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EUDRAGMP MANUAL FOR REGISTERED AND UNREGISTERED

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1. PM 134 44 1 TO Delete an MADAN T 135 4 4 1 4 To Review a Submitted MIA DOGUFTIelil uio oo bx oc aj R eoa RE REX Re EEE ASA ERE ERE ER XE Aaa zet AGA GE dE AOR AREA 135 4 4 1 5 To Print a Preview of a Submitted MIA Document 136 4 4 1 6 To Create a New Draft as a Copy of a Submitted MIA Document 137 4 4 1 7 To Return to the MIA Search Function ccccceccceeeeeee KEEN aaa aaa eres nese nese nnn nnn nnne snnt aaa kaka KEEN nna snnt e KEEN nna nnne EEN nnn nns 137 5 SENCHSIES ee 138 91 1 1 TOFeromia e each Eee 138 6 AdMINIS TAOS SO CU OW E 141 0 1 Zell aile A e e EE 141 02 Managing ACCESS NU EE 142 6 2 1 To Assign Access Privileges me EEUU 142 6 2 1 1 EudraGMP Access Privilege RE nl e 143 6 3 Managing EudraGMP Users in ECD Manager 144 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 6 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking 6 3 1 Setting Up an ECD Manager Account 144 6 3 2 To Create a User for Your Organisation 145 6 3 3 Ree te 149 6 3 4 Belge S 149 6 3 5 EE FISIO ee 150 6 4 Maintaining Company Giatus nennen nennen nnns nnn rese nennen nnne nnne sna nns 151 6 4
2. 2 7 5 2 Help The Help function in EudraGMP provides users with easy access to this User Manual in PDF 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 22 Zatacznik do OPZ ek k European Medicines Agency ATEAN User Manual Communications and Networking 2 1 9 9 Log Off Click the button to exit EudraGMP and any other Eudra SSO applications you have opened See Section 2 6 for more details 2 7 5 4 Language Selection JEngish Click the arrow to select another language for the application s User Interface If you are logged on as a registered user the available languages are English plus any other language that has been configured for your NCA Click to change to the newly chosen language for the application s User Interface 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 23 Zatacznik do OPZ BE Ae European Medicines Agency OT User Manual Communications and Networking 3 THE GMP COMPLIANCE MODULE 3 1 Overview The GMP Compliance Module of EudraGMP is designed to help prepare GMP certificates and Non Compliance Reports review them and finally submit them into the EudraGMP database The number of information items to be entered in a GMP Certificate and Non Compliance Report can be substantial The walkthrough of the multiple data entry screens for each of the above forms provided in this part of the manual is intended to ensure users interact with the application succes
3. li U Detailed written instructions to achieve uniformity of the performance of he special functions These provide a general framework enabling the efficient implementation and performance of the functions and activities or a particular process Definition erm acronym erm acronym Definition erm acronym Definition 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 168 Zatacznik do OPZ Ox European Medicines Agency ENER User Manual Communications and Networking BE Acronym The World Wide Web Consortium The World Wide Web Consortium is an international organization comprising Member organizations a full time staff and the public orking together to develop Web standards erm acronym Definition Acronym eXtensible Mark up Language A standardised language used for the creation and formatting of web documents formalised by the W3C erm acronym Definition 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 169 Zatacznik do OPZ Mr Ae European Medicines Agency OT User Manual Communications and Networking 8 BUSINESS RULES FOR THE GMP CERTIFICATE The current version of the Business Rules for GMP Certificates can be found at this location http euteleproj eudra org eudragmp library htm 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 170 Zatacznik do OPZ Mr Ae European Medicines Agency OT User Manual Communications and Networking 9 BUSI
4. t icon Click sort by E icon to sort by any of the categories t Click once and the records are now arranged in ascending order a z or 1 10 i Click again and the records are now arranged in descending order z a 10 1 1 Click 7 and an exact replica of the draft is created in the Drafts folder 2 Now change the details within the draft and take care to change the Certificate Number too 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 134 Zatacznik do OPZ P k European Medicines Agency ENER User Manual Communications and Networking 4 4 1 3 To Delete an MIA Draft 3 Inthe Draft MIAs screen click 28 next to the draft you want to delete 4 If you are sure you want to delete it click and the draft is removed from the Drafts database 4 4 1 4 To Review a Submitted MIA Document IA E LI a kee wee DINER NT Hates Dt yy Abr Mew fl LA Draft MIAS search MIA 1 If you have found the MIA document you were searching for click on the blue MIA Authorisation Number and the MIA document is called up from the database for review 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 135 Print Preview Zalacznik do OPZ European Medicines Agency User Manual Communications and Networking Update MIA Withdraw invalidate Back To Search Medicines and Healthcare products Regulatory 1 Authorisation Number 2 Nam
5. FR ANMV AFSSA romaintest FR AFSSAPS ramaintest FR AFSSAPS MIALoadJohb FR AFSSAPS MIALoadJok FR_AFSSAPS MIALoadJok FR_AFSSAPS MIALoadJob FR_AFSSAPS MIALoadJob FR AFSSAPS MIALoadJob FR_AFSSAPS MIALoadJok FR_AFSSAPS 2007 02 27 11 14 26 GMT 2007 04 26 11 43 25 GMT 2007 12 11 18 27 50 GMT 2007 11 23 13 53 46 GMT 2007 11 23 13 53 47 GMT 2007 11 23 13 56 50 GMT 2007 11 23 13 56 51 GMT 2007 11 23 13 56 53 GMT 2007 11 23 13 56 54 GMT 2007 11 23 13 56 55 GMT The below sections detail a number of tasks you can perform once you have retrieved a submitted Non Compliance Report from the database 4 3 1 To Update a Submitted MIA In the course of your work it is likely you will need to update or amend a submitted MIA document for example if the company s address changes if the site name changes or if manufacturing operations need to be added following an inspection Click Search MIA in the MIA Menu then search for the submitted MIA document you want to update See Section 4 3 To Search the MIA Database Now scroll down to the results which are displayed below the MIA Search input form and click on the blue MIA Authorisation Number Click Update MIA and a copy of the submitted document is automatically opened at the MIA Header tab and is saved as a draft MIA document in your Organisation s Draft MIAs database Now click and you can amend the MIA documen
6. Personal Tie Dr Firei Name Awsad Lam Hamer Ahmede Daily Mane Assad Ahmede Gender Male hinian Mother Tongue English Affiintion irks Fork MHRA London Tir Ma eps anrmedictest amhr org Telephone Humber Five Humber Mobde Number Eby Salus Adim Modiier L AE en Timestamp Houember 14 2998 12 12 44 PII Ge e Zalacznik do OPZ User Manual 11 Now you must reset password for the user This automatically sends an email to the user prompting them to log in to the system To do this click RESET PASSWORD in the Actions module a Contacts EMEA Internal Directory UI EVERE My Password PE ECD Resources Assad Ahmede C3 Company amp Staff sso Applications Search Display Name Assad Ahmede Mat assad ahmed test mhra org Reset Passwordf Dont Reset Password e M S S word N ont Reset Pass worc Reset Password Search Contacts NS at ages Search Company amp Staff Search SSO Applications Assad Ahmede 12 Click the drop down click RESET PASSWORD a and then click the SAVE button b 13 Click SSO APPLICATIONS in the ECD Resources module on the left of the browser E ECD Resources C Company amp Staff B sso Applications H Search 14 Click SEARCH to see the list of user groups you can administer The name of every user group is composed of INS and a standard acronym for the organisation If you are unsure of the acronym of the organis
7. 2 Now click the blue user name to view the user s details in full The user s details appear Notice the ACTION module on the right hand side of the browser window a 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 149 Zatacznik do OPZ pkk European Medicines Agency CZ User Manual Communications and Networking eegene Assad Ahmede u Actions c History search Contacts Search Company amp Staff Assad Ahmede Personal Title Dr First Name Assad Last Name Ahmede Display Name Assad Ahmede Gender Male Nationality Mother Tongue English Affiliation Yorks Fort MHRA London Title Mail assad ahmed test mhra org Telephone Number Fax Number Mobile Number Entry Status Active Modifier James Lenoel Default Modification Timestamp November 14 2006 12 32 44 PM GMT 00 00 3 Now click EDIT in the Action Module The entry fields become live so you can update or add information i E Actions Reset Password Change History 4 Finally click the SAVE button and the changes you have made are saved to the Contact Information 6 3 5 Change History r E Actions 7 E a EC Change History Change History lets administrators review the changes made to a user s Contact Information Remember that this information is only as good as the details you enter in the CHANGE HISTORY each time you make a change 29 05 2009 10 32 19 EudraGMP User Manual
8. NCA Ref Site Name H YOYOD YNE Ukraine Inc YOYODTNE Ukraine Inc YOYOD YTME Ukraine Inc YOYODYNE Ukraine Inc YOYODYNE Ukraine Inc YOYODYNE Ukraine Inc YOYODYNE La Plata Inc Address H 86 a Artema Street Donelsk 83050 Ukraine 86 4 Alema Street Donetsk 83050 Ukraine B5 3 Artema Street Donetsk 83050 Ukraine 86 3 Artema Street Donetsk 83050 Ukraine 85 3 Artema Street Donetsk 83050 Ukraine 86 4 Artema Street Donetsk 83050 Ukraine Estadio Jorge Luis Hirschi ist Avenue La Plata 23 000 Argentina Site Owner Status 7 n rm f Raka B OZ SUKL CZ SUKL CZ SUKL CZ SUKL Cz SUKL CZ SUKL Ll MHRA TE TT GMPC 2003 03 05 TC0009 12 GMP CP GMPC 2003 03 05 T20009 04 SMP MPE 2003 03 05 TCI GMPC 2008041 5 ES GMP 0027 10 GMPC 2009 03 06 TCD01 0 06 MP TCI WAPI GMPC 2005 03 06 TC0010 06 i3MP TCI WAPI GMPC 2009 04 03 TZ0011 13 EL Lia UL m Key EudraGMP Key This is the unique ID of the GMP Certificate on the database DUNS No D U N S Number for the Site if entered NCA Ref NCA Reference Key This is the Reference Number issued by the NCA who issued the GMP Site Name The name of the site which may include the manufacturer s name Site Address The address of the site including the country and postcode if applicable f C R Certificate a Status The status of
9. do OPZ ide European Medicines Agency te User Manual Communications and Networking 3 4 4 Part2 1 Click the Part 2 tab The form appears as illustrated The form is large so you ll need to use the scroll keys Ea or your mouse wheel to view the bottom half of the form Restrictions and Authorisation Review amp Submit GMP Compliance Manufacturing Prima ry Hatch Importation Mone Manufacturinc F ac King c e rtif Special Reqs Orly Orly Sterile Products C Aseptically prepared a b c d e 1 Large volume Liquids e B Lyophilisates e C E Semi solids Ge C E Small valume liquids e E Solids and implants e C E Other O C E Terminally Sterlised 1 Large volume Liquids C e B Semi solids Ge E E Small volume liquids e C E Solids and implants e C B C P Non sterile products is m Capsules hard shell 9 ry e xs LIE lactam Antibiotics Hormones Or Hormonal Activity Prostaglandins ae le iokines Cytotoxics de C cytostatics Immuna suppressives Medicinal Products Ze onm Frions senntaxics Or Teratogens C Fadiopharmaceuticals i Ectoparasiticides 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 65 Zatacznik do OPZ kk European Medicines Agency Z User Manual Communications and Networking 2 Next you must click the radio button or check box under at least one o
10. ed 1559 SWZ BSL Click radio button to select a particular site only one can be selected Click the Sort By button to arrange the items in ascending t or descending order Use the navigation buttons to refresh _ and jump forward RI and M or backward through results list Only the refresh button is present in the above screenshot as the results list is short Click Select button when you have activated the relevant site s radio button to choose a site that is already in the database 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 31 Zatacznik do OPZ ek x European Medicines Agency AT User Manual Communications and Networking 7 If you are sure that the inspected Manufacturing Site is not in the EudraGMP database a new site entry should be created Click and proceed as described in Section 3 2 3 2 Create New Site 8 Ifthere is a need to change the Name or NCA Heference Key in the Site Details click and proceed as described in Section 3 2 3 3 Update Site Details 9 To choose the MIA Number click the drop down arrow then click the relevant MIA Number 10 Add the Inspection End Date in the entry field using the appropriate format YYYY MM DD This is the date that the inspection was completed on Alternatively click the calendar icon and you can choose the date using the Calendar tool Ewe EES Left click arrows to arrow to choose year choose month Left click
11. or when used for an unauthorised indication or when used to gain further information about the authorised form Inspection Term On Site assessment of the compliance with the Community GMP principles performed by officials of Community Competent Authorities or authorities found equivalent under a Mutual Recognition 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 164 Zatacznik do OPZ kh European Medicines Agency OT User Manual Communications and Networking KZ emm Inspection report Term Report prepared by the official representing the Competent Authority stating whether the company inspected in general complies with the Community GMP principles and or the product and process related issues arising from the assessment of the application Inspecting Competent Authority 7erm The Competent Authority that has undertaken the inspection either and NCA or MRA Inputting Competent Authority Term The Competent Authority that is undertaking the work to enter the information into the EudraGMP system erm acronym Definition Acronym Marketing Authorization Application Across all European markets plus Australia New Zealand South Africa and Israel exceptions amongst major markets include USA Canada China and Japan the Marketing Authorization Application MAA is a common document used as the basis for a marketing application an application for approval to market the product based on a full review of
12. 03 14 Mew 11 47 06 GMT 2008 03 14 Mew 11 46 54 GMT 2008 03 05 New 15 04 22 Pe E E h k Za cznik I do OPZ eet European Medicines Agency AT ED User Manual Communications and Networking Authorisation Number This is the Authorisation Number you issued when you began drafting the GMP Certificate Authorisation Date The date on which the Authorisation is issued Authorisation Holder The name of the company that is to be issued with the MIA Town The town or place where the Authorisation Holder s registered head office is located Last Update By The user who last added to the draft Last Update Date The last save time of the draft Draft Type Draft type can be New which is an MIA that is in the process of being created or Update which is a previously submitted MIA document that is in the process of being updated Copy Draft Click ito create a copy of the draft with a new Draft ID number This draft MIA will be listed as a New Draft Type Delete Click the x icon to delete the draft Draft List Navigation Tool bar Use the navigation buttons to refresh _ and jump forward C and M or backward through results list 2 Now click on the draft you want to complete You can complete drafts created by you or your colleagues 3 To save progress simply click the Draft MIAs hyperlink or click another tab in the MIA form You can sort drafts by various criteria using the sort by
13. 19 EudraGMP User Manual v1 0 CURRENT 25 Zatacznik do OPZ ek k European Medicines Agency AT ED User Manual Communications and Networking 3 2 1 Possible States of a GMP Certificate In order to successfully use EudraGMP for the process of preparation and management of GMP Certificates it is useful to understand the way the system handles GMP Certificates from their initial creation to submission as a Valid document and if applicable its Withdrawal or Invalidation The diagram below shows the possible states in the life of a GMP certificate and how this state can be changed START Log On Using 550 CERTIFICATE Delete END Draft Deleted NO M Draft Valid gt YES VALID CERTIFICATE WITHDRAWN CERTIFICATE INVALIDATED CERTIFICATE END Withdrawn END Submitted Certificate remains on Certificate deleted fram database database Figure 1 GMP Certificate lifecycle 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 26 Zatacznik do OPZ ak European Medicines Agency CZ User Manual Communications and Networking 3 2 2 To Create and Submit a New GMP Certificate 1 Make sure you are logged in and you are on the EudraGMP Home Page below EudraGMP GMP Compliance Manufacturing and Importation Authorisation Operator Admin Help Welcome to EudraGMP Directives 2004 27 EC on human medicinal products and 2004 28 EC on veter
14. 3 for contact details Once you have been registered you will receive your username and initial password by e mail You can change your SSO password at any time using the instructions in Section 2 3 1 3 If you have forgotten your password you must ask your EudraGMP Administrator to reset it You will receive an e mail with the new password shortly afterwards 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 13 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking 2 3 1 2 Obtaining EudraGMP Access Privileges Your EudraGMP Administrator assigns specific EudraGMP access privileges using the Admin Module Section 6 These privileges will enable or disable your access to parts of EudraGMP Contact your EudraGMP Administrator if you believe you do not have the correct access privileges allocation 2 3 1 3 Changing Your Password To change your password connect to ECDManager This web based application manages the user community of EudraGMP and provides access to EMEA s directories 1 Open hitp ecdm eudra org in your browser to connect to ECDManager 2 The ECDManager homepage is displayed with the Log In Module positioned on the left as highlighted below Welcome ECD Manager Release 2 2 Friday August 4 2006 EMEA Internal Directory 4 Contacts EHTER THE CRITERIA FOR YOUR SEARCH Search name Last Name 3 Click in the U
15. 4 1 Adding a Biological Medicinal Product or Dosage Form 1 Ifthe Non Compliance Report applies to manufacturing primary packing or importation from a Dosage Form or a Biological Medicinal product that is not listed on the screen click on Other in the relevant section For example J E lactam Antibiotics Hormones Or Substances With Hormonal Activity Prostaglandins Cytokines C Cytotoxics Cytostatics CJ lmmuno suppressives Medicinal Products Containing Prions fsenotoxics Or Teratogens C Radiopharmaceuticals Rename Cancel In the drop down click Other a above and then click in the text field D and specify the item here Now click and Other becomes the item you have specified Finally close the drop down by clicking on the minimise button d 3 4 5 Adding Active Substances Restrictions and Authorisation Information to the Non Compliance Report The restrictions and authorisation section defines the product s Active Substance its Dictionary ID any restrictions surrounding the manufacture of the product within a site location and the Issuance and Signatory details 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 68 Zatacznik do OPZ BR Ae European Medicines Agency HT User Manual Communications and Networking EudraGMP Active Substance information is stored and managed in two locations for each NCA the Common Dictionary contains all Active Substances that ha
16. CURRENT 116 Zatacznik do OPZ BE Ae European Medicines Agency AT User Manual Communications and Networking b None is the default setting for the radio buttons c Click the radio button beside the dosage forms or the categories of Biological Medicinal Products for which manufacturing is authorised Click the radio button in this column to indicate that the authorisation for a particular dosage form only applies to its primary packing note that this option is not available for all dosage forms types This radio button is unselected Click inside the empty circle to select Move the mouse over the radio buttons for a tooltip Click the check box in this column to indicate that the authorisation for a particular group of dosage forms or category of Biological Medicinal Products only applies to Batch Certification Note that you cannot select this option if the manufacturing option C has been selected g Click button i under SPECIAL REQS to open drop down When a site is engaged in manufacture of products with special requirements you can provide additional detail on the product here or indeed add a product type Click the Importation check box if the MIA document applies to the importation from another country Complete the form according to the scope of the MIA you are creating If you are creating an MIA for multiple sites you must add each site in turn and then click each site and enter the details
17. Found FR Dictiona Ingredient Name in Selected gt e z DE hi Ryk us Ingredient Name English FR NCA Ref Key FR Rechercher substances actives Ingredient Name_FR Fred NCA Ref Key_FR Dictionary ID_FR a Rechercher Recherche substances actives 1 10 de 16 i EDT EE Dictionary Ingredient Name in Ingredient Name Nom de l autorit ID_FR Selected Language FR English FR comp tente DYE OPATINT RED d IRON OXIDE RED INGREDIENTS 2006 11 14 b Yoyodyne Rouge H Yoyodyne Red H FR_AFSSAPS New API PREDNISOLONE Yoyodyne Rouge H Yoyodyne Red H FR_ANMY AFSSA PHENOL RED SALINE SOLUTION BUFFERED Yoyodyne Red H FR_ANMYW AFSSA IRON OXIDE RED E172 g Ajouter substance active 2006 11 14 API Test 16 2 2006 11 14 New API Common Dictionary ID This ID refers to the entry of an Active Substance in the Common Dictionary If you select an entry from the Common Dictionary it is copied to your NCA Dictionary along with its Dictionary ID You should then add its Ingredient Name b and a NCA Ref Key If an entry has both a Dictionary ID and an NCA name this means the NCA user copied the Active Substance from the Common Dictionary then added an additional working language Ingredient Name and NCA Ref Key to create an entry in their own NCA Directory Ingredient Name in Selected Language This entry has been added by a user within the FR AFSSAPS NCA as indicated by its italics and the lack of Dictionary ID Ingr
18. Key BEE Nihddoloramine 150805 F r023 6 You have finished adding a new Active Substance Add any additional Active Substances in the same way You can now advance to the Restrictions form by clicking on the Restrictions tab To delete an Active Substance from the draft click the delete icon x This action does NOT delete the Active Substance from the database only from the draft 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 46 Zatacznik do OPZ P k European Medicines Agency ANEAN User Manual Communications and Networking 3 2 5 5 To Apply Restrictions The Restrictions list lets you indicate that the GMP Certificate applies only to a particular Building Name Room Name or Number Line Equipment QC Quality Control Test Product Name In addition restrictions can be formulated textually in a Comments section though this must in English 1 Click the Restrictions tab to open the Restrictions form 2 Now click Add Restriction and the Restrictions List appears Restrictions and Authorisation B E TTE XS TT Rc TU tien eect eee Restrictions TTE Signatory fi Building Name Room Name or Number Line Equipment QC Test Product Name Pinehearst Lodge Tablet press Mihildolaramirre In English Comments include comments related to the restriction in English here This content will be visible oniy ta registered users Characters remaining 894 999 in English for public user
19. NW 02H Detmold Dezernat 24 DE NW 03H Bezirksregierung D sseldorf DE NW 04 DE NW 05 District Government Muenster DE NW 06 Paul Ehrlich Institute Paul Ehrlich Institute DE PEI mE m State Agency for Health and Occupational Safety of Land Schleswig Holstein Ministry of Justice DE SH 01 DE SL 01 Health and Social Affairs Regierungsprasidium DE SN O1 Dresden Referat 24 GMP inspectorate Local Authority DE SN 02 Regierungsprasidium Leipzig EudraGMP User Manual v1 0 CURRENT 177 Zatacznik do OPZ BR Ae European Medicines Agency AT User Manual Communications and Networking Germany Landesverwaltungsamt Sachsen Department of drug DE ST 01 Anhalt and pharmacy Sachsen supervision Anhalt Germany Th ringer Landesamt f r Thuringian Authority DE TH 01H Lebensmittelsicherheit und for Food safety and Freistaat Verbraucherschutz Consumer Protection Th ringen Germany Th ringer Landesamt f r Thuringian Authority Lebensmittelsicherheit und for Food Safety and Freistaat Verbraucherschutz Consumer Protection Th ringen DE TH 01V Germany Th ringer Ministerium f r Soziales Thuringian Ministry of Familie und Gesundheit welfare family and Freistaat health Th ringen Denmark Leegemiddelstyrelsen Danish Medicines DK DKMA Agency Estonia Ravimiamet otate Agency of EE SAM Medicines Spain Agencia Espanola del Medicamento ES AEMPS y Productos Sanitarios Medicines A
20. OI MEER Uo INS PSC ON M 37 3 2 4 sp 38 3 2 4 4 Adding a Biological Medicinal Product or Dosage tom 40 3 20 Adding Active Substances Restrictions and Authorisation Information to the GMP Certificate 41 uu ov SANIMOMBELONA EE 41 3 2 5 2 National Competent Authority Dictionaries une nenn na a nenn 42 3293 10A08 ere Ee 42 3 2 5 4 To Create a New Active Substance esse aaa ee eee aaa aaa sree sees nennen ninh n ka seeseaseeeeeseaeseeeeeeeseesaeeeeeseeseneeeeess 45 3205 TOAD DIV ISGSIEICUOFIS EE 47 22 00 ToXdisSHidnce apd SIONAION TEE 48 3 2 6 To Review Print and Submit a Draft GMP Compliance Certificate eeeseeeeseeeeeeeeeeeeeeene 49 3 2 6 1 To Print or Save a Preview Draft GMP Compliance Certificate uoaaa aaa aaa a aaa aaa aaa aaa aaaa aa ener nnns 51 3 2 6 2 Successful Submission of a GMP Compliance Certificate ssaa ua aaa aaa aaa aaa aa nenne nnnnnennnnn nennen nenne nnnnnenennn nennen 51 32 00 WTobleshoolng Errors in GMP Module sen GG a AEG A E EE 52 3 3 GMP Non Compliance en CC 53 3 4 Non Compliance Reports Tutorial 2 20002000002000 nenne nnnnn nenne nenne nnnnnennnnn nenne nnnnne anne nennen 53 3 4 1 Possible States
21. Search for Submitted GMP Certificates Deletion of a Valid Certificate If a Certificate was submitted in error for example if an address or name of the site is incorrect it can be removed from the database by invalidating it This process is described in Section 3 5 1 3 To Invalidate a GMP Certificate Withdrawal of a Valid Certificate In some cases such as a failure to meet the previously attained GMP standards in an inspection there is a need to withdraw a Certificate See Section 3 5 1 4 To Withdraw a GMP Certificate for details Issuing GMP Non Compliance Reports If the initial inspection discovers non compliance with GMP standards or if previously attained GMP standards are not complied with in an inspection the issuing of a Non Compliance Report may be necessary See Section 3 4 Non Compliance Reports Tutorial for details Copying of a Valid Certificate or Report as a new Draft In some cases for instance to save editing time you may create a new draft by copying an existing Valid Certificate or Report to your Organisation s Drafts folder See Section 3 5 1 2 To Create a New Draft as a Copy of a Valid GMP Certificate 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 24 Zatacznik do OPZ geet European Medicines Agency ENER User Manual Communications and Networking Previewing and PDF generation Any Draft Valid or Withdrawn GMP Certificate or Non Compliance Report can be previewed in its ent
22. and Networking 3 2 3 1 Certificate Details Pati Part Restrictions and Authorisation Review amp Submit GMP Compliance Certificate Details Legal Basis Of Certificate Type of Inspection Certificate of GMP Compliance for Manufacturer Inspection Details Certificates Ihc avr 010508 Number a MRA Canada Health Canada Hl Partner E ada Health Canada HH Ti Japan Ministry of Health Labour and Welfare HH cite Address Mew Zealand Ministry of Health H M Switzerland Swiss Agency for Therapeutic Products H v l Site Name 1 Click the entry field A and enter the Certificate Number using a format approved by your own Organisation 2 If the GMP Certificate was issued by an MRA partner click the checkbox b and then click the arrow C Click the relevant MRA Competent Authority from the drop down list Select the scope of the document from the three options beneath the drop down Human Medicinal Products Veterinary Medicinal Products and Human Investigational Medicinal Products which should concur with the competence of the relevant NCA MRA Partner Australia Australian Pesticides and Veterinary Medicines Authority OD Human Medicinal Products Ll vete rinary Medicinal Products o Human investigathonal Medicinal Products 4 Now click the button to find and specify the Manufacturer s Site 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 29 Zatacznik do OPZ Wd
