Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: chemical entities and biological medicines

For an interim period, the forms below may be used for making an application for a variation to registered prescription medicines: chemical entities and biological medicines. This is to assist sponsors with finalising their existing minor variation applications and to transition to using the new e-form.

9D(1) Request to correct an ARTG entry

Use this application to request a correction to information in an existing ARTG entry for a registered prescription medicine that is incorrect or incomplete.

9D(2) Safety-related request to vary an ARTG entry

Use this application form if you are requesting a variation to an existing ARTG entry for a registered prescription medicine where the population able to take the medicine has been reduced or a warning or precaution is to be added.

9D(3) Self-assessable request to vary an ARTG entry or minor editorial changes to the PI

Use this application form to request 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
• is 'self-assessable', that is, does not require evaluation of data by the TGA.

Notes:

• This request for variation may be for:
  • quality-related information only and/or a variation to an entry that results in a minor editorial change to the PI only.
  • Introducing or referencing a Patient Support Program (PSP) via an insert in the package, website address on the package, a package sleeve, or amending the content of an existing material on PSP.
  • Note that all materials on PSPs must have the following disclaimer - Patient Support Program is not authorised or approved by the Australian regulator of medicines, the TGA.
  • If making a self-assessable request AND a minor editorial change to the PI please use separate application forms.
  • If the proposed variations include changes to the ARTG entry some of which must be submitted as a category 3 application while others can be submitted as a self-assessable request, for efficient and timely processing, you may wish to submit only a single category 3 application to cover all of the proposed variations.

9D(3) Category 3 application to vary an ARTG entry

Use this application form to request 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
• is a Category 3 application and requires evaluation of data by the TGA.

Notes:

• This request for variation may be for referencing or introducing a PSP that is not described in the previous section. Note that all materials on PSPs must have the following disclaimer - Patient Support Program is not authorised or approved by the Australian regulator of medicines, the TGA.
• If the proposed variations include changes to the ARTG entry some of which must be submitted as a category 3 application while others can be submitted as a self-assessable request, for efficient and timely processing, you may wish to submit only a single category 3 application to cover all of the proposed variations.
• It is not necessary to submit both a category 3 application AND a self-assessable request unless you wish to do so for specific reasons.

Section 23 Category 3 application that creates a separate and distinct good

Use this application form to apply for a variation to a registered prescription medicine (the existing medicine) that results in the creation of a separate and distinct good (the proposed medicine) and requires evaluation of data by the TGA.

The decision for this application will be made under section 25 of the Therapeutic Goods Act 1989.

Note:

• If additional quality-related changes are intended for the proposed medicine, details should be provided under section 2.1. There is no need to complete a separate '9D(3) Category 3 form to vary an ARTG entry' for the proposed medicine.

Section 23 Self-assessable application that creates a separate and distinct good

Use this application form to apply for a variation to a registered prescription medicine (the existing medicine) that results in the creation of a separate and distinct good (the proposed medicine) and does not require evaluation of data by the TGA.

The decision for this application will be made under section 25 of the Therapeutic Goods Act 1989.

Note:

• this application form can only be used for minor changes in formulation relating to colouring agent, flavour or fragrance or the addition, deletion, or variation to, the formulation of an imprinting ink.
• if additional quality-related changes are intended for the proposed medicine and the changes may be self-assessed, details should be provided under section 2.1. There is no need to complete a separate 9D(3) Self-Assessable request form for the proposed medicine.