Listed medicines applications and submissions user guide AUG
Contents
1. amp Please read this Statutory Declaration then select the Agree button to allow Submission of the selected applications Click the Disagree button to cancel the declaration Product Name Application ID Sponsor s Business Name Sponsor Enterprise ID James Blundell Jamie s Vitamin C LM 2013 GL 00450 1 Jamie s Nutritionals 57438 being a person authorised by the Sponsor or by an Agent duly appointed to act on behalf of the Sponsor hereby certify that 2 Read the Statutory Declaration Then press the Agree or Disagree button Note by clicking on Agree you declare that the information given in the application the statements made in the declaration are current and correct 3 Once you have agreed the selected application will be highlighted Repeat steps 1 and 2 to add subsequent applications to your submission All selected applications will be submitted in a single submission hereby declare by clicking on the AGREE button below that the information given in this application and the above statements on this declaration form are current and correct Full Name of Signatory Date James Blundell Tuesday 9 July 2013 ted Agree inf Disagree 4 Each of the applications selected for submission will display Yes in the submit column under Eligible applications as shown below Eligible Applications Product Name C2. Enter the product name and export names if required in the Registration tab Note that the Product code selected will be Drug kits 4 Complete the Manufacturers tab as explained on page 14 15 of this guide Note that you cannot select Manufacture of dosage form within a medicine kit application Products tab Three types of medicines can be added to a medicine kit exempt listed and registered medicines Status Draft Application Id LM 20123 MK 00320 1 Application Registration Manufacturers Products Other Regulatory Requirements Always Required Required under certain conditions Exempt Listed Registered Add Remove Medicine Add Listed Registered Medicine Exempt Medicine Indications Add Remove Warnings Subsection 26B 1 Notification Electronically notify the Secretary thet the certification requirements of Subsection 266 1 do not apply to an application To added a listed or registered medicine 1 Press the Add button from the Exempt Listed Registered medicine section 2 Select Add Listed Registered medicine to open the Medicine details search Medicine Details Medicine AUST L or AUST R CET 3 Enter the AUST L or AUST R number and press the Search button or Enter key Ensure that the correct medicine has appeared and click Save Listed medicines application and submission user guide Page 23
3. passed application has validated successfully 5 Application ID begins with LM and is the identification number of the application you are working on This number can be used to troubleshoot technical issues Username the name of the current applicant Client reference a name that can be entered by the applicant in order to identify the current application This name is not seen or used by the TGA 8 Last updated the date and time the application was last updated 9 Previous Next navigates through the tabs of the application 10 Save save current application 11 Validate validate current application NOTE Validation is not possible until all required fields have been completed 12 Print preview view the application before printing 13 Close close current application returning to the eBS portal Required fields Fields in the application are required or conditionally required depending on a number of different factors Required fields are marked by a red asterisk and conditionally required fields are marked by a grey asterisk Always Required Required under certain conditions Route of Administration Add Jj FETTE Dosage Form Container Type Container Volume Add remove and edit data in fields Where appropriate Add to add an entry press the Add button and insert the required information Remove select the checkbox in front of the entry which you w
4. 8 Navigating through an application 9 Required fields 10 Add remove and edit data in fields _ 10 Application tabs__ SSS 11 Completing an application 11 Applicationtab_o SS 11 Registrationtab_ gt Z S 12 Manufacturers tab _____ gt S 13 Products tab ____ 13 Ingredients _____ o 14 Proprietary Ingredients z 15 Plant part _ _ _ 18 Plant preparation _ _ 18 Equivalent preparation _ 18 Listed medicines application and submission user guide Page 3 of 32 August 2013 Therapeutic Goods Administration Equivalent quantity z _ 18 Final preparation ratio __ _ _ 18 New ratio _ z 18 Preparation steps _ CRNE E 18 Plant preparation ____ _ _ 18 Residue Quantity __ o 18 Indications ____ 19 Standard indications o 19 Warnings _ __ __ a a ar ae a ee ee ae ee ee ee 20 Subsection 26B 1 Notification ____ 21 Other regulatory requirements tab _____ CCCs 22 Other application types 22 Code stock applications_ o SS o 22 Medicine kit applications__ o gt SSS o o 23 Products tab __ 23 Composite pack _ ___ 24 Products _ _ 24 Change multiple current listings application 25 Application tab_ 25 Registration tab 25 Manufacturers tab _ 26 Products tab__ a _ 26 Validating an application 27 Submission 29 Listed medicines application and submission user g
5. Tax System Goods amp SericesTax Actt Subtotal 1 GST Total Listed medicines application and submission user guide Page 31 of 32 August 2013 Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia Email info tga gov au Phone 1800 020 653 Fax 02 6232 8605 http www tga gov au Publication Listed medicines application and submission user guide July 2013