23. ar European Medicines Agency CZ User Manual Communications and Networking 2 1 4 Connectivity At its launch EudraGMP is available only via EudraNet This means that your workstation must be on a local network that is connected to EudraNet Please contact your local IT service desk if you are unsure whether you are connected to EudraNet 2 2 Unregistered User Access to EudraGMP Any user on a workstation that is connected to EudraNet can access EudraGMP This access requires no registration username or password but is limited in functionality Welcome to EudraGMP EudraGMP is a Community database containing information on all pharmaceutical manufacturers lacatet national competent authorities NCAs It includes details of those manufacturers Manufacturing and Imp Read only access to EudraGMP Access to EudraGMP application for registered users 2 3 Registered User Access to EudraGMP To enter and update information in EudraGMP you need to become a registered user with a username and password in the Eudra Single Sign On system Eudra SSO and with EudraGMP Access Privileges 2 3 1 1 Obtaining a Eudra SSO username and password To register for a Eudra SSO username and password contact the EudraGMP Administrator for your organisation The EudraGMP Administrator is responsible for account set up and access privileges If you are unsure who fills this role contact the EudraGMP Service Desk see Section 1
24. created by the NCA user according to their organisation s procedures 3 2 5 2 National Competent Authority Dictionaries Each NCA has a local Dictionary of Active Substances which is entirely separate from both the Common Dictionary and other NCA dictionaries within the NCA users country Every Active Substance created by your NCA appears and is viewable by ALL NCA users within your Country he Dictionary ID of the Active Substance appears if the Active Substance was copied from the Common Dictionary You must add a Substance Name in at least one of your NCA s working languages You must add a Substance Name in English An NCA Ref Key is also required This can be entered according to your NCA s procedures or generated automatically You can create new Active Substance Entries in three ways Create an entirely new entry which will appear within your NCA dictionary and will be visible to other NCA users in your country Select an entry found in the Common Dictionary and add a translation in the NCA working language Select an entry found in the NCA Dictionary of another NCA within your country In this instance you create a copy in your own NCA s Dictionary and can then add a translation in your NCA s working language 3 2 5 3 To Add Active Substances EudraGMP contains a Common Active Substance Dictionary Each Active Substance has a unique Dictionary ID As such you should always attempt to f
25. in the appropriate row C 3 4 5 6 To Add Issuance and Signatory The final section requires you to add the issue date of the Non Compliance Report and the Non Compliance Report s responsible Signatory 1 Click the _ to use the Calendar picker or click the entry field to enter the number manually using the approved order Year Month Day Now click the name of the signatory so it is highlighted and click the button to paste it into the Selected Signatories box To remove names from the Selected Signatories box click the La or 44 buttons You have completed the Issuance and Signatory section It s now time to review and submit your draft Non Compliance Report 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 75 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking 3 4 6 Part 3 Part 3 of the Non Compliance Report contains two tabs The first entitled Regulatory Action provides space for users to provide details of the Nature of the Non Compliance as well as check box options for the Action taken or proposed by the issuing NCA It also contains a field for Additional comments As with the other sections of the Non Compliance Report all text entered in text fields should be in English 3 4 6 1 Regulatory Action This form is separated into three sections the nature of non compliance is mandatory whilst at least one option from the Action taken propose
26. new draft 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 99 Zatacznik do OPZ European Medicines Agency User Manual Communications and Networking Click Search Withdrawn GMPC in the GMP Compliance Menu as illustrated above and the Search Withdrawn GMPC screen appears containing the results of the initial default search The default search returns all GMP Certificates withdrawn over the previous 12 months sorted by descending order of Withdrawn Date C rom 2003 03 26 77 YY Y Y MM DD Te Date 2003 05 08 YY Y Y MM DD bL ss Withdrawn GMPC Search Rosilis 5 ere Certificate Site Name A City H Eugr ab NCA Ref P Lompetem Verdrawmn Number t 2008 04 28 CREATE NEW Honsh Inc 2008 04 03 TCQOU11 08 GMP Oper 2009 04 03 T20011 03 GMP NIP war 2009 04 03 TC0011 03 GMP NIP wil AP 7005 04 03 TCO O11 03 GMP INIP WARI YOYOD YNE J Canada Ine Site 080127 Number 8 Boomer Inc JES Bristow Alberta Inc JES Bristow Alberta Inc J S Bristow Alberta Inc YAMAGUCHISHI Lierpaal Edmonton Edmonton Edmontori Country H Postcode DUNS Number BH H Key H Japan 341044 200 090 4291 23158 Canada K2V 1A5 United Kingdom TEZ 8EM Canada TEZ BEM TEZ BEM Canada Canada Ths SKM 20080428 1430 DEACTIVATED 79 APR D8 14 32 22 814721000 01 00 0901274 E IROD3 230221 238751 346331 mwatson 20
27. of the MIA document in the format it is issued in The document is created as a PDF which you can then print or save See Section 4 2 5 1 Print or Save Preview of MIA 4 4 1 6 To Create a New Draft as a Copy of a Submitted MIA Document D LI d LII d H BAR IF Mewy LA Draft Mls Search MIA If you have the required access privileges you can create a new draft MIA from a previously submitted MIA document 1 Click Search MIA in the MIA Menu then search for the submitted MIA document you want to copy 2 Now scroll down to the results which are displayed below the MIA Search input form and click on the blue MIA Authorisation Number 3 Click Copy As Draft and a copy of the submitted document is automatically opened at the MIA Header tab and is saved as a draft MIA document in your Organisation s Draft MIAs database 4 4 1 7 To Return to the MIA Search Function To return to the Search function click Back To Search Alternatively choose another option from the MIA Menu or the EudraGMP Main Menu bar at the top of the window 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 137 Zatacznik do OPZ at European Medicines Agency ENER User Manual Communications and Networking 5 SEARCH SITES B EudraGMP z hmmm d e GMP Compliance Manufacturing and Importation Authorisation earch Sie Admin FAQ Help Loy off English i It is likely that the inspe
28. only access to EudraGMP Access to EudraGMP application for registered users 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 15 Zatacznik do OPZ ak European Medicines Agency Z User Manual Communications and Networking 2 5 Logging in The login page of the Eudra Single Sign On SSO system appears when you request access to EudraGMP as a registered user e g by clicking the relevant link on the EudraGMP Homepage Section 2 4 SSO Login Page Sign In Enter your Sing Sign On user mamme and G tter to sign im a Daitschen b 1 Click in the USERNAME entry field d and type your username 2 Click in the PASSWORD entry field D and type your case sensitive password 3 Click Login C to advance to the EudraGMP Main Menu Section 2 7 2 Note If you are already logged on to Eudra SSO the EudraGMP Main Menu appears immediately 2 6 Logging off For security reasons you should always log off when you have finished using EudraGMP EudraGMP GMP Compliance Manufacturing and Importation Authorisation Search Site Admin FAQ Help Click the button to close the EudraGMP application If you are creating a GMP Certificate Non Compliance Report or MIA draft click on the En button to confirm that you want to log off Then click YES to display both secure and non secure items as this is a trusted website 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CUR
29. open file ormat created in 1993 It is used for representing two dimensional documents in a device independent and resolution independent fixed layout document format Each PDF file provides a complete description of a 2D document including all of its constituent elements fonts images text and graphics The pdf file format is now being prepared for submission as an ISO standard erm acronym Definition 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 167 Zatacznik do OPZ kh European Medicines Agency ENER User Manual Communications and Networking Acronym Quality Control Quality Control enacts the SOP monitoring and recording the activity of he process Term A laboratory that undertakes role of validating the quality of the products produced by manufacturers Active substance and medicinal Rapid Alerts Term The process by which information is disseminated to the field on he event of a product failure Radio Button Term A term to describe a circular check box which is part of a related group Only one radio button can be activated in one group at one time Rights Term Privileges assigned to a user that control the access to unctionality and visibility of information stored within EudraGMP erm acronym Definition Secondary packing Secondary packing refers to additional packaging beyond the actual container in which a medicinal product is stored OP Acronym Standard Operating Procedure
30. regarding scope of authorisation and allowed products Whilst the system has been designed to incorporate as much product typology as possible you may find it is necessary to add additional dosage forms The Special Requirement section has been created to fulfil this need Click the E SPECIAL REQUIREMENTS button a A drop down opens 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 117 Ak Se Enter the detail here European Medicines Agency Communications and Networking Special Reqs Hja B lactam Antibiotics Hormones Or Substances With Hormonal Activity Prostaglandins Cytokines cytotoxics Cytostatics l immuno suppressives Medicinal Products Containing Prions Genotoxics Or Teratogens L Radiopharmaceuticals J WT Zatacznik do OPZ User Manual To close the drop down click the E SPECIAL REQUIREMENTS button a again Note that the number of special requirements selected appears alongside the button even when the detail is hidden Bear in mind that the Annex is lengthy so ensure you review the bottom half of the Annex before advancing to Annex Il and the Annex Remarks See below for the second half of Annex I which has a slightly different appearance to the top half though is governed by identical business rules 4 2 3 6 Other Products or Manufacturing Activity 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 118 Zatacznik do OPZ pkk European
31. that part of the application i e only veterinary dosage forms are not included Now complete the rest of the form according to the scope of the MIA you are creating If you need to add any qualifying remarks or restrictions click the Annex II Remarks tab and enter any additional comments in the entry fields as described above To go back to the Annex I II section of the manual click here f you don t need to add any restrictions or other remarks click the Signatory Details tab The Signatory Details section follows immediately below 4 2 4 Signatory Details Each MIA must include at least one responsible Signatory to be valid You cannot submit an MIA document without a Signatory IW II ee ccm Signatory Details REGENTA Selected Signatories m GRETA Tel 2 Ur Patrick Llenaumarn gl HUA Pascale Briand Tal 33 1 4977 1350 3 Click the name of the relevant Signatory so it is highlighted blue a 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 122 pkk Za cznik do OPZ European Medicines Agency User Manual Communications and Networking 4 Now click the L paste key to move the Signatory into the Selected Signatories box b 5 You are now ready to review and submit the MIA document so click the Review 6 Submit MIA tab 4 2 5 Review 8 Submit MIA This is the final stage of the MIA document creation process 1 Click the Review and Submit MIA tab Your draft MIA
32. the EudraGMP application enables Registered Users to manage Draft GMP Certificates in their Organisation s Draft GMP Certificate folder 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 101 Zatacznik do OPZ aO European Medicines Agency CZ User Manual Communications and Networking 3 6 1 GMP Drafts Management GMP Compliance Menu Mew GHP Certificate New Mor Compliance Report Search Search GMP Compliance search Non Compliance Search Withdrawn GMPC When you exit EudraGMP or are logged out because of inactivity any progress you have made completing a GMP Certificate or Non Compliance Report is automatically saved within your organisation s Draft GMP Certificate database Click DRAFT GMP CERTIFICATES and the List of drafts appear Note that the Category column heading C indicates whether the draft is a GMP Certificate GMPC or a Non Compliance Report NCR List of draftis items Dran certificate Category SiteName City Update tony Change a Delete Lk EJ Number D H Date Draft Category n 13420 DocTesQ2373 Mi YOYODYNE amp SOUTHFORT EY Birkdale 2304 15 13 39 Inc GMT lenoell 2009 04 30 15 11 13 GMT DacTest23273 GMPC YOYODYNE LONDON lenoell 2009 04 30 CV Inc 12 41 57 GMT NCR lenoeli 2009 04 30 11 26 54 GMT 2008 04 03 GMPC YOTODYNE LIVERPOOL mwatson 2009 04 30 TC0011 15 Tuebrook Inc 08 38 37 GMP CP GMT 144246 2009 03 31 GMPC TOYODYNE Tusca
33. the document Document The document name Click on the blue text to open the document f unsuccessful the following message appears 29 05 2009 10 32 19 Site Owner The NCA that created the site rather than the NCA that created the document EudraGMP User Manual v1 0 CURRENT 139 Zatacznik do OPZ geet European Medicines Agency AT User Manual Communications and Networking Try to make a less specific search 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 140 Ak Se Zatacznik do OPZ European Medicines Agency User Manual Communications and Networking 6 ADMINISTRATORS SECTION This section is relevant for Administrators within Eudra GMP 1 To create users within ECD Manager to enable users to access EudraGMP see section 6 3 Managing EudraGMP Users in ECD Manager 2 To assign access privileges see section 6 1 Admin Module below 3 To Activate Deactivate Company see section 6 4 Maintaining Company Status 4 To Activate Deactivate Site see section 6 5 Maintaining Site Status 6 1 Admin Module Admin Menu Assign Access Privileges Activate Lieactivate Company Activate Deactivate Site Type of Inspection Delete GMIF Compliance Delete MIA The Administration Menu Admin Menu is visible only to Administrators of EudraGMP Its function is to enable EudraGMP Administrators to define access privileges of their user base and to activate
34. the inspection shall enter e jhe GMP te that thay issue into EudmeME The National Competent Authority of Member States shall enter the Manufacturing and Importation Authorisations that they issue into EudraGMP 2 Click GMP COMPLIANCE a and the GMP Compliance Menu appears on the left of the browser window GMP Compliance Menu Mew GHP Certificate New Mor Compliance Search Search GMP Compliance search Non Compliance Search Withdrawn GMPC 3 Click NEW NON COMPLIANCE REPORT in the GMP Compliance Menu on the left of the screen 4 Part 1 of the form appears Notice the tabs along the top of the form pamm Part 1 Part 2 Restrictions and Authorisation Part 3 Review amp Submit Non Compliance Report Report Details Legal Basis Of Certificate Type of Inspection 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 55 Zatacznik do OPZ ux European Medicines Agency Z User Manual Communications and Networking 3 4 3 Part1 Part 1 of the Non Compliance Report contains essential details of the Certificate such as the Certificate s number the legal basis on which the certificate is issued and the type of inspection that was undertaken Part 1 E Restrictions and Authorisation Part3 Review amp Submit Non Compliance Report Report Details RE Kei it Type of inspection Report of Non Compliance for Manufacturer inspection De
35. the navigation tools to browse this list and click the radio button circular box under the Select heading next to the appropriate site then click Select Search Sites Site Name YOYODYNE Country Unite d Kingdom Site Search Result 1 item Competent DUNS T NA he Key DH Site Name Address Authority Number E E Name R Lo 20 090 4232 20090423 23130 YOYODYNE 1113 KATE MORE UK MHRA ap a Select 919 Birkdale 2304 AVENUE Inc SOUTHFORT MERSEYSIDE L98 AVP 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 59 Zatacznik do OPZ P ds European Medicines Agency AT User Manual Communications and Networking through results list Only the refresh button c is present in the above screenshot as the results list is short Click Select button when you have activated the relevant site s radio button to choose a site that is already in the database Click Create Site to create a new site in EudraGMP See below If you are convinced that the inspected Manufacturing Site due to be issued with a Non Compliance Report is not in the EudraGMP database a new site entry may be created Click Create Site and proceed as described in Section 3 2 3 2 Create New Site If there is a need to change the Name Site Address or NCA Reference Key in the Site Details click and proceed as described in Section 3 2 3 3 Update Site Details 9 Once you hav
36. you were searching for click on the blue Report Number and the Report is called up from the database he below sections detail a number of tasks you can perform once you have retrieved a submitted Non Compliance Report from the database 3 5 2 1 To Print a Copy of the Non Compliance Report GMP Compliance Menu Mew GMP Certificate Mew Non compliance Report Draft GMP Certificates Search Search GMP Compliance Search Mon Compliance Search Withdrawn GMPC To print a copy of a Non Compliance Report you must first search for a Non Compliance Report and open it Follow Section 3 5 2 Search for Non Compliance Report to find the Non Compliance Report 1 Once the GMP Certificate is displayed on screen Click the button if you d prefer to review a hard copy of the GMP Certificate in the format it is issued in If you wish to exclude the details of any Teleconference arranged click the checkbox before you click Print Preview 2 The document is created as a PDF which you can then print or save 3 5 2 2 To View Previous Versions of a Non Compliance Report GMP Compliance Menu New GMP Certificate Mew Non Compliance Report Draft GMP Certificates Search Search GMP Compliance earch Man Compliance Search withdrawn GMPC To view previous versions of a Non Compliance Report you must first search for a Non Compliance Report and open it Follow Section 3
37. 08 4222 Au th nsaton Holder RE EE 108 a22 Create New Compay E o mre 111 4224 Legal Basis Eed RE 112 4 2 3 AURON E SES NEN T ERO OO OL OO A 112 LSU Seeed eS DS NT Ure 112 4 2 3 2 Add New Sites for E 113 425 ede E 115 4125324 PNM E 115 42 99 Adding Other Dosage FONS nasadki dci dO Gad ada elta t ka ER LR RR A aka 117 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 5 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking 4 2 3 6 Other Products or Manufacturing AMD uns aan ea ne pa Uca p 118 quon rue IR 120 Wao AO ee a E E E E T E E 121 4 2 4 Signatory RE UE 122 4 2 5 Review amp Submit MIA cccccccccecceceeeeceeeeeeeeeeeeeeeeeeeeseeeesseeeeseeeseeeessneesseeeeseeeeseeeessusesseeeeseeeesensesseeeageees 123 4 2 5 1 PRALOF Save Preview Ol WA P 124 4205 2 SUCCESS SUBMISSION of an MIB istuc is intrat O AAA euren 124 4 2 53 Troubleshooting Errors in MIA e e TT 124 4 3 Ke E e RRE MR EE TE 125 4 3 1 To Update a Submitted MIA 200 ccccccccccecccseeeeceeeeseeeesseeeeseeeeseeceseeeesseeeesueeeseeeesseeeesueceseeeesaeesseeesaeeeeees 128 cow DR Ee TEE e RE 018 c Sk 129 4 3 2 TO WOM ANCA AN EE 130 4 3 3 Tovada a IVI EE 132 4 4 Other Tools in the MIA Module uk 132 4 4 1 MIA Draft Management asa een o mm 133 AA Sor MA Drais By Category EEN 134 24 12 OCOY a0 MA DPA een
38. 0904031 20746 rm llar 2Z0090403114746 nal lar 200950403100306 mel ar Authority E CZ SUI UK MHRA LR MHRA UK MHRA UK MHRA UK MHRA Date fl 3009 04 29 14 31 53 GMT 2009 04 23 15 05 08 GMT 2009 04 03 12 34 21 GMT 2009 04 03 12 13 25 GMT 2009 04 03 11 54 51 GMT 2009 04 03 10 11 10 GMT You can refine the search using the following criteria By Withdrawn Date Enter the date after which the Certificate was withdrawn in the following format YYYY MM DD in the upper number field a Alternatively click on the calendar icon choose the date from the calendar Left click arrows to choose year Left click arrow to choose month 12 13 14 15 Pe JEZ ZPS 22 23 een JH Su 3 Today August 10 2006 IU 11 Left click date to return to the form 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 100 Zatacznik do OPZ kh European Medicines Agency AT User Manual Communications and Networking 3 Then include a date before which the GMP Certificate was withdrawn in the following format YYYY MM DD in the lower number field a Alternatively click on the calendar icon and choose the date from the calendar 4 Click D and the withdrawn GMP Certificate Search Results appear You can sort these alphabetically or numerically using the sorting icons d above See Section 3 6 1 GMP Drafts Management for more detail on managing the lists of
39. 1 Activate Deactivate Company nennsnennsneereosnrerrrrrrrrrrrstrrrsrrrrstrrrstrrrsnrrrstrrrstrrrstrrrstrrrstrrrttrrarennn renn reen ne 151 Cadie Dedeh Eo MIN 152 6 4 1 2 Making a Company INGE TRO 153 6 4 1 3 Making an Inactive Company Active EE 153 6 5 Maintaining Site Status cc ccccccceeeceeeeeeeeeeseeeeeeeeeeeeseeeeeeseeaeeeeeeeeeeeseeueeesseeeeeeeeseeseeeeesseseesaaeeess 154 6 5 1 Activate Deactivate Gute 155 Eu Ee EE 155 031A E Me el Sile e e PNE m 156 6 5 1 3 Making an Inactive Site Active EE 156 0 6 Type OLINSDECNON EE 158 6 7 Delete GMP Compliance nenn onnnnn nenne nenne nnnnnennnnnennnnnnnennennnnnennnnennnnnennnnnenenn 158 6 7 1 To Delete a single GMP Certificate e uaae aaa aaa Rennen nnennnnnnnnnnnnennnnnnennnnnnnnnnnnennnnnnennnnnennnnnnennnnnnnnnnn 158 6 7 2 To Delete Multiple GMP Certificates nenne nnnnnnnnnn nenne nenne nnne nnne enn nenne nnns anne nns 159 0 0 Delete MIA DOCUMEM aaa 160 6 8 1 To Delete a Single MIA 160 6 8 2 To Delete Multiple MIAS cccccccecccsccceeecencccceceeeceueeceeceeeceueesaceseeesaeesauessueesaceseeessuseseeseeessuessueessessaasenes 161 f Clerc m A 162 8 Business Rules for the GMP Certificate ccccccccccccceceeeeeeeeeaeneeeeeeseeeeeeeaaeeeeeeeeseaeeesessaaeeeesessaaees 170 9 Se Rule
40. 126 Zatacznik do OPZ BR Ae European Medicines Agency OT User Manual Communications and Networking For a specific operations search users may now select the Enable Operations Search checkbox Once selected click the available operations options to select them Alternatively you might choose to use the search tips below Enter the details of the MIA you are searching for and click Search If you have no information click to return all MIA documents in the database The MIA Search Results appear You can sort these results using the sort by dynamic function buttons f and see Section 4 4 1 Draft Management for more information 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 127 Zatacznik do OPZ BA European Medicines Agency User Manual Communications and Networking MIA Search Results 1 to 10 of 648 Sl Feo MIA Last Authorisation Site Details H Ho daier ber Last Update By F3 Update Holder H Basis Date Number E Date F 2007 02 27 FRIDOZIR REU 123 Sankar Test M95 239 MMO5 1 50 MO2 215 MM05 109 F05 192 M04 89 M04 156 Yoyodyne Praha Inc Yoyodyne Praha Inc AD PACK LABORATOIRES INNOTHERA CLINICAL PACKAGING CLIPA ABBOTT FRANCE ABBOTT FRANCE AGRIPHARM AGRIPHARM AD PACK Yoyodyne France Inc Site 001 Stade Geoffroy Guichard 14 rue Paul et Pierre Guichard Saint Etienne Rhone Alpes
41. 42028 Key 11860 NCA Ref 2007 01718 IR IROD1 Yoyodyne France Inc Site 001 Stade Geoffroy Guichard 14 rue Paul etPierre Guichard Saint Etienne Rh ne Alpes 42028 Key 11850 NCA Ref 2007 01718 IR IROD1 EFFIK BUROSPACE 24 ROUTE DE GISY BIEVRES CEDEX n a 91572 Key 9550 NCA Ref 1371 A PHARM ZAC DE SUZOT 35 RUE DE LA CHAPELLE SAINT AMANT TALLENDE n a 63450 Key 15469 NCA Ref 544 AGA MEDICAL ZI LE BOURGET 22 RUE HELENE BOUCHER LA COURNEUYE n a 93120 Key 13818 NCA Ref 1066 LABORATOIRES INNOTHERA 10 AVENUE PAUL VAILLANT COUTURIER BP 35 ARCUEIL CEDEX n a 94111 Key 15250 NCA Ref 675 CLINICAL PACKAGING CLIPA 17 PARC DES VAUTES SAINT GELY DU FESC n a 34980 Key 15251 NCA Ref 2092 ABBOTT FRANCE USINE DE L ISLE SAINT REMY SUR AVRE n a 28380 Key 15388 NCA Ref 1 ABBOTT FRANCE ROUTE DE SAINT ANDRE LA MADELEINE DE NONANCOURT n a 27320 Key 15389 NCA Ref 2 AGRIPHARM ZAC DE LA FEUILLOUSE VARENNES SUR ALLIER n a 03150 Key 15390 NCA Ref 2310 AGRIPHARM ROUTE NATIONALE 7 SAINT GERAND LE PUY n a 03150 Key 15391 NCA Ref 5 AD PACK 18 RUE DU DOCTEUR GUY RAGNAUD ANGOULEME n a 16000 Key 15392 NCA Ref 616 France France France France France France France France France France 2008 02 27 2008 02 27 2007 11 2007 11 2007 11 2007 11 2007 11 2007 11 2007 11 2007 11 iadjani
42. 5 2 Search for Non Compliance Report to find the Non Compliance Report 1 Click the drop down to view a list of the versions of a Non Compliance Report 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 93 Zatacznik do OPZ de European Medicines Agency OT User Manual Communications and Networking 2009 05 07 17 06 04 v i i b If there is only one entry the Non Compliance Report has only one version Click View to open 2 a copy of the selected version of the Non Compliance Report 3 You may Copy As Draft put you may not Update Invalidate or Withdraw 3 5 2 3 To Create a New Draft as a Copy of a Non Compliance Report Mew GMP Certificate Mew Non Compliance Report Draft GMP Certificates search Search GMP Compliance Search withdrawn GMPC To create a new draft as a copy of a Non Compliance Report you must first search for a Non Compliance Report and open it Follow Section 3 5 2 Search for Non Compliance Report to find the Non Compliance Report When you have found a Non Compliance Report and are viewing it on screen click Copy As Draft and an exact replica of the Non Compliance Report is created in your Organisation s Drafts area and automatically opened in Part 1 of the form LE 2 Now change the details within the draft as necessary 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 94 Zatacznik do OPZ e
43. 7 Ifthe action is unsuccessful an error message highlights the issue Make the necessary changes and return to point 5 above 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 157 6 6 Type of Inspection Zatacznik do OPZ European Medicines Agency User Manual Communications and Networking Admin Menu Assign Access Privileges Activate Lleactivate Company Activate Lleactivatae Site Type of Inspection Delete GMP Compliance Delete MA This option allows Administrators to maintain the National Legislation that equates to the EU s Type of Inspection 6 7 Delete GMP Compliance Admin Menu Assign Access Privileges Activate Lleactivate Company Activate Deactivate Site Type of Inspection Delete GMP Compliance Delete MA This option is available to users who are assigned an Administrator role To open the Delete GMP Certificates feature you should first open the Admin menu from the top menu bar in EudraGMP then select the option from the side menu to Delete GMP Certificates Once the Delete GMP Certificates page is open you have two options u To delete a single GMPC by entering its Certificate Number in the upper entry field To delete multiple GMP Certificates by entering the location of a csv file in the lower entry field 6 7 1 To Delete a single GMP Certificate 1 Enter the Certificate Number of the GMP Certificate you wish to delete and then
44. 7 41 51 GMT 2009 05 06 1531127 GMT 2009 04 30 09 43 08 CMT 2009 05 07 fester FR_AFSSaPS 2005 05 01 flester FR AFSSAPB 005 05 06 fester FR_AFSSAPS 2005 05 06 fester FR_AFSSAPS v amp ricir CZ SUKL Should you wish you may also select the option to Include Withdrawn documents b To narrow your search by Last Update Date Enter the date after which the Certificate was last updated saved to the database in the following format YYYY MM DD in the upper number field a Alternatively click on the calendar icon 29 05 2009 10 32 19 Left click arrow to choose month EudraGMP User Manual v1 0 CURRENT I3 T2 W EMEN 22 29 24 25 Jb 27 20 28 JU EN Today August10 2006 10 11 and choose the date from the calendar Left click arrows to choose year Left click date to return to the form 92 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking 3 Then include a date before which the Non Compliance Report was last updated in the following format YYYY MM DD in the lower number field a Alternatively click on the calendar icon and choose the date from the calendar Click C and the Non Compliance Search Results appear You can sort these alphabetically or numerically using the sorting icons at the head of each column See Section 3 6 1 GMP Drafts Management for more detail When you have found the Non Compliance Report
