Licence to manufacture controlled drugs - Queensland

Service summary

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.

Definition of terms

Controlled drug

Every substance contained in Schedule 8 of The Poisons Standard - the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Manufacturer

A person licensed to manufacture is also deemed licensed to sell by wholesale.

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.

Transferability

This licence cannot be transferred.

Duration

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

Application

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.

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

Act(s) name

Health Act 1937 (Queensland)

Regulation(s) name

Health (Drugs and Poisons) Regulation 1996 (Queensland)

Contact details

Enquiries
Queensland Health
Public Health Regulation and Licensing

Mailing address:
PO Box 2368
Fortitude Valley
Queensland 4006

Phone:

07 3328 9310

Website:

Public Health Units contact details Opens in a new browser window

Supporting information

Disclaimer

The information contained on the Australian Business Licence and Information Service (ABLIS) web site, or via packages or other sources is intended for general guidance only.

To the full extent permitted by law, the Federal, State, Territory and Local Governments make no representations or warranties (expressed or implied) in relation to the information, including its accuracy, currency or completeness.

The business information provided does not constitute professional or legal advice, nor is the use of any third party resource an endorsement of the information contained, the associated organisation, product or service. It is recommended that you obtain appropriate professional and /or independent legal advice to ensure that the material provided here is relevant to your particular circumstances.

To the full extent permitted by law the Federal, State, Territory and Local Governments, their employees and agents do not accept any liability for any reason, including without limitation, liability in negligence, to any person for the general information which is provided herein, or in respect of anything, including the consequences of anything done, or not done, by any such person in whole or partial reliance upon the information.