Home

MIS Lodgement User Manual

Contents

1. 1 2 Click on View Approved Licences on the Manufacturers Application Lodgement home page Pg 10 Alternatively click on View All TGA Data Pg 97 and then select Licences A list of all the approved licences currently in the system and owned by the user will be displayed Pg 40 To view the licence click on its Licence Number Tracking Number Pg 41 If the number of licences exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required licence using the Search button SIME MIS Lodgement User Guide v1 1 doc Page 13 TGA Online Services Manufacturer Information System MIS Approved To vary a licence Licences continued 1 Approved licences cannot be changed They can however have their status changed by clicking on Vary Application This option is used Suspend Cancel or Re activate a licence A new draft application 1s created which when finalised by the TGA will result in the requested status change Pg 100 2 Click on View Approved Licences on the Manufacturers Application Lodgement home page Pg 10 Alternatively click on View All TGA Data Pg 97 and then select Licences 3 A list of all the approved licences currently in the system and owned by the user will be displayed Pg 40 To view the licence click on its Licence Number Tracking Number Pg 41 4 A new application will be created by clicking o
2. Read Only Fee is the amount due or paid for the application Fields Payment Type is the method of payment SIME MIS Lodgement User Guide v1 1 doc Page 39 TGA Online Services Manufacturer Information System MIS View Approved Licences 3 http tgacbr02 sime mis reposit nsf W ebApprovedLicences 0 pen iew Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help gt 902 AJA m 39 15 Sa Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02sime mis reposit nsf wWeb pprovedLicences 0periiew y Go Link smD Help SIME i t View Approved Licences Previous Next Home Refresh Search Licence Number Manufacturers Name Received Approved MI 20042004 LI 000278 2 A CI BLOWPAK VICTORIA Australia 20 04 2004 20 04 2004 MI 13052004 LI 000011 1 ROCHE COLORADO CORPORATION 20 04 2004 20 04 2004 MI 13052004 LI 000012 1 HOE HIN PAK FAH YEOW MANUFA 20 04 2004 20 04 2004 MI 13052004 LI 000016 1 FERROSAN AS 20 04 2004 20 04 2004 MI 13052004 LI 000018 1 SMITHKLINE BEECHAM DUNGARY 20 04 2004 20 04 2004 MI 13052004 LI 000019 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 LI 000020 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 LI 000021 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 LI 000022 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI
3. Phone Fax amp Mobile are the contact details of the contact person Email is the contact person s email address Quality Control is the name of the person in charge of quality control Production 1s the name of the person in charge of production Authorised For Release 1s the name of the person who 1s authorised to release Manufacturing Items Pg 99 Add is a button which when clicked on brings up a dialog box to enter the item details Fields displayed are Manufacturing Type Sterility Manufacturing Class Dosage Form Product Category amp Manufacturing Step All fields can be populated from the drop down list or 1f it is a new item by typing in the details The Manufacturing Type selected refines what values are permitted for the remaining entries At least one Manufacturing Item must be entered Remove 1s a button which when clicked will remove unwanted items Each item listed has a checkbox in front of it which must be clicked first All items with a clicked checkbox are removed SIME MIS Lodgement User Guide v1 1 doc Page 23 TGA Online Services Manufacturer Information System MIS 3 Licence Application Microsoft Internet Explorer provided by Health File Edit View Favoites Tools Hep 00 E e gt 0319 a BIB HB Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 sime mis lodge nsf 0 6F69F59C2D 91 8FCECA256EAF001FA95427EditDocument 2 Go Links P
4. 4 8 168 QsIME Notes Home E New Clearance GY Exploring Images BY Microsoft Word SI 27 untited Pann PDA 12 26 Fig 39 Clearance Application Client Details Client Details This form is used to input the client details Read Only Applicant Fields Applicant s Name is the name associated with the user currently logged in Client Id is the id of the applicant as recorded in the TGA s Client System Suburb State Post Code Phone amp Fax are the remaining address details associated with the first line of the address that was selected SIME MIS Lodgement User Guide v1 1 doc Page 76 TGA Online Services Manufacturer Information System MIS Read Only Fields continued Editable Fields Applicant Applicants Name 1s the name associated with the user currently signed in Client Id is the id of the applicant as recorded in the TGA s Client System Suburb State Post Code Phone amp Fax are the remaining address details associated with the first line of address that was selected Sponsor Client Id is the id of the sponsor as recorded in the TGA s Client System Suburb State Post Code Phone amp Fax are the remaining address details associated with the first line of address that was selected Applicant Address is the first line of the applicant s address associated with the user currently signed in If there is more than one address associated a drop down list is displayed
5. ASSOC 4 gt Done feat xz En Local intranet Stat AS 76 gt OSIME Notes Home http 2 tgacbr02 Ay Exploring Images Y Microsoft Word SI 47029 SIME_MiSprod EPA AIDEL 13 51 Fig 44 View Draft GMP Clearances List Draft This screen lists all the draft clearance applications owned by the user Clearance List currently logged in Clicking on a tracking number will open that application Read Only Tracking Number 1s created by the system once the application has been Fields saved or submitted It is a unique number which is attached to the application and 1s used for all future tracking of the application through the system Sponsor s Name is the name of the sponsor associated with the application Manufacturer s Name is the name of the manufacturer associated with the application Site Address is the first line of the primary site s address Manufacturer s Own Reference 1s the applicant s reference information that may help in identifying the application SIME MIS Lodgement User Guide v1 1 doc Page 86 TGA Online Services Manufacturer Information System MIS 3 Clearance Application Microsoft Internet Explorer provided by Health a S a ws Back Forverd TT SIME Stop Refresh Home Address a http tgacbr02 51ME MIS lodge nsf d54a336932668f00ca256e3f00789197 5affd3bd681f5180ca256ea6000f7a20 0penDocument Go Links A Fie Edit View Favorites
6. File Edit View Favorites Tools Help Pb gt Aj 3 6 g El Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address l http 4 tgacbr02 sime mis lodge nsf 0 6F69F59C2D 91 SFCBCA256E AF 001 FA9547E ditD ocument P Go Links a Client Details Primary Site Secondary Site Supporting Documents ls this application for the collection of C Yes No fresh blood components Secondary Site Primary Site Primary sence Ne A Primary Site Details C Existing Site New Site Set Ad ress Td Sur O e Sato D Post Code e Country Australia Contact Name AAA Phone CY e Fre 7 Mobil gt Email DS y 4 Personin charge of ualty id Control Add Attachment Remove Attachment Person in charge of Production id Add Attachment Remove Attachment Authorised Person for Release id Manufacturing Items Manufacturer Types Sterility Manufacturing Class Dosage Form Product Category Manufacturing Steps l Application loaded successfully ES CI B Local intranet Mstart A 8 168 OSME Help Ge E Licence Ap A Exploring Ima BY Microsoft Word 47 008_SIME_MI Document Lic SDM ADEL 16 31 Fig 5 Licence Application Primary Site Primary Site This form is used to input the primary site details Read Only Existing Site Fields Suburb State Post Code amp Country are the remaining address details associated with t
7. number of applications exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required application using the Search button Once the application has been displayed 1t can be changed by clicking on the Edit button Pg 61 The application will be opened in edit mode and the changes can be made Save the changes by clicking on the Save button To input the application details 1 2 3 The application form 1s divided into a number of individual pages When first displaying the form the Client Details page 1s shown Pg 50 Clicking on the other page buttons will open them for editing The other individual pages include Primary Site Pg 52 and Supporting Documents Pg 55 All fields marked with a red star are mandatory and must be entered To view and print an application 1 2 To view the entire application click on View Entire App A new window will open which shows the full application in printer friendly view Clicking on Print will print out the full application SIME MIS Lodgement User Guide v1 1 doc Page 44 TGA Online Services Manufacturer Information System MIS Draft Applications continued Applications To save save and close or to exit without saving 1 To save an application without exiting click on Save Clicking on Close will also save the application but wi
8. 000025 1 ENDOTEC 20 04 2004 20 04 2004 MI 13052004 CE 000023 1 MEDICAP LTD 20 04 2004 20 04 2004 MI 13052004 CE 000029 1 BECTON DICKINSON MED PRODUC 20 04 2004 20 04 2004 Previous J Next o Home J Refresh Done T E En Local intranet A Start Ae 0680 Sy SIME Notes Home http tgacbr02 3 Exploring Images BY Microsoft Word SI 7 040_SIME_MISapro i Fig 36 Approved Certifications List IMD 1543 Approved This screen lists all the approved certifications owned by the user Clicking on Certifications a certification number will open that certification for viewing List Read Only Certification Number is the tracking number that was allocated by the system Fields when the application was created It is a unique number which is attached to the application and is used for all future tracking of the application through the system Manufacturer s Name is the name of the manufacturer associated with the application Received is the date the application was received Approved is the date the application was approved SIME MIS Lodgement User Guide v1 1 doc Page 68 TGA Online Services Manufacturer Information System MIS 3 Certification Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help gt 9f AJA m 9 B 3A Back Eomsard Stop Refresh Home Search Favorites History Mail Print Edit Address a http tqgacbr02 sime mis reposit n
9. 1 doc Page 55 TGA Online Services Manufacturer Information System MIS Editable Fields Paper Document List continued Add 1s a button which when clicked on brings up a dialog box whereby the document details can be entered Fields displayed are Document Type Description Method of Submission amp Date Sent All fields are mandatory Document Type can be selected from a drop down list or typed in Method of Submission 1s selected by choosing one of the available radio buttons Fax Post Courier A convenient click on calendar has been included in the dialog box for Date Sent At least one electronic see above or paper document must be entered Remove 1s a button which when clicked on can be used to remove unwanted entries Each entry listed has a checkbox in front of 1t which must be clicked first All entries with a clicked checkbox are removed SIME MIS Lodgement User Guide v1 1 doc Page 56 TGA Online Services Manufacturer Information System MIS 3 Yariation Licence Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 6 9 A 9 E A Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf 0 D734AB27F9212864C4256EBD001868957EditD ocument Go Links ME SIME a Variation Certification Application Save J Close Validate J Delete Submit J Home Applicant s Ref 1
10. 13052004 LI 000023 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 LI 0000241 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 LI 000025 1 ENDOTEC 20 04 2004 20 04 2004 MI 13052004 LI 000023 1 MEDICAP LTD 20 04 2004 20 04 2004 MI 13052004 LI 000029 1 BECTON DICKINSON MED PRODUC 20 04 2004 20 04 2004 MI 13052004 LI 000032 1 BECTON DICKINSON MED PRODUC 20 04 2004 20 04 2004 Previous j Next ji Home j Refresh El Done Po En Local intranet GIAN 1418 Start Ae 0680 SIME Notes Home E http 27tgacbr02 3 Exploring Images BY Microsoft Word SI E 038_5IME_MISapro i Fig 19 Approved Licences List Approved This screen lists all the licence applications submitted by the client and Licences List approved by the TGA Clicking on the licence number will open that licence s details Read Only Licence Number is the tracking number that was allocated by the system Fields when the application was created It is a unique number which is attached to the application and 1s used for all future tracking of the application through the system Manufacturer s Name is the name of the manufacturer associated with the application Received is the date the application was received Approved 1s the date the application was approved SIME MIS Lodgement User Guide v1 1 doc Page 40 TGA Online Services Manufacturer Information System MIS 3 Licence Microsoft Internet Exp
11. 20 04 2004 Active MI 20042004 LI 000278 2 ACI BLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 LI 000273 2 ACIBLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 LI 000278 2 ACI BLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 LI 000273 2 ACIBLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 LI 000273 2 ACI BLOWPAK VICTORIA Australia 44 20 04 2004 Submitted MI 20042004 LI 000273 2 ACIBLOWPAK VICTORIA Australia A4 20 04 2004 Submitted MI 05052004LI 000433 2 WILLIAM PEARCE amp CO P L Australia 34 38B MCEVOY ST 05 05 2004 Submitted MI 20042004LI 000273 2 ACI BLOWPAK VICTORIA Australia 44 20 04 2004 Submitted MI 20042004 LI 000273 2 ACI BLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 LI 000273 2 ACIBLOWPAK VICTORIA Australia 44 20 04 2004 Submitted MI 04052004LI 000426 2 WILLIAM PEARCE amp CO P L Australia 34 38B MCEVOY ST 04 05 2004 Under Review MI 04052004 1 1 100424 2 FRA PRODUCTION Atal FRAZS MATTEO FONDO 38 N4ns 2nn4 ba Done e a En Local intranet A Start Ae 0680 Workspace Lotus http tgacbr02 3 Exploring User Do BY Microsoft Word SI 9 012 SIME_MISvie eOGlaes 9 58 Fig 16 View Submitted Licence Applications List Submitted Licence List This screen lists all of the licence applications submitted to the TGA for processing Clicking on the status will open that application Read Only Status Pg 10
12. A Applicant s Own Ref 1234 Status Draft Tracking Number Ml 10062004 LI 000659 2 Client Details Primary Site Secondary Site Supporting Documents An electronic copy of your Site Master File Quality Manual or Technical Master File MUST support this application or it will not be valid However you may also provide a hardcopy of the files if an electronic one is not available For electronic attachment please limit file size to less than 1mb Electronic Document List Add Attachment Remove Attachment Paper Document List Document Type Description Method add Remove Zi Application loaded successfully pa i ES Local intranet AStar 4 e 160 gt SME Help Licence A Exploring 1 BY Microsoft w 27 010_SIME_ Document SAMA 17 14 Fig 7 Licence Application Supporting Documents Supporting This form is used to input the supporting documents Documents Editable Fields Electronic Document List Add Attachment 1s a button which when clicked on brings up a dialog box whereby the document can be browsed and attached At least one electronic or paper document see below must be entered Clicking on a document will open the document in a new window Remove Attachment is a button which when clicked on can be used to remove unwanted attachments Each attachment listed has a checkbox in front of it which must be clicked first All attachments with a clicked checkbox
13. CL 000086 1 TAG MED P L SULZER CARBOMEDICS INC 1300 EAST ANDERSON L Finalised MI 04062004 CL 000228 2 JOHNSON amp JOHNSON MEDICAL PTY LIMITED FERROSAN AS 5 SYDMARKEN Active MI 13052004 CL 000016 1 JOHNSON amp JOHNSON MEDICAL PTY LIMITED FERROSAN AS 5 SYDMARKEN Submitted MI 03062004 CL 000221 2 SUE ACKEROYD ASSOC FRA 2 PRODUCTION FRAZ MATTEO FOND Submitted MI 03062004 CL 000220 2 SUE ACKEROYD ASSOC FRA 2 PRODUCTION FRAZ 3 MATTEO rono 4 gt Done o W En Local intranet AStart A 08 SIME Notes Home E http 27tgacbr02 3y Exploring Images By Microsoft Word SI 7 031_SIME_MISvie KSQUIDS 13 55 Fig 49 View Submitted GMP Clearances List Submitted This screen lists all the clearance applications submitted by the user currently Clearance List logged in Clicking on the status will open that application Read Only Status Pg 100 shows the current status of the application Fields Tracking Number 1s created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and is used for all future tracking of the application through the system Sponsor s Name is the name of the sponsor associated with the application Manufacturer s Name is the name of the manufacturer associated with the application Primary Street Address 1s the first line of the primary site s address Received 1s the date the application was rece
14. E Bay Local intranet Stan 48 18 gt QsIME Notes Home E http 77tgacbr02 Ay Exploring Images _ BY Microsoft Word SI 47 033_SIME_MiSsub 4 SDA ADE 14 06 Fig 54 View All TGA Data List View all TGA This screen lists of all information recorded on TGA s GMP Register that is data owned by the user currently logged in The items are grouped by tracking number within GMP Register type Clicking on a manufacturer s name will open that application for viewing Read Only Tracking Number is created by the system once the application has been Fields saved or submitted It is a unique number which is attached to the application and is used for all future tracking of the application through the system Manufacturer s Name is the name of the manufacturer associated with the application Site Address is the first line of the primary site s address Status Pg 100 shows the current status of the application SIME MIS Lodgement User Guide v1 1 doc Page 97 TGA Online Services Manufacturer Information System MIS Troubleshooting I am unable to If you are unable to access your work area s homepage please contact your access my work system administrator Adjustments may need to be made to your access area homepage privileges for your account or there may be a system wide fault I am unable to Ask your system administrator to check your account permissions attach a file SIME MIS Lodgement
15. LTD UNITS 8 12 21 24 10 YALGAR ROAD 04 06 2004 Submitted MI 28052004 CE 000143 2 SUE AKEROYD ASSOC 217 221 GOVERNOR ROAD 04 06 2004 Pending Withdrawal MI 17052004 CE 000141 2 GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGHWAY 04 06 2004 Submitted MI 07052004 CE 000140 2 FRA PRODUCTION Italy FRAZ 5 MATTEO MATTUTINA 4 07 05 2004 Submitted MI 06052004 CE 000139 2 BLAKOE PRODUCTS AUSTRALIA PTY LTD Australia PO BOX 141 06 05 2004 Pending Withdrawal MI 06052004 CE 000137 2 William Pearce Gareth amp Co P L 34 38B MCEVOY ST 06 05 2004 Submitted MI 06052004 CE 000136 2 William Pearce Gareth Co P L 34 38B MCEVOY ST 06 05 2004 Under Review MI 06052004 CE 000135 2 William Pearce Gareth Co P L 34 38B MCEVOY ST 06 05 2004 Submitted MI 05052004 CE 000134 2 William Pearce Gareth Co P L PO BOX 69 05 05 2004 Submitted MI 05052004 CE 000133 2 William Pearce Gareth amp Co P L 34 38B MCEVOY ST 05 05 2004 Submitted MI 04052004 CE 000131 2 BIOVITAL PTY LTD UNITS 8 12 21 24 10 YALGAR ROAD 04 06 2004 Submitted MI 09032004 CE 000005 2 SUE AKEROYD ASSOC PO BOX 141 24 05 2004 Previous Next Home Refresh Done E Local intranet AStart A e C amp Workspace Lotus 7 http tgacbrO2_ 3 Exploring Images BY Microsoft Word SI 4 021_SIME_MIS vie EN Pas La E 11 23 Fig 33 View Submitted Certifications List Submitted This screen lists all the certification applications submitt
