Manufacturing licence - medicines - Queensland


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.

Service type


A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

You will need to have a Substance Management Plan (SMP) which identifies and addresses the risks associated with manufacturing the regulated medicines.


Up to 2 years


Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

You can find the current fees here.

Application process


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.

Approval time

Up to 90 days

Administering agency

Queensland Health

Healthcare Approvals and Regulation Unit

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.