TGA Fee Increase 1 July 2019

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.

2020-04-23T10:20:38+00:00June 5th, 2019|Complementary Medicines, Listed Medicines, TGA|