45. BGX 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 152 Zatacznik do OPZ BE SA European Medicines Agency ENER User Manual Communications and Networking 3 As with other sections of the application use the navigation buttons at the top of the window to advance through the list BHA 6 4 1 2 Making a Company Inactive e The purpose of this feature is to ensure that users searching for companies can no longer select inactive companies when creating MIA documents and GMP Certificates In the Company Search Results window click the checkbox in the Select column beside the company or companies you wish to make Inactive then click Deactivate A pop up dialog box appears If you are sure you want to deactivate the company click 6 The selected company or companies are now listed in your NCA s list of Inactive Companies so no longer appear in the Company Search Results window you are currently viewing 6 4 1 3 Making an Inactive Company Active e The purpose of this feature is to ensure that users can search for and select a company that is listed currently as inactive Click the Inactive radio button as it defaults to Active Click LS 4FCH to return all currently inactive companies or enter an element in one of the Search criteria then click Search 3 Inthe Company Search Result window click the radio button alongside the company you want to react
46. GMP Compliance Manufacturing and Importation Authorisation Operator Admin Help Welcome to EudraGMP Directives 2004 27 EC on human medicinal products and 2004 28 EC on veterinary medicinal products introduce the legal framework for the Community database The concept of a European Inspections database is included in the above specified legislation to provide EEA National Competent Authorities and the European Medicines Evaluation Agency EMEA with an overview of the status of pharmaceutical manufacturers The legislation provides for an electronic tool containing complete information on all pharmaceutical manufacturers This includes information on Manufacturing and Importation Authorisations MIA and Good Manufacturing Practice GMP Certificates for authorised sites in the EEA and information on GMP certificates for manufacturers in third countries GMP Compliance Manufacturing and Importation Authorisation Following a site inspection a certificate of Good Manufacturing Practice shall be issued to The manufacture of medicinal products in the EU is undertaken subject to the manufacturer if the outcome of the inspection demonstrates that the manufacturer complies holding of a Manufacturing and Importation Authorisation Such authorisation is with the principles of GMP as provided by Community legislation also required for imports from third countries into a Member State The National Competent Authority of Member States who performs
47. General for Animal Health and Veterinary Drugs Office V Japan Ministry of Health Labour and Ministry of Health JP MHLW Welfare Labour and Welfare Liechtenstein Kontrollstelle f r Arzneimittel Control Authority for LI KA medicinal products Lithuania Valstybin vaistu kontrol s tarnyba State Medicines LT SMCA prie Lietuvos Respublikos sveikatos Control Agency under apsaugos ministerijos the Ministry of Health of the Republic of Lithuania LIETUVOS VALSTYBINE LITHUANIAN STATE Lithuania LT VVPI VETERINARIJOS PREPARATU INSPECTION ON INSPEKCIJA VETERINARY PREPARATIONS Luxembourg Minist re de la Sant Division dela Ministry of Health Pharmacie et des M dicaments Division of pharmacy and medicines Latvia Zalu valsts agent ra State Agency of LV SAM Medicines Malta Awtorit dwar il Medicini Medicines Authority MI MA LU DPM Netherlands College ter Beoordeling van Medicines Evaluation Geneesmiddelen Bureau Board Veterinary Diergeneesmiddelen Medicinal Products Unit NL CBG Netherlands Ministerie van Volksgezondheid Ministry of Health NL FARMATEC Welzijn en Sport Agentschap Welfare and Sport Centraal Informatiepunt Beroepen Central Agency for Gezondheidszorg Unit Farmacie en Information on Health Geneeskundige Technologie Care Professions Unit Pharmacy and Medical Technology 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 179 Zatacznik do OPZ BR Ae European Medicines Age
48. Medicines Agency Z User Manual Communications and Networking Manutacturing Mesum s Other products or manufacturing activity Cither Producta Radiopharmaceuticals Radionuclide a generators Medicinal gases Herbal products Homoeopathic products Biological active starting materials Other atenlisation of active substancesfexcinients finished product Filtration Liry heat Moist heat Chemical Gamma irradiation Electron beam Other Packaging only COOC EEEE Mma 21401 LI LI 01 Secondary packing Quality control testing Microbiological steriity Nicrobrologicai non sternity Chemicar P ysical mim 1 AI Ecological 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 119 Zatacznik do OPZ LR European Medicines Agency CZ User Manual Communications and Networking 4 2 3 7 Annex UI Remarks Use the Annex Remarks sections of the form to add any restrictions or clarifying remarks relating to the MIA you are issuing Tee Annex Remarks ROU Beer Clie ics Any restrictions or clarifying remarks related to the scope of Manufacturing operations In National Language Inserer mots particulier de cette cas Hestrictions or remarks Characters remaining 3962 4000 In English Insert comments specific to this case in English Hestrictions or remarks Characters remaining 3957 4000 Any restrictions or clarifying remarks related to the scope of Importation operation
49. NESS RULES FOR THE MIA 9 1 Introduction The current version of the Business Rules for Manufacturing amp Importation Authorisations can be found at this location http euteleproj eudra org eudragmp library htm 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 171 Zatacznik do OPZ BE Ae European Medicines Agency ENER User Manual Communications and Networking 10 BUSINESS RULES FOR THE NON COMPLIANCE REPORT 10 1 Introduction The current version of the Business Rules for Non Compliance Reports can be found at this location http euteleproj eudra org eudragmp library htm 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 172 Zatacznik do OPZ BE Ae European Medicines Agency ENER User Manual Communications and Networking 11 BUSINESS RULES FOR EUDRAGMP REFERENCE DATA 11 1 Introduction The current version of the Business Rules for EudraGMP Reference Data Authorisation Holders Sites Active Substances can be found at this location http euteleproj eudra org eudragmp library htm 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 173 Zatacznik do OPZ P k European Medicines Agency OT User Manual Communications and Networking 12 NATIONAL COMPETENT AUTHORITY ACRONYMS FOR ECD MANAGER The below list contains all the approved acronyms for the various organisations using EudraGMP This document is relevant for ECD Delegated Administrators who are unsure of the designated acronym
50. RENT 16 Zatacznik do OPZ pkk European Medicines Agency te User Manual Communications and Networking 2 The Eudra SSO Single Sign Off Screen appears The applications that have closed are ticked Single Sign Off You will see a checkmark image next to each application for successful logout If you see any broken images please close all open browser windows to complete logout Partner Application Name Logout Status eudragmp eudra org v 3 Click _Retum to return to the EudraGMP Homepage Section 2 4 2 7 Navigating EudraGMP This section describes how to navigate around EudraGMP and details the options available to you 2 1 Main Menu for Unregistered Users Unregistered users are only allowed to search for and read information in the EudraGMP database and are presented with the menu below GMP Compliance Manufacturing and importation Authorisation Search Site FAG Help English Go The Main Menu is the options bar at the top of the User Interface and is available at all times 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 17 Zatacznik do OPZ aut European Medicines Agency NT A User Manual Communications and Networking 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 18 Zatacznik do OPZ BR Ae European Medicines Agency AT User Manual Communications and Networking 2 2 Main Menu for Registered Users Once you have logged in to EudraGMP t
51. SERNAME entry field and type your username 4 Click in the PASSWORD entry field and type your password 5 Click the LOG IN button 6 The ECDManager displays your personal homepage welcoming you to the system Now click the My Password tab at the top highlighted below 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 14 Zatacznik do OPZ ux European Medicines Agency EE User Manual Communications and Networking Welcome Romain ZZTest ECD Manager Release 2 2 Thursday August 3 2006 Contacts EMEA Internal Director LIBE TE de ECD Resources Romain ZZTest My Password Change Password New Password Confirmation gt History Search Contacts Edit My Password Welcome Romain ZZTest ECD Manager Release 2 2 Thursday August 3 2006 Contacts EMEA Internal Directory DAT ECD Resources Romain ZZTest M Password Update My Password Change Password New Password e EE Ir Search Contacts Confirmation Edit My Password cE 2 4 Browsing to the EudraGMP homepage 1 Open hitp eudragmp eudra org inspections in your browser to access the EudraGMP homepage EudraGMP Homepage EudraGMP Engin Nee d Welcome to EudraGMP EudraGMP is a Community database containing complete information on all pharmaceutical manufacturers It also includes details of those manufacturers Manufacturing and Importation Authorisations and GMP Certificates Read
52. Site is stored in the EudraGMP database in which case you should associate the Non Compliance Report with this site Use the Search Sites form to enter Search Criteria and then retrieve the information from the database see annotated screenshot below DUNS Number NCA Reference Key Site Name yovodyne Country United Kingdom g Sera Click this group of fields to enter a D U N S Number for a particular business or location Click in this entry field to enter the NCA Reference Key of the Site to which the certificate applies This is the unique key used within your National Competent Authority for each Manufacturing Site and is a very accurate way of finding the details of a Manufacturing Site USE THIS KEY IF YOU HAVE IT c Click in this entry field to enter the Site Name Click here to enter the Manufacturer s site Address Click the drop down arrow then scroll down to the Country in which the site is based Click here to enter the EudraGMP Key the number that uniquely identifies the site within the EudraGMP database It is automatically assigned by EudraGMP and is shown on most screens as part of the Site details for example in the MIA Search results screen 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 58 Zatacznik do OPZ xk European Medicines Agency CZ User Manual Communications and Networking Cancel 6 The search results screen appears as shown below Use
53. Substance Term Active Pharmaceutical Ingredient Al Acronym Active Pharmaceutical Ingredient erm acronym Definition Term A rule that is used to define process flow and validation declaration of policy or conditions that must be satisfied CAP Acronym Centrally Authorised Product s Centralised Procedure Term A process undertaken by the EMEA on behalf of all MS CAP authorisation process Competent Authority Term An organisation in an EEA Country responsible for the authorization and supervision of medicinal products Alternative abbreviation is the acronym CA Business Rule Compilation of Community Term The Compilation of Procedures is a collection of GMP inspection Procedures related procedures and forms agreed by the GMP inspectorates of all the Member States and are designed to facilitate administrative collaboration harmonisation of inspections and exchange of inspection related information 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 162 Zatacznik do OPZ Nds European Medicines Agency AT User Manual Communications and Networking Definition Dosage Form Term The form of the completed pharmaceutical product e g tablet capsule injection elixir suppository E a EA Acronym European Economic Area includes the EU Member States Iceland Liechtenstein and Norway EMEA Acronym European Medicines Evaluation Agency London based EEA agency also known as European M
54. T 95 Zatacznik do OPZ BR Ae European Medicines Agency ENER User Manual Communications and Networking Click Update and the Non Compliance Report is automatically opened in Part 1 of the form Now update the details within the Report as necessary Once you have completed the update click on the Review amp Submit Non Compliance Report tab and click Update Non Compliance Report By default all concerned NCAs will be notified of the update to the Non Compliance Report Click the checkbox beneath if you do not wish other NCAs to be automatically notified 3 5 2 5 To Invalidate a Non Compliance Report New GMP Certificate New Non Compliance Report Draft GMP Certificates Search Search GMP Compliance earch Non compliance Search Withdrawn GMPC Invalidation of a submitted Non Compliance Report should only be done if a mistake has been made in the submitted Non Compliance Report The process is irreversible so invalidation should be undertaken only if you are absolutely certain that the submitted Non Compliance Report is in error Click Search Non Compliance in the GMP Compliance Menu The results are automatically returned for all current Non Compliance Reports for the last three months Click on the blue Report Number and the Report appears in the preview window Click _ walidate button at the top of the screen 29 05 2009 10 32 19 Eu
55. T LABORATORIES LIMITED ACE CHEMICALS LIMITED Site 20068 ACE CHEMICALS LTD TRADING AS Kl CO ACS DOBFAR Uk LIMITED ADAMS HEALTHCARE ADDENBROOKE S MHS TRUST AGRIMIN LIMITED 158821200484075552 15982 21506 14793 11127 Pore 3br53 30353 15225 14720 15027 14714 31206 15822 14588 14735 AGROSERVE LTD AINSWORTHS LONDON LIMITED P E C D E mmm Address Fj UNITS 5 8 ENDEAVOUR WAY WIMBLEDON n a 5119 SUH GUEEMBOROUGH KENT n a n a WEIT SEL BROOMHOUSES 2 INDUSTRIAL ESTATE OLD GLASGOW ROAD LOCKERBIE DUMFRIESSHIRE 0611 25D BROOMHOUSES 2 INDUSTRIAL ESTATE OLD GLASGOW ROAD LOCKERBIE n a DG11 250 CAMBOLS BEDLINGTON n a NE22 DB LOTHERTON WAY GARFORTH LEEDS n a L825 Al FINANCE DEPT HILLS ROAD CAMBRIDGE n a CB2 ZO THE FLAREPATH ELSHAM WOLD INDUSTRIAL ESTATE BRIGG nia DN ZU OSP WATERY LANE WYLYE WORKS n a n a BA12 8HT 40 44 HIGH STREET CATERHAM n a CRS SUB 3 As with other sections of the application use the navigation buttons at the top of the window to advance through the list 2 DDD do OPZ Making a Site Inactive The purpose of this feature is to ensure that users searching for sites can no longer select inactive sites when creating MIA documents and GMP Certificates In the Site Search Results window click the checkbox in the Select column beside the site or sites you wish to make Inactive then click Deactivate A pop up d
56. TE en Any restrictions related to the scope ofthis statement Room Linefequipment QC testing Products Building Pinehearst Lodge Annexe Lab 7 Spinal Tap Red Kryptonite Use the scroll keys or your mouse wheel to view the bottom half of the draft Non Compliance Report 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 83 Zatacznik do OPZ BR Ae European Medicines Agency ENER User Manual Communications and Networking 2 Click the button if you d prefer to review a hard copy of the draft If you wish to exclude the details of any Teleconference arranged under Part 3 Followup click the checkbox _ Exclude Teleconference info before you Click Print Preview The document is created as a PDF which you can then print or save see Section 3 4 7 1 below 3 Once you have checked the whole document and you are happy with its content click submit Non Compliance Report button See Section 3 4 7 2 Successful Submission of a Non Compliance Report 3 4 7 1 To Print or Save a Preview Draft Non Compliance Report 1 Click the Review and Submit Non Compliance Report 2 Next click Print Preview A PDF version of the Non Compliance Report is created Windows Explorer users will see the online PDF tool bar at the top of the open browser window 3 To print a hard copy click D and the file is sent to your default printer Click SAVE A COPY a to save a copy of the draft Non Complia
57. User Manual v1 0 CURRENT 154 Zatacznik do OPZ yk X European Medicines Agency E User Manual Communications and Networking Enhance the data integrity of the system by updating or making obsolete reference data inactive Reactivate inactive site if its status changes 6 5 1 Activate Deactivate Site Admin Menu Assign Access Privileges Activate Lleactivatae Company Activate Deactwate t ELE Type of Inspection Delete GMP Compliance Delete MIA If you wish to activate or deactivate a site you must first run a search to find the site in question Any search you run returns only sites that your NCA is responsible for any site created by an entity user within your agency 6 5 1 1 Search Sites 1 Click on the Activate Deactivate Site link and the Search Sites window appears Active ff Inactive NCA Reference Key Site Name Address FO Country United Kingdom za EudraGMP Key Site Details 2 Enter your search criteria into the relevant field or alternatively click to return all the currently active sites The Site Search Results appear 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 155 6 5 1 2 6 5 1 3 29 05 2009 10 32 19 Za cznik hile European Medicines Agency User Manual Communications and Networking Site Search Result 1 to 10 of 409 FE NCA Ret H Site Name jj 2404 30433 14584 15009 A MELSON amp COLTD ABBOT
58. Zatacznik do OPZ eke European Medicines Agency AT User Manual Communications and Networking EUDRAGMP MANUAL FOR REGISTERED AND UNREGISTERED EUDRANET USERS 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 1 Zatacznik do OPZ P Ae European Medicines Agency OT User Manual Communications and Networking Table of Contents s MMF OCIS WO Ui EE 9 el EES EE ee 9 1 1 1 DUM Are 10 1 1 2 Document GONVENUOMNS D HR 10 12 The ele Elei ene BEE 10 1 3 The EudraGMP Service Desk wasza AO Cada nn een wiz 11 2 GUN ONEJ ar D o med 12 2 1 Setup Requirements nee oes dat dl dee 12 2 1 1 Workstation Specification sasz kuti kd T 12 2 1 2 Browser Requirements u een 12 2 1 3 jessica EC T A O AAA RE A AF AOR FO RE A Eee R AA ZERA 12 2 1 4 EE 13 2 2 Unregistered User Access to EudraGMP ccc ccccceecccceeeeeeeeeeeeeeeeeeeeeeeeeeeeseeseeesaeeeeeeseeeeesseeessaeeeeeeas 13 2 3 Registered User Access to EudraGMP neuen nnnnnnennnnnnn nennen nnnnnne nennen nnennnnn 13 2 3 1 1 Obtaining a Eudra SSO username and password s sssssoeesessrtresertrtestrtertttrertrtertrteettttretttreettterttttrentrerettreeettreeentteee 13 2 3 1 2 Obtaining EudraGMP Access Privileges ccccsssscccsseseececsesscecsesecesseseecesseseecenseseeeessueceessaueceessauesecusaeesesseassesssagseess 14 Zako Chanding rour e EE mm 14 2 4 Browsing to t
59. a European Medicines Agency Z User Manual Communications and Networking Site Addre 5 Site Name It is likely that the inspected Manufacturing Site is already stored in the EudraGMP database in which case you should associate the Certificate with this site Use the Search Sites form to enter Search Criteria and then retrieve the information from the database see annotated screenshot 5 below Search Sites Country United United Kingdom E e CS EudraGMP User Manual v1 0 CURRENT 30 29 05 2009 10 32 19 Zatacznik do OPZ ek European Medicines Agency ENER User Manual Communications and Networking EN details for example in the MIA Search results screen 9 f Click when you have entered the search criteria information Note that all search criteria other than country are optional A wide search results in a greater number of results and a slower response time so narrow your search as much as possible Click to close the Search Sites form 6 The search results screen appears as shown below Use the navigation tools to browse this list and click the radio button circular box next to the appropriate site then click Select DUNS Number NCA Reference Key site Mame Yoge CH Address Country United Kingdom Alt EudraGhP Key Seach Cancel Competeni Authority Name Lo 20 090 3300 20090330 23017 YOYODYNE Cv Inc VE RIVER DRIVE LONDON UK_MHRA
60. adt Hamburg Ministry of Social and Family Affairs Health and Consumer Protection Trade and Industrial Inspection Agency of State of Lower Trade and Industrial Inspection Agency of State of Lower Saxony Agency L neburg Trade and Industrial Inspection Agency of State of Lower Saxony Agency Oldenburg Bezirksregierung Arnsberg District Government DE NW 01 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 176 z European Medicines Agency Communications and Networking Nordrhein Westfalen Germany Bezirksregierung Detmold Dezernat 24 Nordrhein Westfalen Germany Bezirksregierung D sseldorf Nordrhein Westfalen Germany Bezirksregierung Koln Nordrhein Westfalen Germany Bezirksregierung M nster Nordrhein Westfalen Germany Landesamt f r Natur Umwelt und Verbraucherschutz des Landes Nordrhein Nordrhein Westfalen Westfalen Germany Germany Landesamt f r Soziales Jugend und Versorgung Rheinland Pfalz Landesamt f r Gesundheit und Arbeitssicherheit des Landes Schleswig Holstein Germany Schleswig Holstein Ministerium f r Justiz Gesundheit und Soziales des Saarlandes Germany Saarland Germany Regierungsprasidium Dresden Referat 24 GMP Inspektorat Freistaat Sachsen Germany Regierungsprasidium Leipzig Freistaat Sachsen 29 05 2009 10 32 19 Zatacznik do OPZ User Manual of Arnsberg Bezirksregierung DE
61. ained GMP standards in an inspection there is a need to withdraw an MIA See Section 4 3 2 To Withdraw an MIA for details See Section 4 4 Other Tools in the MIA Module section for details of additional file management and search functionality within the application 4 1 1 1 Possible States of the MIA Document This diagram shows the possible states of an MIA document and how the state can be changed 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 105 Zatacznik do OPZ yk k European Medicines Agency ENER User Manual Communications and Networking START Log On Using SSO Delete Draft YES END MIA Draft Deleted MIA Draft Valid YES VALID MIA WEehcdrewan MIA cannc be sean by public users MIA Visible 3 all users if nal marked ebnfisenbal red END Submitted MIA on database 4 2 MIA Documents Tutorial Follow the steps below to create and submit a MIA document 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 106 Zatacznik do OPZ Lu European Medicines Agency CZ User Manual Communications and Networking 4 2 1 To Create a New Manufacture and Importation Authorisation 1 Open your browser at http eudragmp eudra org inspections then click ACCESS TO EUDRAGMP APPICATION FOR REGISTERED USERS 2 The Single Sign On Sign In screen appears Enter your username 1 and password 2 then click the Login but
62. al Click Search Non Compliance in the GMP Compliance Menu as illustrated above and the Search Non Compliance screen appears containing the results of the initial default search This list of results includes all active Non Compliance Reports from the last three months sorted by descending order of Last Update Date a Issue 2396 Copy updated Issue 238B HOP for Issue F356 Test issue 2396 2009 04 27 TC0038 01 NCR NIP COPY OF e eA Y Site Name f Birkdale 2304 Inc YOYODYNE TRASK Australia Inc TOYODYNE TRASEK Australia Ini YOYOD TNE Queensland Inc YOYODYNE Queensland Inc Torrada Ceska republika Inc City H Coun ry H SOUTHPORT Unded Eas Melbourne Easi M lboume Brisbane Brisbane Praha Kingdom Australia Australia Australka Australia Czech Republic Postcode DUNS B Hi LIB XVP 8002 8002 FudraGMP NCA Ref Humber D Hey H B 20 090 4232 0819 20 080 3253 20090325 1221 30 00 3253 20090325 1221 220 080 4360 20090323 1600 20 090 4301 20090323 1600 20 090 4274 1720 You can search using the following criteria 20090423 MA 1021 20090427 2009 03 10 2009 05 04 TC OUDT5 05 MIA H bau Date Status Last Update E By H ienoeli 2009 05 07 200 o Uk MHEA 150503 GMT 2009 05 07 15 16 48 GMT 2009 05 07 12 42 28 GMT 2009 05 06 1
63. al Communications and Networking 3 5 1 3 To Invalidate a GMP Certificate MI mpane z DEREN Mn ee ee Mew GMP Certificate Mew Non Compliance Report Dratt GMP Certificates Search Search MP Compliance Search Non Compliance Search Withdrawn GMPC Invalidation of a submitted GMP Certificate should only be done if a mistake has been made in the submitted GMP Certificate The process is irreversible so invalidation should be undertaken only if you are absolutely certain that the submitted GMP Certificate is in error 1 Click Search GMP Compliance in the GMP Compliance Menu 2 Enter the details of the Certificate that you have in the Search GMP Compliance screen and click The GMPC Search results appear You can sort these in the same way as drafts see Draft Management section 3 6 1 for a reminder When you have found the GMP Certificate you need to invalidate click on the blue Certificate Number and the Certificate is called up from the database Now click I valldate button at the top of the screen The Certificate details appear Now insert a Reason for Invalidating Certificate English comments are mandatory while National Language comments are optional 7 Once you have entered your comments click Confirm Invalidation Confirm Invalidation and then click l if you are certain you want to invalidate the GMP Certificate After invalidating the GMP Certificate you will n
64. al human medicinal product inspection is undertaken on behalf of EC EMEA 126 2004 Art 33 2 of al Regulation Check if pre approval veterinary medicinal product inspection is undertaken on behalf of EC 726 2004 EMEA Inspections in Third Countries for IMP Directive 2001 20 EC Other mE Check to activate Other entry field if none of the above apply Add text in text field Other Add additional type of inspection Distant C M check if distant assessment Assesment A M Uf EL Check if the inspection for an IMP is undertaken in a country outside the EEA 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 37 Zatacznik do OPZ ak European Medicines Agency c User Manual Communications and Networking When you have completed this part of the form click on the Part 2 tab to begin entering details for Part 2 of the GMP Certificate 3 2 4 Part2 3 Click the Part 2 tab The form appears as illustrated The form is large so you ll need to use the scroll keys ka or your mouse wheel to view the bottom half of the form Part 1 Pat Restrictions and Authorisation Review amp Submit GMP Compliance Manufacturing E ri rra ry Batt h Importation Mone Manufacturing Packing Cerit Special Regs only only Sterile Products Asentically prepared Large Volume Liquids Lyophilisates cemi salids small volume liquids solids and implants Other Terminally Stenised Lar
65. all quality safety and efficacy data including clinical study reports In the USA the New Drug Application NDA is the MAA equivalent In Canada the New Drug Submission NDS is the MAA equivalent An MAA is comprised of 4 parts Part 1 Summary of the Dossier includes application forms summary of Product Characteristics packaging Expert Reports Part 2 Chemical Pharmaceutical and Biological Documentation drug Substance and drug product lt 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 165 Zatacznik do OPZ geet European Medicines Agency ENER User Manual Communications and Networking Part 3 Pharmacological and Toxicological Preclinical Documentation is a report of all animal pharmacology toxicology and pharmacokinetics Part 4 Clinical Documentation is a report of all Phase I II HI IV V clinical studies conducted up to the time of submission MAH Acronym Marketing Authorization Holder Manufacture Term All operations of purchase of materials and products Production Quality Control release storage distribution of medicinal products and he related controls Manufacturer Term Holder of a Manufacturing Authorisation as described in Article 40 of Directive 2001 83 EC for human products and Article 44 of Directive 2001 82 EC for veterinary products Manufacturing Authorisation Term Required prior to the commencement of production application ill trigger a GMP inspection Marketin
66. and deactivate Companies and Sites Click ADMIN in the Main Menu bar at the top of the EudraGMP User Interface To add a User profile EudraGMP Administrators should use ECD Manager not the EudraGMP Admin Menu See section 6 3 Managing EudraGMP Users in ECD Manager For details on Assigning user s access privileges see the section below To Activate Deactivate Company see section 6 4 Maintaining Company Status To Activate Deactivate Site see section 6 5 Maintaining Site Status To maintain the National Legislation surrounding Type of Inspection see section 6 6 Type of Inspection To Delete GMP Certificates issued by your NCA see section 6 7 Delete GMP Compliance To Delete MIA documents issued by your NCA see section 6 8 Delete MIA Document 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 141 Zatacznik do OPZ aan European Medicines Agency AT User Manual Communications and Networking 6 2 Managing Access Privileges Admin Menu Assign Access Frivileges Activate Lieactivate Company Activate Deactivate eite Type of Inspection Delete GMP Compliance Delete MIA EudraGMP Administrators can manage access privileges in the Assign Access Privileges screen 6 2 1 To Assign Access Privileges Admin Menu Assign Access Privileges Activate Lieactivate Company Activate Deactivate eite Type of Inspection Delete GMP Compliance Delete MIA 1 Click A
