defined 15 Distributors Appl
200. r which you want to retrieve information Country Region Displays information about the selected company as determined District Town above Type of Relation Specify the type of relation for which you want to retrieve information Screen Printer Select where output should go 98 World Health Organization 1998 Chapter 6 Companies 6 2 5 Companies by Geographical Code This screen permits you retrieve information on companies by geographical code i e country region district or town COMPANY GEOGRAPHICAL DISTRIBUTION COUNTRIES Country ARG ARGENT INA Type characters Locate matching data gUp PgDn t y Move Bar Enter or Click Rigth Mouse Select Order hy Description Toun Code Description ALBANIA ALGERIA Screen AMERICAN SAMOA ANDORRA Printer lt ANGOLA ANGUILLA ANTIGUA AND BARBUDA ARGENTINA AUSTRALIA Press lt lt lt Esc gt gt to exit Figure 6 9 Retrieve Companies by Geographical Code In order to retrieve data under this option the levels of geographical codes must have been established at configuration If you are unsure of the code press lt F2 gt or click right mouse to get a list Press lt lt Ok gt gt when done 6 2 6 Companies by Activities and Geographical Distribution This feature retrieves information on companies by activity and geographical distribution COMPANIES BY ACTIVITY AND GEOGRAPHICAL DISTRIBUTION Country DEU GERMANY Town Activity An
201. re and requires that you enter a deadline date for the company to comply World Health Organization 1998 Chapter 7 Inspections WEE Reference Document Risk See All Notes Notes on this Inspection Each Result displays a reference document number to assist in retrieving information about the result This field allows you to edit the number of the reference document Below the reference document field is a numerical date field whose title changes based on the status indicated in the Results pop up window If the inspection concludes that the activity for which it was carried out IS performed consistent to the established requirements then the summary result will be indicated as Approved and the date field title will display Valid Until to indicate the date of validity If the inspected activity IS NOT consistent with the established requirements then the summary result will be indicated as Cancelled and the date field title will display On to indicate the date on which cancellation is effective If the inspected activity IS NOT consistent with the established requirements but can be met within a certain time then the summary result will be indicated as Term to Comply and the date field title will display Must Comply By to indicate the date limit for complying with the recommendations issued by the inspector s Select a risk level that may be associated with the inspection Your options are V
202. redient name On the other hand it contributes to establishing searching criteria that permit you to group together drugs that have the unusually large number of active ingredients in common Hard Drive The physical device in your computer which is used for storage of data The letter C is commonly used to refer to the drive or disk in your computer World Health Organization 1998 241 SIAMED User Manual Inactive Ingredient That portion of a drug which does not produce the intended therapeutic effect Main Register File Consolidates all information relating to each application and licenced product It is linked to other files containing information on ingredients manufacturers regulatory status etc Mouse Buttons Refers to the left and right buttons on the mouse which is used to move the user around the screen or document Multiple Formula Preparation Used to indicate that a drug may have the same container but different appearances and formulae Multiple Searching Criteria Utilized within the QCL retrieval system to search for data using specific criteria or guidelines depending on the information you want to extract Multiple Windows Refers to the user having more than one form window open on screen National Version A screen option via which individual laboratories can define functions and terms that are unique to their operation It allows the user to change words strings of text and to transla
203. regarding the dosage form World Health Organization 1998 53 SIAMED User Manual 5 6 Routes of Administration Routes of Administration describe how the drugs are to be administered product may have more than one route of administration and the system allows you to specify this selection ROUTES OF ADMINISTRATION Code IN Description nhalation ROUTES OF ADMINISTRATION Type characters Locate matching data PgUp PgDn t 4 Move Bar a Enter or Click Rigth Mouse Select Notes der hy Description Description Intraarticular Intradernal Intranuscular Intrathecal Intravenous Replace Delete gt lt Transdermal Vaginal Figure 5 7 Routes of Administration screen Press lt lt lt Esc gt gt to exit Code This is a unique code used to identify the route of administration Description This field displays the full description of the code Notes Use this text field to add any additional information 54 World Health Organization 1998 Chapter 5 Catalogues Sy 5 7 Types Of Licence This catalogue is available for countries that may require the user to specify whether a licence has been granted for importing selling studying or manufacturing purposes Other countries with only one type of licence will have to enter that one type of licence or a code to indicate that the type is not specified TYPES OF LICENCE Code I Description Io import and sell Notes lt Replace Delete
204. rganization 1998 Chapter 8 Drugs WEY Similar Formula Licence Approval Date Expiry Date Licensing Fees Limit Marketing Date Selecting this button causes the system carry out tow simultaneous searches The first reveal search is aimed at retrieving and displaying all drug items having at least one active ingredient Similar Ingredient in common with the item being used You may then select lt Print gt to print the results of the search or after viewing select lt Exit gt When you click lt Exit gt the other search is revealed which displays all items that have the Same Ingredient and Dosage Form as the item being entered unless automatic numbering has been selected at configuration The system checks that the number is not already in use You may again select lt Print gt to print the results of the search or after viewing select lt Exit gt return to the main application entry screen NOTE If you press lt Exit gt before you saved your entry you will be need that all your entry will be lost unless you save it This field will either display an automatic licence number or will allow you to enter the licence number being issued to the applicant Automatic numbering is available only if it was selected at the time of configuration If entered manually the system checks that the number is not already in use By default the system automatically enters the current date as the approval date However
205. rimary area for constructing and maintaining databases regarding various catalogues companies drugs inspections and fees associated with the effective operation of SIAMED Chapters 5 9 describes all the information necessary to properly use this feature of the programme World Health Organization 1998 27 SIAMED User Manual MAINTENANCE The Maintenance label is used to access all operations related to maintenance of the system This option establishes defaults for the entire system and allows you to Exit the programme Chapter 10 describes all the information necessary to properly configure and maintain the system WHO The WHO label permits the user to print product certificates access selected WHO documents and consult the UN Consolidated of Products Whose Consumption and or Sale have been Banned Withdrawn Severely Restricted or Not Approved by Governments Chapter 11 describes all the information necessary to properly use this feature of the program NATIONAL The National label outlines specific national requirements which need to be developed at the time of installation To activate a label on the Main Menu you may perform either of the following actions Y Point and click the left mouse button on the label to pull down the menu lists Press the lt F10 gt or lt Alt gt key and then the highlighted letter of the menu title you want to select A faded menu label means that either your password does not allow ac
