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User Manual for the Export Electronic Lodgement (EEL) System

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1. Save Save amp Close Close Application Home Home Figure 25 Remaining Restricted Solvent Subform To enter the restricted solvent details for an ingredient complete the fields as detailed below Parent Ingredient This field is automatically populated with the parent Name ingredient name Solvent Name These fields are conditionally mandatory Click on the Residue Qty and drop down arrow of the name field to select the solvent Unit Enter the numeric value of the residual quantity and click on the drop down arrow of the unit field to select the unit of measurement 0546548 doc Page 55 Online Services The Indications Subform This subform is available for S26a application W start Export Electronic Lodgement From an application subform clicking the Add button beside the Indications field will provide the user with the Indication subform as shown in the figure below i Therapeutic Goods Administration Indication Microsoft Internet Explorer provided by Therapeutic Goods Administration Image41 Windows Picture and Fax Viewer File Edit View Favorites Tools Help Qa O 3 AOD JD sve fers O B Faua Always Required Indication Type Coded O Custom Address https www ebsacceptance tga gov au ebs LM LMDrafts nsf Indication OpenForm amp ParentUNID 0606 7D 1374666 160CA2574CD00 18CF 1D8Seq 1 m Go TGA e
2. a TGA eBusiness Services Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help sack x A Search sf Favorites O 27 amp a3 ddress https www ebsacceptance tga gov au e e Australian Government TGA eBusinessServices i n User Acceptance Therap Goals Mii ee Portal TGADemo Drafts EET Sponsor Viewing 4 of 4 entries Pac View Drafts Approval Area All Approval Areas x View Lodged Sponsor All Sponsors i Submissions Search on Date v for E ortal He c EA p licati amp Date Identifier Client Reference Information Sponsor reate Applications M 3 09 Submissions E Q2005 05 18 TGA Demo A B e GO 2008 09 16 TGA Demo A PiListed Medicine GO 2008 08 21 DV 2008 MC 56636 3 Viet testing ACC 516 001 TGA Demo Spo v Export Only Medicine GO 2008 08 20 DV 2008 MC 56628 3 TGA Demo Spo v S 26 Export Only General Listing Composite Pack Change Multiple Current Listings x S 26a Solely for Export gt Export Certificates gt Submission Manufacturers Medical Device Over The Counter Medicine gt Prescription Medicine Lodge Supporting Documentation a Maintain Mane Annnunt gt amp Internet E start E r Josh Wiley Inbox TGA eBusiness Se i Microsoft Word Figure 5 Export Medicines Home Page 2 The Export Only S26 application types will be displayed Select the
3. once all the details are completed Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 6 Validation of the application Refer to Validating an Application on Page 74 for details 7 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 8 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 0546548 doc Page 68 Online Services Export Electronic Lodgement Certificate of From this form sponsors can draft and validate an application for a Certificate Exempt of Exempt Product CEP Product CEP Application Creating a CEP 1 From the Export Only Medicine link underneath the Create Applications Application amp Submissions link under the Portal select the Export Certificates link 2 The Export Certificate application types will be displayed 3 Click on the Application for Certificate of Exempt Product link 4 The Certificate of Exempt Product application form will be displayed in edit mode ready for information to be entered see figure 30 below 5 Complete the application using the information in the following table 3 Therapeutic Goods Administration
4. Australian Government Department of Health and Ageing User Manual for the Export Electronic Lodgement EEL System 3j G THERAPEUTIC GODDS ADMINISTRATION Online Services Online Services Export Electronic Lodgement Table of Contents atigefoiT eii e RETE DUET 1 Introd cto 2 93 01 4 oA ac Pone M tosta e ota xoc Do acces A arc At dor cc agentes A Macao ra o I AIR inr MUI LU 1 OITA AE ES ED A AE E EE E EEE E E E EE T 1 Who Should Use This Manual ccccccccccccccceeeeeeeeeeeeeeeeeeceeeeeeeeeeeeeeeeeeeeeeaeeeaeaeauauauauauaeauauaeaeeueauausueueueueueueuens 1 How to Use This Manuals cies iieri rtoeor rete ente exce none era acu e ee ura a Y eee nervo e ren eoa re vex pev ee va d e 1 JASSUIMPUONNS ELE E M m 1 ujpnp M 1 Overview of Export Only Medicines amp Australian Register of Therapeutic Goods ARTG eT 2 FItROCUCTION pact 2 FREACACCESS LP p 2 External aCccess uad p RD HREDRERU EE E UR e RR GANE nee REPRE HASARD In RPaE 2 acte eruew dee a E a coe cu eoeen yes vesylie deen ce esta EE noire eee dae rece 3 Getting Starfed und aaa Idae dab tha Fa onda e XL Cual x reer reCeRTT Prev emT rrr ener errr eerr revere 4 FTO QU CTION RE 4 The TGA eBusiness Services Home Page cscccecceceseceneeeeeeeeaeeeeaeeceaeeseaeeseaeeseaeesaeeseaeeseaeeeeaeeseaeseaeeeeatens 4 ACCESSING CBS SYSISMS si oie eO REO et EROR RON EU SERERE E 5
5. Multiple link Curren Lasin 2 The S 26a Solely for Export application types will be displayed Select the Change Multiple Solely for Export Listings Application link 3 The Change Multiple Solely for Export Listings Application form will be displayed in edit mode ready for information to be entered see Figure 14 below 4 Complete the Application by entering information into the following fields 3 Therapeutic Goods Administration Change Multiple Solely for Export Listings Application Microsoft L EX File Edit View Favorites Tools Help a Qx WAG J Search sie Favorites 4 amp 2 2 e568 Address https www ebs tga gov au ebs EM EMDrafts nsf MultiChangeApp openform TGA eBS Change Multiple Solely for Export Listings Application Save j Save amp Close Close Validate Help Client Reference TGA will not retain this information Always Required x Required under certain conditions Change Multi Listing Name Client Name TGA DemoS Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product your billing address and regulatory correspondence address Please select the relevant addresses for this product entry Billing Address v Regulatory v Correspondence Address Note The addresses are being provided from your Client record If you require reference to a different address it must
6. This field is conditionally mandatory The inclusion of of Divided Dosage particular ingredients may require the declaration of the Form maximum weight of the divided dosage Enter the formulation s recommended maximum single dosage and select the units from the drop down list Ingredient This field is mandatory Single click the Add button to add an ingredient to the formulation Multiple ingredients can be added For details on the Ingredient subform refer to Page 43 Manufacturer s This field is mandatory Single click the Add button to add a manufacturer to the application Multiple manufacturers can be added For details on the Manufacturers subform refer to Page 47 Product Details Indications This field is mandatory Single click the Add button to add an indication to the application Multiple indications can be added For details on the Indications subform refer to Page 56 Warning This field is conditionally mandatory Single click the Add button to add a warning to the application Multiple warnings can be added For details on the Warnings subform refer to Page 57 Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users Page 29 Online Services 0546548 doc Export Electronic Lodgement 5 Validation of the application Refer to Validating an Application on Page 6 74
7. Z TGA eBusiness Se Microsoft Word e 9 Tuesday Figure 34 Submitted Applications view View is showing All Approval Areas filter Withdrawing an Once an application has been submitted to the TGA it can be withdrawn at Application any point up until it is approved and written to the ARTG If you wish to withdraw an applications 1 Click on the View Lodged Submissions as shown in Figure 34 above 2 Click on the Arrow icon in front of the date received to reveal option to Delete the application 0546548 doc Page 79 Online Services Export Electronic Lodgement 0546548 doc Page 80 Online Services Export Electronic Lodgement Australian Register of Therapeutic Goods ARTG Records ARTG Records The ARTG holds records of all Therapeutic Goods that have been approved for distribution in Australia and for export The Web view of the ARTG only shows current entries and does not include entries that have been cancelled from the ARTG The system also provides on line access via the Internet for members of the public to appropriately restricted subsets of the information on the ARTG i e legally appropriate information Access e A Sponsor who has been provided with a valid logon to TGA s SIME Web Site can read information concerning entries they have listed registered on the ARTG and print out an ARTG Certificate for their own products e An Agent who has been provided with a valid l
8. e Phone 1800 092 788 The Export Help Desk operates Monday to Friday between the hours of 9 00 12 00am and 2 00 5 00pm EST If you require assistance gaining access to the TGA Online Services please contact the TGA Online Services Help Desk e E mail ebs tga gov au e Phone 1800 010 624 The Online Services Help Desk operates Monday to Friday between the hours of 8 30am 5 00pm EST Page 9 Online Services Export Electronic Lodgement Export Applications Mandatory and Conditionally Mandatory Fields 0546548 doc In all of the application forms of the Export Only system there are certain information fields that are mandatory and others that are conditionally mandatory The mandatory fields are prefixed with a red coloured star and are always required otherwise the application can not be validated Failure to supply information for a mandatory field prior to validation will result in a validation failure message indicating the field that is missing information Conditionally mandatory fields indicated by a prefixed grey star may become mandatory for validation purposes based upon information supplied in other fields of the application For example in solely for export applications the use of particular ingredients in a product may be cause for limiting the total volume of the product container Hence the container volume field would become mandatory so the total volume of the container could be assessed
9. Application for Certificate of Exempt Product CEP Microsoft I L EX File Edit View Favorites Tools Help a Qsak x a J Search sie Favorites 27 p 16 3 Address https www ebs tga gov au ebs EM EMDrafts nsf cepapp openform TGA eBS Application for Certificate of Exempt Product CEP Save Save amp Close Close Validate Help EJ Go Links Client Reference TGA will not retain this information Submission Cost Application Draft Status Validation Report x Required x Not required under all circumstances Client Name TGA E business account for application processing Sponsor Name TGA E business account for application processing Sponsor Address 36 Narrabundah Lane SYMONSTON ACT 2609 v Sponsor Status a manufactures dosage form Contact Details Certificate sentto Sponsor v Country requesting export v certificate Number of Certificates 1 Required Add Product name Export Name a Bj Internet ti Start E 4 e Josh Wiley Inbox 24 Therapeutic Good Ei Microsoft Word 14 42 Tuesday Figure 30 Application for Certificate of Exempt Product CEP form 0546548 doc Page 69 Online Services Export Electronic Lodgement Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identify
10. Ensure that you have supplied all supporting data Payment for applications must be made to the Financial services group within 14 days Submit Cancel J Last updated 23 September 2008 User Acceptance For further infori URL https www ebsacceptance tga gov au ebs EM EMDrafts nsf SAIIBYUNID F C3F762E21CDD7FBCA2574CD0010E018 OpenDocument contact the eBS Help Desk on 1800 01 eBS tga Therapeutic Goods Administration Cop Security Disclaimer Privacy Stat Done A Internet Wr start E wg Josh Wiley Inbox 24 Therapeutic Good Ul Microsoft Word Figure 32 Submission Check List 11 Select the Submit button 12 The Payment Lodgement page will be displayed See figure 33 below 0546548 doc Page 77 Online Services Export Electronic Lodgement 3 https www ebsacceptance tga gov au ebs EM EMDrafts nsf SAIIByUNID FC3F762E21CDD7FBCAZ25 File Edit View Favorites Tools Help Qa x 2 45 JO search yr Favorites 2 BSBA BX Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf SAlIByUNID FC3F762E21CDD7FBCA2574CD0010E018 EditDocument Australian Government Department of Health and Ageing Therapeutic Goods Administration ABN 40 939 406 804 encor j oO Print t J O Blackmores Limited Tax Invoice lonLo14588 Date of Issue 23 09 2008 invoice Total 560 00 Customer No Enquiries Phone
11. The S 26a Solely for Export application types will be displayed Select the Solely for Export Composite Pack Application link The Solely for Export Composite Pack Application form will be displayed in edit mode ready for information to be entered see Figure 13 below Complete the Application by entering information into the following fields 3 Therapeutic Goods Administration Solely for Export Composite Pack Application Microsoft Interne E EX File Edit View Favorites Tools Help iy Qx WAG J Search she Favorites 4 Gr m Address https www ebs tga gov au ebs EM EMDrafts nsf CompApp openform TGA eBS Solely for Export Composite Pack Application Save Save amp Close j Close Validate j Help j Client E E Reference TGA will not retain this information Always Required x Required under certain conditions Product Name Export Name s Add Edit Product Code x Client Name TGA DemoS Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product your billing address and regulatory correspondence address Please select the relevant addresses for this product entry Billing Address v Regulatory v Correspondence Address Note The addresses are being read from your Client electronic record If you require reference to a different address it must be notified to the TGA for inclus
12. The Online Services Web Environment css eeeeceeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeees 6 NAVE At ON wisn cet IPC E 6 IPWTFOGUCTION feececcevecs tstevesnesasussiscagaceetsaccisaziacceaadsades AAT 6 Help unn A E E E O N A E A N E A E A 8 Introduction ns a a a r a a a a a a aa 8 Accessing Help EE E E ER 8 Help Conventions EM 8 alBI 2 dee EE 9 Export Applications 2 cocci nennt nus oid ecu eu aa au anna ecu c cai ananena Henan aiak a aneian aitia 10 Mandatory and Conditionally Mandatory Fields eese 10 S26 Export Only Applications eeeeeeeeee esses eieee ee ene nennen nnn n nennt nnn nnns annnm nnn tn nasa 11 Overview of an Export Only General Listing Application seeeeneneneeee 11 Creating an Export Only General Listing Application sseeeeeeeeeneeeeenenen nenne 11 The Composite Pack Applications neisiu ene aine nennen eene nnne nnne nnne nnt nnne entente nnne enne 17 Creating a Composite Pack Application sss nnne nennen nennen nnne 17 Creating a Change to Multiple Current Listings eese nennen nnne nnne 22 Changing a Single Current Listing Variation Grouping eeseeeeneneneeeneneenenennene 25 Creating a change to a single current listing through General Listings Application or Composite Pack 25 Cre
13. List Note Schedule will only be accepted in Hard Copy with original signature Attachments intended to be part of the certificate must follow Schedule formatting and be signed and dated in original penmanship that is not photocopied Attachments This is conditionally mandatory depending on if the user has selected to Add an electronic file One or more electronic files can be attached to the application by clicking Add An example of an allowable electronic attachment is an application cover letter To Delete an electronic file select the Delete link under the Action column of Attachments Schedules will only be accepted in hard copy with original signature Paper Supporting Document List Note Schedule will only be accepted in Hard Copy with original signature Document Type Select the type of document from the drop down list Description Provide a free text description of the document Method of Select the method via which the document has been Submission will be sent Date Sent Select the date on which the document was will be sent Complete the addition of a paper supporting document by clicking Add once all the details are completed Page 72 Online Services Export Electronic Lodgement Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 6 Validation of t
14. Spo News gt Help gt Training Logout Last updated 23 09 2008 2 38 12 PM User Acceptance For further information contact the eBS Help Desk on 1800 010 624 eBS URL https www ebsacceptance tga gov au Therapeutic Goods Administration Copyright Security Disclaimer Privacy amp A Internet H start 4 ow S Re Web User Gui Jj TGA eBusiness Se Figure 1 TGA eBusiness Services Home Page The TGA eBusiness Services Home Page is publicly accessible Security will be applied to most of the system beyond this point based upon the access that users have been granted Only users who are registered as an agent or a sponsor will be able to access the Export Medicines applications Page 4 Online Services Accessing Other Business Unit Systems 0546548 doc Export Electronic Lodgement Access to the Export Electronic Lodgement system and TGA s other business unit systems is via the TGA eBusiness Services Home Page 1 Navigate to the Home Page at the URL above 2 Click on the first twistie Portal to reveal the View Drafts link 3 As seen below in Figure 2 all drafts from all business unit systems are now accessible a TGA eBusiness Services Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help sack x A f JP Search K Favorites R a Address https www ebsacceptance tga gov au TGA e
15. Under Review 2008 06 24 MI 24062008 CE 001439 11 Under Review D 2008 06 16 MI 16062008 CE 001431 11 Under Review 2008 06 16 MI 16062008 CE 001432 11 Under Review 2008 06 16 MI 16062008 CE 001430 11 Under Review 2008 06 16 MI 16062008 CE 001429 11 Under Review D 2008 05 16 MI 16052008 CE 001405 11 Under Review 2008 05 15 MI 15052008 CE 001403 11 Under Review 2008 05 15 MI 15052008 CE 001402 11 Under Review D 2008 04 22 MI 22042008 CE 001377 11 Under Review D 2008 04 18 MI 18042008 CE 001374 11 Under Review D 2008 04 18 MI 18042008 CE 001372 11 Under Review Lodge Supporting Documentation Maintain User Account gt TGA Information Accepted Manufacturer Information a Accepted Medical Device Evidence SOLETRADE P Sponsor Cancellation Online Invoice Payment t E EX Ek E E G3 E 3 00000000008 News D 2008 04 01 MI 01042008 CE 001352 11 With Manufacturer Help 2008 04 01 M 01042008 CE 001351 11 With Manufacturer Training D 2008 04 01 MI 01042008 CE 001350 1 Under Review 2008 04 01 ML 01042008 CE 001349 11 Under Review Logout D 2008 03 18 MI 18032008 CE 001343 11 Under Review 2007 11 02 MI 28052007 CE 001060 11 Withdrawn D 2007 10 31 ML31102007 CE 001219 11 With Manufacturer j 2007 09 25 2007 2796 2 CAT 1 NCE Type A Pfizer Date of AEC changed to Australia 188 15th October 2007 as per Pty Ltd d Done amp Internet ti Start Cc wo S Josh Wiley Inbox
16. Word 24 Therapeutic Good 2h Microsoft Word 4 02 Tuesday Figure 11 Solely for Export Medicine prepared from a code stock application form 0546548 doc Page 31 Online Services 0546548 doc Field Export Electronic Lodgement Description Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information Product Name This field is mandatory Enter the name of the product This is the final product name that will be used if the product is listed on the ARTG Export Names This field is not mandatory Single click the Add Edit button to add an export name to the application Multiple export names can be added by adding Enter behind each name Save and Close the subform Product Type This field is mandatory Select the product type from the drop down list Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Only Medicines system Billing Address Regulatory Contact Address This field is Mandatory Select the appropriate address from the drop down list This field is Mandatory Select the appropriate address from the drop down list Is this Application in response to a Section 30 The syste
