Every year the TGA undertakes a comprehensive targeted consultation by engaging with peak therapeutic industry bodies in regard to the fees and charges proposal for the upcoming financial year.
The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA’s public health responsibilities. To do this the TGA must collect charges and fees.
- A fee is charged for a service, such as a product evaluation.
- A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year.
On 7 June 2018, the Australian Government approved an increase of 1.9 % to most TGA fees and charges, subject to rounding and a minimum increase of $10 to the low fee items. The 2018-19 fees and charges schedule applies to applications submitted to the TGA on or after 1 July 2018.
A small number of other changes have also been approved, these include:
- the introduction of an application fee of $530 for inclusion of Class I medical devices;
- annual charges for provisionally registered prescription medicines;
- changes to fees and charges that apply to manufactures of medicines (GMP fees and charges); and
- $100 increase of annual charges for listed medicines to $1,120.
- All relevant fees and charges can be found at the TGA website
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