16. MIS Lodgement User Guide v1 1 doc Page 31 TGA Online Services Manufacturer Information System MIS To Submit A Licence Application E Submitting a Licence Web Page Dialog You must complete the following three steps before Submitting a Licence Step 1 Fees and payments Step 2 Declaration Step 3 Tax Invoice This screen will guide you to complete all three steps mentioned above You can exit this screen at any time by clicking the Cancel Button Please click Continue button to continue Continue Cancel Fig 12 Submitted Licence Submitted When submitting an application a popup box appears requesting a further Licence Steps three steps be actioned as follows Step 1 Fees and Payments Step 2 Declaration Step 3 Tax Invoice SIME MIS Lodgement User Guide v1 1 doc Page 32 TGA Online Services Manufacturer Information System MIS lt Submitting a Licence Web Page Dialog Fees AUC 999 00 Payment Type al Cheque C visa Bank Card Mastercard Payable to Financial Services Group Licence Section Mail ta Financial Services Group Licence Section Therapeutic Goods Administration PO BOs 100 Woden ACT 2606 021 6232 8359 U2 6234 Daza lt Previous Mest gt gt Cancel Fig 13 Fees and Payments Fees and All licence applications are subject to a fee This screen allows the user to Payments nominate how payment will be made NOTE If Visa Bank Card or
17. Mastercard is selected the payment details must be entered on the Tax Invoice see below Card details are NOT kept on the system Read Only Fees contains the fee applicable for the type of application Fields Payable Mail To are the details of who the cheque must be made payable to and where to send it Editable Fields Payment Type indicates the payment type Values are Cheque Visa Bank Card amp Mastercard Cheque No Only displayed if Payment Type is CHEQUE Number of the cheque beeing sent as payment Bank Only displayed if Payment Type is CHEQUE Editable field Name of the bank the cheque has been drawn on SIME MIS Lodgement User Guide v1 1 doc Page 33 TGA Online Services Manufacturer Information System MIS 3 Submitting a Licence Web Page Dialog 1 A Valued Client hold the position of Chairman in MY Company Pty Ltd at Address for Company understand that the certification below is made for the purpose of assisting the Secretary of the Commonwealth Department of Health and 4geing or her delegate to consider whether the applicant I A Valued Client or a licence to manufacture theraputic goods the Applicant persons who participate in or are likely to participate in managing the Applicant s affairs 4pplicant Managers and persons who have or are likely to have effective control over the Applicant 4pplicant Controllers are fit and proper persons for the purposes of section 38 of the Therapeutic Good
18. Mess xs soche ones A sa cetccar a aetna or See ees ante E 30 To Submit A Licence Application 32 Submitted EICSMCE SSC Sissi ae eo A ee a ao a T 32 Fees and Fa Meninas aid ada cs os 33 A a eral deena ahoaadea acca tk Lubes aya Gee bh ouuaened tt ned aue nace oaacemed a 34 SIME MIS Lodgement User Guide v1 1 doc Page ii TGA Online Services Manufacturer Information System MIS TAI VO Gx emt o 35 View Submitted Licence Applications 36 submitted ENC SCS si a o O a sh a dae A eh o etal Ng 36 Submitted Licence Application sai eee en ee AN 37 O cence iets 39 View Approved Licences 40 Approved Licences ElSt untae eee te ee ee es 40 APProVe dice Acer esoo ps 41 Create Declaration 42 Create Declara lO ooo 42 Overseas Manufacturer Certification ooomoccoconocccnonoocconncccnoncccnnnncccononcccnoncccncnncccnonecccncnacccncinecccnno 44 Certification Application Processing 44 ePIC el NS o io da nt 44 ADONC AO A A A 45 Approv d Geriicanon Sia id 46 New Certification Application 48 A soniri n aa aa aa beta de det fan rar ate tacuia bean e aeaa E 48 chent Detale eee te teagan ol eee 50 A atest a tele eeu E el dleg ce eee alas See ed les ies Sanches Oa ea aes 52 SUPP ORIG DOCUMEN a aaa ani eden given Lada 55 A O eee eee oe 57 Variation Certification Application 58 PAO DNC AMOI ED CAINS csr tines aS ns ceba 58 View Draft Certification Applications 60 Drakt Cenmeaon St dis 60 Draft Certiicaton APPIICAUOM setae oseteaasectheecatas coos
19. TGA Online Services MIS Manufacturers Application Lodgement home Online Services page is accessed by clicking on Manufacturers on the TGA Online Services MIS Home Page Home Page 23 http tgacbr02 SIME MIS lodge nsf Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 2 2 9 A AJa a G B 9 a Back Forward Stop Refresh Home Search Favorites History Mail Print Edit TOET A ls Help S M E EN 3 Manufacturers Application Lodgement Licensing of Australian Manufacturers Create New Licence Application User Documentation View Draft Licence Applications i View Submitted Licence Applications Create Declaration What s Hew Overseas Manufacturer Certification Lodge Supporting Documents Create New Certification Application l View Draft Certification Applications View Submitted Certification Applications Overseas Manufacturer GMP Clearance Create New Clearance Application View Draft GMP Clearance Applications View Submitted GMP Clearance Applications View TGA Data View All TGA Data View Approved Licences View Approved Certifications View Approved GMP Clearances Copyright Disclaimer Privacy Statement Produced by Therapeutic Goods Administration 18 August 1999 h e Done a al E Local intranet Stan 18 70 Workspace L TvGuideSeare BY Exploring Use http 77tgac BY Microsoft Wor U ecO
20. User Guide v1 1 doc Page 98 TGA Online Services Manufacturer Information System MIS APPENDIX A Manufacturing Items Manufacturing Item Web Page Dialog Manufacturing Type Active Pharmaceutical Ingredient El Sterility Mon Sterile al Manufacturing Class Single Good j Dosage Form Cream j Product Categor Listed Therapeutic Goods I Manufacturing Step Active Pharamaceutical Ingredient Bulk Crude E Save ltem Close Fig 55 Manufacturing Items Manufacturing Wherever Manufacturing Items are required to be input clicking on the Add Items Dialog button brings up a dialog box to enter the item details Editable Fields Manufacturer Type The type of product being manufactured Sterility Indicate whether the manufacturing type is sterile or non sterile Manufacturing Class The class of the manufacturing item Dosage Form The dosage form applicable to the manufacturing item Product Category The product category of the manufacturing item Manufacturing Step The manufacturing step of the manufacturing item NOTE All items can be selected from a drop down list or typed in if not in the list SIME MIS Lodgement User Guide v1 1 doc Page 99 TGA Online Services Manufacturer Information System MIS APPENDIX B Status Codes Draft Draft Draft application has been saved by the applicant and 1s still being Applications worked on No TGA involvement Submitted Submitted Application has been
21. and is used for all future tracking of the application through the system Clicking on the Tracking Number opens the draft application for viewing Manufacturer s Name is the name of the manufacturer associated with the application Primary Street Address 1s the first line of the primary site s address Manufacturer s Own Reference is the applicant s own reference information that may help in identifying the application SIME MIS Lodgement User Guide v1 1 doc Page 29 TGA Online Services Manufacturer Information System MIS 3 Licence Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e gt 0 D AJA m 391069 Y Back Eomsard Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf 9b44f958abe4053aca256e5b00069e1d 322fd2c4f4518717ca256ea70005074270penDocument y Go Links A a Y SIME Licence Application Edit Close View Entire App New Draft Copy Home Applicant s Own Ref 123456769 Status Draft Tracking Number MI 02062004 LI 000587 2 Client Details Primary Site Secondary Site Supporting Documents Applicant Name Valued Client Client Id 9999999 Address PO Box 1234 Suburb Melbourne State VIC Postcode 3000 Country Australia Phone Fax Email Staff email com x Existing Manufactuer New Manufacturer a l Application loaded successfully
22. are removed SIME MIS Lodgement User Guide v1 1 doc Page 24 TGA Online Services Manufacturer Information System MIS Editable Fields Paper Document List continued Add 1s a button which when clicked on brings up a dialog box whereby the document details can be entered Fields displayed are Document Type Description Method of Submission amp Date Sent All fields are mandatory Document Type can be selected from a drop down list or typed in Method of Submission 1s selected by choosing one of the available radio buttons Fax Post Courier A convenient click on calendar has been included in the dialog box for Date Sent At least one electronic see above or paper document must be entered Remove 1s a button which when clicked on can be used to remove unwanted entries Each entry listed has a checkbox in front of 1t which must be clicked first All entries with a clicked checkbox are removed SIME MIS Lodgement User Guide v1 1 doc Page 25 Manufacturer Information System MIS TGA Online Services 3 Yariation Licence Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help gt 048 84 39 B 9 Mal Pict Edi Back Forverd Stop Refresh Home Search Favorites History Address a http tgacbr02 sime mis lodge nst 0 B 2FC53644BF250E FCA256E BD O004E 687 7E ditD ocument Go Links eee Am Hes isq Help gt ae SIME t Wariation Licenc
23. displayed which brings up a dialog box whereby the CV can be browsed and attached A Remove Attachment button is also displayed which removes the attachment Clicking on the CV will open it in a new window Production is the name of the person in charge of production CV Attachment 1s the CV of the person in charge of production An Add Attachment button is displayed which brings up a dialog box whereby the CV can be browsed and attached A Remove Attachment button is also displayed which removes the attachment Clicking on the CV will open it in a new window SIME MIS Lodgement User Guide v1 1 doc Page 20 TGA Online Services Manufacturer Information System MIS Editable Fields Authorised For Release is the name of the person who is authorised to continued release Manufacturing Items Pg 99 Add 1s a button which when clicked on brings up a dialog box to enter the item details Fields displayed are Manufacturing Type Sterility Manufacturing Class Dosage Form Product Category amp Manufacturing Step All fields can be populated from the drop down list or 1f it is a new item by typing in the details The Manufacturing Type selected refines what values are permitted for the remaining entries At least one Manufacturing Item must be entered Remove is a button which when clicked will remove unwanted items Each item listed has a checkbox in front of 1t which must be clicked first All items with a clicked checkbox are remo
24. e Therapeutic Goods Administration Online Services b Adverse Drug Reactions Latest News gt Australian Manufacturers Database gt Australian Register of Therapeutic 28 05 2004 Extension of Exemption Period 19 05 2004 Online Services Server Performance Goods gt Client Information 25 02 2004 Sponsor wew Print entire ARTG entry function gt Code Tables 23 12 2003 Help desk support during the festive season gt Export Only Medicines 22 12 2003 Electronic Listing Facility ELF Draft applications Status Update 4 30 gt Listed Medicines 21 11 2003 Electronic Listing Facility ELF gt Medical Devices gt Over The Counter Medicines gt Prescription Medicines gt Manufacturers gt New User gt User Management gt Help gt Close Australian Government Department of Health amp Ageing Homepage Therapeutic Goods Administration Copyright Security Disclaimer Privacy Statement Copyright Commonwealth of Australia Produced by Therapeutic Goods Administration UPL http tgacbr02 For further information contact tga sime health gov au or contact the TGA Online Services Help Desk on 1800 010 624 Last updated 04 06 2004 B Local intranet Start A 0680 gt Sy SIME Notes Home 3 Exploring DEAL BY Microsoft Word D TGA Online S untitled Paint SOMA iros 16 44 Fig 1 TGA Online Services Home Page The TGA Online Services Home Page 1s public
25. must complete the folowing two steps before submitting a Certicate Step 1 Fees and payments Step 2 Tax Invoice This screen will quide you to complete two steps mentioned above ou can exit this screen at any time by clicking the Cancel Button Please click Continue button to continue Continue Cancel Fig 30 Submitted Certification Submitted When submitting an application a popup box appears requesting a further two Certification steps be actioned as follows Steps Step 1 Fees and Payments Step 2 Tax Invoice SIME MIS Lodgement User Guide v1 1 doc Page 62 TGA Online Services Manufacturer Information System MIS E Submitting a Certicate Web Page Dialog Fees AUC 100 20 Payment Type Cheque O visa Bank Card Mastercard Payable to CEFinancial Services Group Mail to CEFinancial Services Group Therapeutic Goods Administration PO Bos 100 Woden ACT 2606 02 6232 8359 U4 623z Dlzz gg Previous Herst gt gt Cancel Fig 31 Fees and Payments Fees and All Certification applications are subject to a fee This screen allows the user Payments to nominate how payment will be made NOTE If Visa Bank Card or Mastercard is selected the payment details must be entered on the Tax Invoice see below Card details are NOT kept on the system Read Only Fees contains the fee applicable for the type of application Fields Payable Mail To are the details of who the ch
26. so that the correct one can be selected Email is the applicant s email address Sponsor Sponsor Name is the name of the sponsor of the application The sponsor must be selected from a drop down list of possible sponsors Address is the first line of the sponsor s address If there is more than one address associated a drop down list is displayed so that the correct one can be selected Email is the sponsor s email address Contact Contact Name 1s the name of the contact person Phone Fax amp Mobile are the contact details of the contact person Email is the contact person s email address SIME MIS Lodgement User Guide v1 1 doc Page 77 TGA Online Services Manufacturer Information System MIS Editable Fields Manufacturer continued Manufacturer Indicator is a radio button selection to indicate whether the manufacturer 1s currently registered with the TGA or 1s new Existing manufacturer Search 1s a facility to search on all or part of the manufacturer s name A separate dialog box pops up in which the search criteria can be entered A list of matches are then displayed from where the required manufacturer can be selected Client Id 1s the client number of the manufacturer selected New Manufacturer Manufacturer Name is the name of the manufacturer Site Suburb State Post Code amp Country are the address details of the manufacturer SIME MIS Lodgement User Guide v1 1 doc Page 78 TGA O
27. than one address associated a drop down list is displayed so that the correct one can be selected Email 1s the applicant s email address and 1s used by the TGA for any subsequent correspondence Manufacturer Indicator is a radio button selection to indicate whether the manufacturer is known by TGA and therefore is registered or 1s new SIME MIS Lodgement User Guide v1 1 doc Page 17 TGA Online Services Manufacturer Information System MIS Editable Fields continued Existing manufacturer Search 1s a facility to search on all or part of the manufacturer s name A separate dialog box pops up in which the search criteria can be entered A list of matches are then displayed from where the required manufacturer can be selected Client Id amp Client ABN are the client details of the manufacturer selected New Manufacturer Client Name is the name of the manufacturer ACN or ABN is the manufacturer s ACN or ABN number Address Suburb State Post Code amp Country are the address details of the manufacturer Billing details Address Suburb State Post Code amp Country are the billing address details of the application if different from the main address The fields are optional but if one is entered they must all be entered SIME MIS Lodgement User Guide v1 1 doc Page 18 TGA Online Services Manufacturer Information System MIS 3 Licence Application Microsoft Internet Explorer provided by Health
28. tne cede or a na ieor sen teedet edd acces 61 To Submit A Certification Application 62 Submitted Cercano tepic diia 62 COS anadir a VINCI S iu ositos ollo Maw hed ules ile nR a 63 ANA WAY In 64 View Submitted Certification Applications 65 Submitted Certification List is 65 Submitted Certification Application ooccccocnccocnococnconnncnononononnnnncnnonnnnnnnnnnncnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnns 66 FEES PA MES tado a So nd a a oe ls 67 View Approved Certifications 68 Approved Certifications LIS sit A IA AAA AS 68 APPO VEA GOMMGCANO A o ad dd 69 Overseas Manufacturer GMP Clearances sscccccsssccccssscccsssscccssscccccsssscccssscccccsscsccsssssccsessccoeess 70 Clearance Application Processing 70 Dra Ap pliCAuOnS o eee 70 A A RR ASR a Re ee Ree eee eee eer 71 Approved CI ATACA a a a 72 New Clearance Application 74 ADDICION CLAS es oes ico oe eta e oaata tes vers anes idee adatdenet hee ae este e eee ura 74 A A O Oene rae 76 EVI ACOSO ri eiii sia 79 API PIOGUCE Detalla li Ns a do coda edas 81 e 83 Variation Clearance Application 84 APPICANMA Nas carra e el ciao 84 SIME MIS Lodgement User Guide v1 1 doc Page iii TGA Online Services Manufacturer Information System MIS View Draft GMP Clearance Applications 86 Dratt Clearance bist 236 25 ee ene ee ee ee et 86 Dyson 87 To Submit A GMP Clearance Application 88 Submitted Clearance Steps 2 02 in as 88 Fees ANG Payments la ii in 89 TASINVOICS at rta eta
29. to TGA SIME MIS Lodgement User Guide v1 1 doc Page 42 TGA Online Services Manufacturer Information System MIS Editable Fields Applicant s Name Name of person making the application To be entered in two places Position The position of the applicant in the company Company Name Name of the company Applicant s Address Company s address Optional Further Information Any additional information that relates to the application SIME MIS Lodgement User Guide v1 1 doc Page 43 TGA Online Services Manufacturer Information System MIS Overseas Manufacturer Certification Certification Application Processing Draft Applications To create a new certification application 1 2 3 4 Click on Create New Certification Application on the Manufacturers Application Lodgement home page Pg 10 A new application entry form will be opened Pg 48 Enter the Applicant s Own Reference information 1f required Enter the Client Details Pg 50 Primary Site Pg 52 and Supporting Documents Pg 55 as described below Save the application as a draft copy by clicking on the Save button To edit an existing draft certification application 1 2 3 4 Click on View Draft Certifications on the Manufacturers Application Lodgement home page Pg 10 A list of all the draft applications currently in the system will be displayed Pg 60 To view the application click on its Tracking Number If the