6. and submission user guide Page 16 of 32 August 2013 Therapeutic Goods Administration Essence Ingredients Concentration of mother substance Manufacturer method Applicable when the ingredient role is Essence Enter the quantity and select the unit from the drop down list Applicable when the ingredient role is Essence Select the manufacturing methods from the drop down list Ingredients of Human or Animal Origin Ingredient of human or animal origin Animal origin Animal type Animal part Applicable to AAN or ABN ingredients Note A preclearance certificate issued by the TGA s Office of Laboratory and Scientific Services may be required Select the country or countries of origin for the ingredient from the drop down list Select the animal the ingredient is derived from the drop down list Select the part of the animal from which the ingredient is derived from the drop down list Listed medicines application and submission user guide Page 17 of 32 August 2013 Therapeutic Goods Administration AHN Only Plant part Plant preparation Equivalent preparation Equivalent quantity Final preparation ratio New ratio Preparation steps Remaining restricted solvent Carrier Select the plant part from the drop down list Select the plant preparation from the drop down list Note that selecting a different plant preparation may cause values in other fields to be a
7. Manufacturers tabs as explained previously Products This tab will allow you to add multiple formulations which will make up the composite pack A minimum of two formulations are required This section can be completed as previously described The only difference is in the Component name which will be the name used to distinguish each portion of the composite pack Listed medicines application and submission user guide Page 24 of 32 August 2013 Therapeutic Goods Administration Component Details Component Name Formulation 1 Product Details Dosage Form Route of Administration Add Remove Route of Administration Container Type Container Volumes Container Closure Container Condition Maximum Single Dose Maximum Daily Dose Minimum Weight of Divided Dosage Form tablets capsules metered dose sprays elc Formulation Details Ingredients Add Remove Heip la Save la Save amp Close EQ Close Change multiple current listings application The Change multiple listings application allows for the same change to be made across a number of currently listed medicines Therefore the information required under each tab varies from the General listing application Application tab The application tab in the Change multiple listings application requires a Change multi listing name to be included Registration tab To make a change to sev
8. Type Standard Specific Search For wen Search Type the indication code a word or a phrase which appears in the indication Help lH Save pj Save amp Close i Close 3 Inthe search bar enter key words which appear in the text of the indication required and press the Search button or Enter key to begin the search Indications Indication Type Standard Specific Search For Well Search Type the indication code a word or a phrase which appears in the indication Select standard indication from list L ARTH3 May help reduce joint swelling associated with arthritis Cl GouT3 May help reduce joint swelling associated with gout i WELL Aids assists or helps in the maintenance or improvement of general well being F WELL1 Aids assists or helps in the maintenance of general well being L WELL2 Aids assists or helps in the improvement of general well being Hep H Save H Save amp Close e Close Listed medicines application and submission user guide Page 19 of 32 August 2013 Therapeutic Goods Administration 4 Select the indications which you wish to add from the list Note that multiple indications may be selected at the same time 5 Select Save and close The indication will then appear on the form Note To add multiple indications you may select Save and keep the indications box open allowing the selected indi
9. al use or if you are part of an organisation for internal use within your organisation but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way electronic or otherwise without first being given specific written permission from the Commonwealth to do so Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer Therapeutic Goods Administration PO Box 100 Woden ACT 2606 or emailed to lt tga copyright tga gov au gt Listed medicines application and submission user guide Page 2 of 32 August 2013 Therapeutic Goods Administration Contents Introduction 5 TGA eBS portal for listed medicines _____ _ o gt o o oo o o oo 5 Assumed knowledge ____ __ Z o S oS 5 Accessing help 5 Email__ E _ 5 Phone _ a 5 Getting Started 6 Accessing the electronic Business Service eBS __ 6 To access the eBS system _ 6 To enter the sponsor portal _ Usertypes_ gt Z 7 Home page 7 Creating new applications_ gt gt Z S o 8 Accessing draft applications ___ lt Z gt S o
10. and submissions open the various application types and submit validated applications Lodge supporting documentation upload supporting documentation Maintain user account edit portal options user details and view account activity Your TGA information view current ARTG entries and product information Listed medicines application and submission user guide Page 7 of 32 August 2013 Therapeutic Goods Administration Creating new applications To create a listed medicine application 1 Select Portal your user name to v Portal Your User Name reveal more options View Drafts 2 Select Create applications amp View Lodged Submissions submissions ARTG Cancellation News 3 Select Listed medicine This will result in v Create Applications amp Submissions the following options becoming available Biologicals e General listing the most common v Listed Medicine application type containing a single General Listing medicine Composite Pack e Composite pack allows for two or more Code Stock medicine formulations to be included Medicine Kit forming a pack Change Multiple Current Listings e Code stock creates an application based Submission on a code stock product e Medicine kit previously listed medicines which will be sold together in a purpose built pack e Change multiple current listings allows for minor changes to be made to multiple listings 4 Select the appropriate application type from the list Thi
