Fees for medicines licences
Licences are a type of substance authority under the Medicines and Poisons Act 2019 (MPA). Fees are payable for licences for medicines under the Medicines and Poisons (Medicines) Regulation 2021 (MPMR).
Chapter 9, Part 2 of the MPMR provides the detail about fees payable. Although a licence may cover more than one site on a licence, a fee is payable for each site for the authority for each year of the term of the authority.
The fees payable provided below are calculated by multiplying the fee units payable (as stated in Schedule 19 of the MPMR) by the value of a fee unit (as stated in the Acts Interpretation (Fee Unit) Amendment Regulation 2023).
Current fees
Type of licence | Amount $1 |
|---|---|
Initial application for a manufacturing licence or wholesale licence for an S8 medicine (Act, s 75(c)) | 639.71 |
Initial application for a manufacturing licence or wholesale licence for an S2, S3 or S4 medicine (Act, s 75(c)) | 639.71 |
Initial application for an S2 retail licence (Act, s 75(c)) | 223.13 |
Amendment application for a manufacturing licence or wholesale licence for a medicine to add another site (Act, s 78(2)(c)) | 639.71 |
Amendment application for an S2 retail licence to add another site (Act, s 78(2)(c)) | 223.13 |
Renewal application for a manufacturing licence or wholesale licence for an S8 medicine (Act, s 82(2)(c)) | 639.71 |
Renewal application for a manufacturing licence or wholesale licence for an S2, S3 or S4 medicine (Act, s 82(2)(c)) | 639.71 |
Renewal application for an S2 retail licence (Act, s 82(2)(c)) | 223.13 |
Processing fee for an initial application for a licence for a dealing with a medicine | 148.93 |
1The value of a fee unit is—
- from 1 October 2022 - $1.025 - see the Acts Interpretation (Fee Unit) Regulation 2022;
- from 1 October 2023 - $1.060 - see the Acts Interpretation (Fee Unit) Amendment Regulation 2023.
The fees were last indexed on 1 October 2023, with the value of the fee unit prescribed being $1.060.
Calculating the fee payable
- The first time an application is made for a licence for dealing with a medicine, a processing fee of $148.93 is payable, along with the applicable yearly licence fee specified in lines 1-3 (inclusive) in the Current fees table.
- The fee for renewal of this licence is specified in lines 6-8 (inclusive) in the Current fees table. As long as the requirements for a renewal application are established, there is no requirement to pay a processing fee.
- If the substance authority is not held for a full year, the licencing fee payable is attributable to the number of months (rounded up to whole months) of that year that are in the term.
Related information
- Medicines fees fact sheet - more information on substance authority fees
Contacts
Medicines Approvals and Regulation Unit (MARU): MARU@health.qld.gov.au.