30. 0 shows the current status of the application This will change Fields as the application is processed and finalised by the TGA Tracking Number 1s created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and is used for all future tracking of the application through the system Manufacturer s Name is the name of the manufacturer associated with the application Primary Street Address 1s the first line of the primary site s address Received is the date the application was received by the TGA after being submitted SIME MIS Lodgement User Guide v1 1 doc Page 36 TGA Online Services Manufacturer Information System MIS E Licence Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e 0 N Ala a 3 39 Ya Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf a50d63d6d7b24bdaca256e3f007913c8 9e6edf60df303e58ca256e8a003d5b75 70penDocument Go Links AnD reg eee al UL d i Ds SIME ts Licence Application Close J View Entire App Withdraw New Draft Copy Home Applicant s Own Ref 123456789 Status Submitted Tracking Number MI 29042004 LI 000382 2 Original Tracking Number MI 20042004 L1 000278 2 Migrated Record Application Client Details Primary Site Secondary Site Supporting
31. 0OpenForm Type CE 2 Go Links A Client Details Primary Site Supporting Documents An electronic copy of your Site Master File Quality Manual or Technical Master File MUST support this application or it will not be valid However you may also provide a hardcopy of the files if an electronic one is not available For electronic attachment please limit file size to less than 1mb Electronic Document List Add Attachment Remove Attachment Paper Document List Document Type Description Method El Ei loaded successtully Ea Local intranet Asar 4 e 18 PWorkspace L New Certific BY Exploring User BY Microsoft Word 2 untitled Paint SAAB 11 03 Fig 25 Certification Application Supporting Documents Supporting This form is used to attach the supporting documents in support of the Documents Certification application Editable Fields Electronic Document List Add Attachment is a button which when clicked on brings up a dialog box whereby the document can be browsed and attached At least one electronic or paper document see below must be entered Clicking on a document will open the document in a new window Remove Attachment is a button which when clicked on can be used to remove unwanted attachments Each attachment listed has a checkbox in front of it which must be clicked first All attachments with a clicked checkbox are removed SIME MIS Lodgement User Guide v1
32. 1 08 2006 MI 13052004 CL 000033 1 BECTON DICKINSON MED PRODUCTS 30 TUAS AVE 11 08 2006 NMT 13052N0 4CT NNNN34 1 SHERWOOD DAVIS AND GECK ORTSK ANY FATLTS 130 SOUTH MATIN ST AMAS E Done Pop E Local intranet Saad 15 27 A Start A 0680 Sy SIME Notes Home E http 27tgacbr02 3 Exploring Images BY Microsoft Word SI E 035_SIME_MISapro Fig 52 Approved GMP Clearances List Approved This screen lists all the approved clearance applications owned by the user Clearances List currently logged in Clicking on a clearance number will open that clearance for viewing Read Only Clearance Number is the tracking number that was allocated by the system Fields when the application was created It is a unique number which is attached to the application and is used for all future tracking of the application through the system Manufacturer s Name is the name of the manufacturer associated with the application Site Address is the first line of the primary site s address Expiry Date 1s the date the clearance will expire SIME MIS Lodgement User Guide v1 1 doc Page 95 TGA Online Services Manufacturer Information System MIS 3 Clearance Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e 0 N Ala a 3 39 Ya Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 sime mis reposit nst242ta7a7
33. 234 status Draft Current Tracking Number MI 07062004 CE 000145 2 New Tracking Number MI 24062004 CE 000150 2 x Change Status Client Details Status select new status Suspend Cancel Description El E Variation loaded successfully a lise ES Local intranet Start ends Welcome Variation Gy Exploring BY Microsoft Document MSN Hotm Z untitled Pa SUD ID id 14 36 Fig 26 Certification Application Status Status This form is used to request a change in status to an existing approved certification Editable Fields Select New Status Pg 100 is a radio button option to select the action that is required for the application Description 1s a general comment as to why the change in status 1s required and any additional information that may be relevant SIME MIS Lodgement User Guide v1 1 doc Page 57 TGA Online Services Manufacturer Information System MIS Variation Certification Application ES Variation Licence Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help E gt A a Ga F A Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf 0 FC97D 9562964036E C4256E CF0001 2E 787E ditDocument Go Links a M SIME Te t Variation Certification Application Applicant s Ref 1234 status Draft Current Tra
34. 6 2 FERROSAN AS 5 SYDMARKEN 22 06 2005 MI 13052004 CL 000005 1 FERROSAN AS 5 SYDMARKEN 25 08 2004 MI 13052004 CL 000007 1 BIO RAD 3 BOULEVARDE RAYMOND POINCARE BP 3 MARNES LA COQUETTE 03 09 2004 MI 13052004 CL 000009 1 ROCHE COLORADO CORPORATION 2075 NORTH 55TH ST 22 06 2005 MI 13052004 CL 000011 1 ROCHE COLORADO CORPORATION 2075 NORTH 55TH ST 22 06 2005 MI 13052004 CL 000012 1 HOE HIN PAK FAH YEOW MANUFACTORY LTD FLAT A C amp D 3 F WAH HA FACTORY BUILDING 3 SHIPYARD LAND 07 05 2005 MI 13052004 CL 000016 1 FERROSAN AS 5 SYDMARKEN 13 12 2006 MI 13052004 CL 000018 1 SMITHKLINE BEECHAM DUNGARYAN LTD KNOCKBRACK DUNGARVAN 17 05 2006 MI 13052004 CL 000019 1 ETHICON ENDO SURGERY INC 4545 CREEK RD HEAD OFFICE 02 10 2004 MI 13052004 CL 000020 1 ETHICON ENDO SURGERY INC 4545 CREEK RD HEAD OFFICE 02 10 2004 MI 13052004 CL 000021 1 ETHICON ENDO SURGERY INC 4545 CREEK RD HEAD OFFICE 02 10 2004 MI 13052004 CL 000022 1 ETHICON ENDO SURGERY INC 4545 CREEK RD HEAD OFFICE 02 10 2004 MI 13052004 CL 000023 1 ETHICON ENDO SURGERY INC 4545 CREEK RD HEAD OFFICE 03 10 2004 MI 13052004 CL 000024 1 ETHICON ENDO SURGERY INC 4545 CREEK RD HEAD OFFICE 03 10 2004 MI 13052004 CL 000025 1 ENDOTEC 20 VALLEY STREET SOUTH ORANGE 31 12 2005 MI 13052004 CL 000028 1 MEDICAP LTD 384 SOI 6 PATTANA 3 RD BANGPOO INDUST ESTATE 29 06 2004 MI 13052004 CL 000029 1 BECTON DICKINSON MED PRODUCTS 30 TUAS AVE 11 08 2006 MI 13052004 CL 000032 1 BECTON DICKINSON MED PRODUCTS 30 TUAS AVE 1
35. 61 MOUNTAIN HIGHWAY MI 03062004 CL 000239 2 ALPHAPHARM PTY LTD IPCA LABORATORIES LTD 217 221 GOVERNOR ROAD 12345 MI 08062004 CL 000233 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA 1061 MOUNTAIN HIGHWAY MI 04062004 CL 000230 2 ALPHAPHARM PTY LTD IPCA LABORATORIES LTD 217 221 GOVERNOR ROAD MI 03062004 CL 000223 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA 1061 MOUNTAIN HIGHWAY MI 09062004 CL 000243 2 ROCHE PRODUCTS PTY LTD BIOVITAL PTY LTD 34 38B MCEVOY ST 12345 MI 01062004 CL 000217 2 BLACKMORES LIMITED FRA 2 PRODUCTION FRAZ 3 MATTEO FONDO 38 MI 28052004 CL 000207 2 BIOVITAL PTY LTD MI 27052004 CL 000197 2 BIOVITAL PTY LTD ETHICON ENDO SURGERY INC 34 38B MCEVOY ST ETHICON ENDO SURGERY INC 34 38B MCEVOY ST MI 25052004 CL 000192 2 SUE ACKEROYD ASSOC FRA 2 PRODUCTION 1061 MOUNTAIN HIGHWAY MI 25052004 CL 000191 2 VARIAN MEDICAL SYSTEMS AUSTRALIA PTY LTD MEDICAP LTD 12 MOUNTAIN HIGHWAY MI 25052004 CL 000190 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA 1061 MOUNTAIN HIGHWAY MI 25052004 CL 000139 2 LIVINGSTONE INTERNATIONAL P L NANTONG GUANGDA TEXTILE 3438B MCEVOY ST 12345 IPCA LABORATORIES LTD 217 221 GOVERNOR ROAD GLAXO WELLCOME AUSTRALIA 1061 MOUNTAIN HIGHWAY GLAXO WELLCOME AUSTRALIA 1061 MOUNTAIN HIGHWAY GLAXO WELLCOME AUSTRALIA 1061 MOUNTAIN HIGHWAY MI 05052004 CL 000172 2 ALPHAPHARM PTY LTD MI 05052004 CL 000171 2 SUE ACKEROYD ASSOC MI 30042004 CL 000167 2 SUE ACKEROYD ASSOC MI 02032004 CL 000011 2 SUE ACKEROYD
36. 6EA60017D3267EditDocument 2 Go Links rpe eT mm Py f D Help SIME t Variation Clearance Application Save J Close Validate Delete J Submit Home Applicant s Ref status Draft Current Tracking Number MI 13052004 CL 000012 1 New Tracking Number MI 24062004 CL D0027 7 2 Change Details Change Status Client Details Status Select new status Suspend Cancel Re activate Description Ei amp Variation loaded successfully a lise ES Local intranet Start ends Welcome Variation Gy Exploring BY Microsoft Document MSN Hotm Z untitled Pa KSOSUD ID id 14 54 Fig 42 Clearance Application Status Status This form is used to request a change in status to an existing approved clearance Editable Fields Select New Status Pg 100 is a radio button option to select the status that is required for the clearance Description is a general comment as to why the change to the status is required and any additional information that may be relevant SIME MIS Lodgement User Guide v1 1 doc Page 83 TGA Online Services Manufacturer Information System MIS Variation Clearance Application 3 Variation Clearance Application Microsoft Internet Explorer provided by Health e gt 0 A AJa a G B 9 Y Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf 0 F10B23E 78E
37. Client Client Id 9999999 Address Suburb State Postcode Country Phone Fax Email x Existing Manufactuer New Manufacturer sl Application loaded successfully pos x Es Local intranet Astar 18 8 gt Workspace Lotus E Certification Ap QJ Exploring Images BY Microsoft Word SI 97 020_SIME_MISvie CERES 121 Draft Certification Application Read Only Fields Editable fields Other SIME MIS Lodgement User Guide v1 1 doc Fig 29 View Draft Certification Application This form is used to open an existing draft certification Status is always Draft Pg 100 Tracking Number is created by the system once the application has been saved or submitted It is a unique number which 1s attached to the application and is used for all future tracking of the application through the system The following fields are editable when creating an application or editing an existing draft application These fields become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that may help in identifying the application Client Details Primary Site Supporting Documents and Status Pg 100 are as per New Certification Application Page 61 TGA Online Services Manufacturer Information System MIS To Submit A Certification Application E Submitting a Certicate Web Page Dialog You
38. Details Populated from the contents of the Fields application This form is the Tax Invoice for GST once payment has been made The details must be read to ensure it is correct If not the submission can be cancelled and the application changed to reflect the correct information Submission can then be done again Card Details Only displayed if VISA BANK CARD or MASTERCARD is selected as the Payment Type Card information written on the printed version of the Tax Invoice will ONLY be used to make paymant and is NOT retained in the system Card Holders Signature After clicking Next on the Tax Invoice page a printer friendly version is displayed which must be printed The printed page must be faxed to TGA SIME MIS Lodgement User Guide v1 1 doc Page 90 TGA Online Services Manufacturer Information System MIS View Submitted GMP Clearance Applications 3 http tgacbr02 SIME MIS lodge nsf wW ebS ubmittedCL 70 penView Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 2 gt 9 Ga ua IB 9 a Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address A http 7tgacbr02 SIME MIS lodge nsf ebSubmittedCL 70 penView 2 Go Links A _ o as TEA dd SIME to View Submitted GMP Clearance Applications Previous Next Home Refresh Search Status Tracking Number Sponsor s Name Manufact
39. Documents Fees and Payments Applicant Applicant Name Valued Client Client Id 9999999 Address PO Box 1234 Suburb Melbourne State WIC Postcode 3000 Country Australia Phone Fax Email Staff email com x Existing Manufactuer New Manufacturer sl a loaded successfully E Localintranet A Start e 0 gt Workspace Lotus JLicence Applica 3 Exploring User Do BY Microsoft Word SI Z7 013_5IME_MISsubli SD IDE 10 03 Fig 17 View Submitted Licence Application Submitted This form is used to view an application that has been submitted No changes Licence can be made to the application If changes are required the application must Application be withdrawn and a new draft copy created Read Only Applicant s Own Ref is the applicant s own reference information that may be Fields useful in the client s identification of their application Status Pg 100 is the current status of the application within the system Tracking Number is created by the system once the application has been saved or submitted It is a unique number which is attached to the application and is used for all future tracking of the application through the system The following field is only displayed when viewing a variation Original Tracking Number is the tracking number of the original application SIME MIS Lodgement User Guide v1 1 doc Page 37 TGA Online Services Manufacturer Information System MIS
40. E Eu Local intranet A Start Aenlle alll Workspace Lotus E Licence Applica 3 Exploring User Do BY Microsoft Word SI 9 011_SIME_MIS vie eOHlae s 354 Fig 11 View Draft Licence Application Draft Licence This form is used to view an existing draft licence application that was Application previously saved in draft status Read Only Status 1s always Draft Pg 100 Fields Tracking Number is created by the system once the application has been saved or submitted It is a unique number which is attached to the application and is used for all future tracking of the application through the system Editable fields The following fields are editable when creating an application or editing an existing draft application They become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that will help them to identify the application The following fields are only displayed when creating a variation Change Details Status Indicator Pg 100 indicates to the system whether the variation 1s to change the details of the application to change its status SIME MIS Lodgement User Guide v1 1 doc Page 30 TGA Online Services Manufacturer Information System MIS Other Client Details Primary Site Secondary Site Supporting Documents and Status Pg 100 are as per New Licence Application SIME
41. E t Variation Licence Application Save J Close Validate Delete J Submit Home J Applicant s Ref status Draft Current Tracking Number Ml 20042004 LI 000276 2 New Tracking Number Ml 12072004 LI 000681 2 Change Details Change Status Client Details Primary Site Secondary Site Supporting Documents Applicant Details Applicant Name Valued Client Client Id 9999999 Address PO Box 1234 Suburb Melbourne State IC Postcode 23000 Country Australia Phone Fax Email staff work com Manufacturer Details Current Manufacturer AC BLOWPAK VICTORIA E Variation loaded successfully ne a ES Local intranet A Start e C amp al Workspace Lotus Notes 3 Exploring DEAL Training BY Microsoft Word SIME MI I variation Licence Ap Sao 10 01 Fig 9 Variation Licence Application Application This form is used to create a variation application for an existing licence Details Read Only Status 1s always Draft Pg 100 Fields Current Tracking Number is the tracking number of the original application New Tracking Number 1s the new tracking number created for this variation Editable fields The following fields are editable when creating a variation They become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that will help them to identify the
42. E 4DA28C4256E CFOO033BDD E ditDocument e Go Links A ME Help SIME o Wariation Clearance Application Save J Close Validate Delete J Submit Home J Applicant s Ref status Draft Current Tracking Number Ml 13052004 CL 000012 1 New Tracking Number MI 12072004 CL 000283 2 Change Details Change Status Client Details Evidence APProduct Details Applicant Details Applicant Name Valued Client Client Id 9999999 Address PO Box 1234 Suburb Melbourne State IC Postcode 3000 Country Australia Phone Fax Email Staff email com Manufacturer Details Current Manufacturer HOE HIN PAK FAH YEOWY E Variation loaded successfully piz z ES Local intranet A Start e le Workspace Lotus 3 Exploring DEAL Tra BY Microsoft Word SI Variation Cleara untitled bmp Paint Sao 10 35 Fig 43 Variation Clearance Application Application This form is used to create a variation application on an existing approved Details clearance Read Only Status is always Draft Pg 100 Fields Current Tracking Number is the tracking number of the original application New Tracking Number 1s the new tracking number created for this variation Editable fields The following fields are editable when creating an application or editing an existing draft application They become non editable once the application has been submitted Applican
43. Gaesas 313 Fig 2 The TGA Online Services MIS Manufacturers Application Lodgement Home Page Special Home The TGA Online Services MIS home page has a number of special navigation Page Buttons buttons User Documentation The User Documentation Button This button will open a new window which displays user documentation information What s Hew The What s New Button This button will open a new window which displays recent news regarding the system The information on the page 1s updated regularly and should be revisited often Lodge Supporting Documents The Lodge Supporting Documents Button This button will open a new window which allows the user to lodge with the TGA documents in support of an existing application SIME MIS Lodgement User Guide v1 1 doc Page 10 TGA Online Services Manufacturer Information System MIS Licensing of Australian Manufacturers Licence Application Processing Draft Applications To create a new licence application 1 2 3 4 Click on Create New Licence Application on the Manufacturers Application Lodgement home page Pg 10 A new application entry form will be opened Pg 15 Enter the Applicant s Own Reference information 1f required Enter the Client Details Pg 17 Primary Site Pg 19 Secondary Site Pg 22 and Supporting Documents Pg 24 as described below Save the application as a draft copy by clicking on the Save button To edit an existing draft li
44. MI 02062004 LI 000622 2 FRA PRODUCTION FRAZ 3 MATTEO MATTUTINA 4 MI 08062004 LI 000621 2 ABBOTT AUSTRALASIA PTYLTD PO BOX 12 MI 02062004 LI 000613 2 FRA PRODUCTION STRADA DELLE POSTE 12 MI 07062004 L1 000616 2 ABBOTT AUSTRALASIA PTYLTD PO BOX 12 MI 04062004 LI 000600 2 FRA PRODUCTION STRADA DELLE POSTE 12 MI 02062004 LI 000533 2 FRA PRODUCTION FRAZ 3 MATTEO MATTUTINA 4 MI 02062004 LI 000537 2 FRA PRODUCTION STRADA DELLE POSTE 12 MI 31052004 LI 000532 2 FRA PRODUCTION FRAZ 3 MATTEO MATTUTINA 4 MI 27052004 LI 000560 2 SUE AKEROYD ASSOC GARETH PO BOX 141 MI 27052004 LI 000553 2 SUE AKEROYD ASSOC GARETH PO BOX 141 MI 27052004 LI 000552 2 FRA PRODUCTION STRADA DELLE POSTE 12 1234 MI 27052004 LI 000550 2 SUE AKEROYD ASSOC GARETH PO BOX 141 MI 25052004 LI 000533 2 ABBOTT AUSTRALASIA PTYLTD FPO BOX 12 MI 25052004 LI 000532 2 SUE AKEROYD ASSOC GARETH PO BOX 141 gt 4 b amp Done E W En Local intranet A Start aeng Workspace Lotus Notes le http tgacbr02 sime QJ Exploring User Document EY Microsoft Word SIME Ml cae 9 47 Fig 10 View Draft Licence Applications List Draft Licence This screen lists all the draft licence applications currently in the system List Clicking on a tracking number will open that application Read Only Tracking Number 1s created by the system once the application has been Fields saved or submitted It is a unique number which is attached to the application