11. application for a listed medicine are accessible via eBS This guide is intended to be used as a step by step description of each process of the application and submission process Each section will outline the functionality and describe how each section should be completed Assumed knowledge It is assumed that users will have an understanding of the regulation of complementary medicines in Australia and the legal obligations of a sponsor of a listed medicine For more information refer to the Australian Regulatory Guidelines for Complementary Medicines Accessing help Help is available from within the eBS portal and can be accessed by clicking the Help link in the top left corner on each page of the application This will open help in a new window Email For listed medicine application and submission enquiries please email elf tga gov au with as much information as possible such as a copy of your problem application or screenshots of error messages you have received Phone Listed medicines helpdesk ph 1800 773 312 Operates Monday to Friday between the hours of 10am to 12 noon and 2pm to 4pm TGA eBS helpdesk ph 1800 010 624 Office of Manufacturing Quality helpdesk ph 1800 446 443 Listed medicines application and submission user guide Page 5 of 32 August 2013 Therapeutic Goods Administration Getting Started Accessing the electronic Business Service eBS The TGA eBS is accessed through your web browser Thi
12. ase review the additional information shown under the Other Regulatory Requirements section Application Type New Anew AUST L will be generated Submission Cost 680 00 After reviewing the Other Regulatory Requirements please click Proceed to Submission to submit the application This message includes the Application type and associated Submission cost Press the Ok button to review the Other regulatory requirements Once the Other regulatory requirements have been reviewed press the Proceed to submission button If you do not wish to submit the application straight away press Save and the application will remain in the drafts area of the LM eBusiness portal Thefgeutic Goods Administration eBusiness Services Status Passed Validation Application Id Lw 2012 GL 00551 1 GeneratListing Application Application Registration Manufacturers Products Other Regulatory Requirements Information Messages Herbal Care Manufacturing Ltd MI 2013 LI 00136 1 has conditions none Proceed to Submission lt Previous H Save 4 Validate ES Print Preview J Close NOTE Applications are NOT submitted automatically after successful validation Listed medicines application and submission user guide Page 28 of 32 August 2013 Therapeutic Goods Administration Submission Pressing the Proceed to submission button from the application form will take you to the su
13. be searched for using their ID number Ingredient Details x Search Formulation Type Active Excipient Search Ingredient Role Standard Homoeopathic Proprietary Ingredient Search By Name Proprietary Ingredient by ID Ingredient Name Search E Close 3 Press the Search button or use the Enter key to begin a search Ingredient Details Ingredient Name Ascorbic acid Formulation Type Active Ingredient Role Standard Ingredient Type AAN Ingredient Quantity Equivalent la Save amp Close Close 4 Select the correct ingredient name from the drop down list 5 Enter the ingredient quantity and select the units from the drop down list Proprietary Ingredients Formulation details of Proprietary Ingredients are not released and usually contain either multiple excipient ingredients or a single active preparation which may also include excipient ingredients Active Proprietary Ingredients require ingredient quantities to be entered Some excipient Proprietary Ingredients such as flavours fragrances and printing inks also require quantities to be entered as the following limits apply to the final formulation e Flavour 5 e Fragrance 1 e Printing Ink 0 1 The following options are available in the ingredient box Note that only those fields applicable to the particular ingredient wi
14. bmissions area of the portal as shown below Application Help Jamie_57438 Therap n eBusiness Services Make Listed Medicine Submission Submission Always Required Required under certain conditions Submission Number Applicant Name Jamie s Nutritionals Applicant Billing Address 34 Cranberry Street SYDNEY NSW 2000 Sponsor Name Filter Jamie s Nutritionals Eligible Applications Product Name Head cold relief Jamie s Vitamin C Jamie s Vitamin C Copy of Jamie s Vitamin C Jamie s Vitamin C Jamie s Vitamin C Eligible applications must have successfully passed validation in order to be available for submission Applications available for submission are displayed including their product name application ID date time of validation application type and associated fee Submissions can also be made from the eBS portal under the Listed medicines gt Create applications and submissions gt Submissions link To submit your applications 1 Select the checkbox next to the application you wish to submit This will open the Statutory Declaration as shown below Listed medicines application and submission user guide Page 29 of 32 August 2013 Therapeutic Goods Administration Therapeutic Goods Administration eBusiness Semices Make Listed Medicine Submission Submission Number Applicant Name Applicant Billing Address Sponsor Name Filter Eligible Applications Jamie_57438
15. cation to be added and a new indication search to be conducted Specific indications Specific indications are customised indications the wording of which is the responsibility of the sponsor of the medicine The meaning and intent of customised indications must be in line with what is acceptable for use in listed medicines To add a Specific indication 1 Press the Add button 2 Select the Specific toggle button for the indication type which opens the Specific indications form Indications Indication Type Standard Specific Enter specific indication text Help H Save pj Save amp Close EJ Close Enter the text for the Specific indication 4 Press the Save and close button The indication will then be added to the form Warnings To add a warning 1 Press the Add button next to Warnings to open the form 2 Type in key words from the warning and press the Search button or the Enter key to begin the search Listed medicines application and submission user guide Page 20 of 32 August 2013 Therapeutic Goods Administration Warnings Search For Search j Type the warning code a word ora phrase which appears in the warning Hep H Save H Save amp Close EJ Close 3 Select the required warnings and press the Save and close button Note To add multiple warnings you may press Sav