67. and you can amend the MIA document as necessary Remove the manufacturing operations for which the Authorisation is suspended or if this is applicable remove the site s for which the suspension applies from the MIA If necessary make any qualifying remarks relating to the suspension of the MIA in the relevant annex Hall manufacturing operations for a site have been suspended deleting the site from the site s list is the most efficient approach To retrieve an MIA that has no sites enter the Authorisation Holders Name and select ALL COUNTRIES in the Country drop down 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 129 Zatacznik do OPZ ek k European Medicines Agency ENER User Manual Communications and Networking 6 Once you have finished making changes to the MIA click on the REVIEW AND SUBMIT tab and if you re happy with the changes click Update MIA 4 3 2 To Withdraw an MIA Pew MILA Draft MIAS Search MIA Users should withdraw any MIA document issued by their own agency when it is no longer valid Reasons for this include but are not restricted to Failing an inspection site details have changed manufacturer s name has changed 1 Click Search MIA in the MIA Menu The Search MIA screen appears 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 130 Zatacznik do OPZ ek e European Medicines Agency AT User Manual Communications and Netw
68. ation see Section 12 National Competent Authority Acronyms for ECD Manager 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 147 Zatacznik do OPZ pkk European Medicines Agency CZ User Manual Communications and Networking Selected Results Full name EEE The Page gg Allthe Results 3 Result s Pages 1 Search Contacts Search Company amp Staff Assad Ahmede Search SSO Applications ins at ages INS at ages EudraGMP Users of AT_AGES ins be damp INS be damp EudraGMP Users of BE DGMP lins cy psmoh INS cy psmoh EudraGMP Users of CY PSMOH 15 Click the FULL NAME of the group in the list and the User Group appears Notice the PERMITTED USERS in the lower section a below This is where your user needs to be added INS at_ages Fullname ins at ages Role Name IHS at ages Description EudraGMP Users of AT AGES Search Contacts 3 Search Company amp Staff AT AGES DelegatedAdmin Search Company amp Staff Test Grin amp ssad Ahmede est GET Search SSO Applications Last Modified By James Lenoel Default INS fat ages Last Modified On November 14 2006 4 55 44 PM GMT 00 00 Group Manager olu Tester tester tester1 Member a Remove 17 Now click ADD a above The Directory Manager appears Enter the username or a part of the username in the FULL NAME entry field b below If you prefer enter asterisk for all user names within the
69. ations and Networking Search Tips An asterisk will reveal ALL Certificates so this is the widest possible search e Search terms must be at least three characters long numbers letters and symbols For example Pha is acceptable whilst Ph is not e Enter Inc in the Name entry field to give results of all manufacturers names that end with Inc e Enter Pharmaco in the Name entry field to deliver results of all manufacturers names that begin with Pharmaco e To search for all a company s Non Compliance Reports worldwide select All Countries from the Country drop down If you only want to search for those within the European Union select EU e Users can retrieve all NCRs associated to a particular API anywhere in the world e Users can retrieve all sites that have a Non compliance for the Manufacture of Non sterile Tablets Note If you have a D U N S Number for a particular business or location you may also search for a Site using this For more information on the DUNS Numbering system click the following hyperlink to open the D U N S Number website 5 The GMPC Search results appear GMPCs and MIAs marked as Confidential have a Dark Grey background Non Compliance Reports which are not visible to the General Public appear on a Red background You can sort these alphabetically or numerically see Section 3 6 1 GMP Drafts Management for more detail When you have found the Non Compliance Report you we
70. avotn ctva Ministry of Health of oK MZSR Republic Slovenskej republiky the Slovak Republic 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 180 Zatacznik do OPZ geet European Medicines Agency OT User Manual Communications and Networking Slovak t tny stav pre kontrolu lie iv State Institute for SK SIDC Republic Drug Control United Medicines and Healthcare products Medicines and UK_MHRA Kingdom Regulatory Agency Healthcare products Regulatory Agency United Veterinary Medicines Directorate Veterinary Medicines UK_VMD Kingdom Directorate 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 181 Zatacznik do OPZ BR Ae European Medicines Agency ENER User Manual Communications and Networking 13 HELP Help is provided in the form of this manual and through onscreen help tooltips and icons In addition mouseover certain elements such as radio buttons to reveal a help tip If you see a question mark icon beside an option or element click the icon to learn more about the option If you require any more assistance contact your EudraGMP Administrator or the EudraGMP Service Desk see Section 1 3 If you have any feedback on this User Manual please email your comments to eudragmp emea europa eu and they will be passed onto the EudraGMP project team for consideration 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 182
71. bal products Homoeopathic products Biological active starting materials Other stenisation of active substances excipienta finshed product Filtration Dry heat Moist heat Chemical B HB E LIS TESI ELI Gamma irradiation Electron beam Other Packaging only ae Nr Mr b B ELI Secondary packing Quality control testing Microbiological sterty Microbiologicak non stenty Chemical Physical LIC RR Biological 3 2 4 1 Adding a Biological Medicinal Product or Dosage Form If the GMP Certificate applies to manufacturing primary packing or importation from a Dosage Form or a Biological Medicinal product that is not listed on the screen click on Other in the relevant section For example 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 40 Zatacznik do OPZ P k European Medicines Agency ENER User Manual Communications and Networking LJEB lactam Antibiotics Hormones Or Substances With Hormonal Activity C Prostaglandins Cytokines D Cvtotoxics Cytostatics CJ lmmuno suppressives Medicinal Products Containing Prions fsenotoxics Or Teratogens C Radiopharmaceuticals LJ Ectoparasiticides JE Other Selected Node renaming Rename Cancel In the drop down click Other a above and then click in the text field D and specify the item here in English only Now click and Other becomes the item you have specified Finally close the drop down by
72. ceeeeeeeeeeeeseeceeseeeeeseeeeeeeeeeseeeesseeessaeeeseeesseneetsaees 93 3 5 2 3 To Create a New Draft as a Copy of a Non Compliance Report sess emere 94 3 5 2 4 To Update a Non Compliance e dE 95 3 5 2 5 To invalidate a Non Compliance Rep rt aeuusauns en een 96 3 5 2 6 To Withdraw a Non Compliance Reno 97 332 To Search for Withdrawn GMP Certtcates aaa aaa aaa nnne nenne nnne n nnne nr 99 3 5 3 1 To Print a Copy of the withdrawn GMP Certificate ee aa aaa aa aaa aaa aa aaa aaa nennen nennen nnne nnne nnne nnne nnns 101 3 5 8 2 To Create a New Draft as a Copy of a GMP Certificate ee a aaa aaa aaa aa aaa aaa aa aaa aaa aa aaaa nennen nnne nnne nnns 101 36 Other Fools in ihe SMP MOdUJE iussis ip ER apa AA EE dE 101 3 6 1 GMP Drafts Management o m 102 36 1 SON Diane BY CCION EE 103 30 12 MOO A e uem 103 30 13 To Charges Drams Category E 103 36 14 To Belele H Bg Geer n T 104 4 TAE MIA MOGUC ee ee a aan ee 105 1 OVONIEW G 105 4 1 1 1 Possible States of the MIA Document ssa tun eran tmt APA AAA naar 105 4 2 MIA Documents Tutorial EE 106 4 2 1 To Create a New Manufacture and Importation Authorisation ccccccccceececeeceeeeeeseeceseeceseeesseeeeseeeeeaes 107 4 2 2 KUA US ACN Ie eege 108 zd EN Ir aeui eee er 1
73. ch Screen enter the new Active Substance to check that it hasn t already been entered into the database U Warning The search resulted in zero records 2 If your search has not produced the required Active Substances Search Result you may now click 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 45 Zatacznik do OPZ pkk European Medicines Agency CZ User Manual Communications and Networking NCA Fr080806 123 Fharmacolare CG A Unite 13 Route de Chemin de Fer l Paris Orly Mord Quest Paris 94547 France S IOARRGEIKER Restrictions and Authorisation ROSSI Oe eT eno Active Substances Restrictions Issuance and Signatory Selected Active Substances List Dictionary ID Ingredient Name English NCA Ref Key EAEE Add and Select Active Substance Ingredient Hame mM Nihildoloramine 3 Now click the entry field a and enter the Ingredient Name in English 4 Next enter your Organisation s defined reference key This is not mandatory but you should be guided by the conventions specified by the Organisation you are working for 5 Finally click and the new substance appears in the Selected Active Substance List Check that the substance name and the NCA Ref Key are correct Part 1 Part Restrictions and Authorisation B TE E WU 4 Active Substances Restrictions Issuance and Signatory Selected Active Substances List item Dictionary ID Ingredient Name English NCA Ref
74. ck the La or 44 buttons 9 You have completed the Issuance and Signatory section It s now time to review and submit your draft GMP Certificate 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 48 Zatacznik do OPZ ak European Medicines Agency ENER User Manual Communications and Networking 3 2 6 To Review Print and Submit a Draft GMP Compliance Certificate This is the final stage of the GMP Certificate creation process 10 Click the Review and Submit GMP Compliance tab Your draft GMP Certificate appears 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 49 Zatacznik do OPZ P European Medicines Agency ENER User Manual Communications and Networking Part 1 Part Restrictions and Authorisation Review amp Submit GMP Compliance Submit GMP Certificate Medicines and Healthcare products Regulatory Agency CERTIFICATE NUMBER DocTest2323 CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER Part 1 Issued following an inspection in accordance with Art 11105 of Directive 2001 83 EC as amended The competent authority af United Kingdom confirms the following The manufacturer VOY ODYNE CV Inc aite address VE RIVER DRIVE LONDON SW 85L United Kingdom DUNS Number 20 090 3300 Has been inspected under the national inspection programme in connection with manufacturing authorisation na 20090 03 30 TCOOT78 11 MIA V in accordance with Art 40 of Directiv
75. clicking on the minimise button d 3 2 5 Adding Active Substances Restrictions and Authorisation Information to the GMP Certificate The restrictions and authorisation section defines the product s Active Substance its Dictionary ID any restrictions surrounding the manufacture of the product within a site location and the Issuance and Signatory details EudraGMP Active Substance information is stored and managed in two locations for each NCA the Common Dictionary contains all Active Substances that have been included in the central load while the NCA Dictionaries contain only entries created by users within the specific NCA d Common Dictionary 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 41 Zatacznik do OPZ NT do European Medicines Agency ATEAN User Manual Communications and Networking The Common Dictionary of Active Substances contains a defined set of Active Substances including a Dictionary ID and a Substance Name in English Every Active Substance in this dictionary has a Dictionary ID and is viewable by ALL NCA users NCA users cannot add Active Substances to the Common Dictionary NCA users may copy Active Substance entries from the Common Dictionary into their NCA Dictionary Such copies will take the same Dictionary ID as the entry in the Common Dictionary In addition the National Competent Authority name and an NCA Ref Key are automatically added though the NCA Ref Key may be
76. copy of the draft The document is created as a PDF which you can then print or save 2 Once you have checked the whole document and you are happy with its content click button See Successful Submission of an MIA 4 2 5 1 Print or Save Preview of MIA Click the Review and Submit MIA tab Next click Print Preview A PDF version of the MIA document is created At the top of the window you will see the online PDF tool bar below To print a hard copy click D and the file is sent to your default printer To save a copy click a a Click to print a paper copy of the MIA using your default printer settings b Save a copy of the file as a PDF to your workstation s hard drive 4 2 5 2 Successful Submission of an MIA If you have completed the MIA document according to the business rules an information message appears to notify you that the MIA document has been added to the database i Your MIA Certificate has been submitted successfully M can ERIN OF re 2 kk Tix Eth a Your MIA Reference number is ZZA fyou wish make a note of the MIA Reference number This is a unique number that the MIA document has in the system Print Preview 4 2 5 3 Troubleshooting Errors in MIA Module Should you enter a variable in your draft MIA document that fails to meet the business rules governing the EudraGMP system an error message appears This error message provides detail to point you in the directio
77. cted Manufacturing Site are already stored in the EudraGMP database However the Search Sites function enables users to find licensed manufacturing sites in all countries worldwide from the Main Menu options 5 1 1 1 To Perform a Site Search 1 From the Main Menu above click Search Site The Search Site page appears Include Withdrawn documents 77 gl First select the country using the Country select drop down a This is a mandatory element of the search Next add additional information that is available to you within the Site Name b and Address C text fields Use asterisks if you do not have complete information e g 23 Rue de will return all results beginning 23 Rue de If you wish to include sites with withdrawn GMP Certificates and Non Compliance Reports against them leave the checkbox d ticked If not click it to uncheck it Finally click Search If your search is successful the results appear beneath the Search Sites field in the Search Sites Results window see annotated screenshot below 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 138 Zatacznik do OPZ User Manual Tm European Medicines Agency Communications and Networking Site Sea ch Result 1 tn 10 of 84 no n Key B DUNS Number H 22864 20080305 0933 22864 20090305 0933 22864 20090305 0933 22964 20090305 0933 22964 20090305 0933 22864 20090305 0333 22900 20 090 5201 20090520 1527
78. d by the NCA section must be selected Finally an additional comments section enables any other information which cannot be properly detailed in the previous two sections to be recorded Click the Part 3 tab The Regulatory Action section of Part 3 of the draft Non Compliance Report appears Click within the Nature of Non Compliance Details field and enter text in English to explain why the Issuance of a Non Compliance Report is necessary This is mandatory Under the Action taken proposed by the NCA heading at least one of the tick boxes must be selected If clicking a tick box reveals only a text field adding English text relevant to the option is mandatory Below each of the options are detailed One or more of the below options may be selected Action on the Manufacturing Authorisation MIA Click the Action on the Manufacturing Authorisation checkbox a and the drop down fields D and C and the free text field d appears Action on the Manufacturing CU suspension v Jerme manufacturing authorisation inf e Authorisation a somal det tail relating to the suspension of Characters remaining 910 993 1 Click the drop down arrow D to choose from Revocation Suspension or Requested Variation of the manufacturing authorisation 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 76 Zatacznik do OPZ ek k European Medicines Agency ENER User Manual Communications and Networking Then choose
79. document appears MIA Header Authorised Sites Signatory Details Review amp Submit MIA Submit MIA Agence francaise de s curit sanitaire des produits 1 Authorisation Number 2 Name of authorisation holder 3 Address es of manufacturing site s 4 Legally registered address of authorisation holder 5 Scope of authorisation and dosage forms 6 Legal Basis of authorisation 7 Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation 8 Signature 9 Date 10 Annexes attached SCOPE OF AUTHORISATION de sant CERTIFICATE NUMBER 46000 MANUFACTURER S AUTHORISATION 46000 PharmacoCare S A PharmacoCare S A Unite 13 Route de Chemin de Fer Z I Paris Orly Nord Ouest Paris 94547 France 23 Rue de Bobigny Paris 75008 English ANNEX 1 and or ANNEX 2 Art 40 of Directive 2001 83 EC Laurent Moche Jean Marimbert 2006 08 22 Annex 1 and or Annex 2 ANNEX 1 Name and address of the site PharmacoCare S A Unite 13 Route de Chemin de Fer Z I Paris Orly Nord Ouest Paris 94547 France Use the scroll keys or your mousewheel to view the bottom half of the draft MIA document 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 123 Zatacznik do OPZ P k European Medicines Agency AT User Manual Communications and Networking Click the Print Preview button if you d prefer to review a hard
80. draGMP User Manual v1 0 CURRENT 96 Zatacznik do OPZ eke European Medicines Agency c User Manual Communications and Networking 4 The Report details appear Report Number DocTest232323 Site Name YOYODYHE Birkdale 2304 Inc Site Address 1113 KATE MORE AVENUE SOUTHPORT MERSEYSIDE Lod KWP United Kingdom In English Comments e 5 Now insert a Reason for Invalidating the Report in English in the text field a These comments are mandatory 6 Once you have entered your comments click Confirm Invalidation b and then click if you are certain you want to invalidate the Non Compliance Report After invalidating the Non Compliance Report you will not be able to retrieve it again from a search although its details do remain in the system fyou want to exit do not click the Back button on your browser click C 3 5 2 6 To Withdraw a Non Compliance Report 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 97 Zatacznik do OPZ ak European Medicines Agency ENER User Manual Communications and Networking Mew GMP Certificate New Non Compliance Report Diraft GMP Certificates Search Withdrawn GMPC Search Search GMF Compliance Non Compliance Reports should be withdrawn when the Report is no longer valid Reasons for this include but are not restricted to When the manufacturer is compliant i e passed a previously failed GMP insp
81. draft 3 4 5 5 To Apply Restrictions The Restrictions list lets you indicate that the Non Compliance Report applies only to a particular Building Name Room Name or Number Piece of Line Equipment QC Test Product Name In addition restrictions can be formulated textually in a Comments section 1 Click the Restrictions tab to open the Restrictions form 2 Now click Add Restriction and the Restrictions List appears Restrictions amd Authorisation Review amp Submit Non Compliance Report ETUETUTTTTR Restrictions Issuance and Signatory i Building Name Room Name or Number Line Equipment Product Name Pinehearst Lodge Annexe Lab Spinal Tap Red Kryptonite In English i eefficiude comments related to the restriction in English ONLY here 3 Now click in each entry field a to add Building Name Room Name or Number Line Equipment QC Test and Product Name 4 Click Add Restriction e again if you need to add additional rooms or areas 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 74 Zatacznik do OPZ ek k European Medicines Agency ENER User Manual Communications and Networking 5 Add any Restrictions Comments in English in box D If you have applied more than one restriction ensure that comments are referenced clearly 6 You can now click on the Issuance and Signatory tab You may also refresh the list d To delete a restriction click the 26 icon
82. e 2001 83 EC transposed in the following national legislation Section 8 2 of Medicines Act 1858 From the knowledge gained during inspection ofthis manufacturer the latest af which was conducted an 2009 04 28 itis considered that it complies with The principles and guidelines of Good Manufacturing Practice laid down in Directive 200 3 84 EC This certificate reflects the status af the manufacturing site atthe time ofthe inspection noted above and should nat be relied upon ta reflect the compliance status if more than three years have elapsed since the date of that inspection after which time the issuing authority should be consulted The authenticity of this certificate may be verified with the issuing authority Use the scroll keys or your mouse wheel to view the bottom half of the draft GMP Certificate which contains Part 2 details 11 Click the button if you d prefer to review a hard copy of the draft The document is created as a PDF which you can then print or save See Section 3 2 6 1 below 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 50 Zatacznik do OPZ P k European Medicines Agency OT User Manual Communications and Networking 12 Once you have checked the whole document and you are happy with its content click Submit GMP Certificate button See Section 3 2 6 2 Successful Submission of a GMP Compliance Certificate 3 2 6 1 To Print or Save a Preview Draft GMP Compliance Certi
83. e European Union EuroPharm has been established to fulfil Articles 57 1 l and 57 2 of Regulation 726 2004 It is now known as EudraPharm 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 163 Zatacznik do OPZ x European Medicines Agency OT User Manual Communications and Networking erm acronym Definition erm acronym Definition G MP Acronym Good Manufacturing Practice Good Manufacturing Practice GMP is that part of quality assurance hich ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation MA or product Specification GMP is concerned with both production and quality control GMPC Acronym GMP Certificate GMP Certificate Term A Certificate issued to a manufacturer who has met the standards laid out under the GMP guidelines Term Adherence to GMP standards GMP Information Term Relates to information contained within a GMP Certificate or Non compliance report erm acronym Definition IMP Acronym Investigational medicinal product lt U Q O 3 o Q O Investigational medicinal Term A pharmaceutical form of an active substance or placebo being product tested or used as a reference in a clinical trial including products already with a marketing authorisation but used or assembled formulated or packaged in a way different from the authorised form
84. e and Importation Authorisation the Authorisation Holder and the Legal Basis on which the Authorisation is issued 4 2 2 1 MIA Information MIA Header Authorised Sites Signatory Details Review amp Submit MIA MIA Information MIA Authorisation Number D NC AF EOF MIA Date Of Authorisation 2006 08 18 TEJ reeee MM pn b Authorisation Holder Details Authorisation Holder 1 First click a to enter an MIA Authorisation Number This number is defined by your NCA rather than by EMEA 2 Next add the date of authorization Click EF you want to use the calendar picker tool Otherwise click the entry field b and enter the date manually according to the criteria YYYY MM DD where Y is Year and M is Month and D is day 4 2 2 2 Authorisation Holder Details 3 Now you need to find or add the Authorisation Holder details Click and the Search Companies entry form opens 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 108 Zatacznik do OPZ xk European Medicines Agency User Manual Communications and Networking Search Companies NCA Reference Key 00023 Paris 180806 Authorisation Holder PO Address PT Country France gt or EudraGMP Key Search 4 Youcan search by a number of optional criteria including NCA Reference Key Authorisation Holder which is the company name and the authorisation holder s Address It is essential that you choose the Country t
85. e certification They may be necessary ta verify specific aspects af the clinical or labaratory testing Q amp A or manufacture and control af the product and or to ensure compliance with GMP GCP GLP or Pharmacovigilance quality assurance systems e Click Compilation of Procedures highlighted a to advance to the Compilation of Community Procedures page 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 9 Zatacznik do OPZ w European Medicines Agency AT User Manual Communications and Networking 1 1 1 Dummy Example For the purposes of this user manual we have invented imaginary companies such as PharmacoCare S A and Yoyodyne S A and Inc These imaginary companies manufacture a variety of dummy products and ingredients for the purposes of this manual 1 1 2 Document Conventions Below is an explanation of the various formatting conventions and terminology used in this manual The term click is used to describe navigating and interacting with the EudraGMP application Click describes a single press of the Left Mouse Button if you are using a ee common two button mouse PC and Mac highlighted left It also refers to a single press of e the main button should you use a one button mouse Mac kV The mouse wheel is the central wheel on many PC mice highlighted right and some newer e Mac mice If you don t have a mouse wheel the arrow keys on the right of yo
86. e of authorisation holder 3 Address es of manufacturing site s 4 Legally registered address of authorisafion holder 5 Scope of authorisation and dosage forms 5 Legal Basis of authonsation 7 Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation H Signature 4 Date 10 Annexes attached SCOPE OF AUTHORISATION Agency MANUFACTURER S AUTHORISATION MA 57b YOYODYNE MMEI Liverpool Inc TOYOD YME Conall Inc 2204 MARTIN POTTER AVENUE PERRANPORTH CORNWALL 21 455 United Kingdom I 3JANE HOUSE STRAWBERRY FIELDS PENNY LANE LIVERPOOL MERSEYSIDE 312 96 United Kingdom ANNEX 1 andi or ANNEX 2 Art 40 of Directive 2001 83 EC An 13 of Directive 2001 20 EC Dr Timothy Berridge 4809 12 29 Annex 1 andor Annex 2 Use the scroll keys or your mouse wheel to view the bottom half of the MIA document You can review the submitted MIA onscreen or you can print a preview Registered users can also _Ubdate or invalidate 5 submitted MIA See Section 4 3 1 To Update a Submitted MIA Section 4 3 2 To Withdraw an MIA and Section 4 3 3 To Invalidate an MIA 4 4 1 5 To Print a Preview of a Submitted MIA Document 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 136 Zatacznik do OPZ kh European Medicines Agency ENER User Manual Communications and Networking Click the button if you d prefer to review a hard copy
87. e selected a site the Site Address details are automatically populated To choose the MIA Number click the drop down arrow then click the relevant MIA Number 10 Add the Inspection End Date in the entry field using the appropriate format YYYY MM DD This is the date that the inspection that prompted the Non Compliance Report was completed on Alternatively click the calendar icon to choose the date using the Calendar tool Left click Left click arrows to arrow to choose year choose month Ec ie 15 ie hee SLES AD 22 23 Left click date A ala B er 0825 30 to return to the E form Today August 10 2006 11 You have now completed the Part 1 Report Details form To continue with the Legal Basis of Certificate section refer to Section 3 4 3 4 Legal Basis of Certificate 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 60 Zatacznik do OPZ kh European Medicines Agency AT User Manual Communications and Networking 3 4 3 2 Create New Site If you cannot find the site in the EudraGMP database you need to create a new site entry by clicking the button on the Site Search Result Screen DUNS Humber NCA Reference Key Site Name Address 1 Address 2 Address 3 Address 4 State Postcode Country Create Cancel 1 Click the entry fields to enter details In the absence of another reference such as D U N S Number we recommend
88. ection Site details have changed Manufacturer s name has changed Click Search Non Compliance in the GMP Compliance Menu see above screenshot The results are automatically returned for all current Non Compliance Reports for the last three months Click on the blue Report Number and the Report appears in the preview window Click the Withdraw button at the top of the screen The Report Details appear Now insert a Reason for Withdrawing the Report in English in the text field These comments are mandatory Once you have entered your comments click Confirm Withdrawal and then click if you are certain you want to withdraw the Non Compliance Report which leaves the Report on the database as a record fyou want to exit do not click the Back button on your browser click Cancel 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 98 Zatacznik do OPZ P European Medicines Agency ENER User Manual Communications and Networking 3 5 3 To Search for Withdrawn GMP Certificates GMP Compliance Menu Mew GHP Certificate New Mon Compliance Report Dratt GMP Certificates Search Search GMP Compliance search Non Compliance Search Withdrawn GMPC You can use the Search function to find Withdrawn GMP Certificates on the database Use this to View History of Withdrawn GMP Certificates Print preview of a Withdrawn GMP Certificates Copy a Withdrawn GMP Certificates as a