45. Manufacturer Information System MIS 3 http tgacbr02 sime mis reposit nsf W ebApprovedCertifications 70 pen iew Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e gt 90 A a y Back Forward Stop Refresh Home Search Favorites History RNE Print EA Edit Address http tgacbr02 sime mis reposit nsf w ebApprovedCertifications 70 penView a SIME io View Approved Certifications Previous Next j Home Refresh Search Certification Number Manufacturers Name Received Approved 1M11 07062004 CE 000145 2 ETHICON ENDO SURGERY INC 07 06 2004 20 04 2004 1411 20042004 CE 000273 2 A C I BLOWPAK VICTORIA Australia 20 04 2004 20 04 2004 MI 13052004 CE 000011 1 ROCHE COLORADO CORPORATION 20 04 2004 20 04 2004 MI 13052004 CE 000012 1 HOE HIN PAK FAH YEOW MANUFA 20 04 2004 20 04 2004 MI 13052004 CE 000016 1 FERROSAN AS 20 04 2004 20 04 2004 MI 13052004 CE 000013 1 SMITHKLINE BEECHAM DUNGARY 20 04 2004 20 04 2004 MI 13052004 CE 000019 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 CE 000020 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 CE 000021 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 CE 000022 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 CE 000023 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 CE 000024 1 ETHICON ENDO SURGERY INC 20 04 2004 20 04 2004 MI 13052004 CE
46. Other Client Details Primary Site Secondary Site and Supporting Documents are as per New Licence Application but cannot be edited Fees and Payments is covered in the next section SIME MIS Lodgement User Guide v1 1 doc Page 38 TGA Online Services Manufacturer Information System MIS 3 Licence Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e gt 0 A a a 39 8 9 a Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address l http 4 tgacbr02 SIME MIS lodge nsf a50d63d6d7b24bdaca256e31007913c8 9ebedf60df303e58ca25be8a003d5b75 0penDocument Go Links A dl Hes Help SME _ Licence Application Close View Entire App j Withdraw New Draft Copy Home Applicant s Own Ref Status Submitted Tracking Number MI 29042004 LI 000382 2 Original Tracking Number MI 20042004 L1 000278 2 Migrated Record Application Client Details Primary Site Secondary Site Supporting Documents Fees and Payments Fees and Payment Fee 0 00 Payment Type Visa gi 2 Application loaded successfully Eb Local intranet Mstart A e O E Workspace Lotus Licence Applica BY Exploring Images _ BY Microsoft Word SI 47025 SIME_MiSsub LH sre 11 34 Fig 18 Submitted Application Fees amp Payments Fees amp This form displays the fees and payments information for a submitted Payments application
47. S lodge nsf Entry 0 penForm T ype CE Go Links a M SIME Te t New Certification Application Save J Close Validate View Entire App Submit Home Aplican Own Ret SS Status Draft Tracking Number Client Details Primary Site Supporting Documents Applicant Applicant Name Valued Client Client Id 9999999 Address Po Suburb State Postcode Country Phone Fax Evictina Manufacturar Mow Manufacturar Y Application loaded successfully le Localintranet Start 1e 0 Workspace Lotus Jj new Certificatio J Exploring User Do BY Microsoft Word Sl os SIME_MlISdecl it GON ADE 10 24 Fig 22 New Certification Application Application This form is used to complete a new certification application or a variation Details application for an existing approved certification Read Only Status is always Draft Pg 100 Fields Tracking Number is created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and 1s used for all future tracking of the application through the system The following fields are only displayed when creating a variation Current Tracking Number is the tracking number of the original application New Tracking Number 1s the new tracking number created for this variation application SIME MIS Lodgement User Guide v1 1 doc Page 48 TGA Online Services Manufac
48. TGA Online Services Manufacturer Information System MIS Department of Health and Ageing TGA Online Services Manufacturer Information System MIS Lodgement User Guide 3 13 5 A THERAFENTIE CHORES ADMINISTRA Online Services SIME MIS Lodgement User Guide v1 1 doc Page i TGA Online Services Manufacturer Information System MIS This Document Is under version control 28 07 2004 V1 0 Final Review 10 11 2004 Update to Pictures SIME MIS Lodgement User Guide v1 1 doc Page i TGA Online Services Manufacturer Information System MIS Table of Contents MANGE CRUG OI sooo aioe ons accesses A A dace eascscue ie ccsasaneceetaccucsstenouasusees 1 IAT OUI C LOU ir id Goad wens ee oy wees 1 Y O A et gerne de one ees 1 Who Should se Tins Mantilla E 1 HOWO USE TNS Manuales e a cd escu 1 PASSUMDUOINS rarse aa a a T Sade E a Ta Ta a eaaa Toa bania ta ati 1 tS perenne ee mers a a A a OE eee a Oe ee 1 Overview of the Manufacturer Information System ccccccccssssssssssscccccssssssssssccccsssesssssssccsseseees 2 Talore ble to AAA A e 2 CIEN TACOS ia linia 2 FUMING ACCES Sna A O A o Gt lel 2 Beneto ia wenden ales ances ct natin ase ec easiest io ee 2 Gettine Started italia 3 INTOdUCIO Nr ib vid 3 The TGA Online Services Home PAGS A ti 3 Accessing TGA Online Services SV Stems escerai riedia aes oxen veces ia 4 The TGA Online Services Web Environment sccccccsscccccssssccssssscccssssccccss
49. Tools Help Qu y Search Favorites History a 3 A Mail Print Edit ts Clearance Application Applicant s Own Ref Status Tracking Number Draft MI 01062004 CL 00021 7 2 Client Details Evidence APYProduct Details Applicant Applicant Name Client Id Address Suburb Postcode Phone Email Valued Client 9999999 PO Box 1234 Melbourne State VIC 3000 Country Australia Fax Application loaded successfully pos x EN Local intranet Mstart 4 8 168 gt QsIME Notes Home Clearance Appli A Exploring Images _ BY Microsoft Word SI 7030_SIME_MiSvie LP DAD EL 13 53 Draft Clearance Application Read Only Fields Editable fields Other El Fig 45 View Draft GMP Clearance Application This form is used to open an existing draft clearance application Status is always Draft Pg 100 Tracking Number is created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and is used for all future tracking of the application through the system The following fields are editable when creating an application or editing an existing draft application They become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that may help in identifying the application Client Detail
50. ances Instances where these navigation features will be nullified or changed in functionality will be advised at the appropriate point in the manual The TGA Online Services Home Page Control The TGA Online Services Home button is located in the top left of most pages in the system It consists of the SIME logo Use of this navigation control will return the user to the TGA Online Services home page Although the logo is present in the same location on every page in the system the functionality of the button 1s only activated on pages where 1t 1s sensible to allow users to return directly to the TGA Online Services home page On other pages such as those that are part of application forms this functionality is disabled to protect the integrity of information entered into the TGA Online Services interface un Help The System Help Button This button is located in the top right of all TGA Online Services pages Clicking on this button will open a new window with the appropriate help file for the page that the user is currently viewing Search The Search Button The search button is available when viewing lists of applications It provides the user with the ability to conduct searches based upon application number agent s information manufacturer s information etc Previous The Previous and Next Buttons These buttons will appear on pages that contain lists of applications that exceed a reasonable page le
51. application Change Details Status Indicator Pg 100 indicates to the system whether the variation 1s to change the details of the application to change its status SIME MIS Lodgement User Guide v1 1 doc Page 27 TGA Online Services Manufacturer Information System MIS Other Client Details Primary Site Secondary Site Supporting Documents and Status Pg 100 are as per New Licence Application SIME MIS Lodgement User Guide v1 1 doc Page 28 TGA Online Services Manufacturer Information System MIS View Draft Licence Applications 3 http tgacbr02 sime mis lodge nsf WebDraftLI 70 pen View Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help gt a Back Forward Stop Refresh Home Qu 3 Search Favorites History a oo Mail Print Edit Address E http tgacbr02 sime mis lodge nstWebDraftLI 70penView Go Links A SIME to View Draft Licence Applications Previous Next j Home j Refresh Search Tracking Number Manufacturer s Name A Primary Street Address Manufacturer s Own Reference MI 10062004 LI 000659 2 ABBOTT AUSTRALASIA PTYLTD PO BOX 12 1234 MI 10062004 L1 000656 2 ABBOTT AUSTRALASIA PTYLTD PO BOX 12 12345 MI 10062004 LI 000655 2 SUE AKEROYD amp ASSOC GARETH PO BOX 141 MI 03062004 LI 000625 2 FRA PRODUCTION FRAZ 3 MATTEO MATTUTINA 4 MI 03062004 LI 000623 2 FRA PRODUCTION STRADA DELLE POSTE 12 1234
52. articular combination of information supplied creates a breach of TGA business rules the application will fail validation If an application does fail validation detailed messages informing the user of the problem are displayed in a pop up dialog box Clicking on an error message displays the appropriate place in the application so that it can be corrected An application can not be submitted until it has passed validation The Delete Button This button is available when editing an application Clicking on the button displays a dialog box asking for confirmation of the delete Clicking on OK will permanently remove the application from the system Clicking on Cancel will return to the draft application with no action taking place The Submit Button This button is available when editing an application The button provides the user with a means to be able to submit the application to the TGA The system will automatically do a validation when an application is submitted thereby preventing invalid applications from being submitted The Vary Application Button This button is available when viewing approved applications Clicking on the button creates a new draft application initialised to the values of the current application Once finalised the new application will replace the old one The Create Request Button This button is available when viewing approved applications Clicking on the button creates a request fo
53. be browsed and attached A Remove Attachment button is also displayed which removes the attachment Clicking on the CV will open it in a new window Authorised For Release is the name of the person who is authorised to release SIME MIS Lodgement User Guide v1 1 doc Page 53 TGA Online Services Manufacturer Information System MIS Editable Fields Manufacturing Items Pg 99 continued Add 1s a button which when clicked on brings up a dialog box to enter the manufacturing item details Fields displayed are Manufacturing Type Sterility Manufacturing Class Dosage Form Product Category amp Manufacturing Step All fields can be populated from the drop down list or 1f it is a new item by typing in the details The Manufacturing Type selected refines what values are permitted for the remaining entries At least one Manufacturing Item must be entered Remove is a button which when clicked will remove unwanted items Each item listed has a checkbox in front of it which must be clicked first All items with a clicked checkbox are removed SIME MIS Lodgement User Guide v1 1 doc Page 54 TGA Online Services Manufacturer Information System MIS 3 New Certification Application Microsoft Internet Explorer provided by Health File Edit View Favoites Tools Hep 00 e gt 0319 a BG B 4G Y Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf Entry
54. ber The following field is only displayed when viewing a variation Original Tracking Number is the tracking number of the original application Other Client Details Evidence and API Product Details are as per New Clearance Application but cannot be edited SIME MIS Lodgement User Guide v1 1 doc Page 96 TGA Online Services Manufacturer Information System MIS View TGA Data View All TGA Data 3 http tgacbr02 sime mis reposit nsf W ebApprovedAll 70 pen View amp Start 1 amp Count 30 amp E xpand 1 5 Microsoft Internet Explorer provided File Edit View Favorites Tools Help Q a B 9 Ff Back Forverd Stop Refresh Home Mail Print Edit Address http tgacbr02 sime mis reposit nst WebApproved4ll 0 pen iewsS tart 1 amp Count 308E xpand 1 5 1 5 Qu 3 Search Favorites History SIME nee J Le View All TGA Data Previous J Hext J Home Refresh Search Manufacturers Name Site Address Status w Certification gt MI 13052004 CL 000007 1 Y MI 13052004 CL 000009 1 ROCHE COLORADO CORPORATION 2075 NORTH 55TH ST Active w Clearance gt MI 13052004 CL 000012 1 Y MI 13052004 CL 000016 1 FERROSAN AS SSYDMARKEN Active gt MI 13052004 CL 000019 1 gt MI 13052004 CL 000020 1 Licence Y MI 20042004 LI 000278 2 ACIBLOWPAK VICTORIA Australia 44 Active gt MI 13052004 CL 000024 1 gt MI 13052004 CL 000025 1 gt MI 13052004 CL 000028 1 gt MI 13052004 CL 000029 1 a
55. cations created by the user Certification currently logged in Clicking on a tracking number will open that application List Read Only Tracking Number is created by the system once the application has been Fields saved or submitted It is a unique number which is attached to the application and 1s used for all future tracking of the application through the system Manufacturer s Name is the name of the manufacturer associated with the application Primary Street Address is the first line of the primary site s address Manufacturer s Own Reference 1s the applicant s reference information that helps identify the application SIME MIS Lodgement User Guide v1 1 doc Page 60 TGA Online Services Manufacturer Information System MIS ES Certification Application Microsoft Internet Explorer provided by Health TT File Edit View Favorites Tools Help 7 7 Y a E ala a alp Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf 559644e1b256b8b5ca256e3f0077fedf 1344a5b3da5f6f54ca256e8c0019c7b1 70penDocument Go Links A hia eee n da j El S ME Help t Certification Application Edit J Close 2 View Entire App New Draft Copy Home J Applicant s Own Ref 123456789 Status Draft Tracking Number MI 06052004 CE 000138 2 Client Details Primary Site Supporting Documents Applicant Applicant Name Valued
56. cence application 1 2 3 4 Click on View Draft Licence Applications on the Manufacturers Application Lodgement home page Pg 10 A list of all the draft applications currently in the system will be displayed Pg 29 To view the application click on its Tracking Number If the number of applications exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required application using the Search button Once the application has been displayed it can be changed by clicking on the Edit button Pg 15 The application will be opened in edit mode and the changes can be made Save the changes by clicking on the Save button To input the application details 1 2 3 The application form 1s divided into a number of individual pages When first displaying the form the Client Details Pg 17 page 1s shown Clicking on the other page buttons will open them for editing The other individual pages include Primary Site Pg 19 Secondary Site 22 and Supporting Documents Pg 24 All fields marked with a red star are mandatory and must be entered To view and print an application 1 2 To view the entire application click on View Entire App A new window will open which shows the full application in a printer friendly view Clicking on Print will print out the full application SIME MIS Lodgement U
57. cking Number MI 07062004 CE 000145 2 New Tracking Number MI 12072004 CE 000155 2 x Change Status Client Details Status Applicant Details Applicant Name Valued Client Client Id 9999999 Address PO Box 1234 Suburb Melbourne State i Postcode 3000 Country Australia Phone Fax Email Staff email com Manufacturer Details Current Manufacturer E Variation loaded successfully piz z ES Local intranet Start ends al Workspace Lotus 3 Exploring DEAL Tra BY Microsoft Word SI Variation Licene untitled bmp Paint Sao 10 13 Fig 27 Variation Application Application This form is used to create a variation certification application Details Read Only Status 1s always Draft Pg 100 Fields Current Tracking Number is the tracking number of the original application New Tracking Number is the new tracking number created for this variation Editable fields The following fields are editable when creating a variation They become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that may help in identifying the application Change Details Status Indicator Pg 100 indicates to the system whether the variation 1s to change the details of the application to change its status SIME MIS Lodgement User Guide v1 1 doc Page 58 TGA Online Services Manufacturer I
58. clicked checkbox are removed SIME MIS Lodgement User Guide v1 1 doc Page 80 TGA Online Services Manufacturer Information System MIS 3 New Clearance Application Microsoft Internet Explorer provided by Health File Edt View Favorites Tools Help e gt 0 N Ga RB 3 a Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf Entry 0 penForm amp T ype CL Go Links Client Details Evidence APW Product Details API Product 4PI Name Manufacturing Steps gt El a loaded ue E Local intranet o AStar 4 S 160 QsIME Notes Home New Clearance Gy Exploring Images BY Microsoft Word SI Fquntited Paint SDM are 1243 Fig 41 Clearance Application API Product Details API Product This form is used to input the API or Product details associated with the Details clearance application SIME MIS Lodgement User Guide v1 1 doc Page 81 TGA Online Services Manufacturer Information System MIS Editable Fields API Product 1s a radio button selection which indicates whether the details being provided are for an API or Product API Only displayed if API Product indicator is API Add 1s a button which when click on brings up a dialog box whereby the API details can be entered Fields displayed are APJ Name amp Manufacturing Step All fields are mandatory API Name is an editable fie
59. cument can be browsed and attached At least one electronic or paper document see below must be entered Clicking on a document will open the document in a new window Remove Attachment is a button which when clicked on can be used to remove unwanted attachments Each attachment listed has a checkbox in front of it which must be clicked first All attachments with a clicked checkbox are removed SIME MIS Lodgement User Guide v1 1 doc Page 79 TGA Online Services Manufacturer Information System MIS Editable Fields Evidence Indicator is a radio button selection which indicates whether the continued evidence 1s provided by the applicant or whether the applicant is requesting that 1t be obtained by the TGA Evidence Add is a button which when clicked on brings up a dialog box whereby the document details can be entered Fields displayed are Document Type Document Number Date Of Last Inspection amp Document Expiry All fields are mandatory Document Type can be selected from a drop down list or typed in Method of Submission 1s selected by choosing one of the available radio buttons Fax Post Courier A convenient click on calendar has been included in the dialog box for Date Sent At least one support see above or evidence document must be entered Remove 1s a button which when clicked on can be used to remove unwanted entries Each entry listed has a checkbox in front of 1t which must be clicked first All entries with a
60. d by the system once the application has been saved or submitted It is a unique number which is attached to the application and is used for all future tracking of the application through the system Once an application 1s approved it becomes the licence number The following field is only displayed when viewing a variation Original Tracking Number is the tracking number of the original application Other Client Details Primary Site Secondary Site and Supporting Documents are as per New Licence Application but cannot be edited SIME MIS Lodgement User Guide v1 1 doc Page 41 TGA Online Services Manufacturer Information System MIS Create Declaration 3 Declaration Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e 0 Ala ua 3 39 Ya Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf Declaration 0penF orm Go Links A 140 28 SIME e Declaration Print Preview Home J Certification in Relation to Persons Involved with the Applicant for a Licence to Manufacture Therapeutic Goods and Other Persons Australian Manufacture tC A Valued Client hold the position of Chairman z in Please enter the name of your company at Please enter your address understand that the certification below is made for the purpose of assisting the Secretary of the Commonwealth Department of Health and Age