16. ch Search E Close 2 Select the location of the manufacturer either Australian or Overseas 3 Select what term the search will be conducted using the Name Manufacturer ID or Licence ID for the manufacturer 4 Enter all or part of the information then press the Search button Note If not enough information is entered an error message stating Too many entries found Please refine your search will appear 6 Select the required Manufacturer name from the drop down list 7 Select the Manufacturer location from the drop down list 8 Select the steps performed by the manufacturer Each step can be undertaken by more than one manufacturer 9 When complete press the Save button to return to the manufacturing tab Products tab Please note that some of the sections listed below are only conditionally required depending on a number of factors relating to your product Listed medicines application and submission user guide Page 13 of 32 August 2013 Therapeutic Goods Administration Description Route of administration Press the Add button to enter the route s of administration Multiple routes of administration can be added to a formulation by pressing Save between each addition Dosage Form Select the dosage form for the formulation from the drop down list Container type Only required when the formulation contains ingredients whi
17. ch have Container volume been restricted to a container type closure or size limit Container closure Container condition Information can be entered into the correct field or selected from a drop down list Maximum single dose Only required when restrictions apply Fields to select units from will Maximum daily dose display if using a non divided dosage form for example powder Minimum weight of divided Only required when using a divided dosage form for example tablet and dosage form the formulation contains restricted ingredients Ingredients Australian approved terminology should be used when submitting an application Approved names fall into the following categories AAN Australian Approved Chemical Substance Name ABN Australian Biological Name AFN Australian Food Name AHN Australian Herbal Name AHS Australian Herbal Substance HCN Herbal Component Name To add an ingredient 1 Press the Add button next to the Ingredients section to open the Ingredient details form Application Registration Manufacturers Products Other Regulatory Requirements Ingredients a Add Remove Listed medicines application and submission user guide Page 14 of 32 August 2013 Therapeutic Goods Administration 2 The ingredient details form is displayed as shown below Select the ingredient type ingredient role and enter the ingredient name Proprietary Ingredients can
18. dded Residue Quantity The upper limit maximum amount of solvent allowed in the specifications for the ingredient A carrier is an excipient ingredient which may be included in a herbal ingredient Press the Add button to add a carrier to the ingredient Multiple carriers can be added Listed medicines application and submission user guide August 2013 Page 18 of 32 Therapeutic Goods Administration Indications An indication means the specific therapeutic use of the medicine There are two types of indications which can be added to a medicine Standard and Specific indications Advertising claims are not indications and do not need to be entered in the ARTG As required by the Act the sponsor of a product listed on the ARTG must hold acceptable evidence to support the use of a particular indication for a medicine Therefore the sponsor should ensure that indications meet the relevant requirements for a listed medicine under the Act Refer to the Australian Regulatory Guidelines for Complementary Medicines for more information Standard indications Standard indications are those which are maintained by the TGA and considered acceptable for listed medicines provided appropriate evidence is held To add a Standard indication 1 Press the Add button to open the Indications form 2 Select the Standard toggle button for the indication type Indications Indication
19. e and keep the warning box open allowing the selected warning to be added and a new warning search to be conducted Subsection 26B 1 Notification A certificate is required in relation to patents to the effect that the applicant is not marketing does not propose to market the therapeutic goods in a manner that would infringe a valid claim of a patent in relation to the goods However patent certification requirements only apply where there is a requirement to submit safety or efficacy data of the goods as part of the process for applying for registration or listing As listed medicines do not require submission of such data sponsors must certify that a patent certificate is not required at the time of listing The Subsection 26B 1 Notification enables sponsors to notify the Secretary that the certification requirements of Subsection 26B 1 of the Act have been met Subsection 28B 1 Notification is mandatory and must be completed before an application can be validated and submitted To add a Subsection 26B 1 Notification 1 Press the Add button next to the Subsection 26B 1 Notification heading Answer the questions by selecting either Yes or No radio buttons for the following questions 2 Are you required to submit evidence or information to establish the safety or efficacy of this listing application Usually the answer to this question is No 3 For the purpose of subsection 26B 1 you are notifying