17. added For details on the Indications subform refer to Page 56 Warnings This field is conditionally mandatory Single click the Add button to add a warning to the application Multiple warnings can be added For details on the Warnings subform refer to Page 57 Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 5 Validation of the application Refer to Validating an Application on Page 74 for details 6 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 7 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 Page 39 Online Services Export Electronic Lodgement Creating a A Change Multiple Listing application is used to make specific changes to Change to multiple existing ARTG listings The details that can be changed include the Multiple product name and any common manufacturing steps Additionally new Current common manufacturers can be added to all selected ARTG listings Listings How to createa 1 From the Export Only Medicine link underneath the Create Applications Change to amp Submissions link under the Portal select the S 26a Solely for Export
18. aie oet nx de atra E e open tre Re Reden ergab re pit 83 Other Features M 84 EXpOrtiNeOws 15 oni toate ep pU Dette edite a air eee id e eee ever e 84 0546548 doc Page iii Online Services Introduction Overview Who Should Use This Manual How to Use This Manual Assumptions Help 0546548 doc Export Electronic Lodgement Introduction Welcome to the Therapeutic Goods Administration TGA eBusiness Services system This system has been developed to provide the customers of TGA services with an easy and modern way of conducting business with TGA From the Portal on the homepage all of the sub systems within the Online Services system for the business units within TGA are able to be accessed This document is a user guide for the Export Electronic Lodgement system EEL a sub component of the eBusiness Services system It provides an outline of the Export system and provides external customers with instructions for using the system Any individual or organisation wishing to lodge an Export Only Solely for Export or Export Certification CPP application to the TGA should use this document This document will guide users through the functionality provided by the Export Electronic Lodgement system This manual has been written for users of the Export Electronic Lodgement facility available from the TGA eBusiness Services web site This document identifies each of the
19. appropriate sponsor name from the list Billing Address This field is Mandatory Select the appropriate address from the drop down list Regulatory Contact Address This field is Mandatory Select the appropriate address from the drop down list Validation Report Displays a report of an attempt at validation of the draft application Messages displayed will indicate the source of any application errors These errors must be fixed to proceed with further validation attempts Submission cost Displays the submission cost when the draft application has been entered and validated Application Status This field is populated by the system depending on the current status of the application Payment This field is not mandatory If permitted by the TGA Exemption No enter a payment exemption number if an exemption is applicable to this application Application type Displays the final type of application when the draft application has been entered and validated In the case of multiple listing application type is always Variation Note This field only appears when the application status is Passed Validation List of Medicines to be changed Medicine AUST L This field is Mandatory Single click the Add button to add an existing medicine AUST L to the application Search for the AUST L and Save and Close the subform Multiple medicines can be added Medicines selected w
20. as part of validating the application If circumstances dictate that a conditionally mandatory field is required to be completed and the field is not completed prior to validation a validation failure message will indicate that the information is necessary Similarly in S26 Export Only applications once a shelf life has been nominated the fields Shelf life temperature and Storage conditions require entering also Container Type Container Volume Figure 4 Examples of the Mandatory and Conditional Mandatory stars NB If not printing on a coloured printer the Container Type above is a red star mandatory field the Container Volume is a grey star conditionally mandatory Page 10 Online Services Export Electronic Lodgement S26 Export Only Applications Overview ofan An Export Only General Listing application is used for all medicine products Export Only General Listing Application Creating an Export Only General Listing Application 0546548 doc other than Composite Packs and Change Multiple Current Listings General Listing applications differ from Composite Pack applications only in that they have a single preparation in the same container where as Composite Pack applications have multiple preparations 1 From the Export Only Medicine link underneath the Create Applications amp Submissions link under the Portal select the S 26 Export Only link
21. be displayed in edit mode ready for information to be entered see Figure 12 below 4 Complete the Application by entering information into the following fields application 4 Therapeutic Goods Administration Solely for Export Medicine Kit Listing Application Microsoft Inte File Edit View Favorites Tools Help Qx WAG J Search she Favorites 42 2 468 Address https www ebs tga gov au ebs EM EMDrafts nsf MediKitApp openform TGA eBS Solely for Export Medicine Kit Listing Application Save Save amp Close Close Validate be Client Reference TGA will not retain this information x Always Required x Required under certain conditions Product Name Export Name s Add Edit j Product Code Drug Kits v Client Name TGA DemoS Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product your billing address and regulatory correspondence address Please select the relevant addresses for this product entry Billing Address v Regulatory v Correspondence Address Note The addresses are being read from your Client electronic record If you require reference to a different address it must be notified to the TGA for inclusion in your address list so that this application can be completed Please use the Client web update form to nominate the new address details Is this Application in respons
22. button to add a warning to the application Multiple warnings can be added For details on the Warnings subform refer to Page 57 Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 5 Validation of the application Refer to Validating an Application on Page 74 for details 6 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 7 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 0546548 doc Page 36 Online Services Export Electronic Lodgement Creating a Composite Pack Application How to create a Composite Pack Application A Composite Pack application is used for all listed medicine products other than General Listing including variation and grouping Medicine Kits and products prepared from code stock Composite Pack applications differ from General Listing applications only in that they have multiple preparations in the same container where as General Listing applications have a single preparation From the Export Only Medicine link underneath the Create Applications amp Submissions link under the Portal select the S 26a Solely for Export link
23. form s 0546548 doc Page 60 Online Services 0546548 doc Export Electronic Lodgement Display Dosage Form Manufacturer Details This field will only appear if option b or c is selected for the sponsor status This field offers three choices for the inclusion of the dosage form manufacturer s details Suppress details from certificate Select this option if you wish to keep the dosage form manufacturer details confidential See Schedule 2 for manufacturing details Select this option for the words See Schedule 2 to appear on the certificate Ensure that you elect to show some or all of the manufacturers listed in the ARTG record for this product on this Schedule One of the manufacturers recorded against the AUSTL R selected Select this option to enable one of the manufacturers listed in the ARTG record to be selected in the Select manufacturer to appear on certificate field further down the form Contact details This field is Mandatory The name and telephone number of the person who is to be contact for any queries relating to this application are preferred here Certificate sent to This selects whether the certificate 1s delivered to the sponsor or a third party If the Other option is selected the form will refresh with an extra field for the name and address of the recipient Country requesting export certificate Select the name of the country r
24. have been approved for supply in Australia and for export The TGA eBusiness Services system through Export Medicines and other business area components controls this information through the level of access available to the user as detailed below e The Export system provides read only access for the records for which the client is either the sponsor or agent From the ARTG View clients sponsors or agents can also create an ARTG certificate of that product based on the information found on that product record on the ARTG The system also provides on line access for TGA s clients and members of the public Clients will have access to all their information while the public will have access to legally appropriate information via the Internet Page 2 Online Services Export Electronic Lodgement Benefits The fundamental business objective of the Export Medicines system is to provide an efficient means of managing tracking and reporting upon the processing and evaluation of client submissions Anticipated benefits that TGA clients will gain from the use of the Export Medicines system include the following e The quality of applications submitted will be enhanced by the instant validation of each application before submission e Time required for the creation of an application will decrease e Automatic notification via email if a product is successfully listed on the ARTG e Clients can track the progress of their applic
25. text field allows the user to enter either the whole name of the Ingredient the start of the name or any part of the name depending on the choice made on the Search On field Once populated click the Search button to the right of the field e Search Proprietary Ingredient PI by ID enter the PI TGA s assigned ID and click the Search button to the right of the field e Enter a proposed Ingredient Name if it is not currently an approved ingredient with the TGA enter the proposed name of the ingredient and click the Continue button to the right of the field 0546548 doc Page 43 Online Services 0546548 doc Export Electronic Lodgement Once the search is completed the following form will be provided 4 Therapeutic Goods Administration Ingredient Microsoft Internet Explorer provided by Therapeutic File Edit View Favorites Tools Help Back 3 2 p gt Search sie Favorites 4 a Bae Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf Ingredient OpenForm amp ParentUNID 23E178D9BA9EBO8CCA2574CDOOOES0EC amp Seq 2 v TGA eBS Ingredient Save amp Close Close Application Home Ingredient Name Ingredient Type Specification Ingredient Quantity Is this Ingredient of human or animal origin BP v Component Add Always Required x Required under certain conditions v OYes No Save j Save amp Close Close Last updated
26. the drop down arrow to select the appropriate container type for the formulation Container Volume This field is conditionally mandatory Its status is determined by the rules applied to the ingredients included in the formulation Enter the numeric quantity for the container volume then use the drop down arrow to select the appropriate volume measure These fields are conditionally mandatory If desired select the appropriate description from each corresponding drop down list Container Closure Container Material Container Condition Visual identification of dosage form This field is mandatory Enter a text description of the visual identification of dosage form Is this component supplied sterile This field is mandatory Select Yes or No If Yes is selected then Sterility Description field that appear must be completed This field is conditionally mandatory If selecting Yes to the question above this field will become available Select a description from the drop down list This field is mandatory Single click the Add button to add an ingredient to the application Multiple ingredients can be added For details on the Ingredient Subform refer to Page 43 Sterility Description Ingredient 0546548 doc Page 50 Online Services The Preparation Step Subform used for herbal and homeopathic herbal ingredients 0546548 doc Export Electronic Lodgement Fr
27. the selected applications A message will be displayed requiring that the Statutory Declaration be read and the Agree or Disagree button must be selected Select OK The Statutory Declaration will be displayed 6 Read the Declaration and select the appropriate button at the bottom of the form Agree or Disagree 7 The Make Submission page will be displayed with the selected application in the Applications in this Submission table at the bottom of the form 8 If more than one application is to be submitted repeat steps 4 7 above 9 Once all applications to be submitted are showing in the table select the Submit button 10 The Checklist page will be displayed See figure 32 below 4 Therapeutic Goods Administration Checklist Microsoft Internet Explorer provided by Therapeutic File Edit View Favorites Tools Help sack x 2 search s Favorites 2 BOB s Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf AllIByUNID FC3F762E2 1 CDD7FBCA2574CD0010E018 0penDocument TGA eBS Checklist Submit j Cancel Print The product name stated on the labels of the therapeutic good which is the subject of this application is Product Name The Power and the Passion Take 898 Sponsor s Business name Blackmores Limited Sponsor Enterprise ID 10576 Applications in this Submission Product Name The Power and the Passion Take 898 Checklist
28. this field only appears when the Application status is valid Validation Report Displays a report of an attempt at validation of the draft application Messages displayed will indicate the source of any application errors These errors must be fixed to proceed with further validation attempts Formulation Single click the Add button to add a formulation to the Details application Multiple formulations can be added For details on the Formulation Subform refer to Page 49 Manufacturer s This field is mandatory Single click the Add button to add a manufacturer to the application Multiple manufacturers can be added For details on the Manufacturer s Subform refer to Page 47 Product Details Does this Composite Pack include a medical device registered on the ARTG Select Yes or No System default response is No If Yes is chosen the form will refresh providing a free text field for device details Will product comply with specific and general standards applicable to product under Chapter 3 Part 3 1 Standards of Therapeutic Goods Act 1989 during the entire shelf life of the product The system default response has been set on No Selecting Yes or N A will remove the following text field for non compliance justification Justification for non compliance with specific and general standards applicable to product under Chapter
29. 0 0546548 doc Page 52 Online Services The Carrier Subform 0546548 doc Export Electronic Lodgement From an ingredient subform clicking the Add button beside the Carrier field will provide the user with the Carrier subform as shown in the figure below Image24 Windows Picture and Fax Viewer Ai Therapeutic Goods Administration Carrier Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help Qa AG svo dere O A FSu ebsacceptance tga gov au ebs LM L MDrafts nsf Carrier OpenForm amp ParentUNID 8449475DF83176DCCA2574CD001C9 14C e Go TGA eBS Carrier Save j Save amp Close Close Application Home Help Always Required Required under certain conditions Parent Ingredient Name Hypericum perforatum Carrier Name x Carrier Quantity Lactose m Lecithin Magnesium carbonate Save Save amp Close Close AlMagnesium hydroxide Magnesium oxide Last updated 23 September 2008 Magnesium stearate User Acceptance For further information contact the eBS Help Desk on 1800 01 URL https vww ebsacceptance tga gov au ebs LLA EL ED 8449475DF82176DCCA2574CD001CS14C 624 eBS toa gov a Olive Oil Therapeutic Goods Administration Copyright Security Disclaimer Privac Potassium sorbate Statemer Silica colloidal anhydrous Silicon dioxide Soya Oil Starch acid treated waxy maize Starch glut
30. 23 September 2008 Application Home User Acceptance URLHhttps www ebsacceptance tga gov au ebs EM EMDrafts nsf Ingredient OpenForm amp ParentUNID 23E178D9BA9EB08CCA2574CD000ES0EC amp Seq 2 information contact the Desk on 180 eBS Therape Administration Security Disclaime Done i start Josh Wiley Inbox amp Internet Therapeutic Good Zl Microsoft Word ens Figure 16 Ingredient subform after a successful search To complete the form use the following table for information _ Fild Deseription Ingredient Name Proprietary Ingredient ID Supplier ID Ingredient Role Use the drop down box to select the Ingredient name from the search results If only one ingredient was found this will appear in the field This field will only appear if the ingredient role selected during the search is Proprietary Ingredient This field will be automatically populated once the Ingredient Name is selected This field will only appear if the ingredient role selected during the search is Proprietary Ingredient This field will automatically populate once the Ingredient Name is selected This field will only appear if the ingredient is a proposed ingredient Select between Active Excipient and Active Homeopathic Page 44 Online Services 0546548 doc Export Electronic Lodgement Ingredient Type This field will b
31. 3 Part 3 1 Standards of Therapeutic Goods Act 1989 If No is selected for the above question then this is a mandatory field Enter a text description of the justification for non compliance Page 19 Online Services 0546548 doc Export Electronic Lodgement Has this product been cancelled recalled or rejected for registration or listing on ARTG for supply in Australia Select Yes or No The system default response has been set on No Selecting Yes will result in the following field becoming available Details of prior cancellation recall etc This field is hidden until Yes is selected for the question above Provide details of previous cancellation or recall in the text field Has this product been granted marketing approval for supply in the importing country Select Yes or No The system default response is No Selecting Yes will result in the following field becoming available Details of approval This field is hidden if No is selected for the question above otherwise provide details of the marketing approval in the text field Only one country s approval details are required Have you launched an application for grant of marketing approval in the importing country Please comment on the present status of your application This question is only available if No is selected to the question opposite The system de
