Licence to Manufacture Medicinal Cannabis Products - Australian Government

Description

You will require this licence if you intend to manufacture products containing medicinal cannabis. You must hold both this licence and a Narcotic Drugs Licence before you may begin manufacture.

All goods produced containing medicinal cannabis extracts or ingredients must meet the standards set out under Good Manufacturing Practice (GMP).

This licence allows for entry into agreements with domestic medicinal cannabis cultivators, or for supply by import from countries where the cultivation of medicinal cannabis is allowed at a Federal level.

Please note that you may require State or Territory licensing for certain aspects of the manufacturing site itself, though all licensing for medicinal cannabis is controlled at a Federal level.

Please consult the Contact Officer for more information.

Service type

Licence

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

Eligibility requirements

To apply for this licence you must:

  • be a fit and proper person
  • follow the GMP guidelines
  • submit the required form
  • pay any prescribed fees.

Please consult the Contact Officer for more information regarding eligibility requirements.

Prerequisites

Might Need

Licence to Manufacture Therapeutic Goods

Fees

Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

There are no fees at this time for a manufacture licence or permit.

Act(s) name

Narcotic Drugs Act 1967 Australian Government

Regulation(s) name

Therapeutic Goods Order No. 93 - Standard for Medicinal Cannabis 2017 Australian Government

Administering agency

Department of Health

Office of Drug Control

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:

Medicinal Cannabis Section

Office of Drug Control

Department of Health
Operating address: Sirius Building
23 Furzer Street
Phillip, Australian Capital Territory 2606
Mailing address: GPO BOX 9848
Canberra, Australian Capital Territory 2601
Phone: 02 6232 8433
Email: mcs@health.gov.au