206. rmation regarding manufacturers both domestic and based abroad importers distributors wholesalers government institutions pharmacies etc This database is similar to a catalogue in that it is not possible to use a company or institution that does not exist here while doing drug registration data entry However this database is intended to be used for storing summary information related to the management of licences issued for various domestic premises and the monitoring of the activities of companies based abroad Code A 15 character code that is uniquely assigned to each entity associated with the drug regulatory authority Name The name by which the company is commonly referred i e Roche Full Name Displays the full name of the company institution or entity to which the code has been assigned i e Hoffman La Roche Pharmaceuticals Inc When issuing correspondence users can select which name short or full shall appear on printed material World Health Organization 1998 89 Geographical Codes Mailing Address Plant Address Contact Person Area Code Phone Telex Fax Check Boxes Related Companies Additional Information 90 SIAMED User Manual Codes assigned to define countries regions districts and or towns in your country and make them more easily identifiable This option is used to indicate what those code assignments are See Section 5 3 for more details The location of the company
207. rmits you to search by generic name or part of it Follows the general rule Applicable operators are EQUAL NOT EQUAL and CONTAINS Use CONTAINS to search by part of the generic name Example To list all items where the generic name contains the string SALBUTAMOL select drug name from the fields list then the operator CONTAINS then enter the string SALBUTAMOL and press lt lt Ok gt gt and lt lt Execute gt gt The retrieved items will include SALBUTAMOL SALBUTAMOL INJECTION SALBUTAMOL TABLETS EXTRA STRENGTH SALBUTAMOL 174 World Health Organization 1998 Chapter 8 Drugs WEY Dosage Form Primary Container Specification Type of Licence Availability Restrictions Marketing Conditions National Formulary Code Location of File Shelf Life Withdrawal Period Generic Brand Permits you to search by dosage form Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by primary container Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by specification of primary container or part of it Follows the general rule Applicable operators are EQUAL NOT EQUAL and CONTAINS Use CONTAINS to search by part of the string Example To list all items where the specification of primary container contains the string dark glass select drug name from the fields list then the operator
208. rom here that all entries on drug products are first created The Entry Update application options listed here below permit you to perform various operations on drug licence applications APPLICATION OPTIONS Add Copy Change Delete Print Exit Figure 8 2 Entry Update Application screen To select the operation to perform either point to the operation and click the left mouse button on the required option or highlight it using the keyboard lt Tab gt or arrow keys and World Health Organization 1998 121 SIAMED User Manual press lt Enter gt A basic overview of each operation 1s described below 122 World Health Organization 1998 Chapter 8 Drugs WEY ADD Used to create a new entry COPY Used to create a new entry by copying an existing application or licence CHANGE Used to alter any data except the application number in an application after it has been entered No data can be changed from this menu option once an application has been rejected or approved into a licence However changes can be recorded through the Variations to licences menu option NOTE The history of variations to licences is recorded in a separate file together with date and password in use while the variation was entered DELETE This option is used to remove an entry from the file leaving no record of it Thus its application number can be used again except in automatic numbering mode Data can not be edited in this mod
209. ry information on distributors entered appears in a Distributors window placed in the lower part of the screen Selecting an item listed in the bottom portion of the screen and double clicking on it reveals a window option lt Delete gt the entry or lt Go Back gt one step Items listed in the Distributors window can be deleted by double clicking on them and selecting lt Delete gt or lt Tab gt as many times as is necessary to highlight the distributor s window and move to the item you want with the arrow keys When all information has been entered press lt Exit gt to return to the main application entry screen 138 World Health Organization 1998 Chapter 8 Drugs WEY 8 1 10 Veterinary Data This windows displays a free text field in which unlimited information can be entered relating to veterinary drugs or the veterinary use of human drugs e g withdrawal periods species or animal product related information Retrieval of veterinary data is performed by searching words in the entire text Thus it is important to assure consistency of terms used in data entry to get meaningful retrieval 8 1 11 Manufacturing Process This option permits you to enter critical information if any regarding important steps of the manufacturing process Information is entered as free text Retrieval of manufacturing process information is performed by searching words in the entire text Thus it is important to assure consistency o
210. s The Revalidation licence renewal Applications option permits you to record information about renewal of licence validity RENEWAL APPLICATIONS Licence 2227 1991 Licensed 11 83 1991 Licence Holder COMPANY 000 Drug name ACETOMED Strength 1 MG TAB Renewal application nr 94 Received 82 86 1998 Exit Figure 8 27 Revalidaion Renewal Application screen Revalidation also enables you to re validate a cancelled suspended licence In any case the old licence number is kept Licence renewal takes place in two or three steps First a renewal application number needs to be generated by the computer Y Second the renewal application can be retrieved though the above mentioned number to record decisions made at the different processing steps This is not compulsory 4 Finally the decision to renew or to cancel the licence is recorded The procedure for revalidating an application is as follows From the Licensing Menu select Drug and then Revalidation Application Type in the licence number and press lt Enter gt You can also press lt F2 gt or right mouse to get a list of file contents This displays the file contents list showing all renewable licences i e valid cancelled and expired licences If you do not find the licence you are looking for it means that this has never been entered or has been removed from the system After you have selected the licence summary information licence date licenc
211. s at a step Delayed applications Licence status Use multiple searching criteria Report generator Predefined reports Predefined statistics Price related retrieval Variations Company drug orientated query Correspondence New substances Processing duration Ingredient frequency Generic name frequency Ingredients by classification a b Ci d e f g h i J k 1 n n 0 p q r Figure 8 33 Retrieval menu All instructions indicate that you should type in the information requested Although not stated you also have the option of simply pressing lt F2 gt or clicking the right mouse button to reveal a list showing all applications and or licences from which you can choose that which applies to your needs In the case where both application and licence numbers are retrieval options the system will automatically distinguish among the two types of numbers However if the same number exists for both an application and a licence only the application will be retrieved World Health Organization O 1998 165 SIAMED User Manual 8 14 1 By Application Licence Number This option permits you to print an application or a licence in draft form APPLICATION LICENCE RETRIEVAL Licence 137 1996 Licensed 13 07 1996 Status VALID Expiry date 13 07 2001 Licence Holder DRUG COMPANY JJJ Drug name ADACARD BRAND Strength 26 MG CTD TAB Generic name NICARDIPINE Presentations CARTON BOX WITH 26 CTD TAB BLI