32. 8 doc Indication Type Select either coded or custom If Coded is selected enter a code or term in the Search For field to search for a coded indication If Custom is selected the Enter custom indication text field will be displayed Enter custom indication text This field will only be displayed if Custom is selected in the Indication Type field This field is mandatory Enter the custom indication text here Page 56 Online Services Export Electronic Lodgement Search For This field will only be displayed if Coded is selected in the Indication Type field This field is mandatory Enter the code or term to search upon and single click Search If the search is successful a list of coded indications will appear Select coded This field will only be displayed after a successful indication from search list This field is mandatory Select at least one coded indication by placing a check against it If none of the indications in the list are appropriate enter a new code term in the Search For field and single click Search again The Warnings Subform This subform is available for S26a applications 0546548 doc From an application subform clicking the Add button beside the Warnings field will provide the user with the Warning subform as shown in the figure below 3 Image46 Windows Picture and Fax Viewer Therapeutic Good
33. BS Indication Save j Save amp Close Close Application Home Help Search For well Xt Type either the indication code Search lor a phrase which appears in the indication Select coded indication from list ARTH3 May help reduce joint swelling associated with arthritis GOUT3 May help reduce joint swelling associated with gout WELL Aids assists or helps in the maintenance or improvement of general well being WELL1 Aids assists or helps in the maintenance of general well being WELL2 Aids assists or helps in the improvement of general well being Save Save amp Close Close Application Home Last up 3 September 2008 User Acceptance For further information contact the eBS Help Desk o URL https w ww ebsacceptance tga gov au ebs LM LMDrafts ns Indication OpenForm amp ParentUNID 06067D 1374666 160CA2574CD001BCF1D amp Seq 1 1800 010 624 e8S toa gov a Therapeutic Goods Administration Copyright Security Disclaimer Privac Statemer I https www ebsacceptance tga gov au ebs LM LMDrafts nsf B internet D Ep oe 0 eee es 00 fi ebsPics uy AP awe xa Hu 9 Cc fr e SIME Notes Home Gy Microsoft Word FS 1mage41 Windo Figure 26 Indication Subform with coded indication selection made and indication options provided as a result of the text entered well To enter the indication details for an application complete the fields as detailed below 054654
34. BusinessServices Australian Governme Department of Health a User Acceptance Tr a in Portal TGA Demo Drafts Sponsor i Viewing 4 of 4 entries P View Drafts i Approval Area an Approval Areas view pdoe Sponsor All Sponsors v Portal Help Search on Date for i l Date Identifier Client Reference Information Sponsor EPa e E e D 2008 09 16 TGA Demo A GO 2008 09 16 TGA Demo A gt a edie cil GO 2008 08 21 DV 2008 MC 56636 3 Viet testing ACC 516 001 TGA Demo Spo 3 4 2008 08 20 DV 2008 MC 56628 3 TGA Demo Spo Maintain User Account gt TGA Information 1 Accepted Manufacturer Information Accepted Medical Device Evidence a SOLETRADE Sponsor Cancellation Online Invoice Payment gt News gt Help Training Logout Last updated 23 09 2008 2 38 12 PM User Acceptance For further information contact the eBS Help Desk on 1800 010 624 eBS URL https www ebsacceptance tga gov au Therapeutic Goods Administration Copyright Security Disclaimer Privacy amp l Bj Internet E w g F start Josh Wiley Inbox J TGA eBusiness Se i Microsoft Word 4 The Drafts page will display all current application drafts from all the business systems To identify the drafts from one business area only use the dropdown list at the end of the Approval Area field and select the appropriate business area eg Export Only If an agent with multiple cl
35. D 4109A 1 ADBDO3EB34CA2574CD000F4FCO TGA eB5 Solvent Save j Save amp Close Close Application Home x Always Required x Required under certain conditions Parent Ingredient Ginkgo biloba Name Please enter solvent s for the chosen preparation step Name Percentage Solvent o Solvent x ts Solvent i Solvent 96 Solvent 96 Remainder Water Save Save amp Close Close Application Home Last updated 23 September 2008 User Acceptance URL https www ebsacceptance tga gov au ebs EM EMDrafts nsf SolventList OpenForm amp ParentUNID 4109A1ADBD03EB34CA2574CD000F4FCO information contact the eBS on 1800 010 624 eBS Therapeutic Goods Adm Copyright Security E Privacy Done A Internet ti Start Cc fv e Josh Wiley Inbox J Therapeutic Good Ul Microsoft Word Figure 21 Solvent Subform To enter the solvent details for a preparation step complete the fields as detailed below Solvent Each of these fields is conditionally mandatory At least one solvent needs to be selected and its corresponding percentage entered Percentages must add up to exactly 100 Remainder Water This field is conditionally mandatory Checking this field will create Water purified as a solvent with a percentage value to ensure that the 100 percent total is reached If no other solvents are entered this will set the percentage of Water purified to 10
36. ES PROSEREN Blackmores z CAPSULES Export Ultimate Limited 2008 09 16 EX 2008 EX 14123 B None Blackmores CoQ10 Blackmores Limited 2nna na n5 EX 2nn8 EX 14115 R I s Solely Test I s Sinale Solely Product Blackmores vi amp Internet Josh Wiley Inbox TGA eBusiness Se i Microsoft Word gt 13 03 Tuesday Figure 31 Drafts view for all application types Export Only Medicines filter shown here displays only Export Only draft applications 0546548 doc Page 75 Online Services Export Electronic Lodgement Making a Submission Making a The Make Submission page is used to select one or more validated Submission applications to be submitted to TGA for processing and listing on the ARTG Submissions may be made for the following types of applications 1 S 26 Export Only Applications 2 S 26a Solely for Export Applications 3 Export Certificates How to makea 1 submission 3 Therapeutic Goods Administration Make Submission Microsoft Internet Explorer provided by Thera L EX From the Export Only Medicine link underneath the Create Applications amp Submissions link under the Portal select the Submission link The different types of Export Only applications will be displayed Select the appropriate application type eg Certificates The Make Submission page is displayed as shown in Figure 31 below File Edit View Favorites Tools Help a Back
37. Enter Manufacturer ID Search OR Enter Name Search Close Application Home Last updated 23 September 2008 User Acceptance For further inform URL https www ebsacceptance tga gov au ebs EM EMDrafts nsf Man OpenForm amp ParentUNID 23E178D9BA9EB08CCA2574CD000E80EC contact the eBS Help Desk on 1800 010 eBS tga gr Therapeutic Goods Administration Copyr Security Disclaimer Privacy State El Done Bj Internet i start E v e Josh Wiley Inbox Zj Manufacturer M i Microsoft Word Figure 17 Australian Manufacturer Subform 2 For the Australian Manufacturing form enter either the Manufacturer ID or the Manufacturers Name and press the Search button beside the form a Manufacturer Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help Qa x A Search K Favorites O 2 BEB B Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf Man OpenForm amp ParentUNID 23E178D9BA9EB08CCA2574CD000ES0EC amp Seq 1 Y Go TGA eBS Manufacturer Close Application Home He Always Required x Required under certain conditions Manufacturer O Australian Overseas Has the standard of GMP Yes good manufacturing ONo process been approved by the TGA Enter Clearance ID Search OR Enter GMP Reference Search Number Legacy j 0546548 doc Ghose Application Home Last updated 23 Septemb
38. Fax Contact Email Address 10576 TGA Revenue Department 02 6232 8228 02 6232 8222 TGAAccount health gov au Identifier Application Type Unit Price GST Total Application fees are exempt from GST under Division 81 of A New Tax System Goods amp Services Tax Act 1999 Subtotal 560 00 GST 0 00 PAYMENT OPTIONS Total 560 00 ON LINE PAYMENT OPTION Credit card and Direct Debits may be paid on line at https pnpnet qvalent com tga When paying on line the Reference Number printed below must be quoted Payment Reference No L0145888 CREDIT CARD CC Authorisation form is available at http www tga gov au docs htmlfeesach htm CHEQUES Please make cheques payble to Therapeutic Goods Administration and forward with a copy of this Invoice to PO Box 100 lt Done Bj Internet W start E wo e Josh Wiley Inbox Qj https www ebsa Uli Microsoft Word Figure 33 Payment Lodgement form 13 PRINT the Payment Lodgement form complete the details and send it to the TGA or use the Credit Card link to pay for the submission online Note It is essential that users Print the payment form at this stage as once the application is committed the payment form can not be retrieved 14 Select the Commit Submission button 15 The applications will then be submitted to the TGA for processing Note The application will now be visible from the Submitted Applications view 0546548 doc Page 78 Online Services Export Elec
39. General Listing link 3 The Export Only General Application form will be displayed in edit mode ready for information to be entered see figure 6 below 4 Complete the application using the information in the following table Page 11 Online Services Export Electronic Lodgement File Edit View Favorites Tools Help a sack x A A search s Favorites Ary BGA 3 Address https www ebs tga gov au ebs EM EMDrafts nsf EMGenapp openform E co Links TGA eBS Export Only General Application Save Save amp Close Close Validate Help Client Reference TGA will not retain this information Always Required x Required under certain conditions Product Name Export Name s Add Edit Client Name TGA DemoS Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product y ng address and regulatory correspondence address Please sele elevant addresses for this product entry Billing Address v Regulatory Correspondence Address Note The addresses are being read from your Client electronic record If you require reference to a different address it must be notified to the TGA for inclusion in your address list so that this application can be completed Please use the Client web update form to nominate the new address details Contact Details This application is to v Done B Inter
40. Once the application has successfully validated the Validation Report will indicate the application has Passed Validation 5 Save and Close the application 6 The application can now be submitted to the TGA using the process shown on Page 77 Page 74 Online Services Export Electronic Lodgement Existing Drafts Existing Draft Applications and Certificates Where are Existing Drafts Located All existing drafts for not only EEL but all of TGA s other electronic application lodgement facilities can be found in the main Drafts view which is accessed underneath the Portal see Figure 31 below Having clicked on the Portal users click on the View Drafts link Further filtering of desired draft applications can then be made using dropdown lists located at the end of the Approval Area and Sponsor fields 4 TGA eBusiness Services Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help Qx WAG J Search sie Favorites 4 a amp GB Address https www ebsacceptance tga gov au v Portal Heidi Csellner View Lodged Submissions Portal Help Create Applications amp Submissions Lodge Supporting Documentation Maintain User Account gt TGA Information Accepted Manufacturer Information Accepted Medical Device Evidence SOLETRADE Sponsor Cancellation Online Invoice Payment News gt Help gt
41. Online Services 0546548 doc Export Electronic Lodgement current status of the application Payment Exemption No This field is not mandatory If permitted by the TGA enter a payment exemption number if an exemption is applicable to this application Application type Displays the final type of application when the draft application has been entered and validated e g New Grouping Variation Note this field only appears when the Application status is valid Validation Report On Validating the application the system displays a validation report Messages displayed will indicate any errors will the application These errors must be fixed before the application can be submitted to the TGA Formulation details When an application uses an existing ARTG code stock listing as a base for the formulation details the formulation details are added to the code stock new application and are only available in read mode Manufacturer s This field is mandatory Single click the Add button to add a manufacturer to the application Multiple manufacturers can be added For details on the Manufacturers subform refer to Page 47 Indications This field is mandatory Single click the Add button to add an indication to the application Multiple indications can be added For details on the Indications subform refer to Page 56 Warning This field is conditionally mandatory Sin
42. This field is Mandatory Select the appropriate address from the drop down list Regulatory Contact Address This field is Mandatory Select the appropriate address from the drop down list Is this Application in response to a Section 30 The system default is No Select Yes if this application is being submitted as a response to a Section 30 request Enter the AUST L being responded to Can this product be used as a code stock The system default is No Select Yes if this application can be used as a code stock Page 27 Online Services 0546548 doc Export Electronic Lodgement This application is to change a current listing create a new listing This field is conditionally mandatory Nominate whether this application is to change an existing ARTG listing or to create anew ARTG listing To create a new export only product select Create a New listing If Change a current listing is selected the form will refresh to allow for the creation of a Grouping or Variation to a single current listing See page 25 for further details AUST L This field is hidden until Change a current listing is selected to the question above Enter an AUST L number from which to create a new draft copy Single click the Search button the application form will populate with the details of the AUST L record entered Submission Cost This field will be automatic
43. Tools Help Qa x A Search Yr Favorites Ary BOB B Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf Ingredient OpenForm amp ParentUNID 23E178D9BA9EBO8CCA2574CDO00E80EC E TGA eBS Ingredient Close Application Home Always Required x Required under certain conditions Search Formulation Active O Excipient Type Search Ingredient Standard O Homoeopathic Proprietary Ingredient Role Search On O Whole of field Start of field Any part of the field Search By Name i Search Or Search Proprietary search Ingredient By ID Or Entera proposed Continue Ingredient Name Close Application Home Last updated 23 September 2008 User Acceptance URL https Awww ebsacceptance tga gov au ebs EM EMDrafts nsf Ingredient OpenForm amp ParentUNID 23E 1 78D9BASEBO8CCA2574CDO00E80EC information contact the eBS on 1800 010 624 eBS Therapeutic Goods Adm Copyright Security Disclaimt Done A Internet W start Cwe Josh Wiley Inbox Therapeutic Good Microsoft Word Figure 15 Ingredient Subform To enter an Ingredient onto the application form 1 Select the type of ingredient i e Active or Excipient from the Search Formulation Type radio buttons 2 Select the ingredient role from the Search Ingredient Role radio buttons Searching for an ingredient can be made in the following ways e Search by Name This
44. Training m Logout javascript void displayDrafts i start Cwe TGA eBusinessServices Mies en Department of Health and Ageing User Acceptance mc ni Miis Drafts First Ed 2 3 Final Viewing 61 of 222 entries Page 1 of 3 Approval Area Export only Medicines v Sponsor All Sponsors v Search on Date v for Date Identifier Client Reference Information Sponsor Bo 2008 09 23 EX 2008 EX 14116 B J s Clone Back Attempt Clone of The Power and the Passion Blackmores Limited 80 2008 09 23 EX 2008 EX 14059 B Switcheroo J s Single Solely Product Mark 2 Blackmores 5 Limited 860 2008 09 23 EX 2008 EX 14111 B WILLITWORK J s Single Solely Product Mark 3 Blackmores 1 zi Limited 4 a0 2008 09 23 EX 2008 EX 14112 B BYGEORGEITWORKS J s Single Solely Product Blackmores Limited a 2008 09 23 EX 2008 EX 14129 B Yet Another One The Power and the Passion Take Blackmores ge 898 Limited a 2008 09 23 EX 2008 EX 14130 3 None dfghfdsh Blackmores go EE Limited 2008 09 23 EX 2008 CP 14131 3 None hfsdsfhhddhsf Blackmores Limited 2008 09 23 EX 2008 EX 14132 3 None sdffdhdfs Blackmores Go z Limited 2008 09 23 EX 2008 EX 14133 3 None dfshfdsh Blackmores ao Limi k imited 1 ao 2008 09 20 EX 2008 EX 14112 B BYGEORGEITWORKS J s Single Solely Product Blackmores 4 sz Limited i 2008 09 20 EX 2008 EX 14113 3 Test J s Test Product Solely Blackmores Limited Be 2008 09 16 EX 2008 EX 14122 B None BLACKMOR
45. a TEe Ced aa uan RE an ca Cu cC EH aa Ra RU au ao Ga crc Cu uiian 74 What Happens During the Validation of an Application essseeennm 74 How to validate an application iiia 2 ient rie m eie peri ieri tine ne be he ERE En eek ur eres 74 Existing EbIr ir H 75 Existing Draft Applications and Certificates cesses eneeeeeeeeee enne 75 Where are Existing Drafts located eterne RR ARP REOR HERI pP de 75 Making SubmisslIOn 1 eicoirasires senec oec copa daa ki ano ac cau ananin ROC se a eaaa aani 76 Making a SUBMISSION reniri e e tae ice ipee e ae de d ere geo d es 76 How to make submission irse en nir rere oet ih he AE A HERE a ERR lee Ea EARS aaia 76 Submitted ADDIICAlIORS iii rei saco eaaa SUB S ROSE EDU AU RAN ENG FACE ERR A ERES 79 Viewing Submitted Applications eene nnne nnnm nnne nnne tnit sn nennt reset nnn nnns 79 Withdrawing an Application oii acer epe ipee te ener Renee n tee dre undue e deban pe pe eae a gung eda eere 79 Australian Register of Therapeutic Goods ARTG Records 81 ARTG RIeCOrdS uie n eee nem abe led e item ete dr epic Noted 81 ACCES Sne M EN 81 Viewing ARTG Flecords e tede t Pod t EET Re AT 82 To display details of a Medicine entry in the ARTQG ssssssssssssesseeeeeeeeennee nennen nennen nnne nnne 82 Searching ARTG Biecords i is an te tiem
46. allows only for a single preparation step this field will be locked from editing and will be automatically populated with the value selected for the ingredient Otherwise if the preparation selected for the ingredient allows for multiple preparation steps this field will display as a drop down list which has a default value equivalent to the preparation selected for the ingredient Preparation Ratio These fields are conditionally mandatory The values in each field are by default the same as the ratio for the final preparation ratio Plant Preparation This field is mandatory The number entered here Step determines the sequence of the preparation steps when multiple preparation steps appear in an ingredient Page 51 Online Services Export Electronic Lodgement Solvents This field is conditionally mandatory Single click the Add Edit button and the solvent subform will be provided For details on the solvent Subform refer below The Solvent Subform From a preparation step subform clicking the Add Edit button beside the Solvent field will provide the user with the Solvent subform as shown in the figure below 4 Therapeutic Goods Administration Solvent Microsoft Internet Explorer provided by Therapeutic G File Edit View Favorites Tools Help Qx wa J Search she Favorites 4 ir i mo Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf SolventList OpenForm amp ParentUNI
47. ally populated once an application is validated It displays the submission cost of the application Application Status This field is populated by the system depending on the current status of the application Payment Exemption No This field is not mandatory If permitted by the TGA enter a payment exemption number if an exemption is applicable to this application Application type Displays the final type of application when the draft application has been entered and validated e g New Grouping Variation Note this field only appears when the Application status is valid Validation Report Displays a report of an attempt at validation of the draft application Messages displayed will indicate the source of any application errors These errors must be fixed to proceed with further validation attempts Note Validation rules for solely for export applications are the same as for listed medicines under ELF Formulation Details Dosage Form This field is mandatory Select the dosage form for the formulation from the drop down list Route of Administration This field is mandatory Single click the Add button to display the route of administration table Select the appropriate route s of administration by clicking on them one at a time and then clicking OK Multiple routes of administration can be added Select the Save amp Close button to return to the application fo
