Manufacturing licence - medicines - Queensland

Description

You will need this licence if you intend 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

Licence

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

Eligibility requirements

Please contact the agency to identify any eligibility requirements.

Duration

Up to two years

Fees

Fees Details for this service in table format.

Task Type Business Structure Amount Description
Apply Application All $603.50 Fees for 2022
Apply Application All $140.50

Processing fee for initial application for a substance authority for dealing with a medicine. Fees for 2022

Renew Renewal All $603.50

Fees for 2022

Vary Variation All $603.50

Fee to add another site. Fees for 2022

Application process

Apply

You can obtain this licence by completing the 'Medicines and poisons: manufacture and wholesale licence 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.