89. ed This can be entered according to your NCA s procedures or generated automatically You can create new Active Substance Entries in three ways Create an entirely new entry which will appear within your NCA dictionary and will be visible to other NCA users in your country Select an entry found in the Common Dictionary and add a translation in the NCA working language Select an entry found in the NCA Dictionary of another NCA within your country In this instance you create a copy in your own NCA s Dictionary and can then add a translation in your NCA s working language 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 69 Zatacznik do OPZ ux European Medicines Agency Z User Manual Communications and Networking 3 4 5 3 To Add Active Substances EudraGMP contains a Common Active Substance Dictionary Each Active Substance has a unique Dictionary ID As such you should always attempt to find the Active Substance in the Common Dictionary by running a detailed search Part 1 Part 2 Restrictions and Authorisation WI Review amp Submit Non Compliance Report Active Substances BESTE EE E D K tt Selected Active Substances List ey Ingredient Name English NCA Ref Key pepe a Sera T fthe Active Substance cannot be found after such a search you can create a new Active Substance in your NCA Dictionary see Section 3 2 5 4 To Create a New Active Substance section and assoc
90. edicines Agency EudraGMP D 3 e O O 3 m Term The web based EMEA managed application designed to rationalise and centralise the issuing and recording of Good Manufacturing Practice Certificates and Manufacturing Importation Authorisations by NCA Inspectors EudraGMP Administrator Term An individual within an NCA or EMEA who is responsible for allocating user roles and for the maintenance aspects of the EudraGMP user group and database EudraNet Acronym European Union Drug Regulatory Authorities Network The Ss network infrastructure connecting the NCAs the EMEA and the EC Eudra SSO Acronym The EudraNet Single Sign On username and password system allowing users access to multiple web based applications hrough a single server authentication process European Commission Term The civil service of the European Union Its full name is the Commission of the European Communities however it is often shortened to the Commission It is the executive arm of the European Union It proposes Community policy and legislation implements the decisions taken by the Council of Ministers and supervises the day to day running of Commission policies It is the guardian of the Treaties and can initiate action against Member States that do not comply with EC rules EuroPharm Term EuroPharm is a database of information on all medicinal products for human or veterinary use authorised in th
91. edient Name in English This entry has been added by the user within the FR AFSSAPS NCA who created the Active Substance entry NCA Name This indicates which NCAs users created the entry NCA Ref Key Best practice is for the NCA users to add a unique reference key for each entry in their NCA Dictionary If not EudraGMP will create a unique NCA Ref Key automatically Click radio button to select the active substance result Once you ve checked the radio button click SELECT SELECTIONNER to add the active substance If the Active Substance is not already in the system click CREATE ACTIVE SUBSTANCE CR ER SUBSTANCE ACTIVE button to create one in the database 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 44 Zatacznik do OPZ Wda European Medicines Agency E User Manual Communications and Networking 4 If your search produces results as in this example these appear under the Active Substances Search Result section 5 Click the radio button f if the search has found the Active Substance Then click the button 9 fithas not found the Active Substance or the Active Substance is new refer to the section below 6 The Active Substance appears with its English Ingredient Name You should now confirm your selection and optionally enter an NCA ref key 7 Click Confirm The Active Substance has now been added to your GMP Certificate 3 2 5 4 To Create a New Active Substance 1 In the Sear
92. egories t Click once and the records are now arranged in ascending order a z or 1 10 i Click again and the records are now arranged in descending order z a 10 1 1 Click and an exact replica of the draft is created in the Drafts folder 2 Now click on the new drafts Draft ID to change the details within the draft 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 103 Zatacznik do OPZ j European Medicines Agency ENER User Manual Communications and Networking 3 Click i to change a GMP Certificate to a Non Compliance Report or vice versa 4 Note that you should then click on the new draft s Draft ID to change any necessary details within the draft 3 6 1 4 To Delete a Draft 1 In the Draft GMP Certificates screen click 28 next to the draft you want to delete 2 If you are sure you want to delete it click and the draft is removed from the Drafts database 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 104 Zatacznik do OPZ Mr Ae European Medicines Agency OT User Manual Communications and Networking 4 THE MIA MODULE 4 1 Overview The MIA Module of EudraGMP is designed to help you to enter and maintain the content of the mandatory sections of the Manufacture and Importation Authorisation in the EudraGMP database and to search for MIA data submitted by other National Competent Authorities See Section 4 4 Other Tools in the MIA Module for details o
93. en 22 Zd Left click date Z4 2 5 2b 2 ZB 28 30 to return to the 34 form Today August 10 2006 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 32 Zatacznik do OPZ P k European Medicines Agency OT User Manual Communications and Networking 11 Finally if the GMP Certificate is Confidential and you do not wish this information to be searchable by other users of EudraGMP click the Confidential check box The Confidentiality options appear e s Lorie ral ality ConfidentiaE Reason tor confidentiality Comments for Reasonfor comideniality in Engish Characters remaining 998 998 12 When marking a document confidential you must choose a justification from the list of Reason for confidentiality options Click the drop down to select one If none of the options adequately describe the reason include another justification in the Comments for Reason for Confidentiality field that appears in English If you are working in another language please add the same information in your working language in the working language field 13 You have now completed the Part 1 Certificate Details form To continue with the Lega Basis of Certificate section refer to Section 3 2 3 4 Legal Basis of Certificate 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 33 Zatacznik do OPZ kh European Medicines Agency ENER User Manual Communications and Networking 3 2 3 2 Create New Site If you ca
94. erg Germany Freistaat Bayern Germany Freistaat Bayern Germany Freistaat Bayern Germany Freistaat Bayern Germany Freistaat Bayern Germany Freie und Hansestadt Bremen 29 05 2009 10 32 19 Zatacznik do OPZ kk European Medicines Agency veterin rn ch biopreparatu a l iv Landesamt f r Soziales und Versorgung Brandenburg Landesamt f r Verbraucherschutz Landwirtschaft und Flurneuordnung Landesamt f r Arbeitsschutz Gesundheitsschutz und technische Sicherheit Regierungspraesidium Tubingen Leitstelle Arzneimittelueberwachung Baden Wurttemberg Regierung der Oberpfalz Regierung von Niederbayern Regierung von Oberbayern Regierung von Oberfranken Regierung von Schwaben Senator fur Arbeit Frauen Gesundheit Jugend und Soziales der Freien und Hansestadt Bremen User Manual DE BB 01 DE BB 02 DE BE 01 Protection of Health and Technical Safety Regierungspraesidiu DE BW OI m Tuebingen Leitstelle Arzneimittelueberwac hung Baden Wuerttemberg DE BY 01 Government of Lower DE BY 03 Bavaria Government of Upper DE BY 04 Bavaria Government of Upper DE BY 05 Franconia DE BY 06 DE HB 01 Communications and Networking Biologicals and Medicaments Competent Authority Brandenburg Landesamt f r Verbraucherschutz Landwirtschaft und Flurneuordnung Berlin Office for Occupational Safety Government of the Upper Palatinate D
95. f additional management and search functionality Features include Automatic Saves As you move between sections in the MIA document creation process the application automatically saves the information entered on each screen Draft MIAs If you log out at any time for any reason this information is stored in a Draft MIA document which can be easily accessed later See Section 4 4 1 MIA Drafts Management section for information on retrieving reviewing copying printing and completing a draft MIA Search for Submitted MIAs Submitted MIAs can be retrieved from the database using the Search function See Section 4 3 To Search the MIA Database Amend an Incorrect MIA If an MIA is incorrect or out of date it can be easily amended from the database This process is described in Section 4 3 1 To Update a Submitted MIA Copy a Submitted MIA to Draft To save time you may create a new draft MIA by copying a submitted MIA to your Organisation s Drafts folder See Section 4 4 1 2 To Copy an MIA Draft Invalidation of a Valid MIA If an MIA was submitted in error for example if an address or name of the site is incorrect it can be removed from the database by invalidating it if you have permission to invalidate the MIA This process is described in Section 4 3 3 7o nvalidate an MIA Withdrawal of a Valid MIA In some cases such as the issue of a Non Compliance Report after the failure to meet the previously att
96. f the columns b c d orf in either the first or second part of the form depending on whether the product is being manufactured packaged certified or imported from a third country 3 Scroll down to check that nothing is required in the second half of the form The second half of the form covers other products or manufacturing activities and operates identically to the form detailed above Add other dosage forms or special requirements 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 66 Zatacznik do OPZ hele European Medicines Agency Z User Manual Communications and Networking page ED Manufacturing FE HE Importation Manufacturing Special Requirements Other products or manufacturing activity Other Products Radiopharmaceuticals Radionuclide generators Medicinal gases Herbal products Homoeopathic products Biological active starting materials Other Sterilisation of active substances excipienta finished product Filtration Dry heat Moist heat Chemical CW SW Cal SR WI Gamma irradiation Electron beam Other Packaging only Secondary packing Quality control testing Microbiological sterty Microbiological nan stenity Chemical Physical Seen EE I ara ae Biological 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 67 Zatacznik do OPZ kh European Medicines Agency AT User Manual Communications and Networking 3 4
97. facture or import human investigational medicinal products 4 2 3 Authorised Sites The Authorised Sites section of the form allows you to select add or create additional sites for the manufacture of medicinal products 4 2 3 1 Selected Sites List LIGCSIEEPIHSS Authorised Sites Signatory Details Review amp Submit MIA w Selected Sites List Add Sites MIA Draft 3226 45000 saved by Laurent Fighon on 200 04 05 at 11 55 48 BST The Selected Sites List displays the site s to which the MIA applies 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 112 Zatacznik do OPZ akk European Medicines Agency Z User Manual Communications and Networking 4 2 3 2 Add New Sites for MIA 3 To add a site to the Selected Sites List click Add Sites matte Authorised Sites PETE i AT TE TUIS AKT TALIE Selected Sites List Search Sites NCA Reference Key dg Add Sites ei E Site Name Address Country oF MIA Draft S226 46000 saved by Laurent Fighon on 200 04 05 at 11 33 49 BST Cancel 4 Now add search criteria into boxes a or C 5 Finally click Search The Search results screen appears Search Sites Results Screen 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 113 Zatacznik do OPZ ar European Medicines Agency Z User Manual Communications and Networking OST Dei Authorised Sites Signatory Details Review amp Sub
98. ficate 13 Click the Review and Submit GMP Compliance tab 14 Next click A PDF version of the GMP Certificate is created Windows Explorer users will see the online PDF tool bar at the top of the open browser window 15 To print a hard copy click D and the file is sent to your default printer Click SAVE A COPY a to save a copy of the draft GMP Certificate to your workstation or network 3 2 6 2 Successful Submission of a GMP Compliance Certificate If you have completed the GMP Certificate according to the business rules an information message appears to notify you that the GMP Certificate has been added to the database Tour GMP Certificate has been submitted successfully a Tour GMP Reference number is 556 If you wish make a note of the GMP Reference number This is a unique number that the GMP Certificate has in the system Print Preview 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 51 Zatacznik do OPZ P k European Medicines Agency AT User Manual Communications and Networking 3 2 6 3 Troubleshooting Errors in GMP Module Should you enter a variable in your draft GMP Certificate that fails to meet the business rules governing the EudraGMP system an error message appears This error message provides detail to point you in the direction of the error The following error s were detected in the draft you submitted Please correct them and then resubmit u Site is mandato
99. for their organisation Country Name of the Organisation English name of EudraGMP Organisation amp State Acronym Austria AGES PharmMed Austrian Medicines AT AGES and Medical Devices Agency Australia Australian Pesticides and Veterinary Australian Pesticides AU APVMA Medicines Authority and Veterinary Medicines Authority Australia Therapeutic Goods Administration Therapeutic Goods AU TGA Administration Belgium Federaal Agentschap voor Federal Agency for BE DGMP Geneesmiddelen en Medicines and Health Gezondheidsproducten Agence Products F d ral des M dicaments et Produits de Sant Bulgaria U3nbnHutenka areHuMs no Bulgarian drug BG BDA JlekapcTBaTa agency Bulgaria HauwoHanHa National Veterinary BG BDAV BerepuHapHoMenuuMHcka Cnyx oa Service Health Canada Health Canada CA HC Switzerland Swiss Agency for Therapeutic Swiss Agency for CH SWISSMEDI Products Therapeutic Products C Cyprus MAPMAKEYTIKE2 YOHPEZIE2 Pharmaceutical CY PSMOH YTIOYPTEIO YTEIA Services Ministry Of Health KTHNIATPIKE YTIHPEZIE Veterinary Services CY_VS Czech St tn stav pro kontrolu l iv State Institute for CZ SUKL Republic Drug Control Czech stav pro st tn kontrolu Institute for State CZ USKVBL Control of Veterinary 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 174 Republic Germany Brandenburg Germany Brandenburg Germany Berlin Germany Baden Wurttemb
100. g Authorisation Holder Term Marketing Authorisation Holder is a person who has applied and received a Pan EEA right to market and sell a product ina pharmaceutical form or a set of pharmaceutical forms MIA Acronym Manufacturing Importers Authorisation Term Any substance or combination of substances presented for reating or preventing disease in human beings or animals Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring correcting or modifying physiological unctions in human beings or in animals is likewise considered a medicinal product Member State Term A country member of the European Union Acronym Mutual Recognition A community registration procedure described by Council Directive 75 319 EEC as amended for the authorization of medicinal products Mutual Recognition Procedure One of the routes for seeking regulatory approval in the European Union A submission is first made to a EU Member State authority that assesses grants a national approval and prepares an assessment report This report is circulated by the initial authority to the other concerned Member States who are expected to recognize this decision and grant their own national authorization within a period of 90 days following the initial approval The 90 day period is used to resolve any issues between Member States If serious objections are rai
101. ge Volume Liguids E Eg E E E ES Semi solids Small volume liquids solids and implants Non sterile products h Capsules hard shell E E z B E H E lactam Antibiotics Hormones Or Hormonal Activity Prostaglandins Cytokines Cytotaxics Cytostatics Immuna suppressives Medicinal Products Containing Prions senntaxics Or Teratogens 3 Radiopharmaceuticals Ectoparasiticides a 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 38 Zatacznik do OPZ akk European Medicines Agency Z User Manual Communications and Networking 4 Next click the radio button or check box under columns b c d or f depending on whether the product is being manufactured packaged certified or imported from a third country 5 Scroll down to check that nothing is required in the second half of the form The second half of the form covers other products or manufacturing activities and operates identically to the form detailed above Add other dosage forms or special requirements 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 39 Zatacznik do OPZ Qu European Medicines Agency Z User Manual Communications and Networking page p Manufacturing i Importation Manufacturing Special Requirements Other products or manufacturing activity Other Products a Radiopharmaceuticals Radionuclide generators Medicinal gases Her
102. hat the company s registered address is located in By default the NCA s country you logged in under is selected To choose another location click the key then click the country name f you know the company s EudraGMP Key you need only use that 5 Now click C and the search of companies currently in the database begins Company Search Result item Select Company ll Raj preme Telephone 8 APHARM 109 8144 ZAC DE SUZOTRUE DE LA CHAPELLE SAINT AMANT TALLENDE n a 63450 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 109 Zatacznik do OPZ P ds European Medicines Agency AT User Manual Communications and Networking fthe search is successful the results appear in the Company Search Results area above Click the radio button d and then click b which is found at the bottom of the Company Search Results list The company s details automatically populate the Authorisation Holder details section If the search is unsuccessful click Create Company 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 110 Zatacznik do OPZ ar European Medicines Agency CZ User Manual Communications and Networking 4 2 2 3 Create New Company Create Company NCA Reference Key finnnz2 Paris Fr Co Pharma a Authorisation Holder fPharmacocare S A i Address 1 23 Rue de Bobigny Address 2 Address 3 FO Address 4 FO City pas 0004 State EEEE Po
103. he EudraGMP homepage nennen nnn nennen nnn nane sna nnn nennen 15 29 7ESGOING ee 16 20 MOC CIN ON ses pepe cera a re da E EC O Eon do Zoe A 16 21 e dl e CUO EE 17 2 1 Main Menu for Unregistered Users nene nnne nnne nnns nnn nnne nnne nn nnne nnns 17 2 1 2 Main Menu for Registered Users nennen nennen nennen nnne rn nnne nnns nnne nn nnne nnns 19 2 1 3 GMP Compliance Menu R RE 20 2 1 4 Manufacturing and Importation Authorisation Men 21 2 7 5 ORTEN ON ae ee 22 GG AME near heine aa Fa M 22 va MEE C PE E EEEE 22 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 2 Zatacznik do OPZ ek k European Medicines Agency ENER User Manual Communications and Networking P ARIE o 1 6 PWN ENEA E 23 27 04 LANJUOGEZEEGIOM M RR m m UU uU EMT 23 3 The GMP Compliance Module ne a ea Aia 24 SEG IIS ee ee ee ZA AE er 24 3 2 GMP Certificates Tutorial ssuaauua aaa aaa aaa aaa aaa aaa aaa zakazu aaa zakaz zakaz aaa nnn nnns iaa sanas ansa 25 3 2 1 Possible States of a GMP OCerllfiCale resedit YKK CZA EEEE EGW ai 26 3 2 2 To Create and Submit a New GMP Certificate emen enn aaa aaa rns 27 3 2 3 xg MT t 28 SUR MEEES q 0 29 TIE 29 SUIS MESI C IUE TUUM 34 ORC NE Update Sie DEAS see ee 35 9294 e Eeler 36
104. he GMP Compliance Menu as illustrated above and the Search GMP Compliance screen appears Certificate Humber City County United Kingdom Postcode BukaGhiP Key NCA Reference Key MIA Humber API Active Substance Enable API Search C Legal Basis Of Certificate Enable Scope Seal cli Type of Inspection Enable Inspection Sea ch Operabans Enable Operations Sea che Inchade Walid aan documends O include Non Compliance Report 7 You can search using the following criteria 2 CERTIFICATE NUMBER D U N S NUMBER NAME CITY COUNTRY POSTCODE EUDRAGMP KEY NCA REFERENCE KEY MIA NUMBER Additional search criteria related to Active Pharmaceutical Ingredient Active Substance API Legal Basis of Certificate Type of Inspection and Operations become available if the checkbox alongside them are selected For these options you may select EU EU or even worldwide ALL COUNTRIES even if you do not know the first three letters of the Manufacturers Name 3 Alternatively if you only have a limited amount of information to conduct the search use the search tips below 4 f you would like to include Withdrawn GMP Certificates check Include Withdrawn documents and to include Non Compliance Reports in your search check Include Non Compliance Report 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 87 Zatacznik do OPZ European Medicines Agency OT User Manual Communic
105. he Main Menu appears EudraG MP GMP Compliance Manufacturing and importation Authorisation Search Site Admin FAQ Help ER LEngish KT The Main Menu is the options bar at the top of the User Interface and is available at all times Click GMP COMPLIANCE to access the GMP Compliance Menu Section 2 7 3 Click MANUFACTURING AND IMPORTATION AUTHORISATION to open the MIA Menu Section A Ad Click SEARCH SITE to open the Search Sites page See Section 5 Click ADMIN to open the Administration Menu See Section 2 7 5 This option is only visible to EudraGMP Administrators Click FAQ to open the EudraGMP Frequently Asked Questions PDF in a new window f Click HELP to open the EudraGMP user manual PDF in a new window Note You are reading this manual now Click to quit EudraGMP and any other Eudra SSO applications Section 2 6 h Click the arrow to open the drop down menu then scroll and click to select another language for the application Click to change to the selected language 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 19 Zatacznik do OPZ P ds European Medicines Agency ENER User Manual Communications and Networking 2 7 3 GMP Compliance Menu This menu provides access to the functions of the GMP Compliance Module described in Section 3 New GMP Certificate Mew Mon Compliance Report Draft GMP Certificates Search Search GMP C
106. hin your agency 6 4 1 1 Search Companies 1 Click on the Activate Deactivate Company link and the Search Companies window appears Search Companies Active Inactive Authorisation Halder Details NCA Reference Key Authorisation Holder Address Country United Kingdom Y Eudr aGMP Key 2 Enter your search criteria into the relevant field or alternatively click to return all the currently active companies The Company Search Results appear Company Search Result to 10 of 316 Company bd GR Ref Address H 3M HEALTH CARE LIMITED 12853 3M HOUSE MORLEY STREET LOUGHBOROUGH LEICESTERSHIRE LE11 1EP ABBOTT LABORATORIES af 12560 QUEENBOROUGH KENT n a n a ME11 SEL LIMITED ACE CHEMICALS LIMITED 15802 11787 BROOMHOUSES 2 INDUSTRIAL ESTATE OLD GLASGOW ROAD LOCKERBIE DUMFRIESSHIRE DG11 250 ACS DOBFAR UK LIMITED CAMBOLS BEDLINGTON MORTHUMBERLAND NE22 LB ADDENBROOKES NHS FIMAMCE DEPT HILLS ROAD CAMBRIDGE FOUNDATION TRUST CAMBRIDGESHIRE CB2 200 AEROPAK CHEMICAL VIKING ROAD GAPTON HALL INDUSTRIAL ESTATE PRODUCTS LIMITED GREAT YARMOUTH NORFOLK NER31 ONU AINSVWORTHS LONDON 40 44 HIGH STREET CATERHAM SURREY CRs SUB LIMITED AIR LIQUIDE Uk LIMITED CEDAR HOUSE 38 LONDON ROAD REIGATE SURREY RH2 9QE AIR PRODUCTS PLO MISS LOUISE MCKEVETT 2 MILLENNIUM GATE WESTMERE DRIVE CREWE CHESHIRE Cr BAP ALIA ME THERAPEUTICS GRANTA PARE GREAT ABINGTON CAMBRIDGE n a LIMITED CHI
107. ialog box appears If you are sure you want to deactivate the sites click i the action is successful a confirmation message appears save successful 3 The selected site or sites is now listed in your NCA s list of Inactive sites so no longer appear in the Site Search Results window you are currently viewing Making an Inactive Site Active The purpose of this feature is to ensure that users can search for and select a site that is listed currently as inactive EudraGMP User Manual v1 0 CURRENT 156 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking 2 Click to return all currently inactive sites or enter an element in one of the Search criteria then click Search 3 Inthe Site Search Result window click the radio button alongside the site you want to reactivate A NCA Ref Ej Key i Site Name fy Address FJ e fi 340B51185555854585 13406 CY Ent Gmbh V E River Drive London Guy GSL ALLL E a T L I m bh MII If you are happy that the unique NCA Ref Key has not been reallocated by you or another user within your agency you can now click ctivate If you need to change the NCA Ref Key because the previously used NCA Ref Key is no longer available you may enter a new NCA Ref Key according to your agency s procedures A pop up dialog box appears Click i to confirm If the action is successful a confirmation message appears save successful
108. iate it to the Non Compliance Report 1 First you must search and select the product s Active Substance Make sure the Active Substance tab is selected and click Search The Active Substances Search screen appears Search Active Substances Ingredient Name 2 Now enter the Active Substance s Ingredient Name NCA Reference Key a and b or Dictionary ID in the search entry fields 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 70 Zatacznik do OPZ akk European Medicines Agency Ce User Manual Communications and Networking 3 Once you have entered information in at least one of the above fields click d Restrictions and Authorisation Active Substances Selected Acine Substances Lisi Dictionary ID Ingredient Name English Search Active Substances Active Substances Search Result 1 to 100113 Dictionary Competent NCA Ref Select Ingredien Name English Authority Name ra C RED KRYPTONITE UK MHRA 20090326 0S09 J C 12218 BUTTERSCOTCH COLOURED e 5 1 1 7307 0 12780 COLOUR RED 12308 DYE OPATINT RED 13360 INGREDIENTS 12276 IRON OXIDE RED 13376 IRON OXIDE RED E172 13049 IRON OXIDE RED E172 13121 Ingredient Description 12569 PHENOL RED 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 71 Zatacznik do OPZ Nr Ae European Medicines Agency AT User Manual Communications and Networking Ingredient Name English This entr
109. inary medicinal products introduce the legal framework for the Community database The concept of a European Inspections database is included in the above specified legislation to provide EEA National Competent Authorities and the European Medicines Evaluation Agency EMEA with an overview of the status of pharmaceutical manufacturers The legislation provides for an electronic tool containing complete information on all pharmaceutical manufacturers This includes information on Manufacturing and Importation Authorisations MIA and Good Manufacturing Practice GMP Certificates for authorised sites in the EEA and information on GMP certificates for manufacturers in third countries GMP Compliance Manufacturing and Importation Authorisation Following a site inspection a certificate of Good Manufacturing Practice shall be issued to a manufacturer if the outcome of the inspection demonstrates that the manufacturer complies with the principles of GMP as provided by Community legislation The manufacture of medicinal products in the EU is undertaken subject to the holding of a Manufacturing and Importation Authorisation Such authorisation is also required for imports from third countries into a Member State The National Competent Authority of Member States who performs the inspection shall enter ihe GMP Canincates thal thay Issue into Buda Me The National Competent Authority of Member States shall enter the Manufacturing and Importation Authori
110. ind the Active Substance in the Common Dictionary by running a detailed search 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 42 Zatacznik do OPZ yk European Medicines Agency CZ User Manual Communications and Networking Part 1 Part 2 Restrictions and Authorisation B T35 37217 TTE ELO anergy S TESTIS D 9 Active Substances Restrictions Issuance and Signatory Selected Active Substances List Dictionary ID Ingredient Name English NCA Ref Key ae fthe Active Substance cannot be found after such a search you can create a new Active Substance in your NCA Dictionary see Section 3 2 5 4 To Create a New Active Substance section and associate it to the GMP Certificate 1 First you must search and select the product s Active Substance Make sure the Active Substance tab is selected and click Search The Active Substances Search screen appears Search Active Substances Ingredient Name 2 Now enter the Active Substance s Ingredient Name NCA Reference Key a and EE or Dictionary ID in the search EE fields 3 Once you have entered information in at least one of the above fields click d 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 43 Zatacznik do OPZ BE Ae European Medicines Agency OT User Manual Communications and Networking Substances actives Restrictions D livrance et signataire Liste des substances actives s lectionn es No Entries