48. ame Abies nigra Component Name Lycopene Standardised On this C Yes No ingredient Component Quantity Save Save amp Close Close Application Home jJ Home Figure 3 Component Subform after successful component search To enter the carrier details for a component complete the fields as detailed Online Services Export Electronic Lodgement Parent Ingredient This field is automatically populated with the parent Name ingredient name Component Name This field is mandatory Select from the list of components returned by the search Standardised on This field is mandatory This field defaults to No this Ingredient Select Yes to standardise the parent ingredient with this component Component This field is mandatory Enter the numeric quantity Quantity value and click on the drop down arrow to select the unit of measurement The Remaining From an ingredient subform clicking the Add button beside the Remaining Restricted Restricted Solvent field will provide the user with the Remaining Restricted Solvent Solvent subform as shown in the figure below Subform 3 SIME C Remaining Restricted Solvent Save Save amp Close Close Application Home Home Always Required Required under certain conditions Parent Abies nigra Ingredient Name Name Residue Qty Unit Solvent Solvent I Solvent Solvent x Solvent
49. antity to equivalent quantity The system default is No Use the radio buttons select if this ingredient contains human or animal origins Page 45 Online Services 0546548 doc Preparation Steps Component Remaining Restricted Solvent only required if your product is to be listed under Section 26a Export Electronic Lodgement This field will only appear if the declaration of preparation steps for the selected plant preparation is appropriate Single click the Add button to add a preparation step For further details on the preparation step subform refer to page 51 Once preparation steps are added to the table the name of the preparation step will be a linked to the step details To edit the preparation step select the link To remove the Preparation Step click on Delete in the table This field will only appear if the declaration of carriers for the selected plant preparation is appropriate Single click the Add button to add a carrier For further details on the carrier subform refer to page 53 Once carriers are declared the name of each carrier will be a link to edit the carrier details There will also be a Delete link available to remove the carrier Select the Add button to add a component This will provide a Component subform refer to Page 54 for details on this form Once a component is declared its name will act as a link to the component subform for edi
50. ating a change to a single current listing through an existing ARTG record Error Bookmark not defined S26a Solely for Export Applications eese eee eeeeeeeee seen nennen nnne annt nnmnnn nnn 26 Solely for Export General Listing Application sssssssseseeeeeeeneenneenneen nennen nnne 26 Creating a Solely for Export General Listing Application essen 26 Solely for Export Medicine Application prepared from a Code Stock ssssssssssssssss 31 Creating a Solely for Export Medicine Application prepared from a Code Stock sssssssssssse 31 Solely for Export Medicine Kit application essssesseesesseseeeeneeeeeeenenennnne nennen nennen nnne nnne nnne 34 Creating a Solely for Export Medicine Kit application esee nennen 34 Creating a Composite Pack Application eese nnne neret en nennen nennen nennen 37 Creating a Change to Multiple Current Listings essen nnne nenne 40 PX sert opium 43 The Ingredient SubfOLtm 2i tero qp reete Qa tfe ae a ee edite e t een ds 43 The Man fact rers SubfOrtm 3 5 nma RR ERR RUE tO iet eR Recte nne 47 The Formulation SUBIN iiie degree terere cee cee DUE Eee eu ane averse ieee eee nite 49 The Preparation Step Subfoftm 5 2 e en rei cte rp Ea We peed eens 51 ThE SOlVENt SUDOM eeik eaea aeee av enue ha
51. ation 1 a Accepted Medical Device Evidence SOLETRADE Sponsor Cancellation Online Invoice Payment gt News gt Help gt Training m Logout 1 1 M M XM M Last updated 23 09 2008 2 38 12 PM User Acceptance For further information contact the eBS Help Desk on 1800 010 624 eBS URL https www ebsacceptance tga gov au Therapeutic Goods Administration Copyright Security Disclaimer Privacy E https www ebsacceptance tga gov au ebs ANZTI PAR TTReg nsf intAMedicineProCU OpenView amp Internet 4 start w S Josh Wiley Inbox 4 TGA eBusiness Se Ul Microsoft Word Figure 35 Accessing ARTG Information from the eBS Home Page 1 From the E Business Home Page select the TGA Information link 2 To view Medicines on the ARTG select the Current Medicines link An example is provided below Page 82 Online Services Export Electronic Lodgement File Edit View Favorites Tools Help a Qa x A 5 search e Favorites 2 BBO BX Address https www ebs tga gov au ebs ANZTPAR TTReg nsf intMedicineProCUEO OpenView TGA eBS HAEC EC N Current Devices S _ Search Export Only Prev Next aaa i EESENEE Ajax chemicals concentrate Fluid for Haemodialysis Cat 44055 93037 Listed Fresenius Medical Care Australia No 1927 bottle Export Only ANAMORPH 10mg tablet bottle 65560 128253 Listed Sigma Pharmaceuticals Austral
52. ation when the draft application has been entered and validated e g New Grouping Variation Note this field only appears when the Application status is valid 0546548 doc Page 35 Online Services Validation Report Export Electronic Lodgement On Validating the application the system displays a validation report Messages displayed will indicate any errors will the application These errors must be fixed before the application can be submitted to the TGA Listed Registered Medicine This field is mandatory Single click the Add button to add a medicine to the application Search for the AUST L R and Save and Close the subform Multiple medicines can be added be repeating the process Exempt Medicines Single click the Add button to add an exempt medicine to the application Enter the details Save and Close the subform Multiple exempt medicines can be added by repeating the process Manufacturer s This field is mandatory Single click the Add button to add a manufacturer to the application Multiple manufacturers can be added Fore details on the Manufacturers subform refer to Page 47 Indications This field is mandatory Single click the Add button to add an indication to the application Multiple indications can be added For details on the Indications subform refer to Page 56 Warning This field is conditionally mandatory Single click the Add
53. ations on line 0546548 doc Page 3 Online Services Introduction The TGA eBusiness Services Home Page 0546548 doc Export Electronic Lodgement Getting Started The TGA eBusiness Services system is available through the Department of Health and Ageing web site The TGA eBusiness Services web interface conforms to the Department of Health and Ageing web useability standards The TGA eBusiness Services Home Page is available at the following URL http www tgasime health gov au sime home nsf will need to have this entered later 4 TGA eBusiness Services Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help Qs k x a J Search sie Favorites e 27 amp as Address https www ebsacceptance tga gov au e 2 Australian Governme TGA eBusinessServices E AMAA User Acceptance Tisi Gode Mn Portal TGA Demo Drafts First Sponsor Viewing 4 of 4 entries P gt TGA Information Approval Area All Approval Areas M Accepted Manufacturer Sponsor All Sponsors vj Information Search on Date for Accepted Modica Date Identifier Client Reference Information Sponsor Device Evidence ST Ser TAPSEA 860 09 emo m SOLETRADE BO 2008 09 16 TGA Demo A Sponsor Cancellation GO 2008 08 91 DV 2008 MC 56636 3 Viet testing ACC 516 001 TGA Demo Spo Online Invoice Payment G O 2008 08 20 DV 2008 MC 56628 3 TGA Demo
54. be added to all Application selected ARTG listings Creating a 1 From the Export Only Medicine link underneath the Create Applications Change to amp Submissions link under the Portal select the S 26 Export Only link Multiple 2 The Export Only S26 application types will be displayed Select the Current Listings Change multiple current listings link The Variation Change Multiple Listings Application form will be displayed in edit mode ready for information to be entered see figure 8 below 3 Complete the Application by entering information into the following fields 3 Therapeutic Goods Administration Variation Change Multiple Listings Application Microsoft Interne EX File Edit View Favorites Tools Help a sack x 2 f Search e Favorites Ary BOB 3 Address https www ebs tga gov au ebs EM EMDrafts nsf EMMultiChangeApp openform v EJ Go Links TGA eBS Variation Change Multiple Listings Application Save j Save amp Close Close Validate Help Client Reference TGA will not retain this information Always Required x Required under certain conditions Change Multi Listing Name Client Name TGA DemoS Sponsor Name Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product your billing address and regulatory correspondence address Please sele
55. be notified to the TGA for inclusion in your address list so that this application can be completed Please use the Client web update form to nominate the new address details Submission Cost Application Status Draft Application Type Validation Results List of Medicines to be changed Medicine AUSTL aaa Product Name Text Replacement Done B Internet En dE e Josh Wiley Inbox 9 Microsoft Word 4 Therapeutic Good Ul Change Multiple S ECL Tuesday Figure 14 Change Multiple Solely for Export Listings Application 0546548 doc Page 40 Online Services Export Electronic Lodgement This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft Client Reference Change Multi Listing Name Client Name application TGA will not retain this information This field is mandatory Enter the name of the Change Multiple Listing draft This name will be used to identify the set of current listings that will have the changes made to them However it will not be written to the ARTG System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Only Medicines system Billing Address This field is Mandatory Select the appropriate address from the drop down list Regulatory Contact Address Th
56. ct the relevant addresses for this product entry Billing Address v Regulatory Correspondence Address Validation Results Submission Cost Application Status Draft Payment exemption number a List of Medicines to be changed Medicine AUSTL aaa Product Name Text Replacement Replace ba Done amp Internet 7 start E fv e Josh Wiley In Bk Microsoft Word Therapeutic Go G Document2 Mi Di Microsoft Word i Microsoft Word g 9 7 Tuesday Figure 8 Export Only Multiple Change Listing Form 0546548 doc Page 22 Online Services 0546548 doc Field Export Electronic Lodgement Description Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information Change Multi Listing Name This field is mandatory Enter the name of the Change Multiple Listing draft This name will be used to identify the set of current listings that will have the changes made to them However it will not be written to the ARTG Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Only Medicines system Sponsor Name This field is Mandatory If this form is being used by an Agent select
57. dith a e EEEa E a EAEE Fa a ei Nea RATE aaRS E abii SEA Paint 52 0546548 doc Page ii Online Services Export Electronic Lodgement The Carfier SubfOEm ee E te ebore teer e Gadhia e ir EE ten ca eee ah aceto d 53 The Gomponent SUDfOEIm ic dto teer mtb Die Ert de ame ae toe efe pte Rr Dre due o last 54 The Remaining Restricted Solvent Subform sssesssssssssseeeeeeneeenee nennen nnne nnns 55 The Indications S bfOrrm 1 reete inerte enne rera tore eua tu any E Gd e SY aga ue divert de e ead e 56 The Warnings SUbfOFIm Se imss rer me e cr pectet ore tpe eet LU etie e ip deett theod n to gres 57 Export Certificates 9 59 New Application 2 2 12 2 22 c rciricie iioi iedcecciiecece ci sedueats Socceecusdeccuedvinceesevueesys 59 Certificate of Pharmaceutical Product CPP Application sese 59 Creating a GPP Application 1 ee m p Ades eite de e De a HR Lone egt a Eo ite eoa 59 Certificate of Listable Product CLP Application sessessseseseeeneeeneeenenneeennen nennen nennen 64 Creating a CLP Application iier in e C ERR EHE RM EROR Aaa SiE Eiis 64 Certificate of Exempt Product CEP Application sssssssseseeeeeeeeenenneneenennen nennen nene 69 GCreating a GEP Application iss 3 t bre Segue ade datae ape RUE C eate de etn Re UE daa ete 69 Validating an ApplICallOh iieeiaiceta ccc cian ar do ga sE
58. e application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 6 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 0546548 doc Page 24 Online Services Changing a Single Current Listing Variation Grouping Creating a change to a single current listing through General Listings Application or Composite Pack 0546548 doc Export Electronic Lodgement This option allows users to make changes to a single current listing on the ARTG This is achieved by opening a General Listing Application form or a Composite Pack form from the Export Only Medicines underneath the Create Applications amp Submissions link and selecting the S 26 Export Only link The Export Only S26 application types will be displayed and once the appropriate application form has been selected and opened selecting the Change a current listing button as seen below This application is to Change a current listing C Create a new listing Change Description Search AUST L Add Submission Cost Application Draft Status Payment Exemption No m Validation Report Figure 9 Export Fields available on the Application form for changing a current listing When t
59. e appropriate period of time from the drop the recommended storage condition down list Similarly to nominate shelf life temperature as stated on the label is and storage conditions select the desired options from the appropriate drop down lists Proposed Therapeutic Indications This field is non mandatory Text can be provided for the proposed therapeutic indications to be displayed on the label Electronic Supporting Attachment List Attachments This is conditionally mandatory depending on if the user has selected to Add an electronic file One or more electronic files can be attached to the application by clicking Add For example Product label and Product specification To Delete an electronic file select the Delete link in the Attachment table under the Action column Paper Supporting Document List Paper Supporting Document List This is conditionally mandatory depending on if the user has selected to Add a paper supporting document type Select the type of document Provide a free text description of the document Method of Submission Select the method via which the document has been will be sent Date Sent Select the date on which the document was will be sent Complete the addition of a paper supporting document by clicking Add once all the details are completed Note The system default is today s date however this can be updated To remove a paper supporting documents
60. e automatically populated once the Ingredient Name is selected Ingredient Type Specification Ingredient Quantity Plant Part Plant Preparation Equivalent Preparation Equivalent Quantity Final Preparation Ratio Is this ingredient of human or animal origin Select the specifications from the drop down list provided Enter the quantity in the first field and use the drop down list to select the quantity measure in the second field This field will only appear if the ingredient type is of a herbal origin Select the appropriate plant part that the ingredient is derived from This field will only appear if the ingredient type is of a herbal origin Select the appropriate preparation used to extract the ingredient This field will only appear if the ingredient type is of herbal origin Select the appropriate equivalent preparation type Some ingredients will require the declaration of an equivalent for validation and others will allow only specific equivalent types to be declared Not declared is the default selection Fresh Dry Juice fresh and Juice dry may be selected Enter the quantity in the first field and use the drop down list to select the quantity measure in the second field This field will only appear if the ingredient type is of herbal origin Enter a number in the text field to complete the ratio This ratio must be the same as the ratio of the ingredient qu
61. e common to all the selected medicines will be displayed in the table Delete any common manufacturing steps listed in the table as required Single click the Add button to add common manufacturing steps to all of the selected medicines New Manufacturers Manufacturers Single click the Add button to add common manufacturers to all of the selected medicines For details on the Manufacturers subform refer to Page 47 Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 5 Validation of the application Refer to Validating an Application on Page 74 for details 6 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 7 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 0546548 doc Page 42 Online Services Export Electronic Lodgement Application Subforms The Ingredient From the Application form clicking the Add button beside the Ingredient Subform field will provide the user with the Ingredient Subform as shown in the Figure below 4 Therapeutic Goods Administration Ingredient Microsoft Internet Explorer provided by Therapeutic File Edit View Favorites
62. e to a Section 30 OYes No If itis enter the AUSTL you are responding to AUSTL javascript addSub ExportNamesL ist amp Internet W start E wow e Josh Wiley Inbox Ui Microsoft Word Therapeutic Good i Microsoft Word i Solely for Export Figure 12 Solely for Export Medicine Kit Listing Application Form 0546548 doc Page 34 Online Services Export Electronic Lodgement Client Reference Product Name Export Names This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information This field is mandatory Enter the name of the product This is the final product name that will be used if the product is listed on the ARTG This field is not mandatory Single click the Add Edit button to add an export name to the application Multiple export names can be added Product Type This field is mandatory Select the product type from the drop down list Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export system Billing Address Regulatory Contact Address This field is Mandatory Select the appropriate address from the drop down list This field is Mandatory Select the appropriate address from the drop down list Is thi
63. egulatory Contact Address This field is Mandatory Select the appropriate address from the drop down list This field is Mandatory Select the appropriate address from the drop down list Is this Application in response to a Section 30 The system default is No Select Yes if this application is being submitted as a response to a Section 30 request Enter the AUST L being responded to Can this product be used as a code stock The system default is No Select Yes if this application can be used as a code stock This application is to change a current listing create a new listing This field is conditionally mandatory Nominate whether this application is to change an existing ARTG listing or to create a new ARTG listing To create a new export only product select Create a New listing If Change a current listing is selected the form will refresh to allow for the creation of a Grouping or Variation to a single current listing See page 25 for further details AUST L This field is hidden until Change a current listing is selected to the question above Enter an AUST L number from which to create a new draft copy Single click the Search button the application form will populate with the details of the AUST L record entered 0546548 doc Submission Cost This field will be automatically populated once an application is validated It displays the submissio