20. eneral Listing Application A ran ant memece not seen by TGA f 7 Client Reference Always Requeed Requeed under certen conditions Applicant Name James Ntrfonats Sponsor Name Jamie s Nutritionals peer leg Aro 3 Cranberry Street SYDNEY NSW 2000 Sponsor Regulatory 34 Cranberry Street SYDNEY NSW Corresponcence accress L a Is this Applicaton in response toa Section 20 Arpide nier the AUST L you are mapondng to This application is to Create anew ARTG entry Change a current ARTG entry AUSTL Seach Submission Cost 0 Payment Exemption Number 10 Save 11 Validate f Nea gt id sae lt 2 Vaicme Pree Prevew EJ Cose 9 Previous Next 8 Last Updated 12 PrintPreview 13 Close The various aspects of the form are explained as follows 1 Application allows you to save or close an application It also allows for validation once all necessary information has been entered 2 Help provides definitions and information regarding each step of the application process 3 Application type refers to the type of application being created for example General listing Medicine kit Code stock Listed medicines application and submission user guide Page 9 of 32 August 2013 Therapeutic Goods Administration 4 Status indicates the state of the application that is draft application has not yet been validated or
21. eral ARTG listings enter the AUST L numbers of the products to be changed as shown below List of Medicines to be Changed Medicine AUST L Add Remove To add an AUST L 1 Press Add to open the search function Listed medicines application and submission user guide Page 25 of 32 August 2013 Therapeutic Goods Administration Medicine AUST L Medicine AUST L Application Status Help i Save EQ Close 2 Enter the AUST L number required and press Search 3 Confirm that the details of the required AUST L are correct and press Save Manufacturers tab This tab allows the following changes to be made e Common manufacturing steps Based on information generated from the selected AUST Ls common manufacturing steps will be displayed and can be changed e New manufacturers can also be added by pressing the Add button in the New Manufacturers section of the form shown below Application Help Jamie_57438 ee Se iness Services Status Application Id LI Change Multiple Listings Application eee eee Client only TGA wil not retain this Application Registration Manufacturers Products Other Regulatory Requirements Always Required Required under certain conditions Common Manufacturing Steps Remove Steps a Packaging and labelling for Herbal Care Manufacturing Ltd at 804 Artemesia Avenue E C Testing microbial for Herbal Care Manufacturing Ltd at 804 Artemesia A
22. hie R3 so Australian Government Lest Department of Health and Ageing Therapeutic Goods Administration Listed medicines application and Submission user guide TGA eBusiness Services August 2013 Health Safety Regulation Therapeutic Goods Administration About the Therapeutic Goods Administration TGA e The Therapeutic Goods Administration TGA is part of the Australian Government Department of Health and Ageing and is responsible for regulating medicines and medical devices e TGA administers the Therapeutic Goods Act 1989 the Act applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality safety and efficacy performance when necessary e The work of the TGA is based on applying scientific and clinical expertise to decision making to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices e The TGA relies on the public healthcare professionals and industry to report problems with medicines or medical devices TGA investigates reports received by it to determine any necessary regulatory action e To report a problem with a medicine or medical device please see the information on the TGA website lt www tga gov au gt Copyright Commonwealth of Australia 2013 This work is copyright You may reproduce the whole or part of this work in unaltered form for your own person
23. ish to remove and press the Remove button Edit depending on what data is to be edited either press the Edit button or click on the blue link and the required field will open and allow you to make the changes Once completed press the Save or Save and close button to finalise the changes Listed medicines application and submission user guide Page 10 of 32 August 2013 Therapeutic Goods Administration Application tabs The application has been divided into a number of tabs as shown below Application Registration Manufacturers Products Other Regulatory Requirements Click on each tab in order to navigate through the application Application general information regarding the listing including applicant contact details if the application is a section 30 response and whether the application is for a new listing or change to current listing Registration product name product code export names and code stock notification Manufacturers manufacturer details and steps performed Products information relating to the product including route of administration dosage container specifications ingredients indications and warnings Also includes subsection 26B 1 Notification Other regulatory requirements regulatory information relating to the specific product Completing an application The following will describe the process of completing a general listing Most sections are applicable to all a
24. l There are three user types 1 2 Master is able to set up new users but cannot draft or submit applications Drafter is able to carry out all functions needed to complete applications but cannot submit applications Submitter can perform the same tasks as a drafter and is also able to submit a completed application to the TGA Each sponsor is allocated a user name and password for their Master account They can then create their own users for the Drafter and Submitter roles Once logged in all users are able to see the current applications for the sponsor Home page Once logged in you will see the portal home page as shown below t Australian Government ye Department of Health and Ageing Therapeutic Goods Administration Portal James Blundell Drafts Sponsor Cancellation Online Invoice Payment Approval Area All Approval Areas Sponsor All Sponsors Public TGA Information News Help Filter on Date Training Date Identifier Secure Emal a gy 2013 06 LM 2013 GL 00329 Cold amp Flu 1 Jamie s Nutritionals Logout 1 Remedy ww 3UStrSal3 gov au w a For further Clicking on Portal username will reveal the following View drafts all draft applications completed in eBS can be viewed View lodged submissions view and track the progress of all submitted applications under all eBS systems ARTG News view the latest ARTG news Create applications
