What a Narcotic Drug Manufacture Licence and Permit allows
A Narcotic Drug Manufacture Licence (Manufacture Licence) authorises the manufacture of narcotic drugs excluding medicinal cannabis. For a Medicinal Cannabis Manufacture Licence and information see Manufacturing medicinal cannabis for medicinal or scientific purposes.
To manufacture narcotic drugs all entities are required to have both a Narcotic Drug Manufacture Licence and Narcotic Drug Manufacture Permit (Manufacture Permit). The licence allows you to undertake the following activities under the Narcotic Drugs Act 1967 (ND Act) and the Narcotic Drugs Regulation 2016 (Regulations):
- obtain a narcotic substance from a plant (e.g. extraction of the opium poppy)
- obtain a narcotic from a synthetic process
- transform a substance into a narcotic drug, including from one narcotic to another (e.g. morphine transformed into codeine)
- refine and/or change the concentration of a drug.
A Manufacture Permit places limits on product types and quantities that may be manufactured by the licence holder.
Depending on your activity, you may also need a licence from your state or territory government and the Therapeutic Goods Administration (TGA). Visit the TGA to find out more about their licences for Manufacturing therapeutic goods.
Who can apply
Only these entities can apply for and receive a Manufacture Licence for a chosen site:
- a single human being (referred to as a natural person in the ND Act)
- a body corporate (that holds an ABN, CAN or ARBN and has ‘Ltd’ in its name).
How to apply
All entities wishing to manufacture narcotic drugs must first have a Manufacture Licence. If a licence is granted a Manufacture Permit will be granted with the licence.
If you intend to apply for a licence to manufacture a narcotic drug (other than cannabis), please email us with:
- your contact details, and
- an outline of the proposal.
We will then advise you on the necessary requirements and information you will need to apply for a licence to manufacture narcotic drugs.
Apply by email
If applying by email, send completed application form, along with other relevant information to ncs@health.gov.au.
Apply by post
If applying by post/mail, send completed application form, along with other relevant information to:
Narcotics Control Section
Office of Drug Control
GPO Box 9848
Canberra ACT 2601
How long a licence is valid
The period that each Manufacture Licence is valid for is specific to each applicant and circumstance at the time the application is assessed.
When a licence is not granted
A Manufacture Licence may not be granted. The Secretary may refuse to grant a Manufacture Licence or Manufacture Permit if the application doesn’t meet the conditions in the ND Act or Regulations.
If a Manufacture Licence is refused the applicant does not have the legal right to manufacture narcotic drugs. Without a Manufacture Licence a person cannot participate in any activity related to the manufacture of such drugs including:
- supply
- packaging
- transport
- storage
- possession of narcotic drugs.
Fees
The Office of Drug Control and Australian Government Department of Health and Aged Care does not charge a fee for a Manufacture Licence or Manufacture Permit.