64. en free wheat Starch hydrolysed maize Starch Maize High Amylose Starch Maize Starch oxidised tapioca Starch Potato Starch pregelatinised maize Starch pregelatinised potato Starch pregelatinised wheat Starch Rice Starch soluble maize Starch soluble potato Starch Tapioca Starch Wheat lh Sucrose Sunflower Oil Talc purified EJ on Oe A oe ee v 00 2 752 24 x51WuW 9 SIME Notes Home f ebsPics C Microsoft Word 1 Image24 Windo Cl Indication subfor sat Cw ge Figure 22 Carrier Subform To enter the carrier details for an ingredient complete the fields as detailed below _ Fild Deseription O Parent Ingredient This field is automatically populated with the parent Name ingredient name Carrier Name This field is mandatory Click on the drop down arrow to select the carrier Carrier Quantity This field is mandatory Enter the numeric quantity value and click on the drop down arrow to select the unit of measurement Page 53 Online Services The Component Subform 0546548 doc Export Electronic Lodgement From an ingredient subform clicking the Add button beside the Component field will provide the user with the Component subform as shown in the figure below 4 Therapeutic Goods Administration Component Microsoft Internet Explorer provided by Therapeuti File Edit View Favorites Tool
65. eparation in the same container where as Composite Pack applications have multiple preparations Creating a 1 From the Export Only Medicine link underneath the Create Applications Solely for amp Submissions link unde the Portal select the S 26a Solely for Export Export General link CUm The S 26a Solely for Export application types will be displayed Select the General Application link 3 The S 26a Solely for Export General Application form will be displayed in edit mode ready for information to be entered see Figure 10 below 4 Complete the Application by entering information into the following fields File Edit View Favorites Tools Help a Qs x a J Search sie Favorites 2 826884 8 Address https www ebs tga gov au ebs EM EMDrafts nsf GenApp openform TGA eBS Solely for Export General Application Save Save amp Close Close Validate Help j Client Reference TGA will not retain this information Always Required x Required under certain conditions Product Name Export Name s Add Edit j Product Code v Client Name TGA DemoS Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product your billing address and regulatory correspondence address Please select the relevant addresses for this product entry Billing Address m Regulatory v Corresponde
66. equesting an export certificate from the drop down list then complete the following field Number of Please supply the correct number of certificates required Certificates by each importing country Required Click the Add button to add this request to the form Repeat to add more than one Country to the request Note If the Add button is not used the certificate request for the country will not be added to the CPP Product s AUST Enter the AUST R or L of the product the certificate R L will be created for then click Search to populate other fields If the AUST R L is not valid an error message will appear Product name Populated when a valid AUST R L is supplied and the user has clicked Search Dosage form Populated when a valid AUST R L is supplied and the user has clicked Search Container Populated when a valid AUST R L is supplied and the user has clicked Search Date commenced in Populated when a valid AUST R L is supplied and the the ARTG user has clicked Search Marked for Export Populated when a valid AUST R L is supplied and the Only user has clicked Search Page 61 Online Services 0546548 doc Export Electronic Lodgement Is this product on the market in Australia If Yes is selected for this question there is no requirement to supply a reason as listed below however if the product is not on the market in Aus
67. er 2008 User Acceptance For fu URL https www ebsacceptance tga gov au ebs EM EMDrafts nsf Man OpenForm amp ParentUNID 23E 178D9BA9EB08CCA2574CD000E80EC amp Seq 1 information contact the eBS Help on 1800 010 624 eBS tga gi Therapeutic Goods Administre Copyright Security Disclai Privacv State Online Services Export Electronic Lodgement Note The GMP Approval field if No is selected another subform appears requiring details about the overseas manufacturer If Yes is selected Enter either the Clearance ID number prefaced with MI Or the GMP Reference Number in the field provided and press the Search button Complete the details of the forms and Save amp Close the form The application will be updated with the information 0546548 doc Page 48 Online Services Export Electronic Lodgement The From a composite pack application form clicking the Add button beside the Formulation Formulation field will provide the user with the Formulation subform as Subform shown in the figure below 4 Therapeutic Goods Administration Component Microsoft Internet Explorer provided by Therapeuti File Edit View Favorites Tools Help sack x 2 Search 3 Favorites Ary BGA B Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf Formulation OpenForm amp ParentUNID AE1A72845DEFFCD4CA2574CDO00EE883 s 4 TGA e55 Component Save j Save amp Close Close x A
68. ered and is appropriately licenced for the manufacturing of the chosen product s dosage form s Display Dosage This field will only appear if option b or c is selected Form Manufacturer for the sponsor status Details This field offers three choices for the inclusion of the dosage form manufacturer s details Suppress details from certificate Select this option if you wish to keep the dosage form manufacturer details confidential See Schedule 2 for manufacturing details Select this option for the words See Schedule 2 to appear on the 0546548 doc Page 70 Online Services 0546548 doc Export Electronic Lodgement certificate Ensure that you elect to show some or all of the manufacturers listed in the ARTG record for this product on this Schedule Enter the manufacturer s details that you wish to appear on the certificate Select this option will cause a new text field to be displayed so that the manufacturer s details can be directly entered Manufacturer s details to be displayed on certificate This field will only appear if option b or c is selected for the sponsor status and the option to Enter the manufacturer s details that you wish to appear on the certificate is selected Enter the name and address for the dosage form manufacturer as it is to appear on the certificate Contact Details This field is Mandatory The name and telephone nu
69. fault response is No Selecting Yes will result in the following field becoming available This field is hidden until Yes is selected for the question above Provide details of the application in the text field provided To be exported as fully finished product Select Finished Product or Bulk Product The shelf life of this product under the recommended storage condition as stated on the label is Select the appropriate period of time for the shelf life Once a value is selected select the appropriate option to display time Similarly to nominate shelf life temperature and storage conditions select the desired options from the appropriate drop down lists Proposed Therapeutic Indications This field is not mandatory If desired provide the text for the proposed therapeutic indications to be displayed on the new product record Electronic Supporting Attachment List Attachments This is conditionally mandatory depending on if the user has selected to Add an electronic file One or more electronic files can be attached to the application by clicking Add To Delete an electronic file select the Delete link in the Attachment table under the Action column Page 20 Online Services Export Electronic Lodgement Paper Supporting Document List Document Type Select the type of document from the drop down list provided Description Provide a free
70. ficates required by each importing country Click the Add button to add this request to the form Repeat to add more than one Country to the request Note If the Add button is not used the certificate request for the country will not be added to the CLP Product s AUST L Enter the AUST L of the product the certificate will be created for then click Search to populate other fields If the AUST L is not valid an error message will appear Product name Populated when a valid AUST R L is supplied and the user has clicked Search Dosage form Select the correct dosage form for the product from the drop down list Container Populated when a valid AUST L is supplied and the user has clicked Search Date commenced in the ARTG Populated when a valid AUST L is supplied and the user has clicked Search Page 66 Online Services 0546548 doc Export Electronic Lodgement Marked for Export Only Populated when a valid AUST L is supplied and the user has clicked Search Note This field must be NO for a CLP Yes will mean a CPP is to be issued Do you wish to show excipient quantities on the Schedule Select Yes or No Selecting yes will cause the system to check the existing ARTG record to see if all excipient ingredients have quantity and unit information If Quantity and unit information is missing from current rec
71. fields 4 Therapeutic Goods Administration Solely for Export Medicine prepared from a code stock E EPIS File Edit View Favorites Tools Help a Qsa k x A search ye Favorites O 2 SEG 39 Address https www ebs tga gov au ebs EM EMDrafts nsf codestockapp openform Close j Validate TGA eBS Solely for Export Medicine prepared from a code stock Help Client Reference TGA will nat retain this information x Always Required x Required under certain conditions Product Name Export Name s Add Edit Product Code v Client Name TGA DemoS Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product your billing address and regulatory correspondence address Please select the relevant addresses for this product entry Billing Address m Regulatory vi Correspondence Address Note The addresses are being read from your Client electronic record If you require reference to a different address it must be notified to the TGA for inclusion in your address list so that this application can be completed Please use the Client web update form to nominate the new address details Is this Application in response to a Section 30 OYes OG No If itis enter the AUSTL you are responding to AUSTL Code Stock Source austi Search v amp l amp Internet En E wg Josh Wiley Inbox T Microsoft
72. for details 6 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 7 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 Page 30 7 Valida Page 7 Save from tl Draft If the lt For de Online Services The Solely for Export Medicine Application prepared from a Code Stock Creating a Solely for Export Medicine Application prepared from a Code Stock Export Electronic Lodgement A Code Stock application is used for products prepared from code stock This type of application is based on an existing ARTG listing which has been flagged as being available for use as a code stock 1 From the Export Only Medicine link underneath the Create Applications amp Submissions link under the Portal select the S 26a Solely for Export link 2 The S 26a Solely for Export application types will be displayed Select the Solely for Export Medicine Prepared from a code stock application link 3 The Solely for Export Medicine Prepared from a code stock application form will be displayed in edit mode ready for information to be entered see Figure 11 below 4 Complete the Application by entering information into the following
73. gle click the Add button to add a warning to the application Multiple warnings can be added For details on the Warnings subform refer to Page 57 Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 5 Validation of the application Refer to Validating an Application on Page 74 for details 6 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 7 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 Page 33 Online Services Export Electronic Lodgement The Solely for A Medicine Kit Listing application is used when collections of existing Export medicines are to be sold together as a purpose built kit Medicine Kit application Creating a 1 From the Export Only Medicine link underneath the Create Applications Solely for amp Submissions link under the Portal select the S 26a Solely for Export Export link Medicine Kit 2 The S 26a Solely for Export application types will be displayed Select the Solely for Export Medicine Prepared from a code stock application link 3 The Solely for Export Medicine Kit Listing Application form will
74. gorous with each step An application that fails validation during an early step will only report the errors that caused that failure This may lead to a number of errors initially not being reported Once all errors that have been reported are fixed then validation should be re conducted by clicking on the Validate button again and if any further errors are identified they should be fixed Please be aware that it may take several attempts to successfully validate an application Example Joe Bloggs of Bloggs amp Sons Pharmaceuticals is submitting an S26 General Listing Application Joe has completed most of his application details except that he has forgotten to complete the container type and attached documents list Joe clicks on the validate button and his application fails validation The validation messages indicate that Joe s application is missing mandatory information Because this missing information has caused validation to fail validation checks for ingredient quantities manufacturing steps and other detailed information were not conducted and therefore not reported Joe corrects his application by adding the supporting documents and specifying the container type He clicks the validate button again Validation will pass with respect to the checks for mandatory information but may still fail if there are other problems in Joe s application such as component quantities being of a greater mass than the parent ingredient 4
75. he Export Only Composite Pack Application form will be displayed in edit mode ready for information to be entered see the Figure below Application 3 Therapeutic Goods Administration Export Only Composite Pack Application Microsoft Internet Exp EX File Edit View Favorites Tools Help sack x A Search K Favorites 2 BOB B Address https www ebs tga gov au ebs EM EMDrafts nsf EMCompApp openform Bco Links TGA eBS Export Only Composite Pack Application Save Save amp Close Close Validate Help Client Reference TGA will not retain this information x Always Required Required under certain conditions Product Name Export Name s Add Edit Client Name TGA DemoS Sponsor Address In making a product application for entry on the Register two critical addresses are to be associated with the product your billing address and regulatory correspondence address Please select the relevant addresses for this product entry Billing Address v Regulatory Correspondence Address Note The addresses are being read from your Client electronic record If you require reference to a different address it must be notified to the TGA for inclusion in your address list so that this application can be completed Please use the Client web update form to nominate the new address details Contact Details This application is to v Done A Internet ti S
76. he application Refer to Validating an Application on Page 74 for details T Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 0546548 doc Page 73 Online Services Export Electronic Lodgement What Happens During the Validation of an Application How to validate an application 0546548 doc Validating an Application Validation is a necessary step for all applications This step is necessary to ensure that your application complies with the rules and legislation that apply to each type of application and that all mandatory fields are satisfactorily completed 1 To validate an application select the Validate button see picture below at the top or bottom of the application Validate 2 Validation will check the draft application against a set of Rules maintained by TGA 3 A Validation Report will be displayed on the application under the heading Validation Report indicating any contraindications to the validation rules These errors must be rectified in order to proceed The validation occurs in a multi step process during which the validation that is conducted becomes more ri
77. her validation attempts Formulation Details Dosage Form This field is mandatory Select the dosage form for the formulation from the drop down list Route of Administration This field is mandatory Single click the Add button to display the route of administration table Select the appropriate route s of administration by clicking on them one at a time and then clicking OK Multiple routes of administration can be added Select the Save amp Close button to return to the application form formulation from the drop down list Container Volume Container These fields are conditionally mandatory Enter the Material Container Closure formulation container volume and select the container volume units from the drop down list Repeat the process selecting from the appropriate drop down lists to populate other container related fields 0546548 doc Page 13 Online Services Export Electronic Lodgement isual identification of dosage form This field is mandatory Enter a text description of the Is this component supplied sterile Sterility Description Ingredient Manufacturer s Product Details Pack Sizes Will product comply with specific and general standards applicable to product under Chapter 3 Part 3 1 Standards of Therapeutic Goods Act 1989 during the entire shelf life of the product Justification for non compliance with specific and general standards applicable to product under Chapter 3 Pa
78. his option is selected the AUST L field will be displayed Enter the AUST L number of the product in this field and click on the Search button The application will now be populated with the existing ARTG information for the product selected A Change Description can now be selected from the drop down list in the Change Description field Once selected click on the Add button The desired changes to the existing record can now be made within the application provided that they are changes that can be made either as a Variation or a Grouping The application must be Saved and Validated successfully It can then be submitted to the TGA for processing refer to the Making a Submission section in this manual Note Making the changes to the application will not automatically update the information on the ARTG The application must be submitted to the TGA for processing and approval before the ARTG record will be updated Page 25 Online Services Export Electronic Lodgement S26a Solely for Export Applications The Solely for Solely for Export applications are reviewed under Section 26a of the Export Therapeutic Goods Act 1989 A General Listing application is used for all General listed medicine products other than Composite Packs Medicine Kits and Listing products prepared from code stock General Listing applications differ from Application Composite Pack applications only in that they have a single pr