212. s just an option that permits to relate a second company to an application This field indicates the type of licence This field is linked to the type of licence catalogue Pressing lt F2 gt or clicking the right mouse button will provide a list of options from which you may select This field indicates if there are any restrictions that are placed on the distribution of the drug product Press lt F2 gt or click the right mouse button to get a list of restrictions and select the desired code This field is linked to the availability restrictions catalogue This field is used to specify the dispensing category for this particular application and is linked to the dispensing category catalogue Press lt F2 gt or click the right mouse button to get a list of dispensing categories and select the desired code World Health Organization 1998 Chapter 8 Drugs WEY Shelf Life Type in the number of months of shelf life established by the manufacturer and approved by the licensing authority When the available information is insufficient to make a decision a symbolic figure or zero should be entered Press the lt Storage conditions gt button to enter unlimited notes about storage conditions and shelf life information See below Storage Selecting this button results in a window where you can type Conditions unlimited information about storage conditions National Type in a national formulary list code or reference number if Formulary
213. s many times as is necessary to highlight the therapeutic group s window and move to the item you want with the arrow keys When all information has been entered press lt Exit gt to return to the main application entry screen 134 World Health Organization 1998 Chapter 8 Drugs WEY 8 1 7 Data Sheet Product Information This is an optional field to be set at configuration It offers an unlimited length text for indications contraindications etc Information can be either typed in or imported from an ASCII file submitted by applicants or drawn from any other source which of course can be edited ASCII format is an output mode provided by virtually all word processing packages sometimes also called DOS text mode or text file or ASCII file Importing files which are not in the ASCII format may be impossible or may require long editing work to render text readable In addition to importing an entire file you can also open an external text file while working on the data sheet You can select and transfer parts of such file to the data sheet To provide an example of this feature some text files have been added to the system under the WHO menu pad APPLICATION DATA SHEET Ce Enter data Drive and path lt gt Import from file D DEMON File name DATA SHEET lt Enlarge text ADDITIONAL NOTES Enlarge text Figure 8 10 Application Data Sheet screen Enter Data If this option is selected you may then use the Data Sheet an
214. sion World Health Organization 1998 51 SIAMED User Manual 5 4 Primary Containers This is the container in direct contact with the drug product PRIMARY CONTAINERS Code BOIN Description Bottle for injectables Notes lt Replace Delete gt lt Figure 5 5 Primary Containers screen Code This option is used to build a database of the various containers that are in direct contact with the drug Description This field displays the meaning of the code selected under the Code field For example Code BLIS is described as a Blister Notes Use this text field to add any additional information or notes 52 World Health Organization 1998 Chapter 5 Catalogues Sy 5 5 Dosage Forms This is the presentation form of the product DOSAGE FORMS Code CREA ORAL SOLID ORAL LIQUID Description C INJECTABLE TOPICAL OTHER Replace Delete gt lt Figure 5 6 Dosage Form screen Code This is a unique code used to identify the form For example if the item is paracetamol and it comes in tablet form the dosage form could be TAB Description This field displays the full description of the code Group This field is used to select a group to which the selected form should be assigned from the pop up window The following group options are displayed oral solid oral liquid injectable topical or other Notes Use this text field to add any additional information
215. splays the description of the code Amount Used to specify the amount of the fee Currency This field is used to specify the currency in which the fee is to be paid Annual Fee Check this box to indicate that the fee is to be paid yearly while the marketing authorization remains valid When a fee with this box checked is related to a marketing authorization the system will create as many payment deadlines as the number of years of validity of the authorization Notes Use this text field to add any additional information World Health Organization 1998 73 SIAMED User Manual The process of assigning fees works as follows Establishing Fees Relating Applications Licences to Fees Issuing Invoices Recording Payments amp Issuing Receipts 74 Fees are established under the Fee catalogue option The user must set a relationship between fees and the applications licences by selecting the relevant fee s while entering application data when issuing a marketing authorization or from the Fees submenu option Users can print invoices to applicants licence holders to remind them of payments due or simply to issue lists of fees due This is done through the Fees Retrieval submenu options Users can record payments through the Fees submenu options After recording a payment a receipt is automatically printed World Health Organization 1998 Chapter 5 Catalogues Sy 5 16 Company Activities This ca
216. st selected This reduces duplicate entries See Section 5 13 or 7 1 3 for more information 242 World Health Organization 1998 N Glossary Presentations A text field used to describe how the drug is presented to the consumer i e a bottle with capsules in it abox with ampules in it etc Primary Container The container in which the drug is contained e g a vial tube etc Processing Steps used to define how long an application will be in processing before an authorization is issued Also used to indicate at what phase of the process an application is currently in Product Licence Physical document given to a company organization stating that it is authorized to market a product within the host country Push Buttons Buttons designated by a single set lt gt or double set lt lt gt gt of opposing arrows which are usually found across or near the bottom of an active screen These buttons are used to activate functions such as the completion of an entry searches exit the screen or give the user access to secondary form windows Radio Buttons Used to indicate options where only one choice can be made The choices available via a radio button are referred to as reciprocally excluding options i e if option A is selected then option B can not be selected RAM Random Access Memory Memory which PCs use to store information This type of memory is volatile therefore it loses the information o
217. st to get the name you need to retrieve Permits you to limit search to items where a given ingredient has been entered as either active excipient or other It does not follow the general rule because it can be selected only once If it is not selected all items are retrieved Obviously this searching criterion is meaningful only when associated to an ingredient name It is to be understood as the quantity of ingredient in the formula This permits you to limit the search to items where a given ingredient is present in a certain quantity Follows the general rule Applicable operators are EQUAL NOT EQUAL and CONTAINS Obviously this searching criterion is more meaningful when associated to an ingredient name Permits you to search by route of administration Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by therapeutic group Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by combination of therapeutic groups It does not follow the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by distributor Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search by distributor s country of origin Follows the general rule Applicable operators are EQUAL and NOT EQUAL Permits you to search items with specified text string in data sheet Follows the general rule Applicable opera