61. de v1 1 doc Page 66 TGA Online Services Manufacturer Information System MIS 3 Certification Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 2 gt 9 04 a GiB 83 M Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf cb6369094271 289bca256e3f007b0c2b 231 9a66fd76ca61 2ca256e8c0003cc60 0 penD ocument 2 Go Links a Hes pan S Help Certification Application Close View Entire App Withdraw New Draft Copy Home Applicant s Own Ref Status submitted Tracking Number MI 06052004 CE 000136 2 Client Details Primary Site Supporting Documents Fees and Payments Fees and Payment Fee 100 20 Payment Type Cheque El 2 Application loaded successfully Es Local intranet Start ede al Workspace Lotus E Certification Ap G Exploring Images BY Microsoft Word SI 2 023 SIME_MISsub SAMA 11 28 Fig 35 Submitted Application Fees amp Payments Fees amp This form displays the fees and payments information relating to the Payments application It is only displayed while the application is in submit status Read Only Fee is the amount due or paid for the application Fields Payment Type is the method of payment SIME MIS Lodgement User Guide v1 1 doc Page 67 TGA Online Services View Approved Certifications
62. e Application Save J Close Validate Delete J Submit Home Applicant s Ref status Draft Current Tracking Number Ml 20042004 LI 000278 2 New Tracking Number MI 24062004 L1 O0066 2 Change Details Change Status Client Details Status select new status Suspend Cancel Re activate Description El l Variation loaded successfully pa 53 ES Local intranet Start ends al Workspace Lotus E Variation Licenc 3y Exploring User Do BY Microsoft Ward SI E Document Licence SUD 11 46 Fig 8 Licence Application Status Status This form is used to indicate the change in status required to the current licence Editable Fields Select New Status Pg 100 is a radio button option to select the status that is required Description is a general comment as to why the change to the status is required and any additional information that may be relevant SIME MIS Lodgement User Guide v1 1 doc Page 26 TGA Online Services Manufacturer Information System MIS Variation Licence Application ES Variation Licence Application Microsoft Internet Explorer provided by Health File Edit View Favoites Tools Hep 0 E e gt 0319 a JB 4G Fg Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf 0 7037EE SFEBCS69CDCA256E CFO000091 97E ditD ocument Go Links A ME Help J SIM
63. e the remaining address details associated with the first line of address that was selected SIME MIS Lodgement User Guide v1 1 doc Page 52 TGA Online Services Manufacturer Information System MIS Editable Fields Primary Site Details Site Indicator is a radio button selection to indicate whether the site has already been registered for this manufacturer or is new Existing Site Street Address is the first line of the primary address If there is more than one address available a drop down list is displayed so that the correct one can be selected New Site Street Address Suburb State Post Code amp Country are the address details of the primary site Contact Details Contact Name is the name of the contact person Phone Fax amp Mobile are the contact details of the contact person Email is the contact person s email address Quality Control is the name of the person in charge of quality control CV Attachment is the CV of the person in charge of quality control An Add Attachment button 1s displayed which brings up a dialog box whereby the CV can be browsed and attached A Remove Attachment button is also displayed which removes the attachment Clicking on the CV will open it in a new window Production 1s the name of the person in charge of production CV Attachment is the CV of the person in charge of quality control An Add Attachment button 1s displayed which brings up a dialog box whereby the CV can
64. e413b3d9ca256e6d00168336 ced24f4558 22405ca256ea8001 7d32370 penD ocument Go Links A TT SIME os Clearance Close View Entire App Vary Application Create Request New Draft Copy Home 2 2 2 2 y 2 Applicant s Own Ref Status Active Tracking Number Ml 13052004 CL 000007 1 Migrated Record Application Client Details Evidence APYProduct Details Sponsor Name Bio Stuff Pty Ltd Client Id 1111111 Address Research Institute Suburb Sydney State NSW Postcode 2000 Country Australia Phone Fax Email jii Application loaded successfully a Localintranet A Start Ae 0 SIME Notes Home f Clearance Mic AJ Exploring Images BY Microsoft Word SI 033 SIME_MISapro CERES 15 28 Fig 53 Approved GMP Clearance Approved This form is used to view an approved clearance No changes can be made Clearance but if changes are required a variation application to the clearance can be created Read Only Applicant s Own Refis the applicant s own reference information that may Fields help in identifying the application Status Pg 100 shows the current status of the application Tracking Number is created by the system once the application has been saved or submitted It is a unique number which is attached to the application and is used for all future tracking of the application through the system Once an application is approved it becomes the clearance num
65. ed Client Client Id 9999999 Address PO Box 1234 Suburb Melbourne State VIC Postcode 3000 Country Australia Phone Fax Email Staff email com x Existing Manufactuer New Manufacturer a l Application loaded successfully B al Eu Local intranet Asue 4 A DO gt Ewona Lous fe certication Ap EJ Esplino Imeges__ BY Mirosot Word 9 022 5IME Miss QUags 11 27 Fig 34 View Submitted Certification Application Submitted This form is used to view an application that has been submitted No changes Certification can be made to the application If changes are required the application must Application be withdrawn and a new draft copy created Read Only Applicant s Own Ref is the applicant s own reference information that may Fields help in identifying the application Status Pg 100 1s the current status of the submission within the system Tracking Number is created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and 1s used for all future tracking of the application through the system The following field is only displayed when viewing a variation Original Tracking Number 1s the tracking number of the original application Other Client Details Primary Site and Supporting Documents are as per New Certification Application but cannot be edited Fees and Payments 1s covered in the next section SIME MIS Lodgement User Gui
66. ed by the user Certification currently logged in and their status Clicking on the status will open that List application Read Only Status Pg 100 shows the current status of the application Fields Tracking Number 1s created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and is used for all future tracking of the application through the system Manufacturer s Name is the name of the manufacturer associated with the application Primary Street Address 1s the first line of the primary site s address Received is the date the application was received SIME MIS Lodgement User Guide v1 1 doc Page 65 TGA Online Services Manufacturer Information System MIS ES Certification Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 2 gt 9 0 2 a 9 8 9 Y Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf cb6369094271289bca256e3f007b0c2b 2319a66fd76ca612ca256e8c0003cc 0 0penDocument Go Links A a Y SIME Help to Certification Application Close View Entire App Withdraw New Draft Copy Home Applicant s Own Ref 123456789 Status submitted Tracking Number MI 06052004 CE 000136 2 Client Details Primary Site Supporting Documents Fees and Payments Applicant Applicant Name Valu
67. eque must be made payable to and where to send it Editable Fields Payment Type indicates the payment type Values are Cheque Visa Bank Card amp Mastercard Cheque No Only displayed if Payment Type is CHEQUE Number of the cheque beeing sent as payment Bank Only displayed if Payment Type is CHEQUE Editable field Name of the bank the cheque has been drawn on SIME MIS Lodgement User Guide v1 1 doc Page 63 TGA Online Services Manufacturer Information System MIS 3 Submitting a Certicate Web Page Dialog This document will be a tax invoice for GST when you make payment Please read the information below regarding your payment and ensure itis true and correct Application Details Tracking Number MI 04052004 CE 0001352 2 Application For Applicant s Own Reference 1265 23 Applicant s Details Manufacturer Name Another Company Pty Ltd Manufacturer ID 999995 Contact Details Contact Name Valued Client eee Contact Email Staff email com Phone OO Fax El 2 Previous Next gt gt Cancel Fig 32 Tax Invoice Tax Invoice This form is used to create a tax invoice for a certificate to manufacture therapeutic goods The form must after completion be printed and one copy sent to TGA Read Only All Fields Except Card Details Populated from the contents of the Fields application This form is the Tax Invoice for GST once payment has been made The details must be read to ensure i
68. er or Applicant Controller controlled either directly or indirectly through one or more interposed entities at the time the offence was committed or the time of the conviction c there has been no failure to comply with a condition of a manufacturing licence or conformity assessment certificate however described by the Applicant or any other person who controls the Applicant or Applicant Manager or Applicant Controller either directly or indirectly through one or more interposed entities or any person whom the Applicant or I controlled either directly or indirectly through one or more interposed entities at the time of the failure Optional further information I wish to volunteer the following information about the applicant or other persons to assist the Secretary in determining the application for a licence to manufacture therapeutic goods I hereby declare that the above information is true and correct Signature Witnessed by Date Signature Date Note Giving false or misleading information is a serious offence F ja W En Local intranet A Start ende Workspace Lotus E Declaration Mi 3 Exploring User Do BY Microsoft Word SI untitled Paint SQUAD Es 10 05 Fig 21 Create Declaration Form Create This form is used to create a declaration for a licence to manufacture Declaration therapeutic goods The form must after completion be printed signed and one copy sent
69. he first line of address that was selected SIME MIS Lodgement User Guide v1 1 doc Page 19 TGA Online Services Manufacturer Information System MIS Editable Fields Blood Component is a radio button selection which indicates whether the application 1s for the collection of blood components or not Site 1s a radio button selection to indicate whether this is a primary or secondary site These buttons are only displayed if Blood Component was set to Yes Primary Licence No 1s the licence number of the primary site Only displayed if Blood Component was set to Yes and Site 1s set to Secondary Site Primary Site Details Site Indicator is a radio button selection to indicate whether the site currently exists in the system or is new Existing Site Street Address is the first line of the primary address If there is more than one address available a drop down list is displayed so that the correct one can be selected New Site Street Address Suburb State Post Code amp Country are the address details of the primary site This must be a street address Contact Details Contact Name is the name of the contact person Phone Fax amp Mobile are the contact details of the contact person Email is the contact person s email address Quality Control is the name of the person in charge of quality control CV Attachment is the CV of the person in charge of quality control An Add Attachment button is
70. ia eee ae a te E 90 View Submitted GMP Clearance Applications 91 Submitted Clearance Eis a at 91 Submitted Clearance AppliCatiON ccoocccccccnccocnncccnnnoncnnonnnonocnnnncnnonnnnnonnnonnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnns 92 Foes Ml ie eet ot ead 94 View Approved GMP Clearances 95 Approved ClearanGes List atada ltd dd tilde 95 Ao O AAA a a aa tt lee eee a hela 96 VIEWTIGA Dti E 97 View All TGA Data 97 View al GA data iii A be hades Seer aslo ier a ee este 97 TFOUDICSHOOUING cesicvicicesestesscrarecteicesdesusesvsddeavesdevwsliveckersesdssusssendsesseedsussioeadsesshebesseesendtessoetecueasesasswasevees 98 am unable to access my Work area homepage ccccceecceeeeeeceeeeceeeeeeeeseeeeeeeeeeseeeeseeeesseeeeaeeeeseeeeseeeesaaees 98 lamunable Oath a Me esie a cmaciassaadned isa ai id 98 APPENDIX A Manufacturing Hed scccssscsiscctsiessnsevesssoncessteusssesccalevctansatiuicnsevesancnssseaceadsevscesabauseoes 99 Manttaciurina tems DI a a e a 99 APPENDIX B Status COS e A NN ETEN E A 100 Brat AppliCatlOnS see eet o ot e et od 100 SUDMIbeCvAD DIICALIONS sos E E 100 APPO FD MECANO Sa casas 100 SIME MIS Lodgement User Guide v1 1 doc Page iv TGA Online Services Manufacturer Information System MIS Introduction Overview Who Should Use This Manual How to Use This Manual Assumptions Help Introduction Welcome to the Therapeutic Goods Administration TGA TGA Online Services system Th
71. ing or her delegate to consider whether the applicant yA Valued Client or a licence to manufacture theraputic goods the Applicant persons who participate in or are likely to participate in managing the Applicant s affairs Applicant Managers and persons who have or are likely to have effective control over the Applicant Applicant Controllers are fit and proper persons for the purposes of section 38 of the Therapeutic Goods Act 1989 an extract of which is attached I hereby certify that a there has been no suspension or revocation of a manufacturing licence or conformity assessment certificate however described issued to the Applicant any Applicant Manager or Applicant Controller any other person who controls the Applicant or any Applicant Manager or Applicant Controller either directly or indirectly through one or more interposed entities or any person whom the Applicant or any Applicant Manager or Applicant Controller controlled either directly or indirectly through one or more interposed entities at the time of the suspension or revocation bj there has been no conviction for an offence against a law of the Commonwealth a State or Territory against the Applicant or any Applicant Manager or Applicant Controller or other person who controls the Applicant or the Applicant Manager or Applicant Controller either directly or indirectly through one or more interposed entities or any person whom the Applicant or Applicant Manag
72. is system has been developed to provide the customers of TGA services with an easy and modern way of conducting business with TGA There are a number of sub systems within the TGA Online Services system that provide an electronic interface for many of the business units within TGA This document is a reference guide for the Manufacturer Information System MIS a sub component of the TGA Online Services System It outlines the MIS sub system and provides external customers with instructions for using the system This document is a reference guide for the use of TGA customers particularly Agents Manufacturers and Sponsors of Licence Applications GMP Certifications and GMP Clearances This manual has been written for users to view it alongside the Manufacturer Information System web site to maximise the value of its information There are three main chapters that cover Licence GMP Certification and GMP Clearance applications Each of these chapters is designed to be utilised individually so users can focus on specific types of applications as needed Other parts of this manual cover details that are generic to the whole MIS such as navigation and help features It is assumed that users are familiar with mouse skills and have a basic knowledge of the Web environment Some Web terminology is explained for users in the Navigation Section of this manual Help is available for all TGA Online Services systems For the variou
73. ived SIME MIS Lodgement User Guide v1 1 doc Page 91 TGA Online Services Manufacturer Information System MIS 3 Clearance Application Microsoft Internet Explorer provided by Health 7 08 AJ a G B 9 Y Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf 463b338b6200c3d6ca256e31007b27e9 5dcd95f8963671 afca25beaf001d1316 0penDocument Go Links A a M SIME t Clearance Application Close J View Entire App Withdraw New Draft Copy Home Applicant s Own Ref 4Migration Status Provisionally Submitted Tracking Number Ml 10062004 CL 000253 2 Client Details Evidence API Product Details Fees and Payments Applicant Applicant Name Valued Client Client Id 9999999 Address PO Box1234 Suburb Melbourne State IC Postcode 3000 Country Australia Phone Fax Email Staff email com Sponsor x Application loaded successfully E Local intranet Start 1e 0 gt SIME Notes Home Ctearance Appli 3 Exploring Images BY Microsoft Word SI 2 032_5IME_MISsubli CERERE 13 57 Fig 50 View Submitted GMP Clearance Application Submitted This form is used to view an application that has been submitted No changes Clearance can be made to the application If changes are required the application must Application be withdrawn and a new draft copy created Read Only Applicant s O
74. ld that must be typed in Manufacturing Step can be typed in or selected from a drop down list At least one API must be entered Remove 1s a button which when clicked on can be used to remove unwanted entries Each entry listed has a checkbox in front of 1t which must be clicked first All entries with a clicked checkbox are removed Product Details Only displayed if API Product indicator is Product Add 1s a button which when clicked on brings up a dialog box to enter the product details Fields displayed are Manufacturing Type Sterility Manufacturing Class Dosage Form Product Category amp Manufacturing Step All fields can be populated from the drop down list or 1f it is a new product by typing in the details The Manufacturing Type selected refines what values are permitted for the remaining entries At least one API must be entered Remove 1s a button which when clicked on can be used to remove unwanted entries Each entry listed has a checkbox in front of 1t which must be clicked first All entries with a clicked checkbox are removed SIME MIS Lodgement User Guide v1 1 doc Page 82 TGA Online Services Manufacturer Information System MIS ES Yariation Clearance Application Microsoft Internet Explorer provided by Health 2 gt 9Bg 92 a G B 9 Y Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf 0 CA256DFD000019C4CA25
