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
1.1
Sponsor 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: info@tga.gov.au www.tga.gov.au
Reference/Publication #
1.2
Product details
Medicinal product details
Single active ingredient
Is the product:
AUST R
Multi-active ingredient
a biological medicine?
Active ingredient(s)
Trade
(proprietary)
name
Multi-component
OR
Strength
a chemical medicine?
Dosage form
Container
type
Section 2. Details of request
2.1
Details 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.
2.1
Information provided
Information on data requirements, including relevant guidelines, minimum content, format and
quality of your dossier, is available on the TGA website www.tga.gov.au and in Appendices 8, 12
and 13 of the ARGPM.
Have you provided all the required information?
Request to vary an ARTG entry under subsection 9D(3): Category 3 Application
Yes
No
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2.2.1
Size 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
2.2.2
Number of Volumes
Double Sided?
Yes
No
Yes
No
Yes
No
Submission 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).
Request to vary an ARTG entry under subsection 9D(3): Category 3 Application
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2.3
Other information
2.3.1
DMF, PMF, and CEP
Will your request make reference to any of the following:
Drug Master File (DMF)
Yes
No
Yes
No
Provide TGA file number, if known:
Plasma Master File (PMF)
Provide name of PMF:
Provide TGA file number, if known:
Certificate of Suitability of Monographs of the European Pharmacopoeia (CEP)
Yes
No
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?
Note: refer to Appendix 11 of the ARGPM and guidance on Module 1 of the Common Technical
Document1 for further information about DMFs, PMFs and CEPs.
2.3.2
Good 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:
www.tga.gov.au.
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
1 < http://www.tga.gov.au/industry/pm-ctd.htm#aumod1>
Request to vary an ARTG entry under subsection 9D(3): Category 3 Application
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Details of Australian Manufacturers
Licence or
Tracking Number
2.3.3
Manufacturer Name
Additional documents provided
Which additional documents will be submitted with the request? (Tick as relevant)
Revised labels
Other
If other, please describe:
2.3.4
Source 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)
Request to vary an ARTG entry under subsection 9D(3): Category 3 Application
Country of origin
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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?
2.4
Related submissions
2.4.1
Submissions currently under evaluation
Yes
No
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
Yes
No
If yes, what is the previous submission no.?
2.4.2
Concurrent requests
Are you submitting any other requests with this request?
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:
2
As defined in Schedule 9 of the Therapeutic Goods Regulations 1990
Request to vary an ARTG entry under subsection 9D(3): Category 3 Application
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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 ARTG3.
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
3
Giving false or misleading information is a serious offence under Australian Government law.
Request to vary an ARTG entry under subsection 9D(3): Category 3 Application
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