218. status approved cancelled term to comply or Y the search can be carried out within a given range of inspection dates The criteria are set based on the information you input on the screen INSPECTIONS Company ALF COMPANY JJJ Activity Another activity Distributor Hospital Pharmacy Importer Result Select all S Deselect all Country NEW DEMOLAND Town _ Ce Screen lt gt Printer Figure 7 8 Retrieval by Inspections screen Company The name of the company to be included in this search Leaving the company field blank includes ALL companies in the search Activity Specify what activity ies should be included i e manufacturer distribution etc If you wish to include all activities click the lt Select All gt button below the activity window Country Region Specify the geographical area to be included in the retrieval District Town process Pressing lt F2 gt or clicking the right mouse button will reveal a pop up window from which you can select From To date Specifies the date range in which the inspections were performed World Health Organization 1998 115 Allows you to retrieve information only for companies that have a specific status Approved This result indicates the company has a valid operating licence or if based abroad is accepted by implication Cancelled This result indicates the company does not have a valid operating licence or if based abroad is not or no long
219. t Enter the existing name of the applicant licence holder Company representative manufacturer or distributor You can press lt F2 gt to select from the list of available companies New Company Enter the new name which will replace the existing applicant licence holder representative manufacturer or distributor You can press lt F2 gt to select from the list of available companies from which you may make your selection Reminder The new company name must exist in the database or the system will display an error message Change Select the appropriate check box for the organization to which this Licence Holders change applies Representatives Manufacturers Distributors If you need to change this information only in a few items you should use the appropriate menu options for changing information in applications and record variations to licences After selecting the options to be changed click lt lt Ok gt gt to save your entry The system will prompt you to confirm your action or allow you to go back After you have confirmed your action the system will begin processing and update all relevant information throughout the program Press lt Exit gt to return to the Main Menu World Health Organization 1998 163 SIAMED User Manual 8 13 Deleting Licences This option permits you to remove a licence from the database No information about deleted licences can be retrieved once it has been deleted The database will
220. t define an abbreviation and a description for the abbreviation After entering the desired data select lt lt Ok gt gt to save your data You may begin entering more data or select lt Exit gt to leave the current screen Continent Country Region District 50 This is a pop up field that allows you to select the continent on which your country resides Press lt Enter gt or click the right mouse button to view the list of continents This field contains the abbreviation for your country A predefined list of countries is available by pressing lt F2 gt This list is based on the continent you selected If the country you wish to enter is not on the list you may add the desired abbreviation This field should contain the abbreviation for a defined region in the above country A list of regions is available by pressing lt F2 gt This list is based on the country you selected If the region you wish to enter is not on the list you may add the desired abbreviation This field should contain the abbreviation for a district in the above region Pressing lt F2 gt will display a list of available districts for the region This list will only show districts that have been defined specifically for the selected region If you wish to add a new district enter the abbreviation here World Health Organization 1998 Chapter 5 Catalogues SS Town Use this field to define a specific town in a district Keep in mind that eac
221. t mouse button on the appropriate item group You are also given the option to Select All or Deselect All activities listed on this screen World Health Organization 1998 91 SIAMED User Manual See All Notes Selecting this button reveals a text screen of notes previously entered when using this option or when entering summary information You may enter additional noted on this screen any time These free notes will be accessible when entering summary inspection results Notes of Last This button allows you to view the inspectors notes on the last Inspection inspection of the referenced company Information on Selecting this button will permit you to select another company and Other Company view its information By double clicking on the activities for which the other company has been authorized reveals fields that indicate if the company has been approved cancelled or given a term to comply and corresponding dates the reference document number and notes relating to the document If you select the check box Other another window is revealed where you must indicate an activity drawn from the company activities catalogue This window is similar to the screen shown above with the exception of two additional fields Activity Select an activity from the list by pressing lt F2 gt and double clicking on your choice If the item you need is not in the catalogue you can add it now To add a new entry you simply pull down
222. t permit users to group together drugs that have the unusually large number of active ingredients in common 1 3 5 Types of Companies Four types of company entries can be made in application fields These are labelled Applicant Licence Holder Representative Manufacturer and Distributor A brief description is given here below of their use in the system Applicant Refers to the company submitting the application Usually it is the Licence Holder owner of the trade mark where applicable If the application results in a marketing authorization this company becomes the holder of such authorization As explained previously to make it fit in screens we have used the term licence rather than marketing authorization Thus licence holder and marketing authorization holder are synonyms in this system Only one company can be entered as applicant licence holder World Health Organization 1998 15 Representative Manufacturer Distributor 16 SIAMED User Manual This field is meant to accommodate the name of a company that either represents the licence holder for selected issues or is related to the product or the licence holder in some other way This is a specific requirement of a limited number of countries Refers to acompany that in some way participates in the manufacturing of a drug product The system can accept up to fifty 50 different manufacturers for the same drug product permitting users to specify for eac
223. talogue includes definitions of all the various types of possible company activities whether they require licences or permits issued by the authority or not This catalogue also extends to those companies that may not be involved in the importing or manufacturing of drugs but may merely be end users such as a dispensing physician or hospital pharmacy OMPANY ACTIVITIES Code HP Description Hospital Pharmacy Notes lt Replace Delete gt lt Figure 5 24 Company Activities screen Code This is a unique code used to identify the various types of company activities Description This field displays the description of the code Notes Use this text field to add any additional information All activities involving a specific licence can be listed here as well as those that do not require it To ensure proper functioning of the system Manufacturers Distributors and Community Street pharmacies have preset internal codes and should not be entered here World Health Organization 1998 75 SIAMED User Manual 5 17 Manufacturer s Roles This catalogue allows the user to specify the roles of the different manufacturers that intervene in the production process of each individual drug such as production of raw materials formulation packaging etc ANUFACTURERS ROLES Code FO Description Formulation only Notes lt Replace Delete gt lt Figure 5 25 Sample of Manufacturer s Roles screen Code Th
224. te text into terms appropriate for the nation in which the laboratory functions Changes to the national version are implemented throughout that laboratory s version of QCL Network a group of computers connected together in a small area for the purpose of sharing peripherals applications and files Operating licence Physical document given to a company organization that is authorized to operate perform a specific activity within the host country Peripherals devices that are in some way connected to the computer and enables it to function and or function better Peripheral devices include printers keyboards the mouse etc Pop up Window This is a field or screen that provides a list of specific data from which you can make a selection that best suits your needs Pop up windows can be accessed by selecting lt F2 gt or clicking the right mouse button Often referred to as a pop up screen pop up field or drop down list Pre Defined Reports Reports generated by the system for which the search parameters have already been built into the report when the software was developed Preferred National Name This serves as a system default so that if an item already exists in the system and the user attempts to enter the same item under a different name the system will automatically correct the user s entry to the name that already exists Preferred National Name is established by each individual laboratory when a substance is fir