111. initial human medicinal product inspection is undertaken on behalf of the EMEA iss ze of Check if initial pre approval veterinary medicinal product TECNICO inspection is undertaken on behalf of the EMEA ides cd D Check if routine human medicinal product inspection T26 2004 EC is undertaken on behalf of the EMEA Art 44 3 of Regulation 1 726 2004 EC Check if routine veterinary medicinal product inspection is undertaken on behalf of the EMEA 2001 83 EC initiated and undertaken by NCA Art 80 4 of Check if veterinary medicinal product inspection is Directive 2001 82 EC initiated and undertaken by NCA d ieck if active substance is for human medicinal product manufacture Art 111 1 of Directive F sea regulation already in place L 5138 2 L 5313 1 8 L 5312 1 Further transposition in process 2001 83 EC Art 111 4 of i I Dieke Check if human medicinal product inspection is Active Substance Manufacturer Art 11141 of o Set of regulation already in place L 5138 2 L 5313 1 amp L 5312 1 Further transposition in process Directive Check if active substance is for human medicinal product 2001 83 EC Art 80 1 of Lp Public health code articles L 5146 1 et R 5146 1 R 5146 2 R 5141 79 R 5141 80 for API articles L 5138 1 to L 5138 4 in modification Directive e ing 2001 82 EC Check if active substance is for veterinary medicinal product Centralised Procedure Padded Check if pre approv
112. intended to guide you back to the section where the error occurs See Section 8 Business Rules if you are unsure of the rules relating to the creation and issuance of Non Compliance Reports If a system error occurs please make a note of the error code and contact the EudraGMP Service Desk see Section 1 3 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 85 Zatacznik do OPZ ek k European Medicines Agency OT User Manual Communications and Networking 3 5 GMP Compliance Menu Search 3 5 1 To Search for Submitted GMP Certificates Mew GHP Certificate New Non Compliance Report Uraft GMP Certificates Search search GMF Compliance earch Mon Compliance Search Withdrawn GMPC You can use the Search function to find submitted and withdrawn GMP Certificates as well as Non Compliance Reports on the database Use this to Copy a submitted GMP Certificate or Non Compliance Report as a new draft Withdraw a GMP Certificate or Non Compliance Report because another inspection has superseded the previous one nvalidate a GMP Certificate or Non Compliance Report because the document has been entered incorrectly 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 86 Zatacznik do OPZ P k European Medicines Agency AT User Manual Communications and Networking 1 Click Search GMP Compliance in t
113. irety within your browser window or can be produced as an electronic document in PDF for downloading saving or printing locally Shared Database of Manufacturing Sites The GMP Compliance Module uses a database of manufacturing sites This database is shared with the MIA Module and is shared across all NCAs While many of the submitted Certificates will be for Manufacturing Sites that are already in this database it is possible to create new entries in this database via the GMP Compliance Module Shared Dictionary of Active Substances It is possible to make use of a common Dictionary of Active Pharmaceutical Ingredients This Dictionary can also be extended with entries and translations both of which can be shared between different NCAs within the same country EudraGMP Keys and NCA Keys EudraGMP automatically assigns a unique key to every GMP Certificate the EudraGMP Key This key cannot be changed by the user and remains unique for the lifetime of the system Similarly a EudraGMP Key is assigned to every Manufacturing Site For Sites users can also enter and store the NCA Key the unique Key that is used for the Site in their own NCA s filing system or procedures Both keys can be used to search the database 3 2 GMP Certificates Tutorial This section describes the steps required to create and submit a Valid GMP Certificate Please make sure you have read and understood Section 3 1 Overview before proceeding 29 05 2009 10 32
114. istrict Government of Schwaben Senator f r Arbeit Frauen Gesundheit Jugend und Soziales der Freien und Hansestadt Bremen EudraGMP User Manual v1 0 CURRENT 175 Germany Hessen Germany Hessen Germany Hessen Germany Freie und Hansestadt Hamburg Germany Mecklenburg Vorpommern Germany Niedersachse n Germany Niedersachse n Germany Niedersachse n Germany Niedersachse n Zalacznik do OPZ kk European Medicines Agency Regierungspr sidium Darmstadt Regierungspr sidium Gie en Regierungspr sidium Kassel Freie und Hansestadt Hamburg Beh rde f r Soziales Familie Gesundheit und Verbraucherschutz Amt f r Gesundheit und Verbraucherschutz Abteilung Verbraucherschutz Patientenschutz und Sicherheit in der Medizin Landesamt f r Gesundheit und Soziales Mecklenburg Vorpommern Dezernat 30 Staatliches Gewerbeaufsichtsamt Braunschweig Staatliches Gewerbeaufsichtsamt Hannover Staatliches Gewerbeaufsichtsamt L neburg Staatliches Gewerbeaufsichtsamt Oldenburg User Manual Communications and Networking Regierungspr sidium Darmstadt DE HE 01 DE HE 02 DE HE 03 DE HH 01 DE MV 01 DE NI 01 Saxony Agency Braunschweig Trade and industrial DE NI 02 inspection agency of state of Lower Saxony Agency Hannover DE NI 03 DE NI 04 Regierungsprasidium Gief en Regierungsprasidium Kassel Freie und Hansest
115. ivate 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 153 Zatacznik do OPZ BS Ae European Medicines Agency AT User Manual Communications and Networking BE Company NCA Ref H Address H e 68 3M HEALTH CARE LIMITED 12853 SM HOUSE MORLEY STREET LOUGHBOROUGH LEICESTERSHIRE LE11 1EP A MELSON AND COMPANY LIMITED 1175 11718 UNITS 5 8 ENDEAVOUR WAY WIMBLEDON LONDON 818 SLIH If you are happy that the unique NCA Ref Key has not been reallocated by you or another user within your agency you can now click _ Activate If you need to change the NCA Ref Key because the previously used NCA Ref Key is no longer available you may enter a new NCA Ref Key according to your agency s procedures A pop up dialog box appears Click i to confirm If the action is successful a confirmation message appears T If the action is unsuccessful an error message highlights the issue Make the necessary changes and return to point 5 above Assign Access Privileges Activate Deactivate Company Type of Inspection Delete GMP Compliance Delete MIA Administrators may change a site s status to inactive or re activate a site that was previously made inactive u fa site is closed down for whatever reason e g refurbishment sites may be made inactive fa user creates a site in error it may be decided to remove this error from the possible list of sites 29 05 2009 10 32 19 EudraGMP
116. k UPdate to save the updated details in the GMP Certificate Draft 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 35 Zatacznik do OPZ akk European Medicines Agency Z User Manual Communications and Networking 3 2 3 4 Legal Basis of Certificate Simply click the relevant check box Part 1 Part 2 Restrictions and Authorisation Review amp Submit GMP Compliance ii hom Legal Basis Of Certificate WIR E Legal Basis Of Certificate Art 111 5 of Directive 200183EC a ant 805 or Directive 200182Ec P Art 15 of Directive 200120EC 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 36 Zatacznik do OPZ kkk European Medicines Agency c User Manual Communications and Networking 3 2 3 5 Type of Inspection Now complete the Type of Inspection form Use the annotated screenshots below to assist you with making your choices MAC TTT ACA Type of Inspection National Inspection Program Art 40 of Check if site is for human medicinal products Directive Art L 5124 3 of Public Health Code 2001 83 EC An dd vf Check if site is for veterinary medicinal products Directive Public health code Articles L 5142 1 to L 5142 3 and R 5142 1 to R 5142 49 2001 82 EC Art 13 of Check if site is for human IMP Directive ICT Art L 5124 3 of Public Health Code 2001 20 EC Third Country Inspection Program Art 8 2 of Regulation EQ 726 2004 Check if
117. k k European Medicines Agency AT User Manual Communications and Networking 3 5 2 4 To Update a Non Compliance Report GMP Compliance Menu New GMP Certificate New Non Compliance Report Draft GMP Certificates Search Search GMP Compliance search Non Compliance Search withdrawn GMPC 1 Click Search Non Compliance in the GMP Compliance Menu The results are automatically returned for all current Non Compliance Reports for the last three months Should you wish you may also select the option to Include Withdrawn documents To narrow your search by Last Update Date Enter the date after which the Certificate was last updated saved to the database in the following format YYYY MM DD in the upper number field a Alternatively click on the calendar icon Tl and choose the date from the calendar bat x Left click Left click arrows to arrow to choose year choose month THE PS JARO JS 22 23 Left click date 24 25 DB 27 28 99 30 to return to the form 3 Then include a date before which the Non Compliance Report was last updated in the following format YYYY MM DD in the lower number field a Alternatively click on the calendar icon and choose the date from the calendar Once you have found the Non Compliance Report you wish to update click on the blue Report Number and the Report appears in the preview window 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURREN
118. l action to be taken by EDOM Click within the free text field then add clarifying comments in English by way of explanation Note that these comments are mandatory if the checkbox a is selected Suspension of Clinical Trials Click the Suspension of clinical trials checkbox a and the free text field D appears Suspension of clinical trials n f ny additional detail Click within the free text field then add clarifying comments in English by way of explanation Note that these comments are mandatory if the checkbox a is selected Other If the above options do not accurately cover the action taken or proposed by the NCA Click the Other checkbox a and the free text field D appears Any other action taken or proposed by an NCA not covered by the above options should be detailed here Characters remaining 897 999 Click within the free text field then add clarifying comments in English by way of explanation Note that these comments are mandatory if the checkbox a is selected Additional comments 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 19 Zatacznik do OPZ pkk European Medicines Agency Ce User Manual Communications and Networking This field provides an area for any additional comments not covered within the previous two sections Additional comments Characters remaining 999 999 Click within
119. le MIA 1 Enter the Authorisation Number of the MIA you wish to delete and then click the button 2 If this is a valid Authorisation Number the system returns the details of the MIA Confirm that the details are those of the document you wish to delete then click the Delete button The system displays a Confirmation page into which you should enter the reason for deleting this document You must supply details in the English language entry field You may also provide details in your own language if that is not English at your discretion Once you have done this click the Confirm button 4 The Delete MIA page appears If the deletion has succeeded a Deletion Success message appears 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 160 Zatacznik do OPZ kh European Medicines Agency ATEAN User Manual Communications and Networking 6 8 2 To Delete Multiple MIAs 5 Enter the location of the csv file in the lower entry field You may click the browse button to navigate to the correct location Click the button to retrieve the details of all the Authorisation Numbers contained in the csv file The system displays the details in a results table Each row of the table has a Selection field in the first left hand column These will all be selected when the results are returned This indicates that this row will be deleted 8 If after reviewing the data you decide you do not want to delete one or more documents f
120. lly registered users can manage Draft MIA documents in their organisation s Draft MIA folder 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 132 4 4 1 European Medicines Agency Communications and Networking MIA Draft Management Now MILA Draft Mls Zatacznik do OPZ User Manual When you exit EudraGMP any progress you have made completing an MIA document is automatically saved within your organisation s Draft MIA database If your session is timed out because of inactivity the information is saved in a draft except for the page you were working on when the timeout occurred 1 Click DRAFT MIAs and the List of Drafts appears List of drafts to 20 of 49 Draft Authorisation 3446 cul 2007 01 12 2007 11 15 2007 04 05 2008 01 03 4394 annextest 29 05 2009 10 32 19 Authorisation Authorisation Holder AGRIMIM LIMITED GEODIS LOGISTICS SUD OUEST AGENCE GENERALE DES EGLIPEMENTS ET PRODUITS DE SANTE ETABLISSEMENT FHARMACELITIGLIE DES HOGPITALI amp DE PARIS AGEPS EPHP GEORGIA PACIFIC FRANCE pdates AERRDIS EudraGMP User Manual v1 0 CURRENT Town BRIGG f CLICHY LA GARENNE PARIS CELE 05 KLINHEIM PLAISIK crane d romaintest ftester romaintest romainte st ramaintest romaintest romaintest 2008 04 17 Mew 18 36 46 GMT 2008 03 25 Mew 18 20 35 GMT 2008 03 14 Mew 11 54 20 GMT 2008 03 14 Mew 11 47 14 GMT 2008
121. loosa 2009 03 31 UAT Alabama Inc 11 43 46 Scenario 2 GMT 2009 03 19 GMPC YOYODYNE Pittsburgh 2008 03 23 GMP Sanity Pittsburgh Inc 14 23 15 Check 2 0 9 GMT 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 102 Zatacznik do OPZ MNT European Medicines Agency AT User Manual Communications and Networking Draft ID This is the unique ID of the draft in your Organisation s draft storage database Click the Draft ID number to continue working on the draft Certificate Number This is the Certificate Number you issued when you began drafting the GMP Certificate Category GMPC GMP Certificates GMPDA GMP Certificates based on a Distant Assessment NCR Non Compliance Report Site Name The name of the site which may include the manufacturer s name City The city or place where the site is located f Last Update By The user who last added to the draft Last Update Date The last save time of the draft Copy Draft Click ito create a copy of the draft with a new Draft ID number Change Category Click to change an NCR to a GMPC and vice versa Draft List Navigation Tool bar Use the navigation buttons to refresh and jump forward C and M or backward through results list j Delete Click the 3 icon to delete the draft You can sort drafts by various criteria using the sort by icon EH ERE EN EJ CI KI CE EH KKM ERE ICI Click sort by E icon to sort by any of the cat
122. mit MIA res Shie Lis Search Sites 3 y 219 Site Name Address Country France BE EudraGMP Key Site Search Result 4 items Site Name i Address Ei 2192 10005 ADVANCED TECHHOFARC DU PAYS ACCELERATOR DE GEX RUE DIESEL APPLICATIONS SAINT GENIS POLILLY n a 01630 4473 BOIRBRUN POLE JULES WERNE 5 BOULEVARD MICHEL oIROIG UFF BOYES n a Baa FAMAR FRANCE ZAC DE LA CHARBONNIERE NS 2 BOIGNY SUR BIOMME n a 45760 LABORATOIRES BIOPOLE CLERMONT CY CLOPHARMA LIMAGHE SAINT BEAUZIRE n a 63360 Select Create Site c MIA Draft 3226 45000 saved by Laurent Fignon on 2007 04 05 at 11 33 48 BST 6 Now click the relevant radio button under the Select column D then click to add the site to the Selected Sites List 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 114 Zatacznik do OPZ BR Ae European Medicines Agency AT User Manual Communications and Networking Repeat the process for additional sites you may want to include on the MIA document To add anew site click Add Site See Section 4 2 3 3 Create New Site below for more detailed instructions 4 2 3 3 Create New Site If you cannot find a site in the database you need to create a new site record in the database Click the Create Site button C at the bottom of the Site Search Result Screen see section above after you have made a search Click the entry fields
123. n of the error 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 124 Zatacznik do OPZ pkk European Medicines Agency CZ User Manual Communications and Networking The following erroris were detected in the draft you submitted Please correct them and then resubmit An MIA document must have one or more signatories a The authorised operation Veterinary premixes_FR for site Santecorps S A cannot be selected since the Legal Basis HIP A44 D2001 62 EC is not selected in the MIA Header In the above error message the following items have created the error s message A Signatory or Signatories since MIA documents can include more than one Signatory is required The Veterinary premixes operation is not allowable under the selected business rules A different Legal Basis detailed in the error message including reference to veterinary legislation must be selected However such error messages should be a rare occurrence if an Inspector is experienced and aware of the business rules governing the creation and issuing of MIAs See Section 9 Business Rules if you are unsure of the rules relating to the creation and issuance of MIA documents If a system error occurs an Error code appears The following error s were detected in the draft you submitted Please correct them and then resubmit ja The error code is 171975 f this error persists logout from the application and start a new session Please i
124. n zero records 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 72 Zatacznik do OPZ a European Medicines Agency ENER User Manual Communications and Networking CGA Restrictions and Authorisation TER Active Substances Restrictions Selected Active Substances Lisi ll Dictionary TER EU Ingredient Name English 10 Now click the entry field a and enter the Ingredient Name in English 11 Next enter your Organisation s defined reference key This is not mandatory but you should be guided by the conventions specified by the Organisation you are working for 12 Finally click and the new substance appears in the Selected Active Substance List Check that the substance name and the NCA Ref Key are correct Dictionary ingredient Name English NCA Ref Key Edit ID RED KRYPTONITE 20090326 0809 pf SS Search 13 You have finished adding a new Active Substance Add any additional Active Substances in the same way 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 13 Zatacznik do OPZ P de European Medicines Agency AT User Manual Communications and Networking You can now advance to the Restrictions form by clicking on the Restrictions tab To delete an Active Substance from the draft click the delete icon x This action does NOT delete the Active Substance from the database only from the
125. nal Reference Member State National or EMEA d 4 To add further MPs click Add again f If you selected d in error click the 3 icon to delete the row Then click to confirm Adding Investigational Medicinal Product to the Report Product Name EudraCT Nos D SE D D D D D D 1 Click Ad a above to include an Investigational Medicinal Product IMP Once clicked a product inclusion is mandatory Product Marne EudraC T Nos Delete Kryptonair 2 y 2 Now add the IMP s Product Name a 3 Now add its EudraCT Clinical Trial number if possible D 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 82 Zatacznik do OPZ pkk European Medicines Agency CZ User Manual Communications and Networking 4 To add further IMPs click _A again d If you selected Al in error click the icon C to delete the row Then click to confirm 3 4 7 To Review Print and Submit a Draft Non Compliance Report This is the final stage of the Non Compliance Report creation process Click the Review and Submit Non Compliance Report tab Your draft Non Compliance Report appears YOYODYNE Birkdale 2304 1113 KATE MORE AVENUE SOUTHPORT MERSEYSIDE L98 XVP United Inc Kingdom Part 1 Part 2 Restrictions and Authorisation Part 3 Review amp Submit Non Compliance Report Print Preview Submit Non Compliance Report C exclude Teleconference info Medici
126. natively click on the calendar icon EF D and choose the date from the calendar Left click Left click arrows to arrow to CS choose year choose month io 11 12 15 id 15 16 17 18 19 20 31 72 23 Left click date 24 25 26 27 28 29 30 to return to the 34 form Today August 10 2006 Then enter the Teleconference Time CET in HH MM Note that for clarity it is recommended the 24 hour clock system is used Finally enter the Teleconference Number This is the telephone number all participants should use to dial into the Teleconference just prior to its start time Adding Human and Veterinary Medicinal Products to the Report Dosage Forms Reference Member State National or EMEA Delete 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 81 Zatacznik do OPZ P k European Medicines Agency AT User Manual Communications and Networking 1 Click a above to include a Medicinal Product Once clicked a product inclusion is mandatory Product Tune Product Marne Dosage Forms Reference Member Simo National or FMEA Delete e Le or XL i z a amp d f ma 2 Choose product type Human Veterinary a Ensure that this concurs with the Legal Basis already chosen in Part 1 3 Now add the Medicinal Product s name D Dosage Forms C optio
127. nce Report to your workstation or network 3 4 7 2 Successful Submission of a Non Compliance Report If you have completed the Non Compliance Report according to the business rules an information message appears to notify you that the Non Compliance Report has been added to the database i a Your Non Compliance Report has been submitted successfully a The EudraGMP Reference number for this Non Compliance Report is 7524 fyou wish make a note of the GMP Reference number This is a unique number that the Non Compliance Report has in the system The EudraGMP system now transmits an email to every member on the Rapid Alert mailing list in ECD Manager which is maintained by the Inspections Sector at the EMEA 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 84 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking Print Preview 3 4 7 3 Troubleshooting Errors in GMP Module Should you enter a variable in your draft Non Compliance Report that fails to meet the business rules governing the EudraGMP system an error message appears This error message provides detail to point you in the direction of the error The following error s were detected in the draft you submitted Please correct them and then resubmit x Inspection End Date is mandatory In the above error message the following items have not been included Inspection End date Such error messages are
128. ncy ENER User Manual Communications and Networking Netherlands Inspectie voor de Gezondheidszorg Dutch Healthcare NL_IGZ Inspectorate Norway Statens legemiddelverk Norwegian Medicines NO NOMA Agency New Zealand Ministry of Health Ministry of Health NZ MOH Poland Gtowny Inspektorat The Main PL_GIF Farmaceutyczny Pharmaceutical Inspectorate Poland Gl wny Inspektorat Weterynarii General Veterinary PL GIW Inspectorate Portugal Direc o Geral de Veterinaria General Direction of PI DGV Veterinary Portugal Instituto Nacional da Farm cia e do National Institute of PT INFARMED medicamento Medicines and Pharmacies Romania AGENTIA NATIONALA A NATIONAL MEDICAMENTULUI MEDICINES AGENCY Romania AUTORITATEA NATIONALA NATIONAL SANITARA VETERINARA SI SANITARY PENTRU SIGURANTA VETERINARY AND ALIMENTELOR Directia de control FOOD SAFETY si coordonare a activit tii AUTHORITY farmaceutice veterinare Directorate for control and coordination of the veterinary pharmaceutical activity oweden Lakemedelsverket Medical Products SE MPA Agency Slovenia Javna agencija Republike Slovenije Agency for Medicinal SI ARSZMP za zdravila in medicinske Products and pripomocke Medicinal Devices of the Republic of Slovenia Slovak Ustav tatnej kontroly veterinarnych Institute for State Republic bioprepar tov a lie iv Control of veterinary Biologicals and RO NMA RO NMAV SK ISCVBM Medicaments Slovak Ministerstvo zdr
129. nd Healthcare Products Finland Laakelaitos Lakemedelsverket National agency for Fl NAM medicines France Agence francaise de s curit The French health FR AFSSAPS sanitaire des produits de sant products safety agency France Agence Nationale du M dicament National agency for V t rinaire Agence Frangaise de veterinary medicinal S curit Sanitaire des Aliments products French agency for food safety Greece EONIKO OPI ANIZMO2 National Organization GR NOM QAPMAKON For Medicines Hungary llatgy gy szati Olt anyag Institute For HU IVMP Gy gyszer s Takarm nyellenorzo Veterinary Medicinal Int zet Products Hungary ORSZ GOS GYOGYSZERESZETI National Institute Of HU NIP INTEZET Pharmacy Irish Medicines Board Irish Medicines Board IE IMB 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 178 DE TH 02 Spanish Agency Of FR_ANMV AFSSA Zatacznik do OPZ geet European Medicines Agency HT User Manual Communications and Networking Iceland Lyfjastofnun Icelandic Medicines IS IMCA Control Agency Italy Agenzia Italiana del Farmaco Italian Medicines IT AIFA Agency Italy Ministero della Salute Ministry of Health IT DGSAFV Dipartimento per la Sanit Pubblica Department for the Veterinaria la Nutrizione e la Veterinary Public Sicurezza degli Alimenti Direzione Health the Nutrition Generale della Sanit Animale e del and Food Safety Farmaco Veterinario Ufficio V Direction
130. nes and Healthcare products Regulatory Agency Report No STATEMENT OF NON COMPLIANCE WITH GMP Exchange of information between National Competent Authorities NCAs of the EEA following the discovery of serious GMP non compliance at a manufacturer Part 1 Issued following an inspection in accordance with The competent authority of United Kingdom confirms the following The manufacturer YOYODYNE Birkdale 2304 Inc Site address 1113 KATE MORE AVENUE SOUTHPORT MERSEYSIDE L98 XVP United Kingdom DUNS Number 20 090 4232 From the knowledge gained during inspection of this manufacturer the latest of which was conducted on tis considered thatit does not comply with the Good Manufacturing Practice requirements referred to in This certificate reflects the status ofthe manufacturing site at the time ofthe inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection after which time the issuing authority should be consulted The authenticity of this certificate may be verified with the issuing authority Part 2 1 NON COMPLIANT MANUFACTURING OPERATIONS 1 1 Sterile Products 1 1 1 Aseptically prepared list of dosage forms 1 1 1 1 Large Volume Liquids 1 5 Packaging only 15 2 Secondary packing Manufacture of active substance Names of substances subject to non compliant 20090326 0809 RED KRYPTONI
131. nform the help desk with the error code We ask that you make a note of the error code and contact the EudraGMP Service Desk with this information This feedback can be used to assist our development team making future improvements to the application 4 3 To Search the MIA Database Pew MILA Draft MIMS Search MIA The Search function allows all users to find submitted MIA documents on the EudraGMP database and review save or print them 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 125 Zatacznik do OPZ P k European Medicines Agency AT User Manual Communications and Networking 1 Click Search MIA in the MIA Menu as illustrated above and the MIA Search screen appears below MIA Humber Authorisation Holder Site Details City County United Kingdom Postcode End aGMP Key NCA Reference Key Legal Basis of Authorisation Art 40 of Directive 20018 3EC Art 44 of Directive 2001 82EC Art 13 of Directive 2001 20 EC Operatons Enable Operations Search Irichude Wir aen MAS Search Enter your search criteria into the entry fields Include as much information as you wish though you must include the Country in which the MIA was issued To include withdrawn MIAS in your search click the checkbox beside Include Withdrawn MIAs Use the Legal Basis of Authorisation to further narrow the search 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT
132. nnot find the site in the EudraGMP database you need to create a new site entry by clicking the button on the Site Search Result Screen 1 Click Create Site in the Site Search Results screen and the entry fields to enter details appear DUNS Humber HCA Reference Key Site Name Address 1 Address 2 Address 3 Address 4 City State Postcode Country Create Cancel 2 Click the entry fields to enter details In the absence of another numbering system we recommend you enter an NCA Reference Key for ease of future searching and as much address detail as you have 3 Click Create to save the details in the GMP Certificate Draft 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 34 Zatacznik do OPZ Fr European Medicines Agency OT User Manual Communications and Networking 3 2 3 3 Update Site Details The Site Details in a Draft GMP Certificate can be updated by clicking on the Part 1 Certificate Details form See 3 2 3 1 Certificate Details DUNS Number 20 eng 3300 NCA Reference Key 20090330 1559 Site Name YOYODYNE CV Int D Address T v E RIVER DRIVE Address 2 Address F Address 4 City LONDON State Postcode Syy285L Country Update Cancel 1 Click the entry fields to enter details We recommend you enter an NCA Reference Key for ease of future searching and as much address detail as you have 2 Clic
