TGA use only

This form, whencompleted, willbeclassified as 'For official use only'.
For guidance on how your information willbetreated by the TGA see: Treatment of information provided to the TGA at <

Form for extension of indicationsapplications that do not require supporting data

Please note:This form must be usedfor an application under section 23 of the Therapeutic Goods Act 1989 for extension of indications to a prescription medicine when the application does not require supporting data. For more information, please see guidance onsubmitting extension of indicationsapplications that do not require supporting data.

Only use this form if you propose to group the new medicine with an already registered generic medicine.

You need to provide all the information requested that is relevant to your application, answer all the questions and make all of the declarations. If you do not do this, there is a risk that your application will not comply with the requirements of section 23 and cannot be processed.

Section 1.Sponsor details

Sponsor name:
Client ID:
Postal address:
Contact person:
Position:
(e.g. regulatory affairs officer; agent)
Telephone number:
Fax number:
Email address:

Section 2.Active ingredients

Single active ingredientmulti-active ingredientmulti-component

Is this medicine:a chemical medicine*?

Active ingredients (and components, if multi-component):

*Do not use this form for biological medicines.

You can use this formfor the extension of indications of more than one registered prescription medicine. However, all such medicines must contain the same active ingredients (see clause 1(3) in Part 1 of Schedule 9 to the Therapeutic Goods Regulations 1990).

Section 3. Reference medicines

Provide the trade name and dosage form of the reference medicines with the indications for which you are applying. For more information, see guidance on submitting extension of indications applications that do not require supporting data.

Trade name / Dosage form

Please attach additional pages if more than threereference medicines.

Section 4. Medicine details and new indications

If you wish to apply for different indications for different medicines (all of which have the same active ingredients) then submit multiple copies of section 4 of this application form.

4.1Proposed new indications

The proposed new indications for the new medicines must be identical to those of the reference medicines. For more information, see guidance on submitting extension of indications applications that do not require supporting data.

4.2Existing ARTG entries (medicines to be grouped with the new medicines)

AUST R / Trade name / Strength / Dosage form

Please attach additional pages if more than twelve ARTG entries.

Section 5.Explanation for your applications not requiring supporting data

Explain why your applications do not require supporting data. For more information, see guidance on submitting extension of indications applications that do not require supporting data.

Section 6. Pack sizes

Are you applying for additional pack sizes? Yes No

Justify why you are or are not applying for additional pack sizes. For more information, see guidance on submitting extension of indications applications that do not require supporting data.

If you are applying for additional pack sizes, provide information in the table below.

AUST R / Trade name / Strength / Dosage form / Additional pack sizes

Please attach additional pages if more than ten medicines.

Section 7. Related submissions

Provide details of submissions currently under evaluation for the medicines that are the subject of this submission (e.g. 9D(1) variations that are related to this submission).

Submission ID / Details of submission

Please attach additional pages if there are more than three related submissions.

Section8. Check list

Yes No / A patent certification or notification as described in section 26B of the Act has been included in this submission.

The Secretary cannot register a new medicine unless either a patent certification or notification has been received (see subsection 25AB(4) of Therapeutic Goods Act 1989)

Section 9.Sponsor declaration

Make the following declarations.

I am the sponsor for the purposes of this request.

OR

I am authorised to act on behalf of the sponsor for the purposes of this request.

I certify that to the best of my knowledge:

the ARTG records of the medicines that are the subject of this submissionare complete and accurate in all data fields.

OR

the ARTG records are incomplete and/or incorrect, 9D(1) request(s) to correct ARTG entries have been submitted (details entered in section 7 of this form) and all other aspects of the ARTG records are correct.

In relation to this submission, I certify that to the best of my knowledge:

Yes No / The goods that are the subject of this submission are manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.
Yes / If ‘Yes’, the draft Product Information and CMI include a statement that human embryos or human embryonic stem cells or any other material sourced from a human embryo or human embryonic stem cell were used in the manufacture of the therapeutic good.

In relation to this submission, I certify that to the best of my knowledge:

Yes No / Information included in this submission refers to the use of human embryos, human embryonic stem cells (or materials sourced from human embryos or human embryonic stem cells) in research undertaken in the development of the medicine.

If ‘Yes’, provide details and referencesbelow:

Yes / If ‘Yes’, the draft Product Information and CMI include a statement that human embryos, human embryonic stem cells (or materials sourced from human embryos or human embryonic stem cells)were used in research undertaken in the development of the medicine.

I declare that if hard copies and electronic copies of the dossier have been submitted, they are identical.

I acknowledge that sections 22A and 22B of the Therapeutic Goods Act 1989 provide for offences and civil penalties for making statements that are false or misleading in a material particular, or in connection with, an application under section 23 of the Act in relation to therapeutic goods.

I certify that to the best of my knowledge, the new medicines are identical to the medicines being grouped with the new medicines, with the exception of the differences identified in this submission.

I certify that:

  • the draft Product Information for the new medicines provided with this submission is based on the most recent version of the Product Information for the sponsor’s existing medicinesthat have been approved by the TGA
  • all proposed changes have been clearly identified
  • all information in the Product Information is current and correct
  • all of the differences that are marked up in the annotated Product Information provided in Module 1.3.1 relate to the applications in this extension of indications submission.

I certify that the only changes to labels relate to the pack size descriptor and the labels comply with the current labelling order.

I declare that the information provided for the purposes of this submission, is to the best of my knowledge, current and correct and that the certifications made by me in this form are correct.

Signature of authorised officer: / Date:
Name of authorised officer:
Email:
Telephone number: / Fax number:
Position/relationship to sponsor (if different to front page):

Form for extension of indications applications that do not requiresupporting data (July 2015)

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