25. ll be displayed Listed medicines application and submission user guide Page 15 of 32 August 2013 Therapeutic Goods Administration Ingredient name Formulation type Ingredient role Ingredient type Proprietary ingredient ID Ingredient quantity Homeopathic Ingredients Ingredient name Label name amp potency Reference Description Select the ingredient from the drop down list These fields are automatically populated based on the ingredients selected Ingredient quantities are required for all active ingredients Excipient ingredient quantities are currently not required unless they are AHNSs or have restrictions Enter the ingredient quantity and select the appropriate unit There are two instances where equivalents are used e Equivalent dry or fresh herb where the preparation is an extract e Where a component ofa substance is declared on the label or mandated due to regulatory requirements Select the ingredient from the drop down list Enter the potency of a homeopathic ingredient Enter the label name and potency values of a homeopathic ingredient Press the Add button to add a diluent to the ingredient Select appropriate diluents from the drop down list and enter the percentage Multiple diluents can be added Select the Diluents are not present in the final product box if applicable Select the homeopathic reference from the drop down list Listed medicines application
26. n eBusiness Services Status Draft Application Id eneral bisting Application M 2012 GL 00323 san Cionnorcrence Application Registration Manufacturers Products Other Regulatory Requirements Validation Report at 14 Jun 2013 3 55 PM Validation Messages Double click on a validation message to jump to the part of the application that needs review No Indications have been added You must have at least one Indication This application requires a completed Subsection 26B 1 Notification Each Formulation must have at least one Active ingredient Formulation Formulation 1 The application requires the following Manufacturing Step s to be declared Packaging and labelling Release for supply Testing chemical and physical Testing microbial Manufacture of dosage form lt Previous Ne ii Save Validate EG PrintPreview Close Listed medicines application and submission user guide Page 27 of 32 August 2013 Therapeutic Goods Administration Hovering the mouse over a message highlights the selected message Double click the highlighted validation message to open the section of the form the validation message relates to and make the required corrections Once issues have been corrected press the Validate button again If no more issues arise a successful validation message will be displayed as shown below Application Validation This application successfully passed validation No problems were detected Ple
27. of 32 August 2013 Therapeutic Goods Administration To add an exempt medicine such as a bandage 1 Press the Add button from the Exempt Listed Registered medicine section 2 Select Exempt medicine Medicine Exempt Details Exempt Medicine Hep H Save H Save amp Close 3 Enter the name of the exempt medicine and press Enter or select Save and Close to return to the application To add multiple exempt medicines you may select Save and keep the medicine Exempt Details box open allowing the selected medicine to be added and a new medicine to be entered Composite pack A Composite pack application is used for medicines that are to be sold together in one package where the medicines are either combined before use or administered ina particular sequence for a single treatment or course of treatment For the full definition of composite pack refer to Section 7B of the Act Composite pack applications differ from General listing applications only in that they require the addition of multiple formulations in the same application whereas General listing applications have a single formulation To complete a Composite pack application 1 From the eBS portal select Create applications and submissions then select Listed medicines then select Composite pack 2 Complete the Application Registration and
28. opy of Jamie s Vitamin C Jamie s Vitamin C Jamie s Vitamin C Application Id LM 2013 GL 00451 1 LM 2013 GL 00551 1 LM 2013 GL 00559 1 5 Press the Submit button in the bottom right hand corner Successful submission will take the submitter to the Notification page Listed medicines application and submission user guide August 2013 Page 30 of 32 Therapeutic Goods Administration Application Jamie_57438 Notification James Blundell your submission LM 2013 00052 1 has been successfully submitted to the TGA Select the Print Invoice option to obtain a copy of the invoice Print invoice E3 Close 6 Press the Print invoice button in the bottom right hand corner to print an invoice for this submission as shown below Australian Government Department of Health and Ageing Therapeutic Goods Administration ABN 40 939 406 804 Tax Invoice Jamie s Nutritionals ONLO9S059 34 Cranberry Street 09 07 2013 SYDNEY NSW 2000 i 680 00 Client ID Enquiries Phone Contact Email Address 57438 TGA Accounts Receivable 02 6232 8228 02 6232 8222 accountsrec tga gov au Identifier Description Unit Price GST Total LM 2013 GL 00429 1 New A new AUST Lwill 680 00 0 00 680 00 be generated LM 2013 GL 00429 1 New A new AUST Lwill 00 0 00 00 be generated LM 2013 GL 00429 1 New A new AUST L will 00 0 00 00 be generated Jopeomton ters are exempt from G ST under Division 31 of A New
