Updates to variations to prescription medicines guidance and e-form

The TGA Business Services online application system for variations to prescription medicines was updated on 10 July 2019. This was the second part of a staged release of updates and minor performance improvements. This release includes the addition of new variation types. Updated guidance has now been published - Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data

What have we updated now?

Extension of indications to align with a reference product

Extension of indications to align with a reference product has been added to the Variation e-form. Before the update if you were submitting these applications you were required to download and complete a pdf form. For further information see the updated guidance

Associated changes for separate and distinct goods

When requesting a change that will result in a new and distinct good, there may be situations where other variations (including changes to PAR fields) need to be included. New variation types have been added to the Variation e-form to allow for these situations. These ‘Associated changes’ variation types will help to prevent unnecessary separate submissions and allow you to access different PAR fields. If you select these variation types, the changes will only be applied to the new goods. For further information including an example of how to use these variation types see the updated guidance.

Formulation variation types

The following variation types have been added to the e-form:

• DFCI: Formulation - addition or deletion of, or variation to, an inked imprint
• DFFC: Formulation - change relating to colouring agent, flavour or fragrance.

Before the update if you were submitting these changes you were required to download and complete a pdf form.

New variation types have been added to the e-form to allow for Category 3 formulation changes that require a new AUST R number. These are:

• DFNA: Formulation - changes (CE) - New AUST R number
• PFNA: Formulation - changes (BM) - New AUST R number.

Guidance updates

The guidance has been updated with further information as outlined below.

• Information about new variation types has been included.
• The 'How to apply for a variation' section in the process guidance has been expanded. This section now includes information and examples about requesting multiple related changes and multiple unrelated changes. This clarifies the process for notifications, self-assessable requests and Category 3 requests where multiple variation types could be selected.
• A 'Prior to application submission' section has been included in the process guidance listing points to consider before requesting changes using the Variation e-form.
• Mechanism to approve one-off changes has been clarified.
• Advice regarding advising the TGA of changes made to medicines without the required approval has been included.
• Minor clarifications and corrections to phrasing and layout have been made, including a change in title.

Further information

Register for the webinar which will provide an overview of the updates.