133. nts across the entire database See Section 4 3 for instructions to Search the MIA Database 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 21 Zatacznik do OPZ kh European Medicines Agency AT User Manual Communications and Networking 2 5 Admin Menu Lai i URL ka Ve d EU Assign Access Privileges Activate Deactivate Company Activate Dieactivate Ka A EE Site Legal Basis Delete GMP Compliance Delete MIA ASSIGN ACCESS PRIVILEGES Click this option to assign access privileges to registered users of EudraGMP See Section 6 of this manual for more information on the Admin Module ACTIVATE DEACTIVATE COMPANY Click this option to change a Company s status in EudraGMP See section 6 4 Maintaining Company Status ACTIVATE DEACTIVATE SITE Click this option to change a Company s status in EudraGMP See section 6 5 Maintaining Site Status TYPE OF INSPECTION Click this option to modify the Type of Inspection details See Section 6 6 of this manual for more information DELETE GMP COMPLIANCE Click this option to delete a GMP Compliance Certificate See Section 6 7 of this manual for more information DELETE MIA Click this option to delete a MIA Document See Section 6 8 of this manual for more information Other Options on the Main Menu 2 55 FAQ The FAQ option EudraGMP provides users with easy access to a list of Frequently Asked Questions and their answers
134. of a Non Compliance Report anne nennen 54 3 4 2 To Create and Submit a New Non Compliance Report cccccccccsscccceececeeceeeeeeeeeeceeeeceseeesseesseeeseeeessnees 55 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 3 Zatacznik do OPZ ar European Medicines Agency ce User Manual Communications and Networking 3 4 3 EZ l e 56 SA FRED OME ID STAINS NR NE HS 57 3432 NS NOW cee RANA AAAA ee AW AR AO NAA A A HE 61 34 38 Update Site Details ernennen een ee een EC 62 34 34 Legal Basis of Certificate RTI m 63 34309 Type of ns ocio er oem 64 3 4 4 x 65 3 4 4 1 Adding a Biological Medicinal Product or Dosage tom 68 3 4 5 Adding Active Substances Restrictions and Authorisation Information to the Non Compliance Report 68 34 0 COMMON BENA REEL 69 3 4 5 2 National Competent Authority Dictionaries Au 69 54553 TOAUDACIVE gt UDSIGNCES 70 34 04 To Creale a New AcllVe SUDSIANCE usa in CEA OE AGR AE PRE ance AAAA AE EEK ANARAN AE ARGE AA R AE 12 Roo TOAPBYRE WENDT ee ee ee 74 34 50 FO ACC ISSUANCE and SIQMALONY wa casino GOO O OG GEE tO OOO PO Anil 75 3 4 6 Li E 76 DAG TREU en FCN ON T UN 76 IAG Ge e De ER ee ee ee Eee 80 3 4 7 To Revie
135. ommunications and Networking Now complete the Type of Inspection form Use the annotated screenshots below to assist you with making your choices COE Type of Inspection Legal Basis Human Directive 200394 EC Finished LI a Products Article 47 of Directive 200183 EC b Active Substances Legal Basis Veterinary Directive 91412 ECC Finished c Products Article 51 of Directive 2001 82 EC a Ace Substances Legal Basis Investigational Directive 2003 94 EC Finished 1 Products Ciher Distant Assesment CH f Click check box if site is in breach of Directive 2003 94 EC Finished Products relating to Human Legal Basis Click check box if site is in breach of Article 47 of Directive 2001 83 EC Active Substances relating to Human Legal Basis Click check box if site is in breach of Directive 91 412 ECC Finished Products relating to Veterinary Legal Basis Click check box if site is in breach of Article 51 of Directive 2001 82 EC Active Substances relating to Veterinary Legal Basis Click check box if site is in breach of Directive 2003 94 EC Finished Products relating to human Investigational Medicinal Product IMP Click check box if site is for a distance assessment When you have completed this part of the form click on the Part 2 tab to begin entering details for Part 2 of the Non Compliance Report 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 64 Zatacznik
136. ompliance search Mon Compliance Search Withdrawn GMPC NEW GMP CERTIFICATE Click to begin creating a GMP Certificate Read Section 3 2 for a description of this process NEW NON COMPLIANCE REPORT Click to begin creating a Non Compliance Report Read Section 3 3 for a description of this process DRAFT GMP CERTIFICATES Click this option to view the GMP Certificate drafts currently under preparation in your Organisation Refer to Section 3 6 1 for a description of Draft Management of both GMP Certificate and Non Compliance Reports SEARCH Choose from three options to search for existing and withdrawn GMP certificates and Non Compliance Reports across the entire EudraGMP database Section 3 5 provides instructions and tips on how to search for submitted GMP Certificates 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 20 Zatacznik do OPZ kh European Medicines Agency AT User Manual Communications and Networking 2 4 Manufacturing and Importation Authorisation Menu This menu provides access to the functions of the MIA Module described in Section 3 Me fal Ay Draft MIAS Search MIA NEW MIA Click to begin creating a new MIA document Read the M A Documents Tutorial in Section 4 2 for a full walkthrough DRAFT MIAs Click this option to view the MIA document drafts currently under preparation in your Organisation Refer to Section 4 4 1 for MIA Draft Management SEARCH MIA Search for existing MIA docume
137. on can consult this database via the EudraGMP application At the time of its initial launch EudraGMP and the information in its database is not accessible to other parties than these mentioned above At a later date it is intended that EudraGMP will provide access to the wider public subject to restrictions on confidential and sensitive information EudraGMP database was developed by the EMEA in partnership with the EU National Competent Authorities and is hosted operated and supported by the EMEA 1 3 The EudraGMP Service Desk While the vast majority of user issues are addressed in this manual the EudraGMP Service Desk can be contacted for additional queries about the use of the application In particular any technical problems encountered accessing or using EudraGMP should be reported to this Service Desk so they can be investigated and resolved You can contact the EudraGMP Service Desk in the following ways By telephone 44 0 20 7523 7523 between 09 00h 17 30h UTC GMT By email to eudragmp emea europa eu 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 11 Zatacznik do OPZ BE Ae European Medicines Agency OT User Manual Communications and Networking 2 GETTING STARTED Review this section to ensure you can get started with the EudraGMP application 2 1 Set up Requirements This section details the basic conditions that must be met so you can access EudraGMP 2 1 1 Workstation S
138. organisation KAN u delegatedbusinesscards Enter Tour Search Criteria User For Wildcard Searches MARA London c Affiliation Works For a Search Close _ 1 Result s Assad Ahmede ad 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 148 Zatacznik do OPZ yk k European Medicines Agency OT User Manual Communications and Networking 18 Click SEARCH and the results appear If necessary scroll down then click the user s name once d 19 Click CLOSE and check that the new user s name is in the list then click SAVE The user is added to the group 20 Now you should assign privileges as described in Section 6 2 Managing Access Privileges 6 3 3 To Reset User Passwords reset Passvyord Change History 1 Log In as Delegated Administrator 2 Click on the username of the individual whose password you want to reset 3 In the Actions module on the right of the browser click RESET PASSWORD ad Akbar id Password Display Name Assad Akbar Mai assad akbaritest mbhra org Reset Password zziz Eee 4 Inthe drop down click to select RESET PASSWORD then click the SAVE button An email is automatically sent to the user notifying them of the password reset 6 3 4 Edit User Details In order to keep your user details up to date it may be necessary for you to edit the details of registered affiliates from time to time 1 Click the DELEGATED ADMINISTRATION tab
139. orking MIA Humber Authorisation Holder Site Details DUNS Number Name City Country United Kingdom Postcode EudraGMP Key NCA Reference Key Legal Basis of Authorisation Art 40 of Directive 2001 83 EC Art 44 of Directive 200182 EC Ar 13 of Directive Z00120EC Operations Enable Operations Search Include Withurawn MAS Search 2 Enter the details of the MIA you are searching for and click Search 3 If you have no information click to return all MIA documents in the database The MIA Search results appear You can sort these in the same way as drafts see Draft Management section 3 6 1 for a reminder When you have found the MIA document you wish to withdraw click on the blue MIA NUMBER and the MIA is retrieved from the database The MIA details appear Now click the Withidraw button at the top of the screen The Withdraw MIA Page appears Now insert a Reason for Withdrawing the MIA in the text entry field in English Users may optionally add a translation of the text entered in English Once you have entered your comments click Confirm Withdrawal and then click if you are certain you want to withdraw the MIA document 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 131 Zatacznik do OPZ ek X European Medicines Agency AT User Manual Communications and Networking 4 3 3 To Invalidate an MIA Invalidation of a submi
140. ort creation process 3 4 Non Compliance Reports Tutorial This section describes the steps required to create and submit a Non Compliance Report Please make sure you have read and understood Section 3 1 Overview before proceeding 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 53 Zatacznik do OPZ ek k European Medicines Agency AT ED User Manual Communications and Networking 3 4 1 Possible States of a Non Compliance Report In order to successfully use EudraGMP for the process of preparation and management of Non Compliance Reports it is useful to understand the way the system handles Non Compliance Reports from their initial creation to submission as a Valid document and if applicable its Withdrawal or Invalidation The diagram below shows the possible states in the life of a Non Compliance Report and how this state can be changed START Log On Using 550 Delete Draft END Draft Deleted Draft Valid VALID NCR WITHDRAWN NCR INVALIDATED NCR END Withdrawn NOR END Submitted NOR ramains on database deleted from database Figure 2 Non Compliance Report lifecycle 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 54 Zatacznik do OPZ de European Medicines Agency CZ User Manual Communications and Networking 3 4 2 To Create and Submit a New Non Compliance Report 1 Make sure you are logged in and you are on the EudraGMP Home Page below EudraGMP
141. ot be able to retrieve it again from a search although its details do remain in the system 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 89 Zatacznik do OPZ P k European Medicines Agency AT User Manual Communications and Networking fyou want to exit do not click the Back button on your browser click Cancel 3 5 1 4 To Withdraw a GMP Certificate New GMP Certificate New Non Compliance Report Draft GMP Certificates Search Search GMP Compliance Search Non Compliance Search Withdrawn GMPC You should withdraw a GMP Certificate when the Certificate is no longer valid Reasons for this include but are not restricted to Failing an inspection site details have changed manufacturer s name has changed Click Search GMP Compliance in the GMP Compliance Menu Enter the details you have in the Search GMP Compliance screen and click Search The GMPC Search results appear You can sort these in the same way as drafts see Draft Management section 3 6 1 for a reminder When you have found the GMP Certificate you need to withdraw click on the blue CERTIFICATE NUMBER and the Certificate is retrieved from the database The Certificate details appear Now click the button at the top of the screen The Withdraw GMP Page appears Now insert a Reason for Withdrawing the Certificate in the text entry field English comments are mandato
142. ove the tick from the check box Following the review of the returned documents click the Delete button to continue the deletion process The system displays a Confirmation page into which you should enter the reason for deleting these documents You must supply details in the English language entry field You may also provide details in your own language if that is not English at your discretion Once you have done this click the Confirm button The Delete GMPC page appears If the deletion has succeeded a Deletion Success message appears 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 159 Zatacznik do OPZ BS Ae European Medicines Agency ENER User Manual Communications and Networking 6 8 Delete MIA Document Assign Access Privileges Actvate Deactwate Company Activate Deactivate site Type of Inspection Delete GMP Compliance f Delete MIA This option is available to users who are assigned an Administrator role 1 Click the Admin menu from the top menu bar in EudraGMP then click the Delete MIAs option from the Admin menu 2 Delete MIA page appears You now have two options To delete a single MIA by entering its Authorisation Number in the upper entry field To delete multiple MIAs by entering the location of a CSV file in the lower entry field For details on the format and composition of the CSV file please refer to the Annex to this document 6 8 1 To Delete a Sing
143. pecification EudraGMP requires a workstation running Windows MacOS or Linux The application is best viewed at a screen resolution of 1024x768 However all application pages larger than the screen view can be scrolled using your browser s scroll buttons see image below for an example of the right scroll button lL eft click arrows to scroll 2 1 2 Browser Requirements SJ For those of you who prefer to use a different browser EudraGMP has also been tested for the Mozilla Firefox 3 0 10 5 web browser on Windows PC s and Apple Macs The Eudra GMP application has been optimised for the Internet Explorer 6 web browser for Windows PCs Eudra GMP does function within Safari which is the default Apple Macintosh OSX browser However some issues are reported so we recommend you install Mozilla Firefox 1 5 above 2 1 3 Adobe Reader All printable output in EudraGMP is rendered in Adobe s Portable Document Format known sks commonly as the PDF Use of EudraGMP requires Adobe Reader to be installed as a minimum requirement if you are reading this manual on your computer s screen you have a version of Reader or Acrobat the full version installed ge Adobe The latest version of Adobe Reader is freely available from Adobe and can be dde M downloaded from www adobe com or by clicking the icon to the left of this text 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 12 Zatacznik do OPZ
144. rd for ECD Manager the application that allows you to create users and add them to your organisation s EudraGMP user groups so users can access EudraGMP through EMEA s Single Sign On portal 3 1 Setting Up an ECD Manager Account Telephone 44 0 20 7523 7523 between 09 00h 17 30h GMT CET 1 hr 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 144 EBENE Ll Zatacznik do OPZ P European Medicines Agency E User Manual Communications and Networking Email at eudragmp emea europa eu 6 3 2 To Create a User for Your Organisation Username jienael Pazzwyprd R Log in as Delegated Admin using the Log In ECD Manager module at http ecdm eudra org Once you have entered your username and password click the LOG IN button First you should check that the user has not already been entered in ECD Click on the Contacts tab or the Search link in the ECD Resources dialog on the left of the screen Now search for the users name Enter the user s first and last name and click the Search button If a user is already in the ECD system it is essential you do not create a duplicate user entry Now click on the DZLEGATED ADMINISTRATION tab The Delegated Administration screen appears a Contacts EMEA Internal Directory PETERS My Password d Je WDelec ated Organisations JE ECD Resources C 8 Staff Company Statt Organisatonname __Englishiame J _shortName Busines
145. re searching for click on the blue Certificate Number and the Certificate is called up from the database he below sections detail a number of tasks you can perform once you have retrieved a submitted Non Compliance Report from the database 3 5 1 1 To Print a Preview of a Valid GMP Certificate To print a preview of a Valid GMP Certificate you must first search for a Valid GMP Certificate and open it Follow Section 3 5 1 Search for Submitted GMP Certificates to find the GMP Certificate 1 Once the GMP Certificate is displayed on screen click the Print Preview putton if you d prefer to review a hard copy of the GMP Certificate in the format it is issued in 2 he document is created as a PDF which you can then print or save see Section 3 2 6 1 3 5 1 2 To Create a New Draft as a Copy of a Valid GMP Certificate To create a new draft as a copy of a valid GMP Certificate you must first search for a Valid GMP Certificate and open it Follow Section 3 5 1 Search for Submitted GMP Certificates to find the GMP Certificate 1 Click Copy As Draft and an exact replica of the GMP Certificate is created in your Organisation s GMP Drafts area and automatically opened in Part 1 of the form 2 Now change the details within the draft taking good care to change the Certificate Number too 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 88 Zatacznik do OPZ yk X European Medicines Agency AT User Manu
146. results When you have found the withdrawn GMP Certificate you were searching for click on the blue Certificate Number and the Certificate is called up from the database he below sections detail a number of tasks you can perform once you have retrieved a withdrawn GMP Certificate from the database 3 5 3 1 To Print a Copy of the withdrawn GMP Certificate To print a copy of a withdrawn GMP Certificate you must first search for a withdrawn GMP Certificate and open it Follow Section 3 5 3 To Search for Withdrawn GMP Certificates to find the withdrawn GMP Certificate 1 Click the Print Preview putton if you d prefer to review a hard copy of the GMP Certificate in the format it is issued in 2 he document is created as a PDF which you can then print or save see Section 3 2 6 1 3532 To Create a New Draft as a Copy of a GMP Certificate To create a new draft as a copy of a withdrawn GMP Certificate you must first search for a withdrawn GMP Certificate and open it Follow Section 3 5 3 To Search for Withdrawn GMP Certificates to find the withdrawn GMP Certificate 1 Click Copy As Draft and an exact replica of the withdrawn GMP Certificate is created in your Organisation s Draft GMP Certificates area and automatically opened in Part 1 of the form 2 Now change the details within the draft as necessary 3 6 Other Tools in the GMP Module In addition to the functionality described in the sections above
147. rivilege Definitions 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 143 Zatacznik do OPZ Nr Ae European Medicines Agency AT ED User Manual Communications and Networking GMP Read GMP Confidential User can view all confidential GMP Certificate fields and input data Note that API data is considered confidential GMP Read GMP Non Confidential User can view all non confidential GMP Certificate fields and input data GMP Read API Only Certificates User can view GMP Certificates which contain only API Legal References GMP Read Own Country Certificate User can view GMP Certificates for own country GMP Read 3rd Country Certificate User can view GMP Certificates for 3rd country j GMP Read MRA Certificates User can view GMP Certificates for a country with whom the user s country has an MRA if the user is from the EEA these are the MRA Countries if the user is from an MRA Country these are the EEA Countries MIA Write Full User can create and update MIA documents MIA Read Confidential User can view all MIA fields and input data including confidential data MIA Read Non Confidential User can view only non confidential MIA fields and input data EudraGMP Admin User can administer own country access privilege assignments I O Click to save any changes you have made to the access privileges 6 3 Managing EudraGMP Users in ECD Manager As Administrator you are issued with a username and passwo
148. rom Revocation Suspension or Requested Variation of the marketing authorisation 4 Then click within the free text field to add any additional comments by way of explanation optional Recall of batches already released Click the Recall of batches already released checkbox a and the free text field D appears Recall of batches already released v Mandatory inclusion of clarifying remarks if d selected Click within the free text field then add clarifying comments in English by way of explanation Note that these comments are mandatory if the checkbox a is selected Prohibition of supply Click the Prohibition of supply checkbox a and the free text field D appears Tl Prohibition of supply EI landatory inclusion of clarifying remarks if a selected Characters remaining 449 53 Click within the free text field then add clarifying comments in English by way of explanation Note that these comments are mandatory if the checkbox a is selected Suspension or voiding of CEP action to be taken by EDQM Click the Suspension or voiding of CEP action to be taken by EDQM checkbox a and the free text field D appears 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 78 Zatacznik do OPZ BE Ae European Medicines Agency TE User Manual Communications and Networking Suspension or voiding of CEP fv ny additional detai
149. rom the group then click to remove the tick from the check box 9 Following the review of the returned documents click the Delete button to continue the deletion process 10 The system displays a Confirmation page into which you should enter the reason for deleting these documents You must supply details in the English language entry field You may also provide details in your own language if that is not English at your discretion Once you have done this click the Confirm button 11 The Delete MIA page appears If the deletion has succeeded a Deletion Success message appears 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 161 Zatacznik do OPZ w European Medicines Agency AT User Manual Communications and Networking 7 GLOSSARY The EudraGMP Glossary is included to ensure you can quickly learn the definition of a particular term or acronym used within the GMP Certificate and MIA document creation processes A erm acronym Definition Active Pharmaceutical Ingredienti Term Any substance or mixture of substances intended to be used in the manufacture of a drug medicinal product and that when used in the production of a drug becomes an active ingredient of the drug product Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis cure mitigation treatment or prevention of disease or to affect the structure and function of the body Active
150. ry u Inspection To Date is mandatory Issue Date is mandatory a One Signatory is required for a GMPC certificate Select at least one Legal Basis In the above error message the following items have not been included Site name Inspection End or Inspection Expiry date Date of Issue of GMP Certificate A Signatory No Legal Basis has been checked Such error messages are intended to guide you back to the section where the error occurs See Section 8 Business Rules if you are unsure of the rules relating to the creation and issuance of GMP Certificates fasystem error occurs please make a note of the error code and contact the EudraGMP Service Desk see Section 1 3 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 52 Zatacznik do OPZ ek k European Medicines Agency AT ED User Manual Communications and Networking 3 3 GMP Non Compliance Reports Blew Non Compliance Report Dra P Certificates Search Search GMP Compliance search Non Compliance Search Withdrawn GMPC Registered users of EudraGMP can now take advantage of additional functionality which facilitates the creation of GMP Non Compliance Reports NCRs on manufacturing sites Use this to Create a new Non Compliance Report To access draft Non Compliance Reports choose the Draft GMP Certificates option Follow the Tutorial below for a walkthrough of the Non Compliance Rep
151. ry while National Language comments are optional 7 Once you have entered your comments click _Confirm Withdrawal and then click if you are certain you want to withdraw the GMP Certificate which leaves the Certificate on the database as a record fyou want to exit do not click the Back button on your browser click Cancel 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 90 Zatacznik do OPZ ek k European Medicines Agency ENER User Manual Communications and Networking 3 5 2 To Search for Submitted Non Compliance Reports Mew GHP Certificate New Non Compliance Report Draft GMP Certificates Search Search GMP Compliance Search Non Compliance Search Withdrawn GMPC You can use the Search function to find submitted Non Compliance Reports on the database By default the summary provides details of all NCRs issued over the preceding three months Use this to View History of Non Compliance Reports if an NCR has been updated Update a submitted Non Compliance Report Copy a submitted Non Compliance Report as a new draft Withdraw a Non Compliance Report nvalidate a Non Compliance Report because the Report has been entered incorrectly 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 91 European Medicines Agency Communications and Networking Zatacznik do OPZ User Manu
152. s Comments friciude comments related to the restriction in English here This content will be visible to all users Characters rem 3 Now click in each entry field to add Building Name Room Name or Number Line Equipment QC Quality Control Test and Product Name a 4 Click Add Restriction f again if you need to add additional rooms or areas 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 47 Zatacznik do OPZ ek k European Medicines Agency OT User Manual Communications and Networking 5 Add any Restrictions Comments in English in box D In addition you may add the text in English in box C which will be visible to Public Users If you have applied more than one restriction ensure that comments are referenced clearly 6 You can now click on the Issuance and Signatory tab You may also refresh the list C To delete a restriction click to highlight a restriction then click the 3 icon 3 2 5 6 To Add Issuance and Signatory The final section requires you to add the issue date of the GMP Certificate and the GMP Certificate s responsible Signatory 7 Click the to use the Calendar picker or click the entry field to enter the number manually using the approved order Year Month Day 8 Now click the name of the signatory so it is highlighted and click the button to paste it into the Selected Signatories box To remove names from the Selected Signatories box cli
153. s In National Language Restrictions ar remarks Characters remaining 4000 4000 In English Restrictions or remarks Characters remaining 4000 4000 5 Click in the entry fields and add any restrictions or other remarks relevant to the MIA 6 Click Annex II tab if the authorisation applies to the manufacturing of an Investigational Medicinal Product on that Site Otherwise click on the Signatory Details tab 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 120 European Medicines Agency Communications and Networking To advance to the Signatory Details section click here 4 2 3 8 Annex II Annex Sterile Investigational medicinal products Aseptically prepared Large Volume Liquids Lyophilisates Semi solids Small volume liquids solids and implants Other Terminally Steriised Large volume Liquids semb salids Small volume liquids solids and implants Other Non sterile Investigational medicinal products Capsules hard shell 29 05 2009 10 32 19 IX aes Annex II e e None Manufacturing Annex II Remarks S E S S g H S Zatacznik do OPZ User Manual Importation EudraGMP User Manual v1 0 CURRENT 121 Zatacznik do OPZ a European Medicines Agency EE User Manual Communications and Networking You may notice Annex II is very similar to Part 2 of the GMP Certificate form if you are already familiar with