79. ia Export Only ANAMORPH morphine sulfate 10mg tablet blister pack 64384 125690 Listed Sigma Pharmaceuticals Australia Export Only Coumadin 5mg Tablets 34261 77542 Listed Sigma Pharmaceuticals Australia Export Only Naila EAGLE APPELIN B12 41635 88719 Listed Eagle Pharmaceuticals Pty Ltd Export Only Weile EAGLE TRESOS B ANTIOXIDANT tablet 43699 92388 Listed Eagle Pharmaceuticals Pty Ltd Export Only EAGLE VITASINE B HIGH POTENCY VITAMIN B 40310 86452 Listed Eagle Pharmaceuticals Pty Ltd COMPLEX WITH 500 mg of VITAMIN C tablet bottle Export Only E gt Done amp Internet EDT 2 fev e Josh Wiley Inbox the Register Exp Cli Microsoft Word n 55 Tuesday Figure 36 ARTG Records view of Export Only Medicines Searching ARTG The ARTG can be searched using a variety of filters eg by medicines Records devices export only products To search for records on the ARTG 1 Click on the Search button on the Button Bar on the List of Entries screen 2 The Full Text Search screen will be displayed 3 Enter a word or words to search for in the search field 4 Select the number of results to be returned click on the downwards facing arrow to get a list to choose from Select sort and word match options as required 6 Click on the Search button m Printing ARTG To print an ARTG Certificate of the product s details on the ARTG click on Certificates the blue Actions bu
80. ients to search the drafts view for a specific client use the filter beside the Sponsor field Page 5 Online Services Export Electronic Lodgement The eBusiness Services Web Environment Navigation Introduction The TGA eBusiness Services system is designed to be easy to use The system looks and works like many other prominent web based applications but it is useful to know and understand the functionality of the controls on the Online Services web pages particularly those used for navigation The information regarding these navigation controls applies in the majority of circumstances Instances where these navigation features will be nullified or changed in functionality will be advised at the appropriate point in the manual TGA eBS The eBS Button The eBS Home button is located in the top left of most pages in the system It consists of the eBS logo Use of this navigation control will return the user back to the TGA eBusiness Services home page Although the logo will be present in the same location on every page in the system the functionality of the button to allow users to return to the TGA eBusiness home page is only activated on pages where appropriate 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 application interface Previous Next The Previous and Next Buttons These buttons wil
81. ill be displayed in a table on the application form Product Name Text Replacement Replace Enter the part of the product name text to be replaced This text must be common to the names of all the products selected Enter the new text to use in the product name Page 23 Online Services Export Electronic Lodgement Common Manufacturing Steps Remove Steps Only manufacturing steps that are common to all the selected medicines will be displayed in the table Delete any common manufacturing steps listed in the table as required by clicking on the tick box next to the step Single click the Add button to add common manufacturing steps to all of the selected medicines New Manufacturers Manufacturers Single click the Add button to add common manufacturers to all of the selected medicines Refer to Page 47 for details on the Manufacturers subform Common Pack Sizes Remove Pack Sizes Only pack sizes that are common to all the selected medicines will be displayed in the table Delete any common pack sizes listed in the table as required Single click the Add button to add common pack sizes to all of the selected medicines Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 4 Validation of the application Refer to Validating an Application on Page 74 for details 5 Save and Close th
82. ing your draft application TGA will not retain this information Submission cost Once the application has been validated this field displays the submission cost of the application Application Status This field is populated by the system following validation depending on the current status of the application Validation Report On validating the application the system displays a validation report Messages displayed will indicate any errors will the application These errors must be fixed before the application can be submitted to the TGA Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Electronic Lodgement system Sponsor Name This field is mandatory if the application is being completed by an Agent Select the appropriate sponsor name from the drop down list Sponsor Address This field allows for the selection of a street address registered to the sponsor The selected address is the address that will appear on the certificate Sponsor Status This field indicates the role of the sponsor in the production of the product Options are a Manufactures dosage form b Packages labels and or releases for supply dosage form manufactured by independent manufacturer c Is involved in none of the above If a is selected please ensure that the sponsor address selected belongs to a location that is regist
83. ion in your address list so that this application can be completed Please use the Client web update form to nominate the new address details Is this Application in response to a Section 30 OYes No If itis enter the AUSTL you are responding to AUSTL javascript addSub ExportNamesL ist amp Internet Wr start E wg Josh Wiley Inbox Ti Microsoft E Therapeutic Good E Export EEE S Tuesday Figure 13 Solely for Export Composite Pack Application Form 0546548 doc Page 37 Online Services Export Electronic Lodgement Client Reference Product Name Export Names This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information This field is mandatory Enter the name of the product This is the final product name that will be used if the product is listed on the ARTG This field is not mandatory Single click the Add Edit button to add an export name to the application Multiple export names can be added by clicking Enter and the end of each name Product type This field is mandatory Select the product type from the drop down list Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Only Medicines system Billing Address R
84. is field is Mandatory Select the appropriate address from the drop down list Submission cost This field will be automatically populated once an application is validated It displays the submission cost of the application Application Status This field is populated by the system depending on the current status of the application Application type Displays the final type of application when the draft application has been entered and validated e g New Grouping Variation Note this field only appears when the Application status is valid Validation Results On Validating the application the system displays a validation report Messages displayed will indicate any errors will the application These errors must be fixed before the application can be submitted to the TGA List of Medicines to be Changed Medicine AUST L Single click the Add button to add an existing medicine AUST L to the application Multiple medicines can be added Medicines selected will be displayed in a table Product Name Text Replacement Replace With Enter the part of the product name text to be replaced This text must be common to the names of all the products selected Enter the new text to use in the product name 0546548 doc Page 41 Online Services Export Electronic Lodgement Common Manufacturing Steps Remove Steps Only manufacturing steps that ar
85. is field is only required if the previous field is answered No Otherwise this field will be hidden Select Yes or No The system default response has been set on No Selecting Yes will result in the following field becoming available This field is hidden if No is selected as above Otherwise details of previous cancellation or recall in are required to be entered in the text field Select Yes or No The system default response is No Selecting Yes will result in the following field becoming available This field is hidden if No is selected for the question above otherwise provide details of the marketing approval in the text field Only one country s approval details are required Page 14 Online Services Export Electronic Lodgement Have you launched an application for This question is only available if No is selected to the grant of marketing approval in the question opposite importing country The system default response is No Selecting Yes will result in the following field becoming available Please comment on present status of This field is hidden if No is selected for the question your application above If Yes is selected for the above field provide details of the status of the marketing application in the text field To be exported as fully finished Select Finished Product or Bulk Product product The shelf life of this product under Select th
86. it an application to the TGA It is only available from the Make Submission screens An application must be successfully validated before it can be submitted The Save Button This button will save the changes to the edited document without closing it The Save amp Close Button The Save amp Close button will save and close the current document You will return to the main view The Close Button This button closes the current document without saving the changes You will be returned to the main view Sorting The ability to sort information is provided in the Drafts view within EEL allowing for users to find specific information more quickly In the Drafts view for example users are able to sort by the date an application was created Clicking on the triangle icon at the top and to the right of the Date column heading will cause the view to be ordered by the column either in ascending or descending order of its contents Page 7 Online Services Export Electronic Lodgement Help Introduction All TGA Online Service systems provide users with an on line Help facility Help is available through the Help button found in the top right corner of each page within the application forms Accessing Help Help is available on every screen within the EEL application forms By Help clicking on the Help button a Help window will open to display context sensitive information relating to the page within an applica
87. l appear on view screens where lists of information are provided For example the ARTG Records view They allow the user to navigate forwards or backwards through the list and to move from one page to the next within a view Search The Search Button The search button is available when viewing lists of information In the Export system this function is available in the ARTG Records view Home The Home Button The home button is different from the SIME Home button It will appear in application forms and at the top and bottom of a page Clicking on this button will return the user to the Export home page 0546548 doc Page 6 Online Services Validate Submit Save Save amp Close Close 0546548 doc Export Electronic Lodgement The Validate Button This button is only available from all the application forms This button allows a user to validate the information that they have supplied in an application prior to submission If a particular mandatory field in the application has not been completed or if a particular combination of information supplied creates a breech of TGA Export business rules the application will fail validation If an application does fail validation detailed messages informing the user of the problem will be displayed near the top of the form An application can not be submitted until it has passed validation The Submit Button This button allows the user to subm
88. lways Required x Required under certain conditions Component Name Formulation 1 Dosage Form xj Route of Add Edit Administration Container Type Container Volume E Container Closure v Container Material o 0 i Container Condition v Pack Sizes Add Edit Visual identification of dosage form Is this component supplied OYes sterile ONo FORMULATION DETAILS Ingredient Add Done 8 Internet 75 start A fer ES JoshWiley Inbox d Therapeutic Good Cl Microsoft Word Ingredient Add Figure 19 Formulation Subform To enter a formulation onto the application form complete the following fields _ Fild Deseription O Formulation This field is mandatory Enter the name for the Name formulation This name will assist to differentiate between multiple formulations in a composite pack at a quick glance Formulation Details Dosage Form This field is mandatory Use the drop down arrow to select the appropriate dosage form for the formulation 0546548 doc Page 49 Online Services Export Electronic Lodgement Route of Administration This field is mandatory Single click the Add button and the route of administration table will be provided Multiple routes of administration can be added Select the Save amp Close button to return to the application form Container Type This field is mandatory Use
89. m default is No Select Yes if this application is being submitted as a response to a Section 30 request Enter the AUST L being responded to Code Stock Source This field is Mandatory Enter an AUST L number of an existing ARTG entry which can be used as a code stock from which to create a new draft copy Single click the Search button to create the new draft application based on the entered AUST L number This application is to e Change a current listing or e Create a new listing This field is conditionally mandatory Nominate whether this application is to change an existing ARTG listing or to create anew ARTG listing To create a new export only product select Create a New listing If Change a current listing is selected the form will refresh to allow for the creation of a Grouping or Variation to a single current listing See page 25 for further details AUST L Submission Cost This field is hidden until Change a current listing is selected to the question above Enter an AUST L number from which to create a new draft copy Single click the Search button the application form will populate with the details of the AUST L record entered This field will be automatically populated once an application is validated It displays the submission cost of the application Application Status This field is populated by the system depending on the Page 32
90. mber of the person who is to be contact for any queries relating to this application are preferred here Certificate sent to This selects whether the certificate is delivered to the sponsor or a third party If the Other option is selected the form will refresh with an extra field for the name and address of the recipient Country requesting export certificate Select the name of the country requesting an export certificate from the drop down list then complete the following field Number of Certificates Required Please supply the correct number of certificates required by each importing country Click the Add button to add this request to the form Repeat to add more than one Country to the request Note If the Add button is not used the certificate request for the country will not be added to the CEP Product name Enter the Product Name into the free text field Export name This is a free text field for users to enter the export name of the product If an export name is selected The export name will appear on the certificate in place of the product name Dosage form Select the correct dosage form for the product from the drop down list Is this product on the market in Australia If Yes is selected for this question there is no requirement to supply a reason as listed below however if the product is not on the market in Australia No
91. must be selected and then one or more reasons why must also be selected Page 71 Online Services 0546548 doc Export Electronic Lodgement Reasons the product is not on the market in Australia Select one or more reasons why the product is not on the market in Australia Most reasons simply require the user to check the checkbox next to the reason with the exception of This product has the same formulation as another product on the Australia market which is supplied in a different container or packaging If selected the form will refresh to allow for the selection of an existing ARTG entry This product is approved for supply in the following markets list countries below If selected one or more countries will need to be selected from the list supplied To select multiple countries hold the Ctrl key whilst clicking on the name of each country to be included Other Selecting Other will cause the form to refresh with a free text field so that custom reasons can be supplied All reasons selected will appear on the certificate Ingredient Click Add to search for and select one or more ingredients for the product For details on completing the Ingredient subform refer to Page 43 Manufacturer Click Add to search for and select one or more manufacturers for the product For details on completing the Manufacturer subform refer to Page 47 Electronic Supporting Attachment
92. n cost Page 38 Online Services 0546548 doc Export Electronic Lodgement of the application Application Status This field is populated by the system depending on the current status of the application Payment Exemption No This field is not mandatory If permitted by the TGA enter a payment exemption number if an exemption is applicable to this application Application type Displays the final type of application when the draft application has been entered and validated e g New Grouping Variation Note this field only appears when the Application status is valid Validation Report On Validating the application the system displays a validation report Messages displayed will indicate any errors will the application These errors must be fixed before the application can be submitted to the TGA Formulation Single click the Add button to add a formulation to the Details application Multiple formulations can be added For details on the Formulation Details subform refer to Page 49 Manufacturer s This field is mandatory Single click the Add button to add a manufacturer to the application Multiple manufacturers can be added Form details on the Manufacturers subform refer to Page 477 Product Details Indications This is a mandatory field Single click the Add button to add an indication to the application Multiple indications can be
93. nce Address Note The addresses are being read from your Client electronic record If you require reference to a different address it must be notified to the TGA for inclusion in your address list so that this application can be completed Please use the Client web update form to nominate the new address details Is this Application in response to a Section 30 OYes OG No If itis enter the AUSTL you are responding to AUSTL Done Bj Internet 4 start E fr e Change tothe TG Cl Microsoft Word J Therapeutic Good P xx Tuesday Figure 10 Solely for Export General Application Form 0546548 doc Page 26 Online Services 0546548 doc Export Electronic Lodgement Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information Product Name This field is mandatory Enter the name of the product This is the final product name that will be used if the product is listed on the ARTG Export Names This field is not mandatory Single click the Add Edit button to add an export name to the application Multiple export names can be added by pressing Enter and the end of each name Save and Close subform Product Type This field is mandatory Select the product type from the drop down list Billing Address
94. ned and dated in original penmanship that is not photocopied Attachments This is conditionally mandatory depending on if the user has selected to Add an electronic file One or more electronic files can be attached to the application by clicking Add An example of an allowable electronic attachment is an application cover letter To Delete an electronic file select the Delete link under the Action column of Attachments Schedules will only be accepted in hard copy with original signature Paper Supporting Document List Note Schedule will only be accepted in Hard Copy with original signature Document Type Select the type of document from the drop down list Description Provide a free text description of the document Method of Select the method via which the document has been Submission will be sent Date Sent Select the date on which the document was will be sent complete the addition of a paper supporting document by clicking Add once all the details are completed Time Taken Providing this information is optional It will be used by TGA to monitor and improve the experience of web users 6 Validation of the application Refer to Validating an Application on Page 74 for details 7 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 fo