29. otify TGA that payment is not required Description Enter the name of the product This is the final product name that will be used if the product is listed on the ARTG A unique name assigned to the goods by the sponsor to appear on the label Select the code that best describes the type of product being submitted from the drop down list for example Most listed medicines are generally Other products unless they contain homeopathic ingredients Multiple export names can be added to a product Press the Add button to add export names To remove export names select the box beside the name you wish to remove and press the Remove button Listed medicines application and submission user guide Page 12 of 32 August 2013 Therapeutic Goods Administration Description Can this product be used as a Indicates if the product can be used as a code stock code stock Note Selecting code stock does not mean the formulation will be confidential If the application is for a product made from a code stock source the code stock source details will be displayed here Manufacturers tab To add a manufacturer 1 Press the Add button beside the Manufacturers section to open the Manufacturer Details form Manufacturer Details Manufacturer Australian Overseas Context Name Manufacturer ID Licence ID Enter part all of a manufacturer s name or id then click Sear
30. pplication types however more specific guidance for each application type can be obtained from the relevant section of this guide Application tab Description Applicant name Displays your client name based on your login ID Sponsor name Select the sponsor name from the drop down list Sponsor addresses Billing address Select the preferred billing address for this product If the required address is not available Regulatory correspondence address Select the sponsor address please contact the eBS Help Desk from the drop down list provided Listed medicines application and submission user guide Page 11 of 32 August 2013 Therapeutic Goods Administration Description Is this application in response to a Select Yes if this application is being submitted as a response toa Section 30 This application is to Submission cost Payment exemption number Registration tab Field Product code Section 30 request Enter the AUST L being responded to if Yes has been selected Nominate whether this application is to change an existing ARTG listing or to create a new ARTG listing There are two situations where this field is used e Enter a current AUST L to update the listing e Enter a current AUST L to create a new listing based on an existing listing Displays the submission cost when the draft application has been completed and validated Enter a payment exemption number if applicable to n
31. s is commonly Internet Explorer but may also be Chrome Firefox or Safari To access the eBS system 1 Open your internet browser 2 Goto www ebs tga gov au The homepage will appear as shown below This page is accessible by all however secure login is required to access the application system via the sponsor portal m IC eBusiness Therapeutic Goods Administration Services Report a Therapeutic Product Latest News 13 11 2012 Australian regulatory guidelines for sunscreens Public TGA Information 04 05 2012 eBS Updated Public Search Facilities Problem 21 06 2011 Agreement to creation of joint therapeutic goods regulatory scheme by the Australian and New Zealand eBS Access Forms Governments 31 05 2011 New Biologicals Framework Training Latest News Secure Email Secure Login To enter the sponsor portal 1 Ensure you have the password provided to you by the eBS helpdesk 2 Select Secure login from the left hand side of the eBS homepage 3 The login screen will display Enter your user name and password Please identify yourself User name Password Cancel Login Note User name and password are case sensitive Your password will not be readable on screen appearing as a row of Listed medicines application and submission user guide Page 6 of 32 August 2013 Therapeutic Goods Administration User types Security for the TGA eBS is handled at an organisational leve
32. s will open the associated form The process of filling out each application type varies slightly The following sections of the document will guide you through the process Accessing draft applications Previously completed draft applications which have not been submitted can be accessed via the eBS Portal as shown below v Portal James Blundell View Drafts View Lodged Submissions ARTG Cancellation News Selecting View drafts will open a list of current draft applications Click on the draft application you wish to continue editing To access other functions such as copy delete or print preview press on the arrow to the left of the application you wish to access Date Identitier Client Reference Information B _ 2013 06 20 LM 2013 GL 00363 1 None Jamie s Vitamin C Jamie s Nutritionals 4 2013 GL 00323 1 None Cold amp Flu Remedy Jamie s Nutritionals Listed medicines application and submission user guide Page 8 of 32 August 2013 Therapeutic Goods Administration NOTE Draft applications are automatically deleted from the system if they have not been updated in the last six months Once deleted records are not retrievable Please manage draft documents accordingly Navigating through an application Once a new application type or draft has been selected the application will open as shown below 1 Application 5 ApplicationID Appia at Status a Application Id G
33. the Secretary that a certificate under subsection 26B 1 is not required for this application Usually the answer to this question is Yes 4 Press the Save and Close button to return to the Application form Listed medicines application and submission user guide Page 21 of 32 August 2013 Therapeutic Goods Administration Other regulatory requirements tab This section contains other general information and regulatory requirements applicable to the application Information contained under this tab is generated after successful validation Other application types Code stock applications Code stock applications are prepared from an existing medicine that has been made available for use as a code stock by the sponsor A code stock formulation can be sold to a number of sponsors who then sell the product under their own brand name The stock formulation is the same in every instance The only difference is the brand product name it is sold under and the indications for therapeutic use A product created from a code stock formulation cannot be altered apart from the product name indications and warnings To complete a new medicine prepared from a code stock 1 From the eBS portal select Create applications and submissions then select Listed medicines then select Code stock 2 Inthe section titled Code stock source on the Registration tab enter the AUST L number of the code s