225. ted in some countries entail elsewhere issue of a new marketing authorization and cancellation of the previous one To accommodate such a variety of requirements the system permits you to record variation of all marketing authorization data except number and validity In all cases the history of variations is recorded World Health Organization 1998 11 SIAMED User Manual 12 World Health Organization 1998 Chapter 1 Introduction To SIAMED WEY 1 3 3 Application Processing Steps This system is based on the assumption that applications are treated as follows RECEIVE yo RECORD INFORMATION APPLICATIONS IN COMPUTER DISTRIBUTE FOR ASSESSMENT ACCORDING TO TYPE OF APPLICATION AND ORGANIZATION SET UP a INFORM REACH AND RECORD APPLICANT A FINAL DECISION The above diagram makes two basic assumptions 1 It is assumed that as soon as applications are received they are entered into the computer system In the case of applications for new marketing authorizations this operation entails at least the following numbering the application and entering number applicant name drug item name strength dosage form and primary container revalidation and variation applications this operation entails retrieving the marketing authorization to which the application refers and reading the application number that the computer generates At this point with three key strokes the computer can issue a receipt st
226. tem the names of the individual ingredients constituting the formula of a drug are called substance names The term generic name is used with reference to a product Two drug products may have the same generic name if they contain the same base of an active ingredient regardless of the dosage form or molecular form used in the formulation Description AL HYDROR IDE MG HYDROKIDE lt Replace Delete gt lt Figure 5 21 Generic Names screen When determining generic name it is strongly recommended that the consideration provided below be given careful review 70 World Health Organization 1998 Chapter 5 Catalogues SE Drug Products In this case the generic name is the name of the base that with Only One constitutes the active ingredient regardless of the molecular form Active Ingredient used in the formulation unless a specific salt has unique therapeutic uses unrelated to those of the base For example The generic name ampicillin applies to all drugs containing either ampicillin trihydrate ampicillin sodium ampicillin hydrochloride etc In this way a search based on the generic name ampicillin would permit you to retrieve all products containing any form of ampicillin irrespective of the dosage form This simplification applies only to the generic name field of an application It does not limit the possibility for users to record the full name and quantity of the active substance s in the ingredient fields
227. ter them For example one could use a plus sign to separate the two names and enter them only in alphabetical order e g amoxycillin clavulanic acid instead of clavulanic acid amoxycillin Drug Products with More Than Two Active Ingredients Building a generic name by adding those of the individual components is not practical In addition it is infrequent that a rational drug has three or more active ingredients The proposed approaches are these 1 enter in the generic name field the same predefined term for all drugs e g combination see composition or 2 enter an arbitrary term to indicate a loosely homogeneous group and use a predefined term for those drugs for which an homogeneous group is not easily identified e g multivitamin minerals minerals multivitamin electrolytes electrolytes glucose cold preparation combination see conposition The use of these arbitrary generic names does not limit search on the basis of an individual ingredient name On the other hand it contributes to establishing searching criteria that permit you to group together drugs that have the unusually large number of active ingredients in common World Health Organization 1998 Chapter 8 Drugs WEY Presentations This is a free text field of unlimited length It is used to describe the different presentations of the drug as appropriate Example bottle with 30 capsules box with 10 dark glass ampules plus 10 solvent clear glass ampules b
228. th Organization 1998 131 SIAMED User Manual If the substance name you entered or selected is accepted by the system it means that the name had already been previously used and established as Preferred National Name If the name you typed in is not accepted you should first look for synonyms in the substance names dictionary by pressing lt F2 gt or right mouse button If you do not find any synonyms or if the one you find is not convenient for you then you need to add the new substance name to the system See Section 5 13 Active Excipient Indicate whether the ingredient is Active Excipient or Other other Other is meant to help differentiate excipients to be mentioned on the label like alcohol tartrazine amaranth etc Quantity Enter the quantity of such ingredients in free text space up to 90 characters Press lt lt Ok gt gt to save your entry and it will appear in an ingredients window together with its quantity and the indication of Active Excipient or Other All subsequent ingredients will appear in that window the same way Ingredients listed in the window can be edited or deleted by clicking on them or retyping their name at the substance prompt or lt Tab gt as many times as is necessary to highlight the ingredient s window and move to the item you want with the arrow keys When all ingredients have been entered you can return to the main application entry screen by pressing lt Exit gt 8 1 3 1 Mu
229. that all companies will be printed Partial means that you are shown on the screen the list of all companies in file Pressing lt Enter gt or clicking left mouse when the bar is on acompany name results the data being printed for that specific company You can repeat this as many times as is necessary You can leave this selection mode by pressing lt Esc gt This feature in the case of a Total printout allows you to select whether companies should be listed by code or by name Once selections have been made press lt lt Ok gt gt to execute the selected action or lt Exit gt to return to the main menu 6 2 2 Multiple Searching Criteria The multiple searching criteria feature under the Retrieval option permits you to select groups of companies rather than the entire file COUNTRIES COMPANIES MULTIPLE SEARCHING CRITERIA AFGHANISTAN State owned ALBANIA Private ALGERIA All COMPANY ACTIVITIES Handles Nar Psy Another activity nels authorized Hospital Pharmacy Importer Item group Controlled Substances Cosmetics Injectables Countries Figure 6 6 Multiple Searching Criteria screen Select any number of countries ranging from one country to all countries within the database If you do not select anything the system includes all countries in the search If you select country A B and C the system lists companies from country A companies from country B as well as companies from country C
230. the new password is Class Unlimited This field is used to identify what level of access the user will have Access Limited i e unlimited or limited access Access If you select limited access this will reveal a window where all menu options are shown Simply click on the menu options that you wish to assign to that password Click again if you want to remove a selection already made Press lt lt Ok gt gt when entry is completed If you select unlimited access the user will have access to ALL SIAMED modules and catalogues and be authorized to make changes to the data within the system Click lt lt Ok gt gt to save the password just created lt Delete gt to remove an existing password lt Exit gt to return to the main menu Please Note To activate a new or an edited password you must either quit the system and World Health Organization 1998 213 SIAMED User Manual enter again or use the menu option Change Active User that permits you to shift to another password 10 1 2 Users Log This option permits you to display or print a list indicating system usage statistic for all users SYSTEM USAGE LOG Fron User ATZ To gt Users currently logged in Screen gt Users currently logged off gt Printer gt Both logged in and logged off 0k lt Delete Figure 10 5 Users Log screen The following is a brief description of the fields in Users Log From To These fi
