Applying for a fee reduction for a prescription medicine major variation application
Guidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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Purpose
The purpose of this guidance is to outline the eligibility criteria and process for sponsors to potentially receive reduced fees for major variation applications to registered medicines, specifically for safety-related changes under certain exceptional circumstances.
Eligibility criteria
Amendments to the Therapeutic Goods Regulations 1990 came into effect in late November 2018 that allow discretion to reduce application and evaluation fees for a major variation application in exceptional circumstances.
In order to be eligible, sponsors need to meet all eligibility criteria. The fee reduction is only intended for safety related changes in certain circumstances.
The eligibility criteria are captured in regulation 45(5):
- the application is made under S23 of the Therapeutic Goods Act 1989
- the medicine is of a kind specified in Part 1 of Schedule 10
- apart from the directions for use the medicine is the same as another that is included in the register
- the differences in directions for use or dosage model are necessary to ensure the safe use of the medicine
- evaluation of non-clinical or quality data is not required for registration
- information relating to the medicine enables preliminary assessment and evaluation of the medicine to be abridged.
If you consider that an intended application meets all of the above criteria, please contact the TGA at AET.Application.Entry.Team@health.gov.au
The TGA will consider eligibility as part of the preliminary assessment process of a prescription medicine registration application.
What is the reduced fee?
Fees in Schedule 9 of the Therapeutic Goods Regulation 1990 may be reduced as set out in regulation 45(6) of the Therapeutic Goods Regulations 1990.