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; and
The medicine is of a kind specified in Part 1 of Schedule 10; and
Apart from the directions for use the medicine is the same as another that is included in the register; and
The differences in directions for use or dosage model are necessary to ensure the safe use of the medicine; and
Evaluation of non-clinical or quality data is not required for registration; and
Information relating to the medicine enables preliminary assessment and evaluation of the medicine to be abridged
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.