34. tock source to be used and press the Search button If the entered AUST L can be used as a code stock the following message will appear Message from webpage 1 Code stock source found 2 Press the Save button to view code stock source details 3 An authorisation from the code stock owner is required 3 Press the Ok button To load the details of the code stock into the form press the Save button from the bottom menu 4 Complete the Application tab as explained on page 13 of this guide Complete the Registration tab explained on page 14 taking note of the Code stock source section Details relating to the formulation of the code stock cannot be changed The only details which can be changed relate to the product name including export names warnings and indications Listed medicines application and submission user guide Page 22 of 32 August 2013 Therapeutic Goods Administration Medicine kit applications A Medicine kit application is used when existing medicines are to be sold together as a purpose built kit For the full definition of medicine kit refer to Section 7B of the Act To complete a new Medicine Kit application 1 From the eBS portal select Create applications and submissions then select Listed medicines then select Medicine kit 2 Complete the Application tab as explained on page 13 of this guide 3
35. uide Page 4 of 32 August 2013 Therapeutic Goods Administration Introduction TGA eBS portal for listed medicines Listed medicines are considered low risk based on their ingredients and the indications made for them Most listed medicines are complementary medicines such as vitamin and mineral formulations herbal preparations homeopathic preparations and essential oils The TGA eBusiness services eBS portal provides an electronic facility for the listing of medicines on the Australian Register of Therapeutic Goods ARTG A medicine is listed on the ARTG on the basis of information provided by the applicant and a certification by the applicant that the goods that are the subject of the application meet the requirements of Section 26A of the Therapeutic Goods Act 1989 the Act The Act allows for cancellation of a product from the ARTG if a sponsor s certification is incorrect Access to the eBS system is via a secure login on the eBS homepage and requires a user name and password In order to get access to eBS applicants must first submit a Client Details Form to obtain a client identification number Having obtained a client identification number an eBS Access Request Form can be submitted The TGA will establish access for the applicant to become the E Business Administrator for their company and then applications for user accounts can be made All necessary tools required to lodge change and maintain an
36. utomatically updated Select the appropriate equivalent preparation from the toggle buttons if required Enter the amount of equivalent preparation to be used in the ingredient Select the unit from the drop down list Enter the final preparation ratio The ratio will reverse depending on the preparation type selected Applicable when the ingredient ratio requires updating Enter the new ratio value then press the Update button to the right of the ratio field Press the Add button to add a preparation to the ingredient Multiple preparation steps can be added Plant preparation Select the plant preparation from the drop down list This will automatically default to the plant preparation value previously selected on the parent ingredient page Preparation ratio Enter the ratio values if different to the original ratio entered on the parent ingredient Plant preparation step This is automatically generated by the system Solvents Press the Add button to add a solvent Multiple solvents can be added Select appropriate solvents from the drop down list and enter the percentage Note Total percentage must equal 100 Select the Remainder water box if applicable Required if solvents are restricted The solvent to be added must be the same as those used in preparation steps previously completed Click the Add button to add a Remaining restricted solvent to the ingredient Multiple solvents can be a
37. venue BRISB Testing chemical and physical for Herbal Care Manufacturing Ltd at 804 Artemesia Avi El Release for supply for Herbal Care Manufacturing Ltd at 804 Artemesia Avenue BRISE Manufacture of dosage form for Herbal Care Manufacturing Ltd at 804 Artemesia Aver New Manufacturers Manufacturers Products tab Common words used in the product name of the selected AUST L s can be changed using the replacement function To make a change across the selected AUST L s 1 Enter the text to be replaced in the Replace field 2 Enter the replacement text in the With field Listed medicines application and submission user guide Page 26 of 32 August 2013 Therapeutic Goods Administration Product Name Text Replacement Replace lane With JB s Subsection 26B 1 Notification Add Electronically notify the Secretary that the certification requirements of Subsection 26B 1 do not apply to an application Validating an application Once an application has been completed it must be validated prior to submission for processing To validate an application 1 Press the Validate button which appears in the lower right hand corner of the application During validation the application and all related sub documents are checked against the listed medicine business rules If issues are found validation results will be displayed in a side bar as shown below Therapaygic Goods Administratio
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