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Guidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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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.
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):
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.
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.
Title changed from 'Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances' to 'Applying for a fee reduction for a prescription medicine major variation application' as part of migration to new 'Guidance' content type:
Title changed from 'Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances' to 'Applying for a fee reduction for a prescription medicine major variation application' as part of migration to new 'Guidance' content type:
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