231. ticular application Exem pt Check the Exempt check box in cases where an application is exempt from fees To complete the entry press lt lt Ok gt gt Summary information on licensing fees entered appears in a Licensing Fees window placed in the lower part of the screen Selecting an item listed in the bottom portion of the screen and double clicking on it reveals a window option to lt Delete gt the entry or lt Go Back gt one step Items listed in the Licensing Fees window can be deleted or changed by double clicking on the desired item and selecting the appropriate button or lt Tab gt as many times as is necessary to highlight the licensing fee window and move to the item you want with the arrow keys When all information has been entered press lt Exit gt to return to the main application entry screen 140 World Health Organization 1998 Chapter 8 Drugs WEL 8 1 14 Reminders The Reminders option permits you to enter brief notes in a file These notes unless deactivated will pop up automatically at the time of issuance of the marketing authorization The same notes can be used to communicate with colleagues having access to the same file in order to draw their attention to any specific issue To enter a reminder into the system 1 Type in any notes Press lt lt Ok gt gt The first 40 characters of the entered text will be shown in the window placed in the lower part of the screen together with the d
232. tions f Drugs 4 bi Inspections by inspector g Retrieval Inspection outcome e Companies with no inspection h Fees d i Retrieval Figure 7 6 Retrieval Inspections menu 7 4 1 Inspectors This retrieval option permits you to produce a list of inspectors It also allows you to limit the search to a given geographical area i e country region district or town INSPECTORS Country Region District Town Screen Printer Figure 7 7 Retrieval by Inspectors Country Region Specify the geographical area to be included in the retrieval District Town process Pressing lt F2 gt or clicking the right mouse button will reveal a pop up window from which you can select a country Once the search criteria is established you can determine if you want to display the output on screen or send it to the printer 114 World Health Organization 1998 Chapter 7 Inspections ILE 7 4 2 Inspections This retrieval option permits you to retrieve information on various inspections This process can be carried out through different grouping criteria The search criteria options are as follows Y the search can be related to one company or to ALL companies by simply leaving the company field blank the search can be limited to one or more specific activity or open to all Y the search can be limited to companies based in one specific country or region Y the search can be limited to companies having a given
233. to another password without leaving the system Selecting this option activates the Password Checking process Activate this option at anytime by pressing lt Alt gt lt U gt This option closes all open files and leaves the system Pressing the lt Alt gt lt X gt keys or the lt F7 gt key will activate the same process World Health Organization 1998 Chapter 10 Maintenance 10 1 Maintenance Tools This menu option allows you to structure your system to be used by several different individuals while defining the extent of each user s access within the system Password assignment Users log Configuration National version Initialization Indexation Year end optimization Backup Restore Figure 10 2 Maintenance Tools menu Note for Network Users There are several options which are unavailable if more than one user is logged on the system 10 1 1 Password Assignment Use the main menu option Maintenance select 1 Maintenance Tools and then a Password assignment to reveal the screen via which passwords can be assigned to each user PASSWORD ASSIGNMENT Name NA Password NA Class e Unlimited access Limited access lt Delete Figure 10 3 Password Assignment screen Passwords are used to determine the level of access a user has to menu entries Password options are 4 unlimited access passwords 4 limited access passwords An Unlimited password always has access to
234. to issue correspondence with applicants and product certificates generate and make use of retrieval and reporting functions to make decisions present work done and check quality and consistency of data 1 2 2 Security A few basic rules must be respected to ensure that data are stored securely install the computer s in an appropriate place where it is protected from excess heat direct sunlight and unnecessary access back up data on a regular basis and store back ups in a secure place separate from the system allocate individual passwords to those authorized to use the system These passwords imply a specified level of authority allowing activities ranging from reading to entering data to validating and or changing data to allocating passwords and levels of authority to potential users 1 2 3 Factors for Successful Program Implementation Availability of the required hardware and software is not enough to achieve efficient drug registration The success of a computer based drug registration system also depends on legal and regulatory framework to clearly define policy Each country needs legislative measures to assign responsibility for establishing and enforcing drug control to a central Drug Regulatory authority This must have a structure that is appropriate to the various responsibilities involved in drug registration including control of labelling information and advertising and for inspection and control o
235. tor is CONTAINS Example To list all items where postpartum hemorrhage is mentioned in data sheet select data sheet from fields list type postpartum hemorrhage at the appropriate prompt then press lt lt Ok gt gt and lt lt Execute gt gt World Health Organization 1998 Chapter 8 Drugs WEE Additional Notes Permits you to search items with specified text string in additional notes field Follows the general rule Applicable operator is CONTAINS Example To list all items where counterfeit is mentioned in additional notes field select additional notes from fields list type counterfeit at the appropriate prompt then press lt lt Ok gt gt and lt lt Execute gt gt User Defined Fields defined by users when setting the configuration of the Fields system can be used as searching criteria They follow the general rule Applicable operators are EQUAL and NOT EQUAL World Health Organization 1998 179 SIAMED User Manual 8 14 6 2 How the Multiple Search Criteria Retrieval Tool Operates Example You want to know how many licences were valid on 31 December 1993 for imported tablets or capsules containing salbutamol as the sole active ingredient Process You select valid licences enter 31 12 1993 and press lt lt Ok gt gt in the first screen Then 1 Select Dosage Form from the field list Select EQUAL from the drop down list Press lt F2 gt or the right mouse button to c
236. tween application licence and one or more fees and to record information about fees and individual fee payments It is intended for managing any type of fee like application fee QC laboratory testing fee licence fee retention fee certificate fee etc To operate effectively this feature requires that fees exist in the appropriate catalogue Licence 294 95 Licence Holder COMPANY GGG Drug name A D C BAL Status VALID Expiry date 28 12 2668 LIC Application Fee 69 06 1998 89 66 1998 Figure 9 1 Payment of Fees by Application Licence Application Number or Licence Number Applicant Drug Name Status This is the unique number associated with each application licence The system will first search the applications database If the same number exists for both the application will be found Or you can press lt F2 gt to pick up the item you wish from a list This will automatically retrieve summary information describing the selected item This field displays the name of the applicant company Displays the name of the drug for which the licence has been sought Describes what phase of processing the application licence is in The central part of the screen displays the description name of any fee linked to the 200 World Health Organization 1998 Chapter 9 Fees WEE application the date on which payment is was due and the date on which payment was made recorded This data may be displayed with on