154. s Category ae Delegated Organisations E Add New Affiliate MHRA MHRA est UNITED KINGDOM UK E em rm mme gt b c fthe user is already in the system when you enter Delegated Admin do not click ADD NEW AFFILIATE Of course you may edit the user s details under the Actions dialog 6 Ifthe user is not in the system click ADD NEW AFFILIATE in the ECD Resources panel 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 145 Zatacznik do OPZ P k European Medicines Agency AT A User Manual Communications and Networking 7 The User CREATION form appears Creation List of Personal Titles Dr Personal Title Dr Last Name Display Name Mother Tongue Affiliation YVorks For Y Title Phone Country ity Number Fax no Country ity Number Mobile Country 5 Number 8 You should now enter the details of the Affiliate new user Those fields with a red asterisk are MANDATORY a b and c whilst we advise you include as much information as possible in other fields for the benefit of all users of the database You are only authorised to add Affiliates who work for the same organisation that you are the delegated Admin for so the drop down may only contain one organisation 10 Finally click CREATE The Affiliate s new contact appears 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 146 European Medicines Agency Communications and Networking
155. s for hie MIA vss X 171 TE ATOU UO E 171 10 Business Rules for the Non Compliance Henort 172 10 1 MOCC UON WE 172 11 Business Rules for EudraGMP Reference Data ccccccesssccecesessseeecsseesseecseeuseeeesseaseesesseaseeeees 173 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 7 Zatacznik do OPZ geet European Medicines Agency ENER User Manual Communications and Networking 11 1 HAG COUCH OM zion AE T m 173 12 National Competent Authority Acronyms for ECD Manager 174 15 ve Mm 182 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 8 Zatacznik do OPZ Lux European Medicines Agency CZ User Manual Communications and Networking 1 INTRODUCTION 1 1 This Document This user manual provides step by step instructions for every aspect of EudraGMP functionality and details the main concepts of the application It also includes instructions for use of the ECDManager features that are required to enable the use of EudraGMP The manual can be used as a step by step tutorial to guide you through the creation saving editing and printing of GMP Certificates and Manufacturing amp Importation Authorisations This document does not describe any of the underlying business processes These are defined in the Compilation of Community Procedures found on the EMEA s Inspections web page http www emea europa eu Inspection
156. s index html gt European Medicines Agency E ZY NZ l What s New Human Medicines Veterinary Medicines General Reporting Overview vae Inspections Activities of the sector Certificates of Medicinal Products Overview Bennie Prete MEI The EMEA s Inspections Sector deals with a number of tasks laid down in Regulation EC Good Clinical Practice 725 2004 specifically those concerned with the coordination of the verification of compliance with Overview the principles of Good Manufacturing Practice GMP Good Clinical Practice GCP and Good SEE RIO Shean Laboratory Practice GLP and with certain other aspects of the supervision of authorised Procedures and Guidance medicinal products in use in the European Community The sectors activities are summarised in ORA Chapter 4 of the EMEA s work programme and annual reports Good Laboratory Practice Good Manufacturing The Sector is responsible for co ordinating any inspection requested by the CHMP or CMP in Practice GDP c connection with the assessment of marketing authorisation applications and or the assessment of matters referred to these committees in accordance with Community legislation These Inspectors Working Group i EudraGMp database inspections may cover GCP GLP GMP Pharmacovigilance PhV or they may be performed in Compilation of Procedures a the context of Vaccine Antigen Master File VAMF and Plasma Master File PMF Joint Audit Programm
157. sations that they issue into EudraGMP 2 Click GMP COMPLIANCE a and the GMP Compliance Menu appears on the left of the browser window GMP Compliance Menu Mew GMP Certificate New Non Compliance Report Draft GMP Certificates Search Search GMP Compliance search Non Compliance Search Withdrawn GMPC 3 Click NEW GMP CERTIFICATE in the GMP Compliance Menu on the left of the screen 4 Part 1 of the form appears Notice the tabs along the top of the form 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 2 Zatacznik do OPZ ux European Medicines Agency Z User Manual Communications and Networking 3 2 3 Part1 Part 1 of the GMP Certificate contains essential details of the Certificate such as the Certificate s number the legal basis on which the certificate is issued and the type of inspection that was undertaken Part 1 Part 2 Restrictions and Authorisation Review amp Submit GMP Compliance Certificate Details EES Se Certificate of GMP Compliance for Manufacturer Inspection Details Certificate Number MRA Partner Site Address Site Name Site Address NCA Reference Key Inspection End Date a inspection End Date mr MM D I Confidentiality Comicon C 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 28 Zatacznik do OPZ P k European Medicines Agency OT User Manual Communications
158. sed then the application is referred to the CHMP for arbitration leading to a binding decision Note Concerned Member State A Member State that is concerned i e included in the mutual recognition phrase with an application for Mutual Recognition and expected to recognize the initial approval of the 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 166 Zatacznik do OPZ ek k European Medicines Agency AT User Manual Communications and Networking Reference Member State RA Acronym Mutual Recognition Agreement lt An agreement between 2 regulatory agencies to recognize the regulatory assessment or inspection of a site for GMP compliance or review pharmaceutical devices conducted by one another Term Australia Switzerland New Zealand Canada and Japan S Acronym Member State MS CA Acronym Member State Competent Authority CA Acronym National Competent Authority Acronym Non Compliance Report erm E Definition A gt Q O C on Z erm acronym Definition Acronym All operations including filling and labeling which a bulk product has to undergo in order to become a finished product Note Sterile filling would not normally be regarded as part of packaging the bulk product being the filled but not finally packaged primary containers U Q O s Q Q 2 Q DU DF Acronym Portable Document Format Adobe Systems Portable Document Format or PDF is an
159. select the Search button 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 158 Zatacznik do OPZ P k European Medicines Agency ENER User Manual Communications and Networking 2 lfthis is a valid Certificate Number the system will return the details of the GMPC Confirm that the details are those of the document you wish to delete and then click the Delete button 3 The system displays a Confirmation page into which you should enter the reason for deleting this document You must supply details in the English language entry field You may also provide details in your own language if that is not English at your discretion Once you have done this click the Confirm button The Delete GMPC page appears If the deletion has succeeded a Deletion Success message appears 6 7 2 To Delete Multiple GMP Certificates Enter the location of the csv file in the lower entry field You may click the browse button to navigate to the correct location Click the button to retrieve the details of all the Certificate Numbers contained in the csv Comma Separated Value file The system displays the details in a results table Each row of the table has a Selection field in the first left hand column These will all be selected when the results are returned This indicates that this row will be deleted If after reviewing the data you decide you do not want to delete one or more documents from the group then click to rem
160. sfully and efficiently The GMP Compliance Module has the following main features Multi screen and tab based Creation of a GMP Certificate and Non Compliance Report To divide the entry of the information into manageable parts and to facilitate the understanding of the entry process the GMP Compliance Module uses a tabbed screen design for the entry of data Each main tab refers to the main sections and each secondary tab refers to the subsections of the Certificate or Report Automatic Saving of Drafts As you move between tabs in the creation process EudraGMP automatically saves the information entered on each screen in a Draft documents area This draft information is retained even after you have logged off and can be accessed easily if you log in again at a later time Read Drafts Management Section 3 6 1 for information on retrieving reviewing copying printing and editing a draft Validation When all the appropriate information has been provided in a draft Certificate and the document is submitted by a user as a final definitive version its contents are validated against a set of rules Details of these can be found in the Business Rules Annex see Section 0 Business Rules Search functionality for All GMP Compliance Certificates Non Compliance Reports All GMP Compliance Certificates whether valid or withdrawn and Non Compliance Reports can be located and viewed using the Search function by all users See 3 5 To
161. ssign Access Privileges in the Admin Menu Select Competent Authority Competent Authority ins_uk_mhra lb b Get User Roles 2 Now click the drop down arrow a and click the relevant authority In the above example the UK s MHRA is selected 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 142 Zatacznik do OPZ Qu European Medicines Agency Ce User Manual Communications and Networking 3 Next click Get User Roles to reveal the current list of users and their roles within the selected NCA a b c d e f gh i j k mn User And Roles 5 items MM ESSE eh ah www Roles gmp gmp gmp gmp gmp gmp gmp gmp i mia 5 e read read read read mia write write write read e read eudragmp gmp api own ard read own 3rd mra gmp non admin non only country country z conf eu XD SR conf conf certif certif certif cont Username Charley Mottet Pascl Simon Laurent Fignon Romain ZZTest Bernard Hinault Regis Simon m im cs oo 1433414 A TAAA qo ago m im c oo aqaa MALA AA DI 1999777 OO AI AI TI TI To change access privileges click check boxes to insert or delete a tick A ticked box indicates the account has that access privilege when the save button is selected When you have finished making changes to access privileges click to save all changes The Save Successful message appears save successful 6 2 1 1 EudraGMP Access P
162. stcode 7enna Country Face o zl Fax Number 337272727 Telephone Number 3337777773 s net Click the entry field a and enter an NCA Reference Key in accordance with your Organisation s procedures To enter the Authorisation Holder click in the Authorisation Holder entry field b and type the name of the company Then enter the full registered address of the new company 4 Finally enter contact phone number and fax number if applicable and click Create p The Legal Address field is now populated with the details you added The details are only stored within the draft at this point they are not available to others until the draft is submitted successfully 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 111 Zatacznik do OPZ ek k European Medicines Agency ANEAN User Manual Communications and Networking 4 2 2 4 Legal Basis of Authorisation 1 Now you must indicate what the Legal Basis of the Manufacturing and Importation Authorisation is To do this click the relevant check boxes Legal Basis of Authorisation Art 40 of Directive 2001 83 EC W Art 44 of Directive 2001 82 EC TI Art 13 of Directive 2001 20 EC Art 40 of Directive 2001 83 EC For authorisation to manufacture or import human medicinal products Art 44 of Directive 2001 82 EC For authorisation to manufacture or import veterinary medicinal products Art 13 of Directive 2001 20 EC For authorisation to manu
163. t as necessary 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 128 Zatacznik do OPZ ek k European Medicines Agency ENER User Manual Communications and Networking 5 When you ve finished making your changes click again Then click on the Review amp Submit MIA tab f you want to review the updated MIA document before applying updates click on Print Preview and a PDF of the document is created You can save this locally or print it out See Section 4 2 5 1 Print or Save Preview of MIA 6 Finally click Update MIA to apply the updates to the database and overwrite the previously submitted MIA document 4 3 1 1 To Suspend an MIA In certain situations such as the result of a negative inspection it is necessary to suspend an MIA fora certain site or for a particular manufacturer To do this you should update the MIA document removing the operations for which the authorisation is suspended For multi site MIAs you can remove the entire site if the site no longer has an MIA Search for the relevant MIA following the instructions in Section 4 3 To Search for an MIA Now scroll down to the results which are displayed below the MIA Search input form and click on the blue MIA Authorisation Number Click Update MIA and a copy of the submitted document is automatically opened at the MIA Header tab and is saved as a draft MIA document in your Organisation s Draft MIAs database Now click
164. tails site Address Site Address NCA Reference Key Inspection End Date Inspection End Date 75 YYYY MM DD 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 56 Zatacznik do OPZ kk European Medicines Agency ANEAN User Manual Communications and Networking 3 4 3 1 Report Details Part 1 Part 2 Restrictions and Authorisation Part 3 l Review amp submit Non Compliance Report Report Details Legal Basis Of Certificate Type of Inspection Report of Non Compliance far Manufacturer Inspection Details Report Number MRA Australia Australian Pesticides and Veterinary Medicines Authority v T Partner ET D Human Medicinal Products _ veterinary Medicinal Products L Human Investigational Medicinal Products Site Address Site Name If the Non Compliance Report was issued by an MRA partner click the checkbox b and then click the arrow C Click the relevant MRA Competent Authority from the drop down list Select the scope of the document from the three options H V and I which should concur with the competence of the relevant NCA this is indicated in parentheses after each NCA in the drop down options Site Address Site Name Search 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 57 Zatacznik do OPZ ur European Medicines Agency OT ED User Manual Communications and Networking 5 A previously inspected Manufacturing
165. the free text field then add clarifying comments in English by way of explanation Its completion is purely as required by the creator of the Non Compliance Report 3 4 6 2 Followup Details The Followup Details section is intended to allow the creator of a Non Compliance Report a standardised method of arranging a teleconference to discuss the Non Compliance Report once submitted Restrictions and Authorisation Pat3 Rei bei Non Compliance Report Regulatory Action Followup Details Teleconference Details Teleconference Dates j YYYY MM DD Teleconference Time CET in Teleconference Number Human and Veterinary Medicinal Products Product Type Product Name Dosage Forms Reference Member State National or EMEA Delete Investigational Medicinal Products Product Name EudraCT Nos Teleconference Details Teleconference Details are optional and may be included as required by the creator of the Non Compliance Report 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 80 Zatacznik do OPZ pkk European Medicines Agency c User Manual Communications and Networking Teleconference Details Teleconference Date 2009 05 11 MY Y Y Y MM DD E sie oe Je Teleconference Number 00 44 2075992323 1 First enter the Teleconference Date in the following format YYYY MM DD in number field a Alter
166. to enter details We recommend you enter an NCA Reference Key for ease of future searching and as much address detail as you have When you have finished adding the details click Create and the site is added to the Selected Sites List and Annex 1 of the MIA appears see below 4 2 3 4 Annex Include specific details of the activities dosage forms to be authorised for manufacture or importation in Annex It is very similar to Part 2 of the GMP Certificate form as you can see on the next page 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 115 Zatacznik do OPZ de European Medicines Agency Ce User Manual Communications and Networking Annex Bits diets ee E EL LEE T L9 a ete Scope of Authorisation Human Medicinal Products 7 Veterinary Medicinal Products Manufacturing Importation Sterile Products d a Asepticalhy r prepared Large volume e D LJ i Liquids T vaphilisates v C Semi solids e C H Small volume v C E liquids Solids and e C n Implants Other e C I Terminal M Sterlised Large Volume ie C EJ Liquids Semi solids fe C E Small volume s e m liquids Solids and e C RI implants Other e e BN Non sterile e M M products i Capsules x C EJ hard shell Capsules soft e shell Chewing v C C gums impregnated v C E L matrices Liquids for e C l external use Liquids for C E 29 05 2009 10 32 19 EudraGMP User Manual v1 0
167. ton 3 sign In Enter your Single Sign On user name and password to login 1 User Name D 2 Password D 3 Er Cancel Unauthorized use of this site is prohibited and may be subjected to civil and criminal prosecution 3 The EudraGMP Home Page below appears EudraGMP GMP Compliance Manufacturing and Importation Authorisation Admin FAQ Help Welcome to EudraGMP Directives 2004 27 EC on human medicinal products and 2004 28 EC on veterinary medicinal products introduce the legal framework for the Community database The concept of a European Inspections database is included in the above specified legislation to provide EEA National Competent Authorities and the European Medicines Evaluation Agency EMEA with an overview ofthe status of pharmaceutical manufacturers The legislation provides for an electronic tool containing complete information on all pharmaceutical manufacturers This includes information on 4 Click MANUFACTURING AND IMPORTATION AUTHORISATION a and the MIA Home Page appears including the MIA Menu on the left of the browser 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 107 Zatacznik do OPZ hale European Medicines Agency CZ User Manual Communications and Networking MI Menu Geena Draft MILAS Search 5 Click NEW MIA in the MIA Menu above and the MIA Header form opens 4 2 2 MIA Header The MIA header provides details on the Manufactur
168. tted MIA document should only be done if a mistake has been made in the submitted MIA document Only MIAs created by your own agency may be invalidated The process is irreversible so invalidation should be undertaken only if you are absolutely certain that the submitted MIA document is in error 1 Search for the relevant MIA following the instructions in Section 4 3 To Search for an MIA 2 Now scroll down to the results which are displayed below the MIA Search input form You can sort these in the same way as drafts see Draft Management section 3 6 1 for a reminder When you have found the MIA document you wish to withdraw click on the blue MIA NUMBER and the MIA is retrieved from the database The MIA details appear Now click the validate button at the top of the screen The Withdraw MIA Page appears Now insert a Reason for Withdrawing the MIA in the text entry field in English only Users may optionally add a translation of the text entered in English in the separate text field Once you have entered your comments click Confirm invalidation and then click LL you are certain you want to invalidate the MIA document 4 4 Other Tools in the MIA Module As well as creating MIA documents the EudraGMP application has a variety of additional functions allowing users and the public to search for submitted MIA documents Registered Users can also search for copy and amend submitted MIA documents Additiona
169. ur keyboard can A be used instead talicisedtext is used when referencing another section of the manual or for terminology defined in the Glossary Section 7 Any text in UPPER CASE appears onscreen Any text within a grey box is a step by step instruction to perform a task To return to the previous point in the manual after clicking a hyperlink to another part of the manual click the Previous View button located at the bottom of the Acrobat window ter Adobe e Se Any button is included in this manual as it appears in the EudraGMP User Interface Ul such as the Search button pictured here 1 2 The EudraGMP Application EudraGMP is an application that allows Inspectors of the European Economic Area EEA National Competent Authorities NCA to create and enter Good Manufacturing Practice GMP Certificates Non Compliance Reports and Manufacturing Importation Authorisations MIA s into a Community database This database provides a valuable inventory of the status of pharmaceutical manufacturers of both active substances finished medicinal products and their presentations that have been subject to inspection by NCA inspectors either within the EU or in a third country 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 10 Zatacznik do OPZ NT do European Medicines Agency VEL User Manual Communications and Networking Users of all NCAs connected to EudraNet of the EMEA and the European Commissi
170. v1 0 CURRENT 150 Zatacznik do OPZ P European Medicines Agency ENER User Manual Communications and Networking 6 4 Maintaining Company Status Admin Menu Assign Access Privileges Activate Deactivate Compan Activate Deactivate olte Type of Inspection Delete GMP Complance Delete MIIA Administrators may change a company s status to inactive or re activate an inactive company fa company ceases trading or is taken over users may wish and it is advised to change the company s status to Inactive within EudraGMP fa user creates a company in error making it inactive and therefore invisible to users is advisable Reactivate inactive company information if its status changes Use these features to enhance the data integrity of the system by updating or making obsolete reference data inactive 6 4 1 Activate Deactivate Company Admin Menu Assign Access Privileges Activate Deactivate Compan Activate Deactivate SI E Type of Inspection Delete GMP Compliance Delete MIA 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 151 Zatacznik do OPZ ux European Medicines Agency CZ User Manual Communications and Networking If you wish to activate or deactivate a company you must first run a search to find the company in question Any search you run returns only companies that your NCA is responsible for any company created by an entity user wit
171. ve been included in the central load while the NCA Dictionaries contain only entries created by users within the specific NCA 3 4 5 1 Common Dictionary The Common Dictionary of Active Substances contains a defined set of Active Substances including a Dictionary ID and a Substance Name in English Every Active Substance in this dictionary has a Dictionary ID and is viewable by ALL NCA users NCA users cannot add Active Substances to the Common Dictionary NCA users may copy Active Substance entries from the Common Dictionary into their NCA Dictionary Such copies will take the same Dictionary ID as the entry in the Common Dictionary In addition the National Competent Authority name and an NCA Ref Key are automatically added though the NCA Ref Key may be created by the NCA user according to their organisation s procedures 3 4 5 2 National Competent Authority Dictionaries Each NCA has a local Dictionary of Active Substances which is entirely separate from both the Common Dictionary and other NCA dictionaries within the NCA users country Every Active Substance created by your NCA appears and is viewable by ALL NCA users within your Country The Dictionary ID of the Active Substance appears if the Active Substance was copied from the Common Dictionary You must add a Substance Name in at least one of your NCA s working languages You must add a Substance Name in English An NCA Ref Key is also requir
172. w Print and Submit a Draft Non Compliance Report nannnannnennnannnnnnnrnnnnrnnrinnnrrnnrrsrrrenrrsrrrerrren 83 3 4 7 1 To Print or Save a Preview Draft Non Compliance Henort ee aaa aaa anawa nenne nnnnne nenne nnnnnenennnnnennn nenn nnne nennen 84 3 4 7 2 Successful Submission of a Non Compliance Report 84 3 4 7 3 Troubleshooting Errors in GMP Modull cccccsssssccecsssecsseesecessaseccesseneecesseneecessegecesseneeeessaneecesseseeeesseseeeesseeseessanees 85 3 5 GMP Compliance Menu Gearch nenn nenne nenne nnnnnennnnnennnnn nenne nnnnnennnnnnnnnnenennnn 86 3 5 1 To Search for Submitted GMP Certttcates nnne nennen nnn rn nennen nnns 86 3 5 1 1 To Print a Preview of Valid GMP Certificate tame nr thu OEG AERO KAS ak EKES a han Are has re ERBE Eee 88 3 5 1 2 To Create a New Draft as a Copy of a Valid GMP Certificate seeesssssssesseseeeeeenenenn nennen 88 S et DNK Rn Ke EE are 89 3 2 14 ho Withdraw a GMP CeUiICRIE ee tege EE EE eege 90 95 2 To Search for Submitted Non Compliance Reports ccccccccceececeseeeeececeeeesseceeaeeeeseeceseeessueeeseeeeseeeesanees 91 3 5 2 1 To Print a Copy of the Non Compliance Report 93 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 4 Zatacznik do OPZ ar European Medicines Agency ce User Manual Communications and Networking 3 5 2 2 To View Previous Versions of a Non Compliance Report cccceccccscc
173. whether the above criterion is to be imposed in part or in full using drop down C Finally click within the free text field to add any additional comments If the part option is chosen from drop down C include details within the text field If the full option is selected then additional comments are optional Withdrawal of current valid GMP certificate s Click the Withdrawal of current valid GMP certificate s checkbox a and GMP Certificates list D and the free text field C appears Withdrawal of current valid GMP e E b FZ ceniicate s thoose GMP Certificates from the above list or add here Characters remaining 943 999 1 GMP Certificates related to the site selected in Part 1 appear in field D Click to choose the relevant GMP Certificate Ctrl click to select multiple GMP Certificates 2 Then click within the free text field to add any additional explanatory comments optional Action on Marketing Authorisation Click the Action on the Marketing Authorisation checkbox a and the drop down field D and the free text field C appears Action on the Marketing CC Suspension w fof Marketing Authorisation s TEMES A any additional detail 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 77 Zatacznik do OPZ ek k European Medicines Agency OT User Manual Communications and Networking 3 Click the drop down arrow D to choose f
174. y has been added by the user within the FR AFSSAPS NCA who created the Active Substance entry NCA Name This indicates which NCAs users created the entry NCA Ref Key Best practice is for the NCA users to add a unique reference key for each entry in their NCA Dictionary If not EudraGMP will create a unique NCA Ref Key automatically Click radio button to select the active substance result Once you ve checked the radio button click to add the active substance If the Active Substance is not already in the system click t eate Active Substance to create one in the database Use the navigation buttons to refresh and jump forward C and M or backward greyed out in this example through results list If your search produces results as in this example these appear under the Active Substances Search Result section 5 Click the radio button e if the search has found the Active Substance Then click the Select button f fithas not found the Active Substance or the Active Substance is new refer to the section below 6 The Active Substance appears with its English Ingredient Name You should now confirm your selection and optionally enter an NCA ref key 7 Click C9firm The Active Substance has now been added to your Non Compliance Report 8 Inthe Search Screen enter the new Active Substance to check that it hasn t already been entered into the database u T Warning The search resulted i
175. you enter an NCA Heference Key for ease of future searching and as much address detail as you have 2 Click Create to save the details in the Non Compliance Report Draft 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 61 Zatacznik do OPZ w European Medicines Agency OT User Manual Communications and Networking 3 4 3 3 Update Site Details The Site Details in a Draft Non Compliance Report can be updated by clicking on the Part 1 Report Details form See 3 2 3 1 Certificate Details DUNS Number 20 030 13300 NCA Reference Key 20090330 1559 Site Hame YOYODYNE CV Inc Address 1 wv E RIVER DRIVE Address 2 Address X Address 4 City LONDON H State Postcode Syy2 85L Country Update Cancel 3 Click the entry fields to enter details In the absence of another reference such as D U N S Number we recommend you enter an NCA Heference Key for ease of future searching and as much address detail as you have 4 Click UP date to save the updated details in the Non Compliance Report Draft 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 62 Zatacznik do OPZ ux European Medicines Agency c User Manual Communications and Networking 3 4 3 4 Legal Basis of Certificate Simply click the relevant check box 29 05 2009 10 32 19 EudraGMP User Manual v1 0 CURRENT 63 Zatacznik do OPZ Pd European Medicines Agency AT User Manual C

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