Licence to manufacture controlled drugs - Queensland

Description

You require this licence to operate as a manufacturer of Schedule 8 medicines (controlled drugs), including for veterinary use.

Service type

Licence

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

Eligibility requirements


Before submitting an application, ensure you satisfy the criteria set out under Section 15 of the Health (Drugs & Poisons) Regulation 1996 - Suitability of applicant.

Duration

This licence remains in effect for 12 months from the day it was granted. A renewal notice will be issued to you annually.

Act(s) name

Health Act 1937 QLD

Regulation(s) name

Health (Drugs and Poisons) Regulation 1996 QLD

Application process

You can obtain this licence by completing the Medicines and and poisons: manufacture and wholesale licence form and submitting it with the appropriate fee and supporting documentation. The form provides instructions about what to include with your application and the basic fee schedule.

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 Health (Drug and Poisons) Regulation 1996.

Advice service

Queensland Health provides free advice to applicants and licencees to help you to:

  • identify the correct schedule and classification for a medicine or poison 
  • ensure storage, packaging, labelling, sales and advertising meet regulated requirements or standards.

Transfer

This licence cannot be transferred.

Additional information

Commonwealth requirements

Contact the Therapeutic Goods Administration on 1800 020 653 for additional information on Commonwealth requirements relating to controlled drugs for human use.

Veterinary requirements

Contact the Australian Pesticides and Veterinary Medicines Authority on 02 6210 4700 for additional information regarding controlled drugs for veterinary use.

 

Administering agency

Queensland Health

Chief Health Officer Branch

Medicines Regulation and Quality

Contact details

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

Enquiries

Public Health Regulation and Licensing

Queensland Health

Mailing address: PO Box 2368
Fortitude Valley
Queensland 4006
Phone: 07 3328 9310
Website: Public Health Units contact details (Opens in new window)