237. u will be able to type in the new text and press lt Enter gt Y Then press the up or down arrow key on the keyboard to see the entry changed in the window You can edit any text as many times as necessary NOTE THE SAME TEXT IS SOMETIMES USED IN VERY DIFFERENT CIRCUMSTANCES IT IS RECOMMENDED THAT YOU USE AS GENERIC A TEXT AS POSSIBLE TO MAKE IT USABLE IN MANY DIFFERENT CIRCUMSTANCES Messages codes are obviously the same for all languages Unfortunately the message text is not For this reason you may find that the same message or word is shown more than once This is due to the fact that depending on the context in which the word is used the same English word may require two or more different words in another language Thus if you know that you have already translated a word and you still find it ther in the old form you just have to do the translation one more time 10 1 5 Initialization This option allows you to empty and clean out the company and application licence files after you have carried out tests of the system using imaginary data entered to familiarize yourself with the system INITIALIZATION This process leaves some files empty proceed only if you know what you are doing Figure 10 7 Initialization warning screen If you choose the initialization option by selecting lt lt Ok gt gt a warning message is then displayed asking you to confirm your action by clicking lt lt Ok gt gt or ignoring your sele
238. ue of a product licence This option is used to build a database listing the various reasons for which an application could be rejected or a licence cancelled This is an optional catalogue which is used to define processing steps for applications and indicate how long an application could be in a particular phase of process This option is used to build a database that defines levels drug classification World Health Organization 1998 Chapter 5 Catalogues Sy Substance Names Dictionary Priority Fees Company Activities Manufacturers Roles Correspondence Formats Professions Item Groups Professionals Types of Relation Types of Price Gives access to the file holding information on over 80 000 different non proprietary names of pharmaceutical substances including their cross related synonyms and A T C codes The priority levels that are built in this database can be used to determine in what priority applications will be processed This option is used to build a database that defines the different types of fees used within the system This database is designed to contain the various types of company activities Users must NOT create codes here for the following activities manufacturer distributor or pharmacy These have preset codes within the system This option is used to build a database containing the different roles that manufacturers may play in the production process This opt
239. uires that you select whether or not you wish the system to automatically prompt you to generate correspondence for a specific licence or application every time you complete an entry In some countries licences lose validity if the licenced item is not marketed within a certain number of months You must enter the number of months as appropriate Once data entry is complete click on lt lt Ok gt gt to save your entry and return to the main configuration window World Health Organization 1998 217 SIAMED User Manual Selection of From the main configuration window if you click on the Processing lt Selection of processing steps gt button another screen will Steps appear Mark as appropriate to indicate that you will be using the processing steps facility for new drug licence applications renewal applications variation applications Click lt lt Ok gt gt to save your entries and return to the main configuration screen The purpose of this option is for you to indicate which processing steps you will be using in this application Click lt lt Ok gt gt to set the new configuration or on lt Exit gt to quit without saving 10 1 4 National Version SIAMED is available in Brazilian English French Portuguese and Spanish All messages you see on the screen or on the printouts are drawn from a separate file which is different for the different languages This file can accommodate an alternative expression that can
240. ula preparation Ce Standard preparation Substance ACTIVE Quantity Substance Quantity Act Exci Figure 8 7 Application Ingredients screen Formula This field is used to describe what unit the formula is referred to Referred To For example Each tablet contains 5 ml contain one sachet contains one metered dose delivers etc Multiple Formula Select the appropriate option between multiple formula preparation Preparation and standard preparation We have called multiple formula Standard preparation a drug like some oral contraceptives where the same Preparation container comes with tablets of different appearance that have different formulae If you select Multiple Formula Preparation see detailed information below Substance Enter the ingredient name This can be accomplished using one of the following options 1 Type in the name of the ingredient and press lt Enter gt It may seem to be the simplest and easiest way but it is not always so See options b and c 2 Press lt F2 gt or click the right mouse button to get a list and select the desired item This is the preferred option 3 Type part of the name of the ingredient and press lt F3 gt A list will appear showing only substance names containing the string you have entered regardless of its position in the name i e entering AMPT will display ampicillin bacampicillin etc Select the item you need World Heal
241. ure 3 5 Alphabetical Search Window The purpose of this window is to help you in locating an item in the file or to make sure that it is not there When searching names written with special characters e g Bogot M rida ug you may experience some imprecisions in the appearance of the alphabetical order When using an alphabetical search window the following actions may be performed To locate and point to an item Regardless of the position of the cursor type any number of characters An alphabetical search will start automatically positioning the light bar on the first item whose description matches the entered string of characters if one exists or on the item that immediately follows the one closest to the entered string Y Move the bar through the existing codes using lt PgUp gt lt PgDn gt or the arrow keys Move the mouse pointer to the item and click the left mouse button To select an item Y Press lt Enter gt or click the right mouse button when the light bar is on the item To exit without selecting an item Press lt Esc gt escape or click the left mouse button on the little square box that appears in the upper left corner of the window World Health Organization 1998 33 Moving From Field to Field SPECIAL KEYS lt F1 gt lt F2 gt lt F3 gt lt F7 gt lt F10 gt lt F12 gt lt Alt gt lt D gt lt Alt gt lt l gt lt Alt gt lt S gt 34 The easiest w
242. use lt F2 gt to select from the list Payment Due Enter the date on which the payment is due From To The list produced under this option shows application licence number drug name fee name amount date payment is was due status A as well as date payment was received 204 World Health Organization 1998 Chapter 9 Fees WEY 9 4 3 Fee by Licence Holder This feature permits you to print a list of all fees grouped by applicant licence holder FEES BY LICENCE HOLDER Licence Holder TAMI COMPANY BBB Payment due Screen Fron 897 23798 _ gt Printer To ie Figure 8 7 Fee by Licence Holder screen Licence Holder Specify the licence holder or use lt F2 gt to select from the list Payment Due Enter the date on which the payment is due From To The list produced under this option shows application licence number drug name fee name amount date payment is was due status A as well as date payment was received World Health Organization 1998 205 Chapter 10 Maintenance 10 MAINTENANCE The Maintenance menu option gives access to all operations related to the maintenance of the system Maintenance WHO Edit National a About the system b What s new c User manual d Calculator e Special Characters f ASCII chart g Change foremost window CTRL F1 h Select printer ALT D i Maintenance tools j Chek validities k Change password 1 Change active user
