TGA fees will increase by 2.05% (subject to rounding) as of 1st July 2019.This increase is based on the previously used formula of 50% of the CPI and 50% of the WPI. The 2019-20 fees and charges have been published to provide advance notice to sponsors and manufacturers. You can download a copy here.
Basic fees for Listed Medicines will be as follows:
- Annual charge – $1140
- Application fee – $840
- Processing fee (variation to existing listing) – $430
- Application for section 14 and 14A of the Act – $480
Basic fees for Listed Export-Only Medicines will be as follows:
- Application fee – $840
- Processing fee (variation to existing listing) – $430
Basic fees for Assessed Listed Medicines will be as follows:
- Annual charge – $1140
Basic fees for Permitted Indication application fees will be as follows:
- Application fee for New indication to be added to Permitted Indications – $1060
Basic fees for Section 9D application to change registered complementary medicines will be as follows:
- Notification requests Upfront fees –$810 Refund if no evaluation – N/A
- RCMC1 Upfront fees – $1440 Refund if no evaluation– N/A
Please note that the 2019-20 fees and charges schedule applies to applications submitted to the TGA on or after 1 July 2019.