Manufacturing licence - medicines - Queensland

Description

You require 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.

All manufacturing licensees must comply with the standard conditions. Please see the application form for information regarding conditions that apply to manufacturing licences.

Service type

Licence

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

Eligibility requirements

The agency will determine whether you satisfy eligibility requirements for this authority by making an assessment based on the following considerations:

  • prior compliance history
  • background, skills and qualifications of persons who will be responsible for overseeing activities to be carried out or will have access to regulated substances- you must submit a relevant persons form
  • which regulated substances are to be included in the substance authority
  • proposed activities and locations where regulated substances are to be used and stored
  • the documented governance arrangements in place relevant to the substance authority.

An inspection of the premises may also be undertaken.

Persons who hold an authority to manufacture regulated substances granted under a Commonwealth law (e.g. a licence from the Therapeutic Goods Administration, the Office of Drug Control or the Australian Pesticides and Veterinary Medicines Authority) do not require a manufacturing licence under the MPA to manufacture the same substances at the same place within the same conditions.

Duration

Up to two years

Fees

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

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

Transfer

This licence cannot be transferred.

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.

Please use these contact details for help or more information:

Healthcare Approvals and Regulation Unit

Queensland Health

Queensland
Email: HARU@health.qld.gov.au