243. ush Buttons The three buttons labeled lt lt Ok gt gt lt Replace Delete gt lt Exit gt at the bottom of most form windows should be pressed by either clicking the left mouse button or pressing lt Enter gt when they are highlighted to highlight them press lt Tab gt as many times as required to position the cursor on them The fields are highlighted when they change colour or shade PRIMARY CONTAINERS Code Description Notes lt Replace Delete gt lt Figure 3 4 Illustrates the position of Push Buttons The following is a description of each button and how they should be used lt lt Ok gt gt This button is used to complete entries write them to disk and clear the screen fields lt Replace This button is used to remove the entry shown on the screen from Delete gt the database After pressing this button a new window appears indicating the entry to be replaced or deleted If you press the lt Delete gt button the system will search all your data to check whether the entry you want to delete is in use If so it will not 30 World Health Organization 1998 Chapter 3 Commands And Functions er allow you to delete it until you have replaced it with another one If you wish to Replace the data with new values you must first enter the new data that shall replace the old one After pressing the lt Replace gt button the system will go through all your data and replace all occurr
244. utomatically convert to the preferred national name This will prevent licensing drugs with the same ingredients being recorded under different names To change the preferred national name see Section 5 13 5 Group A T C The A T C code for the substance See Section 5 13 2 for more details Source Indicates the origin of the information 64 World Health Organization 1998 Chapter 5 Catalogues SS 5 13 2 A T C The anatomical Therapeutic Chemical ATC classification system is an international coding system provided by the WHO Collaborating Centre for Drug Statistics and Methodology of Oslo Norway and recommended by the WHO The ATC provides a common basis for drug classification to facilitate comparative data for drug consumption between different countries Drugs in this system have been divided into 14 main groups called the first level with two 2 subdivisions called second and third levels which are therapeutic subgroups There are two additional levels referred to as fourth and fifth levels which describe the chemical therapeutic subgroups and the single chemical substance respectively SIAMED comes with the 1993 version of the complete ATC classification list A T C CLASSIFICATION Type characters Locate matching data PgUp PgDn t Move Bar Enter or Click Rigth Mouse Select Order by Code Description ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS CARIES PROPHYLACTIC
245. w page bold type from the pop up list NOTE All correspondence formats must end with anew page mark The text may appear to be out of alignment but you will be able to edit this appearance once the variables have been replaced by real data and before sending the letter to the printer 78 World Health Organization 1998 Chapter 5 Catalogues Sy 5 19 Professions This catalogue works in conjunction with the Professionals catalogue option and permits greater flexibility in the definition of professions Its use is related to the management of inspections Code ANAL Description finalyst Notes lt Replace Delete gt lt Figure 5 27 Sample of Professions screen Code This is a unique code used to identify a profession Description This field displays the description of the code Notes Use this text field to add any additional information World Health Organization 1998 79 SIAMED User Manual 5 20 Item Groups The Item Group catalogue is utilized to provide additional specifications of the activities of a given company For example a manufacturer can deal with oral forms injectables external liquid forms disinfectants cosmetics etc each of these has been called an item group This additional specification can be used as a searching criterion for retrieval as well as a planning criterion when programming inspections ITEM GROUPS Code INJ Description Injectables Notes lt
246. will be retrieved whichever role they played in the manufacturing process Ingredient Permits you to search by ingredient Does not follow the general rule it uses OR to relate to other ingredients and combination of ingredients it uses AND for all other fields Applicable operators are EQUAL NOT EQUAL and CONTAINS Use Contains to search by part of the ingredient name Example To list all items containing any CHLOROQUINE salt select ingredient from the fields list then the operator CONTAINS then enter the string CHLOROQUINE and press lt lt Ok gt gt and lt lt Execute gt gt The retrieved items will include CHLOROQUINE CHLOROQUINE SULPHATE SULFATE DE CHLOROQUINE CHLOROQUINE DIPHOSPHATE The string to enter does not need to be an entire word if you enter CILLIN the retrieved items will include PENICILLIN AMPICILLIN etc Please Note Ingredients entered through this field will be linked with the OR operator That is if you choose chloroquine and then ampicillin the system will look for items containing EITHER chloroquine OR ampicillin To search for fixed dose combinations i e items containing BOTH chloroquine AND ampicillin you should use the specific INGREDIENTS COMBINATION option If you enter an ingredient name and press lt Enter gt the system will search exactly for the name you have entered Thus if you are not sure about the spelling or about the preferred national n
247. y enter any number of manufacturers for each application The responsible individual who handles company activities Indicates what part of the production process is carried out by each company participating in the production of the drug being entered This information is taken from the roles entered in the manufacturer role catalogue A free text field used to record free notes of any length only limit being hard disk space To complete the entry press lt lt Ok gt gt Summary information on manufacturer s entered appears in a manufacturers window placed in the lower part of the screen Clicking with the mouse on any company that appears in that window will permit you to edit data of that company or delete it You can also edit or remove a manufacturer from that window by typing in its name again at the manufacturer name prompt or lt Tab gt as many times as is necessary to highlight the manufacturer s window and move to the company you want with the arrow keys To return to the main application entry screen simply press lt Exit gt 130 World Health Organization 1998 Chapter 8 Drugs Sy 8 1 3 Ingredients Both active and inactive ingredients are entered here There is no limit to the number of ingredients that can be entered Provisions have been made to accommodate drugs e g some oral contraceptives that have multiple formulae in the same presentation INGREDIENTS Formula referred to gt Multiple form
248. y to the catalogue Users must be careful not to create unnecessarily large numbers of generic names When determining generic name it is strongly recommended that the information provided below be given careful review Drug Products with Only One Active Ingredient In this case the generic name is the name of the base that constitutes the active ingredient regardless of the form used in the formulation unless a specific salt has unique therapeutic uses unrelated to those of the base For example The generic name ampicillin applies to all drugs containing either ampicillin trihydrate ampicillin sodium ampicillin hydrochloride etc World Health Organization 1998 125 SIAMED User Manual This simplification applies only to the generic name field of an application It does not limit the possibility for users to record the full name and quantity of the active substance s in the ingredient fields Thus searches can be based on either the generic name or the individual full substance names of the ingredients Drug Products with Two Active Ingredients In this case the generic name reflects the names of the base that constitutes the two active ingredients regardless of the form used in the formulation unless a specific salt has unique therapeutic uses unrelated to those of the base These two names need to be entered in the same field Itis therefore recommended that to avoid repetitions a fixed format is used to en

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