75. line Services Manufacturer Information System MIS View Submitted Licence Applications 3 http tgacbr02 SIME MIS lodge nsf wW ebS ubmittedLI70 pen View amp Start 91 Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 2 gt 9 Ga ua IBIM Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address A http 7tgacbr02 SIME MIS lodge nsf ebS ubmittedLl 70 penViewsStart 91 2 Go Links A d o pinne mos TP Epey a SIME t View Submitted Licence Applications Previous Next j Home j Refresh Search Status Tracking Number Manufacturer s Name Primary Street Address Received Active MI 20042004 LI 000273 2 AC IBLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 L1 000278 2 A CIBLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 L1 000273 2 A CIBLOWPAK VICTORIA Australia 44 20 04 2004 Submitted MI 05052004 L1 000444 2 ANTHOEYR INSTRUMENTATION DENTAIRE France qlq1 05 05 2004 Under Review 1I1 05052004 L1 900007 2 BULLIVANTS NATURAL HEALTH PRODUCTS PTY LIMITED Australia 87 YARRAMAN PLACE 05 05 2004 Under Review MI 05052004 LI 900006 2 BULLIVANTS NATURAL HEALTH PRODUCTS PTY LIMITED Australia 87 YARRAMAN PLACE 05 05 2004 Submitted 1II 05052004 MTLI 000002 2 A C I BLOWPAK VICTORIA Australia 44 20 04 2004 Active MI 20042004 LI 000273 2 ACIBLOWPAK VICTORIA Australia 44
76. ll then exit to the Manufacturers Application Lodgement home page 2 To exit without saving any changes made to the currently displayed page click on Home Control will be returned to the Manufacturers Application Lodgement home page To validate an application 1 Once all the data has been entered into the form the application should be validated by clicking on Validate 2 Any errors will be listed on the screen via a dialog box Clicking on an error displays the corresponding place in the application so that 1t can be corrected 3 All applications must pass validation successfully before they can be submitted To submit an application 1 To submit an application you must be in edit mode Click on the Submit button 2 All applications are automatically validated and if errors are found a dialog box will be displayed listing the errors Clicking on an error will position the application in the appropriate place so that it can be corrected 3 When submitting an application a dialog box appears requesting a further two steps be actioned Pg 62 as follows e Step 1 Fees and Payments Pg 63 e Step 2 Tax Invoice Pg 64 Click on the Continue button to continue 4 Fees and Payments Pg 63 The cost of the application is displayed and an option to select a method of payment If the cheque option 1s taken then the cheque number and the bank must be entered 5 Tax Invoice Pg 64 A
77. lorer provided by Health gt 90g a a DGB 3M Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr05 sime mis reposit nsf 7de21 3785357ecadca256e75001 1337 1 9a584b75a605260ca256eb70023c26F70 penD ocument 2 Go Links TT SIME DO e Les Licence Close View Entire App Vary Application Create Request New Draft Copy Home 2 2 2 2 y 2 Applicant s Own Ref Licence Application 1 Status Active Tracking Number Ml 18062004 LI 000523 5 Client Details Primary Site Secondary Site Supporting Documents x Existing Manufactuer New Manufacturer Existing Manufacturer Manufacturer Name Another Company Pty Ltd Client Id 426 Client ABN Address Suburb State Postcode Country E Application loaded successfully Po 24 m Eg Local intranet A Start A amp B Welcome Lotus Notes 3 Exploring Images BY Microsoft Word SIME MI E Licence Microsoft l SQUAD Es 13 50 Fig 20 Approved Licence Approved This form is used to view an application that has been approved No changes Licence can be made but 1f changes are required a variation application can be created Read Only Applicant s Own Ref is the applicant s own reference information that may be Fields useful in the client s identification of their application Status Pg 100 shows the current status of the application Tracking Number is create
78. ly accessible Security will be applied to most of the TGA Online Services system beyond this point based upon the access that users have been granted Only users who are formally registered with TGA as an Agent Manufacturer or a Sponsor will be able to access protected MIS data SIME MIS Lodgement User Guide v1 1 doc Page 3 TGA Online Services Manufacturer Information System MIS Accessing TGA Access to the individual systems is via the TGA Online Services Home Page eri 1 Navigate to the TGA Online Services Home Page at the URL above 2 Click on the Manufacturers link 3 The client will be asked to login entering an appropriate username and password as provided by the TGA A new user should click on the New User link for information on how to apply to the TGA for access 4 The Manufacturers Application Lodgement home page will be displayed SIME MIS Lodgement User Guide v1 1 doc Page 4 TGA Online Services Manufacturer Information System MIS The TGA Online Services Web Environment Navigation Introduction The TGA Online Services system is designed to be easy to use TGA Online Services looks and works like many other prominent web based applications but it is useful to know and understand the function of the controls within the TGA Online Services web pages particularly those used for navigation The information regarding these navigation controls applies in the majority of circumst
79. ment details must be entered on the Tax Invoice see below Card details are NOT kept on the system Read Only Fees contains the fee applicable for the type of application Fields Payable Mail To are the details of who the cheque must be made payable to and where to send it Editable Fields Payment Type indicates the payment type Values are Cheque Visa Bank Card amp Mastercard Cheque No Only displayed if Payment Type is CHEQUE Number of the cheque beeing sent as payment Bank Only displayed 1f Payment Type is CHEQUE Editable field Name of the bank the cheque has been drawn on SIME MIS Lodgement User Guide v1 1 doc Page 89 TGA Online Services Manufacturer Information System MIS 3 Submitting a Yariation for a Clearance Web Page Dialog This document will be a tax invoice for GST when you make payment Please read the information below regarding your payment and ensure itis true and correct Application Details Tracking Number MI 03062004 CL 000223 2 Application For Applicant s Own Reference Applicant s Details Manufacturer Name Manufacturer ID Contact Details Contact Name Client Contact Contact Email wdwodgd Phone Fax lt lt Previous Next gt gt Cancel Fig 48 Tax Invoice Tax Invoice This form is used to create a tax invoice for a clearance application The form must after completion be printed and one copy sent to TGA Read Only All Fields Except Card
80. n Vary Application The new application once finalised by the TGA will cause the details to be updated on the Licence If you want to create a brand new application based on the same details of the current record then use the New Draft Copy option SIME MIS Lodgement User Guide v1 1 doc Page 14 TGA Online Services Manufacturer Information System MIS New Licence Application 3 New Licence Application Microsoft Internet Explorer provided by Health 2 gt 90Bg 92 a G B 9 Y Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 5IME MIS lodge nsf Entry 0 penForm amp T ype Ll Go Links SIME t New Licence Application Save J Close Validate View Entire App Submit Home Aplican Own Ree A Status Draft Tracking Number Client Details Primary Site Secondary Site Supporting Documents Applicant Name Valued Client Client Id 9999999 Address Po Suburb State Postcode Country Phone Fax Evictina Manufacturar Naw Manufacturar zi E Application loaded successfully aa iz ia ES Local intranet A Start A Fl amp SIME Help Generic New Licence A 3 Exploring Images BY Microsoft Word Si Y untitled Paint it CON 15 39 Fig 3 New Licence Application Application This form is used to complete a new licence application or a variation to an Details exis
81. nd forwards Alternatively search for the required application using the Search button Once the application has been displayed 1t can be changed by clicking on the Edit button The application will be opened in edit mode and the changes can be made Save the changes by clicking on the Save button To input the application details 1 2 3 The application form 1s divided into a number of individual pages When first displaying the form the Client Details page 1s shown Pg 76 Clicking on the other page buttons will open them for editing The other individual pages include Evidence Pg 79 and API Product Details Pg 81 All fields marked with a red star are mandatory and must be entered To view and print an application 1 2 To view the entire application click on View Entire App A new window will open which shows the full application in a printer friendly view Clicking on Print will print out the full application SIME MIS Lodgement User Guide v1 1 doc Page 70 TGA Online Services Manufacturer Information System MIS Draft Applications continued Applications To save save and close or to exit without saving 1 To save an application without exiting click on Save Clicking on Close will also save the application but will then exit to the Manufacturers Application Lodgement home page 2 To exit without saving any changes made to the curre
82. nformation System MIS Other Client Details Primary Site Supporting Documents and Status Pg 100 are as per New Certification Application SIME MIS Lodgement User Guide v1 1 doc Page 59 TGA Online Services Manufacturer Information System MIS View Draft Certification Applications 3 http 7 tgacbr02 SIME MIS lodge nsf W ebDraftCE 0penYiew Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e 0 Ala u 3 39 M Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address A http tgacbr02 SIME MIS lodge nsf WebDraftCE 70 penView v 2 Go Links a e TR T A ld S ME e t View Draft Certification Applications Previous Next j Home Refresh Search Tracking Number Manufacturer s Name Primary Street Address Manufacturer s Own Reference MI 06052004 CE 000138 2 VALLEYLAB AUSTRALIA PTY LTD T A TYCO HEALTHCARE PO BOX 12 1234 MI 04052004 CE 000132 2 HILTON HEALTHSTREAM PTY LTD STRADA DELLE POSTE 12 14345 MI 29042004 CE 000130 2 R P SCHERER HOLDINGS PTY LTD FRAZ 5 MATTEO MATTU Previous Next j Home j Refresh Done fas oa za En Local intranet A Start Ae 0680 Workspace Lotus http tgacbr02 3 Exploring Images BY Microsoft Word SI 2 017_SIME_MISsup SONAS 11 18 Fig 28 View Draft Certifications List Draft This screen lists all the draft certification appli
83. ng User BY Microsoft Word 27 016_SIME_MI SDE 1049 Fig 23 Certification Application Client Details Client Details This form is used to input the client details Read Only Applicant s Name 1s the name associated with the user currently signed in Fields Client Id 1s the id of the applicant as recorded in TGA s Client System Suburb State Post Code Phone amp Fax are the remaining address details associated with the first line of address that was selected Editable Fields Address is the first line of the applicant s address associated with the user currently signed in If there is more than one address a drop down list is displayed so that the correct one can be selected Email is the applicant s email address Manufacturer Indicator is a radio button selection to indicate whether the manufacturer has already been registered with the TGA or 1s new SIME MIS Lodgement User Guide v1 1 doc Page 50 TGA Online Services Manufacturer Information System MIS Editable Fields Existing manufacturer continued Search 1s a facility to search on all or part of the manufacturer s name A separate dialog box pops up in which the search criteria can be entered A list of matches are then displayed from where the required manufacturer can be selected Client Id 1s the client number of the manufacturer selected New Manufacturer Client Name 1s the name of the manufacturer Address Suburb State Post Code am
84. ngth They allow the user to navigate forwards or backwards through the list Next SIME MIS Lodgement User Guide v1 1 doc Page 5 TGA Online Services Manufacturer Information System MIS Home Refresh Close View Entire App New Draft Copy Withdraw Edit Save The Home Button The home button 1s different from the TGA Online Services Home button It will appear in application forms and at the top and bottom of list pages Clicking on this button will return the user to the Manufacturers Application Lodgement home page The Refresh Button The refresh button is available when viewing lists of submitted or approved applications It provides the user with the ability to refresh the details being displayed on the current screen The Close Button The close button is available when viewing or editing an application When viewing it returns control to the previous list screen In edit mode it saves any changes made to the application and returns to the Manufacturers Application Lodgement home page The View Entire Application Button This button is available when viewing an application in detail through the individual pages of an application form Clicking this button will display the entire application in a dialog box in a printer friendly format which can be printed by clicking on the Print button The New Draft Copy Button This button is available when viewing an application in detail
85. nline Services Manufacturer Information System MIS 3 New Clearance Application Microsoft Internet Explorer provided by Health lt e Q9 01402 a 3 8 A Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr027 SIME MIS lodge nsf Entry 0 penForm amp T ype CL Go Links Client Details Evidence APWYProduct Details Is this application in Yes CNo S31 Reference Number O response to a 531 request Supporting Documents Attached Documents Add Attachment Remove Attachment Evidence provided TGA to obtain evidence Document Type Document Number Last Inspection Expiry Date a Remove al l Application loaded successfully ES En Local intranet Star 4 8 16 gt O SIME Notes Home New Clearance GY Exploring Images 7 Microsoft Word SI 47 028 SIME_MiSevid PD ADE 12 37 Fig 40 Clearance Application Evidence Evidence This form is used to attach the evidence documents associated with the application Editable Fields 37 Request is a radio button selection which indicate whether or not the application is in response to a S31 request from the TGA S31 Reference Number Only displayed if S31 Indicator is YES To be completed with the number on the request received from the TGA Supporting Documents Add Attachment is a button which when clicked on brings up a dialog box whereby the do
86. nt application To withdraw an application 1 2 3 4 Click on View Submitted Certification Applications on the Manufacturers Application Lodgement home page Pg 10 A list of all the submitted applications currently in the system will be displayed Pg 65 The first column 1s the applications status Pg 100 which indicates the progress of the application To view the application click on its Status Pg 66 Click on Withdraw to withdraw the application A dialog box will pop up asking for confirmation of the withdrawal Click on OK to continue The status of the application will be changed to Pending Withdrawal Pg 100 To view an approved certification 1 2 Click on View Approved Certifications on the Manufacturers Application Lodgement home page Pg 10 Alternatively click on View All TGA Data Pg 97 then select Certifications A list of all the approved certifications currently in the system and owned by the user will be displayed Pg 68 To view the certification click on its Certification Number Tracking Number Pg 69 If the number of certifications exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required certification using the Search button To vary a certification 1 Approved certifications cannot be changed They can however have their status changed by clicking on Vary A
87. ntly displayed page click on Home Control will be returned to the Manufacturers Application Lodgement home page To validate an application 1 Once all the data has been entered into the form the application should be validated by clicking on Validate 2 Any errors will be listed on the screen via a dialog box Clicking on an error displays the corresponding place in the application so that 1t can be corrected 3 All applications must pass validation successfully before they can be submitted To submit an application 1 To submit an application you must be in edit mode Click on the Submit button 2 All applications are automatically validated and if errors are found a dialog box will be displayed listing the errors Clicking on an error will position the application in the appropriate place so that it can be corrected 3 When submitting an application a dialog box appears Pg 88 requesting a further two steps be actioned as follows e Step l Fees and Payments Pg 89 e Step 2 Tax Invoice Pg 90 Click on the Continue button to continue 4 Fees and Payments Pg 89 The cost of the application 1s displayed and an option to select a method of payment If the cheque option 1s taken then the cheque number and the bank must be entered 5 Tax Invoice Pg 90 A tax invoice is displayed with details taken from the application It must be checked to ensure it is correct After clicking
88. nufacturers Application Lodgement home page Pg 10 A list of all the submitted applications currently in the system will be displayed Pg 91 The first column 1s the applications status Pg 100 which indicates the progress of the application To view the application click on its Status Pg 92 Click on Withdraw to withdraw the application A dialog box will pop up asking for confirmation of the withdrawal Click on OK to continue The status of the application will be changed to Pending Withdrawal Pg 100 To view an approved clearances 1 2 Click on View Approved Clearances on the Manufacturers Application Lodgement home page Pg 10 Alternatively click on View All TGA Data Pg 97 then select Clearances A list of all the approved clearances currently in the system and owned by the user will be displayed Pg 95 To view the clearance click on its Clearance Number Tracking Number Pg 96 If the number of clearances exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required clearance using the Search button To Vary a clearance 1 2 Approved clearances cannot be changed They can however have their status changed by clicking on Vary Application This option is used Suspend Cancel or Re activate a clearance A new draft application is created which when finalised by the TGA will result in the
89. o identify the application The following fields are only displayed when creating a variation Change Details Status Indicator Pg 100 indicates to the system whether the variation 1s to change the details of the application to change its status Other Client Details Evidence API Product and Status Pg 100 are covered in the next sections SIME MIS Lodgement User Guide v1 1 doc Page 75 TGA Online Services Manufacturer Information System MIS 3 New Clearance Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 2 gt 9 054 a GiB 83 M Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf Entry 0 penForm T ype CL 2 Go Links Client Details Evidence APYProduct Details Applicant Applicant Name Valued Client Client Id 9999999 Address Po Box 1234 Suburb Melbourne State IC Postcode 23000 Country Australia Phone Fax Email CC A Sponsor Name Australian Company Pty Ltd x Client Id 9999999 X Address Sunny Street z Suburb Brisbane State QLD Postcode 4000 Country Australia Phone Fax Contact Name O Phone O era E Moti Cd Emai AY greneeenees Seenseeeeed New Manufacturer Cien Name CS Adress A Subut Cd e AAA Postcode ee E E Application loaded successfully ul Ea Local intranet Mstart