95. net En E wg Josh Wiley Inbox h Microsoft Word Z Therapeutic Good Document2 Micr 2 Microsoft Word g onl R Tuesday Figure 6 Export Only General Application Form Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information Product Name This field is mandatory Enter the name of the product This is the final product name that will be used if the product is listed on the ARTG Export Names This field is not mandatory Single click the Add Edit button to add an export name to the application Multiple export names can be added Save and Close the subform Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Only Medicines system Billing Address This field is Mandatory Select the appropriate address from the drop down list Regulatory Correspondence Address This field is Mandatory Select the appropriate address from the drop down list Contact Details This field is Mandatory The name and telephone number of the person who is to be contact for any queries relating to this application are preferred here 0546548 doc Page 12 Online Services Export Electronic Lodgement This application is to change a This field is conditionall
96. ntact for any queries relating to this application are preferred here This application is to change a current listing create a new listing This field is conditionally mandatory Nominate whether this application is to change an existing ARTG listing or to create anew ARTG listing To create a new export only product select Create a New listing If Change a current listing is selected the form will refresh to allow for the creation of a Grouping or Variation to a single current listing See page 25 for further details Change Description This field only becomes available if selecting Change a Current Listing to the question above To nominate the type of change being made to an existing listing select from the drop down list and click on the Add button Submission Cost Displays the submission cost when the draft application has been entered and validated Application Status This field is populated by the system depending on the current status of the application Payment Exemption No This field is not mandatory If permitted by the TGA enter a payment exemption number if an exemption is applicable to this application 0546548 doc Page 18 Online Services 0546548 doc Export Electronic Lodgement Application type Displays the final type of application when the draft application has been entered and validated e g New Grouping Variation Note
97. ogon to TGA s SIME Web Site can read information concerning entries for all Sponsors they are authorised to represent e Members of the public have read access to query the ARTG for specific products or ingredients that may be contained in a product no logon required 0546548 doc Page 81 Online Services Viewing ARTG Records 0546548 doc Export Electronic Lodgement The Sponsor of Export medicines that are current and recorded in the ARTG database for which the organisation is sponsor or their agent can view their entries To View ARTG Records see figure 35 below a TGA eBusiness Services Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help Qe x A 5 search K Favorites O 27 amp 3 Address https www ebsacceptance tga gov au ML Australian Governme Department of Health at TGA eBusinessServices User Acceptance Tin Cod Ai Portal TGA Demo Drafts ETE First Sponsor Viewing 4 of 4 entries P Y TGA Information Approval Area All Approval Areas v Sponsor AtSporsr E Current Devices Searchon Date Y for Australian Date Identifier Client Reference Information Sponsor Manufacturers SO 2008 09 16 TGA Demo A Code Tables GO 2008 09 16 TGA Demo A Ingredients GO 2008 08 21 DV 2008 MC 56636 3 Viet testing ACC 516 001 TGA Demo Spo Accepted Manufacturer 2008 08 20 DV 2008 MC 56628 3 TGA Demo Spo Inform
98. om an ingredient subform clicking the Add button beside the Preparation Step field will provide the user with the Preparation Step subform as shown in the figure below 4 Therapeutic Goods Administration Preparation Step Microsoft Internet Explorer provided by Ther File Edit View Favorites Tools Help sack x Search K Favorites Ary BEG B Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf ExtractionStep OpenForm amp ParentUNID BF827B028ED78506CA2574CD000F3CCF S 4 TGA eS Preparation Step Save Save amp Close Close Application Home x Always Required x Required under certain conditions Plant Preparation Extract dry concentrate standardised v Preparation Ratio 5 H Plant Preparation 1 Step Solvents Add Edit Save i Save 8 Close i Close Application Home Last updated 23 September 2008 User Acceptance URL https www ebsacceptance tga gov au ebs EM EMDrafts nsf ExtractionStep OpenForm amp ParentUNID BF827B028ED78506CA2574CD000F 3CCF information contact the Desk on 180 eBS Therapeutic Goods Adm Copyright Security C Privacy Done Bj Internet En E wg Josh Wiley Inbox Z Therapeutic Good B Microsoft Word Figure 20 Preparation Step Subform To enter the details for a preparation step complete the following fields Plant Preparation This field is mandatory If the preparation selected for the ingredient
99. on the current status of the application Validation Report On validating the application the system displays a validation report Messages displayed will indicate any errors with the application These errors must be fixed before the application can be submitted to the TGA Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Electronic Lodgement system Sponsor Name This field is mandatory if the application is being completed by an Agent Select the appropriate sponsor name from the drop down list Sponsor Address This field allows for the selection of a street address registered to the sponsor The selected address is the address that will appear on the certificate Sponsor Status This field indicates the role of the sponsor in the production of the product Options are a Manufactures dosage form b Packages labels and or releases for supply dosage form manufactured by independent manufacturer c Is involved in none of the above If a is selected please ensure that the sponsor address selected belongs to a location that is registered and is appropriately licenced for the manufacturing of the chosen product s dosage form s 0546548 doc Page 65 Online Services 0546548 doc Export Electronic Lodgement Display Dosage Form Manufacturer Details This field will only appear if
100. option b or c is selected for the sponsor status This field offers three choices for the inclusion of the dosage form manufacturer s details Suppress details from certificate Select this option if you wish to keep the dosage form manufacturer details confidential See Schedule 2 for manufacturing details Select this option for the words See Schedule 2 to appear on the certificate Ensure that you elect to show some or all of the manufacturers listed in the ARTG record for this product on this Schedule One of the manufacturers recorded against the AUSTL R selected Select this option to enable one of the manufacturers listed in the ARTG record to be selected in the Select manufacturer to appear on certificate field further down the form Contact details This field is Mandatory The name and telephone number of the person who is to be contact for any queries relating to this application are preferred here Certificate sent to This selects whether the certificate 1s delivered to the sponsor or a third party If the Other option is selected the form will refresh with an extra field for the name and address of the recipient Country requesting export certificate Select the name of the country requesting an export certificate from the drop down list then complete the following field Number of Certificates Required Please supply the correct number of certi
101. or c and the user has selected the One of the manufacturers recorded against the AUSTL R selected option for the Display Dosage Form Manufacturer Details field This field allows for the selection of one manufacturer from all manufacturers listed on the ARTG for the selected AUST L R The name and address of the selected manufacturer will appear on the certificate Do you wish to show manufacturers on Select AII Some or None Selecting Some will cause the form to refresh with a list of manufacturers Users can click the Don t show link to have those as Schedule 2 manufacturers details suppressed from Schedule 2 lists Is officially Select Yes Not Provided or No This response will approved appear on the certificate information complete and consonant with the licence attached Do all manufacturers of this product have a Select Yes or No This information will assist TGA s evaluation Page 62 Online Services 0546548 doc Export Electronic Lodgement GMP licence and or a valid overseas Pre Clearance certificate Certify labels with Select Yes if labels are to be included as a schedule certificate Otherwise select No Electronic Supporting Attachment List Note Schedules will only be accepted in Hard Copy with original signature Attachments intended to be part of the certificate must follow Schedule formatting and be sig
102. ords a warning will be displayed Do you wish to add supplementary information to the formulation Select Yes or No Selecting yes will cause the form to refresh offering the user a list of ingredients against which supplementary information can be supplied To provide supplementary information click on the ingredient name The system will navigate to the supplementary information form where a user can enter supplementary information in a free text field then click Save and close to be returned to the application form Select manufacturer to appear on certificate This field will only appear if the selected sponsor status is b or c and the user has selected the One of the manufacturers recorded against the AUSTL R selected option for the Display Dosage Form Manufacturer Details field This field allows for the selection of one manufacturer from all manufacturers listed on the ARTG for the selected AUST L R The name and address of the selected manufacturer will appear on the certificate Do you wish to show manufacturers as Schedule 2 Select AII Some or None Selecting Some will cause the form to refresh with a list of manufacturers Users can click the Don t show link to have those manufacturers details suppressed from Schedule 2 lists Do all manufacturers of this product have a GMP licence and or a valid overseas Pre Select Yes or No This information
103. r Select coded This field will only be displayed after a successful warning from list search This field is mandatory Select at least one coded warning by placing a check against it If none of the warnings in the list are appropriate enter a new code term in the Search For field and single click Search again 0546548 doc Page 58 Online Services Export Electronic Lodgement Export Certificates New Application The Certificate From this form sponsors or agents can draft and validate an application for a of Certificate of Pharmaceutical Product CPP Pharmaceutical Product CPP Application Form Creating a CPP 1 From the Export Only Medicine link underneath the Create Applications Application amp Submissions link under the Portal select the Export Certificates link 2 The Export Certificate application types will be displayed 3 Click on the Application for Certificate of Pharmaceutical Product link 4 The Certificate of Pharmaceutical Product application form will be displayed in edit mode ready for information to be entered see figure 28 below Complete the application using the information in the following table 3 Therapeutic Goods Administration Application for Certificate of Pharmaceutical Product CPP Mic EX File Edit View Favorites Tools Help a sack x 2 f Search K Favorites Ay BEB B Address ht
104. r details on viewing Draft Applications 8 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 Page 63 Online Services Export Electronic Lodgement Certificate of From this form sponsors can draft and validate an application for a Certificate Listable of Listable Product CLP Product CLP Application Creating a CLP 1 From the Export Only Medicine link underneath the Create Applications Application amp Submissions link under the Portal select the Export Certificates link 2 The Export Certificate application types will be displayed 3 Click on the Application for Certificate of Listable Product link 4 The Certificate of Listable Product application form will be displayed in edit mode ready for information to be entered see figure 29 below 5 Complete the application using the information in the following table 3 Therapeutic Goods Administration Application for Certificate of Listable Product CLP Microsoft L EX File Edit View Favorites Tools Help aw Qsa k x a J Search sie Favorites e 27 p 3d 3 Address https www ebs tga gov au ebs EM EMDrafts nsf clpapp openform TGA eBS Application for Certificate of Listable Product CLP Save Save amp Close Close Validate Help Client Reference TGA will no
105. rm Container Type Container Volume This field is mandatory Select the container type for the formulation from the Drop down list This field is conditionally mandatory The use of particular ingredients in the formulation may require the declaration of the container volume Enter the formulation container volume and select the container volume units from the drop down list Page 28 Online Services 0546548 doc Export Electronic Lodgement Container Closure Container Condition Maximum Single Dose These fields are conditionally mandatory The inclusion of particular ingredients may require the declaration of the container closure type particularly if the ingredient can not be supplied without a child resistant closure Select the container closure for the formulation from the drop down list Similarly select the container condition option from the appropriate drop down list This field is conditionally mandatory The inclusion of particular ingredients may require the declaration of a maximum single dose Enter the formulation s recommended maximum single dosage and select the units from the drop down list Maximum Daily Dose This field is conditionally mandatory The inclusion of particular ingredients may require the declaration of a maximum daily dose Enter the formulation s recommended maximum daily dosage and select the units form the drop down list Minimum Weight
106. rt 1 3 Standards of the Therapeutic Goods Act 1989 Has this product been cancelled recalled or rejected for registration or listing on ARTG for supply in Australia Details of prior cancellation recall etc Has this product been granted marketing approval for supply in the importing country Details of Approval 0546548 doc visual identification of dosage form This field is mandatory Select Yes or No If Yes is selected then the Sterility Description field that appears must be completed This field is conditionally mandatory If selecting Yes to the question above this field will become available Select the method of sterility from the drop down list This field is mandatory Single click the Add button to add an ingredient to the application Multiple ingredients can be added For details on the Ingredient Subform refer to Page 43 This field is mandatory Single click the Add button to add a manufacturer to the application Multiple manufacturers can be added For details on the Manufacturer Subform refer to Page 47 This field is conditionally mandatory Single click the Add Edit button to add or edit a pack size for the application Multiple pack sizes can be added Save amp Close to update the application The system default response has been set on No Selecting Yes or N A will remove the following text field for non compliance justification An entry in th
107. s Administration Warning Microsoft Internet Explorer provided by Therapeutic Goods Administration Fle Edt View Fevortes Tods Hep Pwr Serm 2 DBB Axes MA MDrafts nf AarmingsiistNOpeeFormMP ar entuNID 060670 1374565 162CA2674CO00 18CF Diens TGA eBS Warning Save Save Close Close Application Home Always Required Search For Seuch cold Type either the waming code a word or a phrase which appears in the warning Select coded warning from list URN For the treatment cf burns immediate treatment should consist ef the rapid apphicatien cf cold for a suitable penod and the product should only be applied later or words to 1 the product is for the first aid treatment of minor bums only and medical advice should be sought for the treatment of more serious bums Or words to that effect EZ COLD Adults only OR Not to be used in children under two years of age without medical adace or words to that eflect Save amp Close Close Application Home Cees amp Ae A eo Wy start w CS E Thursday Figure 27 Warning Subform displaying warning options when cold has been selected as search word To enter the warning details for an application complete the fields as detailed below Page 57 Online Services Export Electronic Lodgement Search For This field is mandatory Enter the code or term to search upon and single click Search If the search is successful a list of coded warnings will appea
108. s Application in response to a Section 30 The system default is No Select Yes if this application is being submitted as a response to a Section 30 request Enter the AUST L being responded to This application is to change a current listing create a new listing This field is conditionally mandatory Nominate whether this application is to change an existing ARTG listing or to create anew ARTG listing To create a new export only product select Create a New listing If Change a current listing is selected the form will refresh to allow for the creation of a Grouping or Variation to a single current listing See page 25 for further details AUST L This field is hidden until Change a current listing is selected to the question above Enter an AUST L number from which to create a new draft copy Single click the Search button the application form will populate with the details of the AUST L record entered Submission Cost This field will be automatically populated once an application is validated It displays the submission cost of the application Application Status This field is populated by the system depending on the current status of the application Payment Exemption No This field is not mandatory If permitted by the TGA enter a payment exemption number if an exemption is applicable to this application Application type Displays the final type of applic
109. s Help Qax WAG J Search sie Favorites 4 e B E Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf Component OpenForm amp ParentUNID BF827B028ED78506CA2574CD000F3CCF TGA e55 Component Close Application Home x Always Required x Required under certain conditions Parent Ingredient Name Ginkgo biloba Search For Component Search Search On O Whole of field Start of field OAny part of the field Or Enter a proposed Continue Component Name 3 Close Application Home Last updated 23 September 2008 User Acceptance URL https Avww ebsacceptance tga gov au ebs EM EMDrafts nsf Component OpenF orm amp ParentUNID BF827B028ED78506CA2574CDO00F3CCF information contact the eBS on 1800 010 624 eBS Therapeutic Goods Adm Copyright Security E Privacy Done Bj Internet W start Cc v e Josh Wiley Inbox J Therapeutic Good f Document2 Micr Figure 23 Component Subform To enter an Ingredient onto the application form 1 Enter the start of a part of or all of the component name in the Search for Component text field 2 Single click the Search button If the search is successful the Component subform will refresh to provide the following fields a gt SIME t Component Save Save amp Close J Close Application Home jJ Home j Always Required Required under certain conditions Parent Ingredient N
