You will need this licence to manufacture, buy, possess, supply primarily by wholesale, and dispose of waste from manufactured medicines. This licence allows you to undertake manufacturing activities related to schedule 2, 3, 4 and 8 medicines.
A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.
You will need to have a Substance Management Plan (SMP) which identifies and addresses the risks associated with manufacturing the regulated medicines.
Up to two years
Fees Details for this service in table format.
You can find the current fees here.
Medicine and Poisons Act 2019 Queensland (Opens in new window)
Medicines and Poisons (Medicines) Regulation 2021 Queensland (Opens in new window)
You can obtain this licence by completing the application form and submitting it with the appropriate fee and supporting documentation. Before approval is granted an inspection of your business premises may be conducted to ensure that it complies with the requirements set out in the Act.
You can obtain this licence by completing the application form and submitting it with the appropriate fee and supporting documentation.
Before approval is granted an inspection of your business premises may be conducted to ensure that it complies with the requirements set out in the Act.
Up to 90 days
Queensland Health
Healthcare Approvals and Regulation Unit
Contact Email, Phone and Address Details for this service in simple two column table format, header then data.
Manufacturing medicines (Opens in new window)