90. on Next a printer friendly version 1s displayed which can be printed by clicking on Print A copy of the printed tax invoice must be faxed to TGA Credit card details will have to be filled in if paying by credit card 6 Click on Finish to complete the submission To view the progress of an application 1 Click on View Submitted Clearance Applications on the Manufacturers Application Lodgement home page Pg 10 SIME MIS Lodgement User Guide v1 1 doc Page 71 TGA Online Services Manufacturer Information System MIS Applications continued Approved Clearances 2 3 A list of all the submitted applications currently in the system will be displayed Pg 91 The first column 1s the applications status code Pg 100 which indicates the progress of the application To view the application click on its Status Pg 92 If the number of applications exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required application using the Search button An application in submission status cannot be changed It can however be withdrawn and a new application made Clicking on New Draft Copy will result in a new draft application being created with the details initialised to the values in the current application To withdraw an application 1 2 3 4 Click on View Submitted Clearance Applications on the Ma
91. on Microsoft Internet Explorer provided by Health 2 gt 9000 92 ua IB 9 Y Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 sime mis lodge nsf 0 6F69F59C2D 91 8FCECA256EAF001FA95A7EditDocument Go Links A Client Details Primary Site Secondary Site Supporting Documents Applicant Applicant Name Valued Client Client Id 9999999 Address FO Suburb state Postcode Country Phone Fax k Email PO Existing Manufacturer New Manufacturer Existing Manufacturer Manufacturer Name Search Client ld Client ABN adios A Sibu Cte A Postcode e Country Py ES Application loaded successfully Ml i Es ES Local intranet A Start Ae le SIME Help Ge Licence Ap G Exploring Ima BY Microsoft Word 47 006_SIME_MI E Document Lic SQUAD E 15 50 Fig 4 Licence Application Client Details Client Details This form is used to input the client details Read Only Applicant s Name 1s the name associated with the user currently signed in Fields Client Id 1s the id of the applicant as recorded by the TGA in the Client System Suburb State Post Code Phone amp Fax are the remaining address details associated with the first line of address that was selected Editable Fields Address is the first line of the applicant s address associated with the user currently signed in If there is more
92. on through the system Once an application is approved 1t becomes the certification number The following field 1s only displayed when viewing a variation Original Tracking Number 1s the tracking number of the original application Other Client Details Primary Site and Supporting Documents are as per New Certification Application but cannot be edited SIME MIS Lodgement User Guide v1 1 doc Page 69 TGA Online Services Manufacturer Information System MIS Overseas Manufacturer GMP Clearances Clearance Application Processing Draft Applications To create a new clearance application 1 2 3 4 Click on Create New Clearance Application on the Manufacturers Application Lodgement home page Pg 10 A new application entry form will be opened Pg 74 Enter the Applicant s Own Reference information 1f required Enter the Client Details Pg 76 Evidence Pg 79 and API Product Details Pg 81 as described below Save the application as a draft copy by clicking on the Save button To edit an existing draft clearance application 1 2 3 4 Click on View Draft Clearances on the Manufacturers Application Lodgement home page Pg 10 A list of all the draft applications currently in the system will be displayed Pg 86 To view the application click on its Tracking Number Pg 87 If the number of applications exceeds the page size use the Previous and Next buttons to page backwards a
93. ons on the Manufacturers Application Lodgement home page Pg 10 A list of all the submitted applications currently in the system will be displayed Pg 36 The first column 1s the applications status Pg 100 which indicates the progress of the application To view the application click on its Status Pg 37 If the number of applications exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required application using the Search button An application in submission status cannot be changed It can however be withdrawn and a new application made Clicking on New Draft Copy will result in a new draft application being created with the details initialised to the values in the current application To withdraw an application 1 2 3 4 Click on View Submitted Licence Applications on the Manufacturers Application Lodgement home page Pg 10 A list of all the submitted applications currently in the system will be displayed Pg 36 The first column 1s the applications status Pg 100 which indicates the progress of the application To view the application click on its Status Pg 37 Click on Withdraw to withdraw the application A dialog box will pop up asking for confirmation of the withdrawal Click on OK to continue The status of the application will be changed to Pending Withdrawal Pg 100 To view an approved licence
94. p Country are the address details of the manufacturer SIME MIS Lodgement User Guide v1 1 doc Page 51 TGA Online Services Manufacturer Information System MIS 3 New Certification Application Microsoft Internet Explorer provided by Health MEJ E4 File Edit Yiew Favorites Tools Help e 3 9 a A 3 B 39 Bw Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address l http tgacbr02 SIME MIS lodge nsf Entry 0 penForm T ype CE Go Links al Client Details Primary Site Supporting Documents Primary Site Details Existing Site New Site a Sub a EE ON EE Post Code E Country Australia y Contact Name A Phone ee AS Mobie Cd Emai _ _ aerea Person in charge ofQuaity d Control C Attachment Add Attachment Remove Attachment Person in charge of Production S C Attachment Add Attachment Remove Attachment Authorised Person for Release id Manufacturing Items Manufacturer Types Sterility Manufacturing Class Dosage Form Product Category Manufacturing Steps El E loaded successfully E Localintranet Star A e 18 PWorkspace L E New Certific A Exploring User BY Microsoft Word 2 untitled Paint _ OD 105 Fig 24 Certification Application Primary Site Primary Site This form is used to input the primary site details Read Only Existing Site Fields Suburb State Post Code amp Country ar
95. pplication This option is used Suspend or Cancel a certification A new draft application 1s created which when finalised by the TGA will result in the requested status change Pg 100 SIME MIS Lodgement User Guide v1 1 doc Page 46 TGA Online Services Manufacturer Information System MIS Approved 2 Click on View Approved Certifications on the Manufacturers Application Certifications Lodgement home page Pg 10 Alternatively click on View All TGA continued Data Pg 97 then select Certifications 3 A list of all the approved certifications currently in the system and owned by the user will be displayed Pg 68 To view the certification click on its Certification Number Tracking Number Pg 69 4 A new application will be created by clicking on Vary Application The new application once finalised by the TGA will cause the details to be updated on the Certification If you want to create a brand new application based on the same details of the current record then use the New Draft Copy option SIME MIS Lodgement User Guide v1 1 doc Page 47 TGA Online Services Manufacturer Information System MIS New Certification Application 3 New Certification Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help gt 0 hh Aaaa GiB 3 E Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MI
96. production line Status submitted Tracking Number MI 18062004 CL 000517 5 Client Details Evidence APYProduct Details Fees and Payments Fees and Payment Fee 100 11 Payment Type Cheque A 2 Application loaded successfully Es Local intranet Star 4 e 10 PWelcome Lotus Notes A Exploring Images By Microsoft Word SIME MI Clearance Applicatio LC HETDIDL 16 34 Fig 51 Submitted Application Fees amp Payments Fees amp This form displays the fees and payments information relating to the Payments application It is only displayed while the application is in submit status Read Only Fee is the amount due or paid for the application Fields Payment Type is the method of payment SIME MIS Lodgement User Guide v1 1 doc Page 94 TGA Online Services Manufacturer Information System MIS View Approved GMP Clearances 3 http tgacbr02 sime mis reposit nsf W ebApprovedClearances 0 pen iew Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help 2 gt 9 Baja a 39 15 3 A Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 sime mis reposit nsfwWeb pprovedClearances 0peniew y Go Links A a SIME is View Approved GMP Clearances Previous Next j Home j Refresh Search Clearance Number Manufacturers Name Site Address Expiry Date MI 05052004 CL 00017
97. r action by TGA The request can be a request for copies of a document an update of evidence or simply a general enquiry The Print Preview Button This button is available when creating a declaration Clicking this button will display the declaration in a dialog box in a printer friendly format which can be printed by clicking on the Print button In all of the application forms of the MIS system there are certain information fields that are mandatory The mandatory fields are prefixed with a red coloured star and are always required otherwise the application will not pass validation SIME MIS Lodgement User Guide v1 1 doc Page 7 TGA Online Services Manufacturer Information System MIS Help Introduction Throughout each of the TGA Online Services systems on line help is available either through the help button in the top right corner of the page or through help buttons located next to particular input fields on the application forms Accessing Help Accessing help through either the main page button or a button on an application form will open a new window to display a context sensitive help topic If the main help button is used the help file will describe the general use of the page that the user is currently viewing If the help button beside an input field is used the help file will display detailed information about that field Help Throughout the on line help system certain actions and object
98. read the information below regarding your payment and ensure itis true and correct Application Details Tracking Number Application For MI 27052004 LI 000550 2 Applicant s Own Reference Applicant s Details Manufacturer Name Manufacturer ID Contact Details Contact Name Contact Email Phone Fax Tax Invoice Read Only Fields MY Company Pty Ltd 13 A Valued Client Staff email com gg Previous Next gt gt Cancel Fig 15 Tax Invoice This form is used to create a tax invoice for a licence to manufacture therapeutic goods The form must after completion be printed and one copy sent to TGA All Fields Except Card Details Populated from the contents of the application This form is the Tax Invoice for GST once payment has been made The details must be read to ensure it is correct If not the submission can be cancelled and the application changed to reflect the correct information Submission can then be done again Card Details Only displayed if VISA BANK CARD or MASTERCARD is selected as the Payment Type Card information written on the printed version of the Tax Invoice will ONLY be used to make paymant and is NOT retained in the system Card Holders Signature After clicking Next on the Tax Invoice page a printer friendly version is displayed which must be printed The printed page must be signed and faxed to TGA SIME MIS Lodgement User Guide v1 1 doc Page 35 TGA On
99. requested status change Pg 100 Click on View Approved Clearances on the Manufacturers Application Lodgement home page Pg 10 Alternatively click on View All TGA Data Pg 97 then select Clearances SIME MIS Lodgement User Guide v1 1 doc Page 72 TGA Online Services Manufacturer Information System MIS Approved 3 A list of all the approved clearances currently in the system and owned by Clearances the user will be displayed Pg 95 To view the clearance click on its continued Clearance Number Tracking Number Pg 96 4 A new application will be created by clicking on Vary Application The new application once finalised by the TGA will cause the details to be updated on the Clearance If you want to create a brand new application based on the same details of the current record then use the New Draft Copy option SIME MIS Lodgement User Guide v1 1 doc Page 73 TGA Online Services Manufacturer Information System MIS New Clearance Application 3 New Clearance Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help n AA Ga F A Back Forverd Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 SIME MIS lodge nsf Entr 0penForm amp T ype CL Go Links dEl SIME Ls New Clearance Application Applicant s Own Ref Status Tracking Number Client Details Evidence API Product De
100. rther three steps be actioned as follows e Step l Fees and Payments Pg 33 e Step 2 Declaration Pg 34 e Step 3 Tax Invoice Pg on page 35 Click on the Continue button to continue Fees and Payments Pg 33 The cost of the application 1s displayed and an option to select a method of payment If the cheque option 1s taken then the cheque number and the bank must be entered Declaration Pg 34 A declaration form 1s displayed with details taken from the application If required the details can be changed before continuing After clicking on Next a printer friendly version is displayed which can be printed by clicking on Print The printed declaration must be signed witnessed and dated and one copy must be faxed to TGA Tax Invoice Pg 35 A tax invoice 1s displayed with details taken from the application It must be checked to ensure it is correct After clicking on Next a printer friendly version 1s displayed which can be printed by clicking on Print A copy of the printed tax invoice must be faxed to TGA Credit card details will have to be filled in if paying by credit card Click on Finish to complete the submission SIME MIS Lodgement User Guide v1 1 doc Page 12 TGA Online Services Manufacturer Information System MIS Applications continued Approved Licences To view the progress of an application 1 2 3 Click on View Submitted Licence Applicati
101. s Evidence API Product Details and Status Pg 100 are as per New Clearance Application SIME MIS Lodgement User Guide v1 1 doc Page 87 TGA Online Services Manufacturer Information System MIS To Submit A GMP Clearance Application 3 Submitting a Yariation for a Clearance Web Page Dialog You must complete the following two steps before submitting a Clearance Step 1 Fees and payments Step 2 Tax Invoice This screen will quide you to complete two steps mentioned above You can exit this screen at any time by clicking the Cancel Button Please click Continue button to continue Continue Cancel Fig 46 Submitted Clearance Submitted When submitting an application a popup box appears requesting a further two Clearance Steps steps be actioned as follows Step 1 Fees and Payments Step 2 Tax Invoice SIME MIS Lodgement User Guide v1 1 doc Page 88 TGA Online Services Manufacturer Information System MIS Submitting a Variation for a Clearance Web Page Dialog Fees AUC 1000 00 Payment Type Cheque Visa Bank Card Mastercard Payable ta Testingg fggfgfngdf f Mail ta Testingg fggfgfngdf f dsf sdfd st dsfsd gg Previous Next gt gt Cancel Fig 47 Fees and Payments Fees and All Clearance applications are subject to a fee This screen allows the user to Payments nominate how payment will be made NOTE If Visa Bank Card or Mastercard is selected the pay
102. s Act 1989 an extract of which is attached I hereby certify that a there has been no suspension or revocation of a manufacturing licence or conformity assessment certificate however described issued to the Applicant any Applicant Manager or Applicant Controller any other person who controls the Applicant or any Applicant Manager or 4pplicant Controller eltther directly or indirectly through one or more interposed entities or any person whom the Applicant or any Applicant Manager or Applicant Controller controlled ferther directly or indirectly through one or more interposed entities at the time of the suspension or revocation Ed lt lt Previous Next gt gt Cancel Fig 14 Declaration Declaration This form is used to create a declaration for a licence to manufacture therapeutic goods The form must after completion be printed signed and one copy sent to TGA Editable Fields Applicant s Name Name of person making the application To be entered in two places Position The position of the applicant in the company Company Name Name of the company Applicant s Address Company s address Optional Further Information Any additional information that relates to the application SIME MIS Lodgement User Guide v1 1 doc Page 34 TGA Online Services Manufacturer Information System MIS S Submitting a Licence Web Page Dialog This document will be a tax invoice for GST when you make payment Please
103. s are indicated Conventions in the following ways e On screen button names are placed in single quotes For example click on OK means click once on the button labelled OK e Keyboard key names are placed in greater less than symbols For example press lt CTRL gt means press the control CTRL key on your keyboard e Important messages and notes are written in italics For example Note These notes should always be read e Italics are also used for field descriptions For example Field 1 refers to the first field within the on line form SIME MIS Lodgement User Guide v1 1 doc Page 8 TGA Online Services Manufacturer Information System MIS Help Desk If at any time you are experiencing problems using the MIS system or need further assistance contact the MIS Help Desk e E mail tgasime health gov au Please include the word MIS in the subject line of the E mail e Phone 1800010 624 The Help Desk operates Monday to Friday between the hours of 8 30am 5 00pm EST If you are experiencing problems with your User Account or accessing the TGA Online Services system please contact the TGA Online Services Help Desk e E mail tgasime health gov au Please include the words TGA Online Services in the subject line of the E mail e Phone 1800 010 624 SIME MIS Lodgement User Guide v1 1 doc Page 9 TGA Online Services Manufacturer Information System MIS Manufacturers Application Lodgement The TGA The
104. s forms of help refer to the Help Section in this document SIME MIS Lodgement User Guide v1 1 doc Page 1 TGA Online Services Manufacturer Information System MIS Overview of the Manufacturer Information System Introduction Client access Public access Benefits The Manufacturer Information System is a component of the larger TGA Online Services system The Manufacturer Information System is designed to provide a web based interface between TGA s clients and the GMP section of TGA It provides the electronic forms necessary for submitting licences GMP Certification and GMP Clearance applications The Manufacturer Information system then provides support to TGA staff in the processing of applications and once a licence application is successfully processed supports the publishing of the licence to the Australian Manufacturer s Database The Manufacturer Information System also provides the following client access facilities for TGA clients e Read only display of Licences GMP Certifications and GMP Clearance records owned by the client e The ability to create applications or to clone or vary these entries The system also provides a level of on line access for members of the public In the case of the Manufacturer Information System public access to legally appropriate information via the Internet is limited to the Australian Manufacturers Database which gives basic information on approved Australian Manufac