110. select the item number of the document from the drop down list and select Remove Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 0546548 doc Page 15 Online Services Export Electronic Lodgement 5 Validation of the application Refer to Validating an Application on Page 74 for details 6 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 7 Ifthe application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 0546548 doc Page 16 Online Services Export Electronic Lodgement The Composite A Composite Pack application is used for composite packs as defined in Pack Therapeutic Goods Act 1989 Subsection 7B 2 Composite Pack applications Application differ from General Listing applications only in that they have multiple preparations in the same container where as General Listing applications have a single preparation Creating a 1 From the Export Only Medicine link underneath the Create Applications Composite amp Submissions link under the Portal select the S 26 Export Only link Pack The Export Only S26 application types will be displayed Select the Composite Pack link 3 T
111. t Once the application has been validated this field displays the submission cost of the application Application Status This field is populated by the system following validation depending on the current status of the application Validation Report On validating the application the system displays a validation report Messages displayed will indicate any errors with the application These errors must be fixed before the application can be submitted to the TGA Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Electronic Lodgement system Sponsor Name This field is mandatory if the application is being completed by an Agent Select the appropriate sponsor name from the drop down list Sponsor Address This field allows for the selection of a street address registered to the sponsor The selected address is the address that will appear on the certificate Sponsor Status This field indicates the role of the sponsor in the production of the product Options are a Manufactures dosage form b Packages labels and or releases for supply dosage form manufactured by independent manufacturer c Is involved in none of the above If a is selected please ensure that the sponsor address selected belongs to a location that is registered and is appropriately licenced for the manufacturing of the chosen product s dosage
112. t retain this information Submission Cost Application Draft Status Validation Report Required x Not required under all circumstances Client Name TGA E business account for application processing Sponsor Name TGA E business account for application processing x Sponsor Address 36 Narrabundah Lane SYMONSTON ACT 2609 v Sponsor Status a manufactures dosage form s 5 i M Contact Details Certificate sentto Sponsor Country requesting export v certificate 2 Number of Certificates t Required Add Enter the Aust L for the product you wish to include on the certificate and press search to populate the product fields below Product s AUSTL Search Done A Internet r x 14 41 ti start E v S Josh Wiley Inbox Therapeutic Good Z4 Microsoft Word Tuesday Figure 29 Application form for a CLP 0546548 doc Page 64 Online Services Export Electronic Lodgement Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information Submission cost Once the application has been validated this field displays the submission cost of the application Application Status This field is populated by the system following validation depending
113. tart Cc sv e Change to the TG Cl eBS LodgementU d Therapeutic Good Figure 7 Export Only Composite Pack Application Form 4 Complete the Application by entering information into the following fields 0546548 doc Page 17 Online Services Export Electronic Lodgement Field Description Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information Product Name This field is mandatory Enter the name of the product This is the final product name that will be used if the product is listed on the ARTG Export Names This field is not mandatory Single click the Add Edit button to add an export name to the application Multiple export names can be added by adding lt Enter gt at the end of each name Save and Close the subform Client Name System inserts client name based on log on ID Displays your client name based on the logon id used to access the Export Only Medicines system Billing Address This field is Mandatory Select the appropriate address from the drop down list Regulatory Contact Address This field is Mandatory Select the appropriate address from the drop down list Contact Details This field is Mandatory The name and telephone number of the person who is to be co
114. text description of the document Method of Select the method via which the document has been will Submission be sent Date Sent Select the date on which the document was will be sent Complete the addition of a paper supporting document by clicking Add once all the details are completed Note The system default is today s date however this can be updated To remove a paper supporting document select the item number of the document from the drop down list and select Remove Time Taken An optional field Data entered to only be used by TGA to monitor and improve the experience of web users 5 Validation of the application Refer to Validating an Application on Page 74 for details 6 Save and Close the application The application will now be available from the View Drafts option underneath the Portal Refer to Page 75 for details on viewing Draft Applications 7 If the application has the status of Passed Validation it can now be submitted to the TGA For details on Submitting applications please refer to Page 76 0546548 doc Page 21 Online Services Export Electronic Lodgement The Change A Change Multiple Listing application is used to make specific changes to to Multiple multiple existing ARTG listings The details that can be changed include Current certain parts of the product name and any common manufacturing steps Listings Additionally new common manufacturers and pack sizes can
115. three main areas of export application Export Only S26 Solely for Export S26a and Export Certificate and treats each separately so as to allow the user to focus on the specific type of application as required Other parts of this manual cover more generic system features such as site navigation and accessing Help It is assumed that users possess mouse skills and have a basic knowledge of the World Wide Web Some Web terminology is explained for users in the Navigation section of this manual Help is available for all TGA eBusiness systems For the various forms of help available refer to the Help Section in this document Page 1 Online Services Export Electronic Lodgement Overview of Export Only Medicines amp Australian Register Introduction Read access External access 0546548 doc of Therapeutic Goods ARTG The Export Medicines system is a component of the larger TGA eBusiness Services system The Export Medicines system is designed to provide a web based interface between TGA s clients and the Export Medicine Unit of TGA It provides the electronic forms necessary for submitting S26 S26a and for export certificates CPP applications The Export system then offers support to TGA staff in the processing of these applications and once a listing application is successfully processed supports the writing of these applications to the ARTG The ARTG holds records of all Therapeutic Goods that
116. ting purposes There will also be a Delete link available to remove the component This field will only appear if the declaration of remaining restricted solvents is appropriate for the selected plant preparation Single click the Add button to add a restricted solvent For further details on the remaining restricted solvent subform refer to page 55 Once restricted solvents are declared the name of each solvent will be a link to edit the solvent details There will also be a Delete link available to remove the solvent Page 46 Online Services Export Electronic Lodgement The From the Application form clicking the Add button beside the Manufacturers Manufacturers field will provide the user with the Manufacturer Subform Subform Use the radio buttons to identify if the Manufacturer is Australian or Overseas Depending on the selection one of the following two forms will be provided a Manufacturer Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help Qa x A Search e Favorites 2 BEB B Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf Man OpenForm amp ParentUNID 23E178D9BA9EB08CCA2574CD000E80EC TGA eBS Manufacturer Close Application Home E Always Required x Required under certain conditions Manufacturer Australian O Overseas Enter Licence ID Search OR
117. tion or an application type itself D ei EM How to use Help Index Back Close Print The use of Export Only Medicine system functions are documented in this on line Help system To get help click on o the Help button in the Button Bar at the top right hand side of the screen This will display context sensitive help specific to the current page the Index button on any of the help screens will take you to the Help Index which displays a list of all available help Figure 3 An Example of a Help Page within the Export Medicines system Help Throughout the on line help system certain actions and objects are indicated Conventions in the following ways e Buttons commands The name of the button is placed in single quotes 5 For example click on OK means the user clicks once on the button labelled OK e Keyboard commands 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 0546548 doc Page 8 Online Services Help Desk 0546548 doc Export Electronic Lodgement If at any time you are experiencing problems using Export Medicine system or need further assistance please contact the Export Help Desk on e E mail ebs tga gov au Please include the word EXPORT in the subject line of the E mail
118. tps www ebs tga gov au ebs EM EMDrafts nsf cppapp openform Bco Links TGA eBS Application for Certificate of Pharmaceutical Product CPP Save j Save amp Close Close Validate Help Client Reference TGA will not retain this information Submission Cost Application Draft Status Validation Report Required x Not required under all circumstances Client Name TGA E business account for application processing Sponsor Name TGA E business account for application processing v Sponsor Address 36 Narrabundah Lane SYMONSTON ACT 2609 v Sponsor Status a manufactures dosage form Contact Details Certificate sentto Sponsor v Country requesting export v certificate Number of Certificates t Required i Add 2 Enter the Aust R L for the product you wish to include on the certificate and press search to populate the product fields below Product s AUST RIL Search v el amp Internet 75 start E fr e Change to the TG Therapeutic Good P sod Tuesday Figure 28 Application for Certificate of Pharmaceutical Product form 0546548 doc Page 59 Online Services Export Electronic Lodgement Client Reference This field is not mandatory Enter a descriptive name useful to you This reference will be displayed on the main page view to assist in quickly identifying your draft application TGA will not retain this information Submission cos
119. tralia No must be selected and then one or more reasons why must also be selected Reasons the product is not on the market in Australia Select one or more reasons why the product is not on the market in Australia Most reasons simply require the user to check the checkbox next to the reason with the exception of Other Selecting Other will cause the form to refresh with a free text field so that custom reasons can be supplied All reasons selected will appear on the certificate Do you wish to show excipient quantities on the certificate Select Yes or No Selecting yes will cause the system to check the existing ARTG record to see if all excipient ingredients have quantity and unit information If quantity and unit information is missing from current records a warning will be displayed Do you wish to add supplementary information to the formulation Select Yes or No Selecting yes will cause the form to refresh offering the user a list of ingredients against which supplementary information can be supplied To provide supplementary information click on the ingredient name The system will navigate to the supplementary information form where a user can enter supplementary information in a free text field then click Save and close to be returned to the application form Select manufacturer to appear on certificate This field will only appear if the selected sponsor status is b
120. tronic Lodgement Submitted Applications Viewing This screen provides a list of all submitted applications that a sponsor has Submitted permission to access generally only the applications that a sponsor Applications themselves has drafted The user has the ability to track the progress of submitted applications or delete any unwanted drafts Submitted applications may be viewed by clicking on the View Lodged Submissions link accessed underneath the Portal see Figure 34 below Further filtering of desired draft applications can then be made using dropdown lists located at the end of the Approval Area and Sponsor fields 4 TGA eBusiness Services Microsoft Internet Explorer provided by Therapeutic Goods Administration File Edit View Favorites Tools Help a Qs x A f Search siz Favorites 4 Br amp as Address https www ebs tga gov au TGA eBusinessServices Mies nm MED Department of Health and Ageing Verification Testing Tire Goods Nato v Portal Mike Johnston Submissions First J 2 3 Final View Drafts Viewing 51 of 51 entries Page 1 of 3 View Lodged Approval Area All Approval Areas Submissions Sponsor All Sponsors Ss Portal Help i Search on Received for E Create Applications amp Received _ Identifier Workflow Status Description Product Sponsor Submissions M Name 2008 08 15 MI 15082008 CE 001497 11 Under Review 2008 06 30 MI 30062008 CE 001448 11
121. tton to the left of the ARTG product listing name The option of Create ARTG Certificate appears Click on this to obtain certificate 0546548 doc Page 83 Online Services Export Electronic Lodgement Other Features Export News Export News is available from the News link on the eBusiness home page The Export News link displays the latest news information and status of the Export Medicine system This screen will keep users informed of any changes or problems with the Export system on a daily basis 4 TGA eBusiness Services Microsoft Internet Explorer provided by Therapeutic Goods Administration X File Edit View Favorites Tools Help a Qa x A 5 search e Favorites 2 SEO B Address https www ebs tga gov au Eco Links s d s Australian Government TGA eBusiness Services V ifi T e m erification Testing Tiam Ges Miis gt Portal Mike Johnston NIE gt TGA Information Latest Help 01 05 200 g Accepted Manufacturer 31 03 200 Information 25 10 200 x Accepted Medical Device Evidence EM EM News a SOLETRADE a Xii 5 X B C los Sponsor Cancellation m ose Print Online Invoice Payment EE Welcome to Export v News 1 Public News Electronic Lodgement EEL Medical Devices N Manufacturers ews Listed Medicines EEL offically went Live on 8 November 2004 and is Export Only Medicines now available for use to sponsors to draft validate and Help s
122. ubmit applications for both Export Only and Solely for Export Listings and for applications for Certificates of Parente Pharmaceutical Product Logout i IMPORTANT INFORMATION FOR SPONSORS CO Last updated 28 10 2008 2 45 29 PM OF REGISTERED MEDICINES ON THE ARTG w ctthe eBS Help Desk on 1800 010 624 eBS tga gov au URL https www ebs tga gov au Aa Copyright Security Disclaimer Privacy Statement javascript var digHelp dhtmlwindow open Help iframe ebs help2 nsf Help EM_F_DAP_Export_News OpenDocument Help hi S Internet 3 start a fev e Josh Wiley Inbox Z TGA eBusiness Se Uli Microsoft Word BR OU Tuesday Figure 4 Export News Page from eBusiness Home Page 0546548 doc Page 84
123. will assist TGA s evaluation Clearance certificate Certify labels with Select Yes or No This information will assist TGA s certificate evaluation Page 67 Online Services Export Electronic Lodgement Electronic Supporting Attachment List Note Schedule will only be accepted in Hard Copy with original signature Attachments intended to be part of the certificate must follow Schedule formatting and be signed and dated in original penmanship that is not photocopied Attachments This is conditionally mandatory depending on if the user has selected to Add an electronic file One or more electronic files can be attached to the application by clicking Add An example of an allowable electronic attachment is an application cover letter To Delete an electronic file select the Delete link under the Action column of Attachments Schedules will only be accepted in hard copy with original signature Paper Supporting Document List Note Schedule will only be accepted in Hard Copy with original signature Document Type Select the type of document from the drop down list Description Provide a free text description of the document Method of Select the method via which the document has been Submission will be sent Date Sent Select the date on which the document was will be sent Complete the addition of a paper supporting document by clicking Add
124. x A f Search se Favorites R gt as Address https www ebsacceptance tga gov au ebs EM EMDrafts nsf Submission openform amp app se TGA eBS Make Submission Cancel _ Print Submission Number Client Name Blackmores Limited Select Application to add J Select Deselect Applications Eligible for Submission Product Name Sponsor Name Validated Application Type The Power and the Passion Take 898 Blackmores Limited 23 09 2008 9 18 15 AM New A new AUST L will be generated 560 00 Applications in this Submission None Cancel Last updated 23 September 2008 User Acceptance For further information contact the eBS Help Desk on 1800 010 624 URL https www ebsacceptance tga gov au ebs EM EMDrafts nsf Submission openform amp app se eBS tga gov au Therapeutic Goods Administration Copyright Security Disclaimer Privacy Statement iDone B Internet is start E wow EN Josh Wiley Inbox d Therapeutic Good Microsoft Word 13 06 0546548 doc Tuesday Figure 31 Make Submission Page Page 76 Online Services Export Electronic Lodgement 4 Select the application to add to the submission using the drop down list Note Only those applications that have passed validation will be available in the list If the application is not in the list check the Existing Drafts folder and ensure the application has passed validation 5 Single click the Select button to submit
125. y mandatory Nominate current listing create a new listing whether this application is to change an existing ARTG listing or to create a new ARTG listing To create a new export only product select Create a New listing If Change a current listing is selected the form will refresh to allow for the creation of a Grouping or Variation to a single current listing See page 25 for further details Change Description This field only becomes available if selecting Change a Current Listing to the question above To nominate the type of change being made to an existing listing select from the drop down list and click on the Add button Submission Cost Displays the submission cost when the draft application has been entered and validated Application Status This field is populated by the system depending on the current status of the application Payment Exemption No This field is not mandatory If permitted by the TGA enter a payment exemption number if an exemption is applicable to this application Application type Displays the final type of application when the draft application has been entered and validated e g New Grouping Variation Note this field only appears when the Application status is valid Validation Report Displays a report of an attempt at validation of the draft application Messages displayed will indicate the source of any application errors These errors must be fixed to proceed with furt

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