Office use only

Request to vary an ARTG entry under subsection 9D(3):Category 3 application

Application form

Please note:This application form must be used if are making a request for a variation to an existing ARTG entry for a registered prescription medicine that does not result in the creation of a separate and distinct good, does not reduce the quality, safety or efficacy of the product, and requires evaluation of data by the TGA. Please refer to the Therapeutic Goods Act 1989 and the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) to determine the type of application relevant to the variation you are requesting. Further guidance on what constitutes a variation under s. 9D(3) can be found in Appendix 12 (for chemical entities) or Appendix 13 (for biological medicines) of the ARGPM.

Section 1.Sponsor and product details

1.1Sponsor details

Sponsor name
eBS Client ID
Postal address
Contact person (eg, regulatory affairs officer, agent)
Position
Telephone number
Fax number
Email address

PO Box 100 Woden ACT 2606 ABN 40 939 406 804

Phone: 1800 020 653 Fax: 02 6232 8605 Email:

Reference/Publication #

1.2Product details

Medicinal product details

Single active ingredientMulti-active ingredientMulti-component

Is the product:a biological medicine?ORa chemical medicine?

AUST R / Active ingredient(s) / Trade (proprietary) name / Strength / Dosage form / Container type

Section 2. Details of request

2.1Details of variation

Please provide a brief description of the variation being requested in the box below:

If the request is approved, will the Product Information (PI) require amendment as a consequence? Yes No

Note: an amendment to the PI must be approved by a delegate under s. 25AA(4) of the Act.

If so, you must attach a clean copy and a marked-up copy of the draft revised PI with this request. Please refer to Appendices 8, 12 and 13 of the ARGPM for details on requirements for PI documents.

2.1Information provided

Information on data requirements, including relevant guidelines, minimum content, format and quality of your dossier, is available on the TGA website and in Appendices 8, 12 and 13 of the ARGPM.

Have you provided all the required information?Yes No

2.2.1Size of Submission

Note: All Category 3 applications should be formatted according to the Common Technical Document (CTD) format (see Section 1.6 of the ARGPM), however, only a single copy of any supporting data is required.

Module / Number of Volumes / Double Sided?
Yes No
Yes No
Yes No
2.2.2Submission details

Please provide an overview of your submission, including an overview of the proposed variation with cross-references to the relevant Module 3 sections, if relevant. Please also include information regarding proposed dates of implementation (pending TGA approval).

2.3Other information

2.3.1DMF, PMF, and CEP

Will your request make reference to any of the following:

Drug Master File (DMF)Yes No

Provide TGA file number, if known:

Plasma Master File (PMF)Yes No

Provide name of PMF:
Provide TGA file number, if known:

Certificate of Suitability of Monographs of the European Pharmacopoeia (CEP)

Yes No

Version of the DMF/PMF/CEP being referenced:
Name of the company responsible for the DMF/PMF/CEP:

Modules 1.6.1, 1.6.2 and/or 1.6.3?Yes No

Note: refer to Appendix 11 of the ARGPM and guidance on Module 1 of the Common Technical Document[1] for further information about DMFs, PMFs and CEPs.

2.3.2Good Manufacturing Practice (GMP)

Please provide the following details for all manufacturers: requirements for GMP clearances, certifications and manufacturing licence applications are available from the TGA website:

Note: Clearance must be valid for at least 6 (six) months after the date of this request.

Details of Overseas Manufacturers
GMP Clearance or Certification Tracking Number / Manufacturer Name / Country / Expiry Date
Details of Australian Manufacturers
Licence or Tracking Number / Manufacturer Name
2.3.3Additional documents provided

Which additional documents will be submitted with the request? (Tick as relevant)

Revised labels

Other

If other, please describe:

2.3.4Source of materials in product

Is material of human or other animal origin used at any stage in the manufacture or formulation of this component? Yes No

If no, go to 2.4

Are you proposing to change any aspects of the material of human or animal origin?

Yes No

If no, go to 2.4

If yes, please provide details for those aspects of the ingredients that are proposed to be changed:

Name of ingredient / Animal species (eg bovine) / Animal part (eg hide) / Country of origin

For category IV ruminant ingredients, does the ingredient comply with the TGA’s Supplementary requirements for therapeutic goods for minimising risk of transmitting transmissible spongiform encephalopathies (TSEs)?

Name of ingredient / Comply with requirements?
Yes No
Yes No
Yes No

If of animal origin, is the animal an endangered or native species?Yes No

2.4Related submissions

2.4.1Submissions currently under evaluation

If your submission is related to any other submissions currently under evaluation with the TGA, provide applicable submission numbers:

Note: Variations under s.9D(3) can only be requested for products that are currently registered (that is, that aren’t the subject of a current application under s.23).

Submission ID / Details of submission

Is this a resubmission?Yes No

If yes, what is the previous submission no.?

2.4.2Concurrent requests

Are you submitting any other requests with this request?Yes No

If you are submitting more than one request for the same active ingredient simultaneously, and the combination of requests meets the criteria of a submission,[2] a single fee may be payable. Further information about submissions is available in Appendices 12 and 13 of the ARGPM.

If yes, please provide details:

Section 3. Sponsor declaration

Sponsors should note that the Therapeutic Goods Act 1989 provides penalties for making statements that are false or misleading in a material particular in or in connection with an application for registration of therapeutic goods.

I acknowledge that it is a serious offence to give false or misleading information to the Secretary for the purposes of making this request for a variation to an entry in the ARTG[3].

I declare that the information provided in this form and in the submission is, to the best of my knowledge, current and correct.

I certify that, to the best of my knowledge, this submission is accompanied by such information and in the required format as will allow the determination of the request (that is, complies with the current ARGPM for preparing requests to vary medicinal products and any associated or supplementary guidelines).

I certify that only the variations proposed are those identified in the request, and that no other aspects of the quality information have been changed, including manufacturing procedures and equipment, and raw material and drug product specifications.

I certify that the PI provided with this request is the most recently-approved version, that all of the proposed changes relate to the requested variations to the ARTG entry, and no other unidentified changes are being proposed or are being made to the PI.

Signature of authorised officer / Date / dd/mm/yy
Name
Email
Telephone number
Fax number
Position/Relationship to sponsor

Request to vary an ARTG entry under subsection 9D(3): Category 3 ApplicationPage 1 of 7

[1]

[2] As defined in Schedule 9 of the Therapeutic Goods Regulations 1990

[3] Giving false or misleading information is a serious offence under Australian Government law.