105. ser Guide v1 1 doc Page 11 TGA Online Services Manufacturer Information System MIS Draft Applications continued Applications To save save and close or to exit without saving 1 2 To save an application without exiting click on Save Clicking on Close will also save the application but will then exit to the Manufacturers Application Lodgement home page Pg 10 To exit without saving any changes made to the currently displayed page click on Home Control will be returned to the Manufacturers Application Lodgement home page Pg 10 To validate an application 1 2 3 Once all the data has been entered into the form the application should be validated by clicking on Validate Any errors will be listed on the screen via a dialog box Clicking on an error displays the corresponding place in the application so that 1t can be corrected All applications must pass validation successfully before they can be submitted To submit an application 1 2 3 4 5 6 7 To submit an application you must be in edit mode Click on the Submit button All applications are automatically validated and if errors are found a dialog box will be displayed listing the errors Clicking on an error will position the application in the appropriate place so that it can be corrected When submitting an application a dialog box appears Pg 32 requesting a fu
106. sf6bfRa2f084dhe3e3ca25be6d0016a782 22edcd8c729d62bbca256eb0001 fObe6 0 penDocument y Go Links a Y SIME Help os Certification Close View Entire App Vary Application Create Request New Draft Copy Home Applicant s Own Ref 1234 Status Active Tracking Number MI 07062004 CE 0001 45 2 Client Details Primary Site Supporting Documents Existing Manufactuer x New Manufacturer New Manufacturer Client Name Overseas Company Site Address Corporate Street l Suburb CINCINNATI State OHIO Postcode OH 45242 Country United States Of America amp Application loaded successfully fs Za Local intranet BN Start Ae DO gt Sy SIME Notes Home Certification M 3 Exploring Images BY Microsoft Word SI untitled Paint SOMA s 15 54 Fig 37 Approved Certification Approved This form 1s used to view an approved certification No changes can be made Certification but if changes are required a variation application to the certification can be created Read Only Applicant s Own Ref is the applicant s own reference information that may Fields help to identify the application Status Pg 100 shows the current status of the application Tracking Number is created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and is used for all future tracking of the applicati
107. sscccssscccsssscccssssscsessess 5 Navigation 5 MOGUCOM aritna dd OE 5 Mandatory MOMO css elena eesti iets rose 7 Help 8 INTOodUCIO Nc ri a ari 8 o A A 8 Help Conventions ccccccccssceccseecceseecececeneecseeesneesenecsaeeesaeeseaeecaaeeseaeeeseeeseaeessaeeesaeessaseeeseaeessusessuseeseeeesags 8 HeD DES ene Pe meer SC Ser CE POOP ao eee eee eee ee 9 Manufacturers Application LOdgemen ccccccccssssssssssccccsssssssssssccccccsssssssssccccssssessssssccsssseeeees 10 The TGA Online Services MIS Home Page escoria iaa 10 Special Home Page BuU tONS ooccccococnncconcnncconnnconononononcnnonnnnnonnnnnnnnnrnnnnnnrnnnrnnnnnnnnnnnnrnnrnnnrnnnnrnrannnnnenrnnenanens 10 Licensing of Australian Manufacturers ccisicccsnscccedstssccunsusdesecssscccasscdcassteliesssssssdesssccavecsaeetassseasevceseess 11 Licence Application Processing 11 Dat 216 8 ors 16 Si eri 11 PAP ONC ATION S atc vi A d a 12 PO PFOVER LICENCES ci e ai oe tii lo 13 New Licence Application 15 PAD DIC ATION Detalla as a a deanna 15 UVTI Dedie reese atten crc E ocean areca Sentient tet tate oem gue eteead teas 17 Pae gt meet ete ane nner A eee ee Caer ere 19 Secondary o le eoa AS Sadi ame ven A nemecs eee 22 supporting Documents a a te seal h oa fa ele ae ag eh o A 24 A cee ee ee ee 26 Variation Licence Application 27 PADDING ATION DEIS us sats dl E 27 View Draft Licence Applications 29 Die ICC ING Cs Star ati iids 29 Dra LiCenee APPA tO
108. submitted by the applicant as is awaiting Applications confirmation of payment of the application fee Paid Application has been submitted and the application fee confirmed as paid Awaiting commencement of review processing by TGA Under Review Application is being reviewed by TGA With Manufacturer Application is with the applicant manufacturer awaiting further information to be provided Pending Withdrawal Application has been withdrawn by the applicant Awaiting processing by TGA Withdrawn Application has been withdrawn Finalised Application has been finalised and a decision recorded accepted or rejected Awaiting expiry of appeal period or process completion by TGA Complete Application has been completed Approved Active Application has been approved and is active Applications Inactive Application has been approved but is inactive Suspended Licence Certification has been suspended for a period of time Cancelled Licence Certification Clearance has been cancelled SIME MIS Lodgement User Guide v1 1 doc Page 100
109. t s Own Ref is an editable field in which the applicant can place any reference information that may help in identifying the application Change Details Status Indicator Pg 100 indicates to the system whether the variation 1s to change the details of the application to change its status SIME MIS Lodgement User Guide v1 1 doc Page 84 TGA Online Services Manufacturer Information System MIS Other Client Details Evidence API Product Details and Status Pg 100 are as per New Clearance Application SIME MIS Lodgement User Guide v1 1 doc Page 85 TGA Online Services Manufacturer Information System MIS View Draft GMP Clearance Applications 3 http tgacbr02 SIME MIS lodge nsf wW ebDraftCL 0 penView Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e 0 A A Back Forward Stop Refresh Home Qiu 3 Search Favorites History a oo Mail Print Edit Address A http 7tgacbr02 SIME MIS lodge nsf ebDraftCL 0penview 2 Go Links A _ o Fu de hts s S IME Help to View Draft GMP Clearance Applications Previous Next Home Refresh Search Tracking Number Sponsor s Name Manufacturer s Name Site Address Manufacturer s Own Refere MI 10062004 CL 000251 2 SUE ACKEROYD ASSOC MI 10062004 CL 000250 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA GLAXO WELLCOME AUSTRALIA 1061 MOUNTAIN HIGHWAY 10
110. t is correct If not the submission can be cancelled and the application changed to reflect the correct information Submission can then be done again Card Details Only displayed if VISA BANK CARD or MASTERCARD is selected as the Payment Type Card information written on the printed version of the Tax Invoice will ONLY be used to make paymant and is NOT retained in the system Card Holders Signature After clicking Next on the Tax Invoice page a printer friendly version is displayed which must be printed The printed page must be faxed to TGA SIME MIS Lodgement User Guide v1 1 doc Page 64 TGA Online Services Manufacturer Information System MIS View Submitted Certification Applications 3 http tgacbr02 SIME MIS lodge nsf wW ebS ubmittedCE 70 penView Microsoft Internet Explorer provided by Health File gt 0f AJa a IB 9 y Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address A http 7tgacbr02 SIME MIS lodge nsf ebS ubmittedCE 70 penvView 2 Go Links Edit View Favorites Tools Help SME gt t View Submitted Certification Applications Previous Next j Home Refresh Search Status Tracking Number Manufacturer s Name Primary Street Address Received Submitted MI 07062004 CE 000145 2 BIOVITAL PTY LTD UNITS 8 12 21 amp 24 10 YALGAR ROAD 07 06 2004 Submitted MI 04062004 CE 000144 2 BIOVITAL PTY
111. tails Applicant Applicant Name Valued Client Client Id 9999999 Address Suburb State Postcode Country Phone Fax Sponsor OUUU O zl l Application loaded successfully E lia ia ES Local intranet Start 1e 0 Sy SIME Notes Home 3 new Clearance 3 Exploring Images BY Microsoft Word ale os SIME_MISsub it Saas 12 22 Fig 38 New GMP Clearance Application Application This form is used to complete a new clearance application or a variation to an Details existing approved clearance Read Only Status is always Draft Pg 100 Fields Tracking Number is created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and is used for all future tracking of the application through the system The following fields are only displayed when creating a variation Current Tracking Number is the tracking number of the original application New Tracking Number is the new tracking number created for this variation SIME MIS Lodgement User Guide v1 1 doc Page 74 TGA Online Services Manufacturer Information System MIS Editable Fields The following fields are editable when creating an application or editing an existing draft application These fields become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that may help t
112. tax invoice is displayed with details taken from the application It must be checked to ensure it is correct After clicking on Next a printer friendly version is displayed which can be printed by clicking on Print A copy of the printed tax invoice must be faxed to TGA Credit card details will have to be filled in if paying by credit card 6 Click on Finish to complete the submission To view the progress of a submission 1 Click on View Submitted Certification Applications on the Manufacturers Application Lodgement home page Pg 10 SIME MIS Lodgement User Guide v1 1 doc Page 45 TGA Online Services Manufacturer Information System MIS Applications continued Approved Certifications 2 3 A list of all the submitted applications currently in the system will be displayed Pg 65 The first column is the applications status code Pg 100 which indicates the progress of the application To view the application click on its Status Pg 66 If the number of applications exceeds the page size use the Previous and Next buttons to page backwards and forwards Alternatively search for the required application using the Search button An application in submission status cannot be changed It can however be withdrawn and a new application made Clicking on New Draft Copy will result in a new draft application being created with the details initialised to the values in the curre
113. through the individual pages of an application form Clicking this button will create a new application with the fields initialised to the values contained in the current selected application The Withdraw Button This button is available when viewing an application with a submit status Clicking this button will result in the application being withdrawn from the system The status of the application will be changed to Pending Withdrawal Once the withdrawal is completed by TGA the status will be changed to Withdrawn The Edit Button This button is available when viewing a draft application Clicking on the button changes the appropriate form fields from read mode to being editable so that changes can be made The Save Button This button is available when editing an application Clicking on the save button saves the changes as a draft application The application remains on the screen in edit mode and more changes can be made SIME MIS Lodgement User Guide v1 1 doc Page 6 TGA Online Services Manufacturer Information System MIS Validate Delete Submit Vary Application Create Request Print Preview Mandatory Information The Validate Button This button is available when editing an application The button allows a user to validate the information that they have supplied in the application prior to submission Ifa particular mandatory field in the application has not been completed or if a p
114. ting approved licence Read Only Status is always Draft Pg 100 Fields Tracking Number is created by the system once the application has been saved or submitted It 1s a unique number which 1s attached to the application and 1s used for all future tracking of the application through the system The following fields are only displayed when creating a variation Current Tracking Number is the tracking number of the original application New Tracking Number 1s the new tracking number created for this variation SIME MIS Lodgement User Guide v1 1 doc Page 15 TGA Online Services Manufacturer Information System MIS Editable Fields The following fields are editable when creating an application or editing an existing draft application These fields become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that will help them to identify the application The following fields are only displayed when creating a variation Change Details Status Indicator indicates to the system whether the variation is to change the details of the application to change its status Pg 100 Other Client Details Primary Site Secondary Site Supporting Documents and Status Pg 100 are covered in the next sections SIME MIS Lodgement User Guide v1 1 doc Page 16 TGA Online Services Manufacturer Information System MIS E Licence Applicati
115. turer Information System MIS Editable Fields The following fields are editable when creating an application or editing an existing draft application These fields become non editable once the application has been submitted Applicant s Own Ref is an editable field in which the applicant can place any reference information that will help them to identify the application Other Client Details Primary Site Supporting Documents and Status Pg 100 are covered in the next sections SIME MIS Lodgement User Guide v1 1 doc Page 49 TGA Online Services Manufacturer Information System MIS 3 New Certification Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e 0 D AJA m Ip 3A Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address a http tgacbr02 5IME MIS lodge nsf Entry 0 penForm T ype CE Go Links a Client Details Primary Site Supporting Documents Applicant Applicant Name Valued Client Client Id 9999999 Address PO Box1234 v Suburb Melbourne State VIC Postcode 3000 Country Australia Phone Fax Emai Existing Manufacturer New Manufacturer New Manufacturer NN a X Adress amp Suu A e AA Postcode Fl Country Australia y Application loaded successfully a Local intranet Astar Ae 0 al Workspace L E New Centific GY Explori
116. turer Licences The fundamental business objective of the Manufacturer Information System is to provide an efficient means of managing tracking and reporting upon the processing and evaluation of applications by clients to have their information recorded on the TGA GMP Register The Manufacturer Information system will deliver the following business benefits e Quicker turn around of client applications and queries e Greater accessibility to business information e Improved communication between business areas SIME MIS Lodgement User Guide v1 1 doc Page 2 TGA Online Services Manufacturer Information System MIS Getting Started Introduction The TGA Online Services system 1s available through the Department of Health and Ageing web site The TGA Online Services web interface conforms with the Department of Health and Ageing web useability standards The TGA The TGA Online Services Home Page is available at the following URL Online Services Home Page http www tgasime health gov au sime home nsf ES TGA Online Services Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help gt 9B00 9 a 9 8 9 Back Omara Stop Refresh Home Search Favorites History Mail Print Edit Address http wiwvw tgasime health gov au sime home nsf Go Links fee Australian Government Therapeutic Goods Administration e Department of Health and Ageing
117. urer s Name Site Address submitted MI 10062004 CL 000253 2 SUE ACKEROYD amp ASSOC FRA 2 PRODUCTION FRAZ 5 MATTEO FOND Active MI 13052004 CL 000016 1 JOHNSON amp JOHNSON MEDICAL PTY LIMITED FERROSAN AS 5 SYDMARKEN Active MI 13052004 CL 000016 1 JOHNSON amp JOHNSON MEDICAL PTY LIMITED FERROSAN AS 5 SYDMARKEN Submitted MI 09062004 CL 000242 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGH Submitted MI 09062004 CL 000240 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGH Paid MI 07062004 CL 000237 2 SUE ACKEROYD amp ASSOC GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGH Active MI 05052004 CL 000176 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGH Submitted MI 07062004 CL 000234 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGH submitted MI 04062004 CL 000232 2 SUE ACKEROYD ASSOC GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGHT Pending Withdrawal MI 04062004 CL 000231 2 SUE ACKEROYD amp ASSOC GLAXO WELLCOME AUSTRALIA LTD 1061 MOUNTAIN HIGH Active MI 13052004 CL 003715 1 LIVINGSTONE INTERNATIONAL P L NANTONG GUANGDA TEXTILE CO LTD NO 16 BAOCHANG N Ru Active MI 13052004 CL 000675 1 ALPHAPHARM PTY LTD IPCA LABORATORIES LTD 48 KANDIVLI INDUSTRI Active MI 13052004 CL 000593 1 ALPHAPHARM PTY LTD BIOGAL PHARMACEUTICAL CO LTD 13 PALLAGI STREET Active MI 13052004 CL 000106 1 HEXAL AUSTRALIA PTY LTD LUPIN LABORATORIES LIMITED 202 NEW INDUSTRIAL A Active MI 13052004
118. ved SIME MIS Lodgement User Guide v1 1 doc Page 21 TGA Online Services Manufacturer Information System MIS Applicant s Own Ref 1234 Tracking Number Ml 1 006 24004 LI UU0bS9 2 Y Sweet js A Post Code Country Australia Phone dC Fe _ Person in charge of Quality Control Person in charge of Production Authorised Person for Release Manufacturing Items Manufacturer Types Sterility Manufacturing Class Dosage Form Product Category Manufacturing Steps Save Site Close Fig 6 Licence Application Secondary Site Secondary Site This form is used to input the secondary site details Read Only Existing Site Fields Suburb State Post Code amp Country are the remaining address details associated with the first line of address that was selected SIME MIS Lodgement User Guide v1 1 doc Page 22 TGA Online Services Manufacturer Information System MIS Editable Fields Secondary Site Details Site Indicator 1s a radio button selection to indicate whether the site currently exists in the system or is new Existing Site Street Address is the first line of the secondary address If there is more than one address available a drop down list is displayed so that the correct one can be selected New Site Street Address Suburb State Post Code amp Country are the address details of the secondary site Contact Details Contact Name is the name of the contact person
119. wn Refis the applicant s own reference information that may Fields help in identifying the application Status Pg 100 is the current status of the submission within the system Tracking Number is created by the system once the application has been saved or submitted It is a unique number which is attached to the application and is used for all future tracking of the application through the system The following field is only displayed when viewing a variation Original Tracking Number is the tracking number of the original application SIME MIS Lodgement User Guide v1 1 doc Page 92 TGA Online Services Manufacturer Information System MIS Other Client Details Evidence and API Product Details are as per New Clearance Application but cannot be edited Fees and Payments is covered in the next section SIME MIS Lodgement User Guide v1 1 doc Page 93 TGA Online Services Manufacturer Information System MIS 3 Clearance Application Microsoft Internet Explorer provided by Health File Edit View Favorites Tools Help e 0 N Ala ua 3 39 M Back Forward Stop Refresh Home Search Favorites History Mail Print Edit Address l http 4 tgacbr05 S IME MIS lodge nsf 463b338b6200c3d6ca256e3 007b27e9 5e2f38Eceb6c487fca25beb7001e889b 0penDocument Go Links ee da Hes SIME _ Help t Clearance Application Close View Entire App Withdraw New Draft Copy Home Applicant s Own Ref For the new

Download Pdf Manuals

Related Search

Related Contents

IP Finder UltraView Pro 取扱説明書（5.70MB）  Sandberg Telephone Plug RJ11(in)->SE  詳細取扱説明書（CD-ROM内収録）の訂正について  Tubulure de remplissage pour nutrition parentérale - Euro  Manual - Avaya Support  \\Masuyama-xp\カタログ\AE-9020  Focus Electrics Jelly Belly Party Pack  Manual de Instrucciones - Burkert Fluid Control Systems  

Copyright © All rights reserved. Failed to retrieve file