A person may apply for a licence to manufacture narcotic drugs involving cannabis under the Narcotic Drugs Act 1967 (ND Act).
You must hold both a ND Act licence and a permit before manufacture can occur.
There are several factors to consider when making an application.
- Can I apply for a licence to manufacture medicinal cannabis now?
Applications to manufacture medicinal cannabis products are now being accepted. The relevant forms and guidance materials are available on the manufacturers section of the website.
- Medicinal cannabis products must be manufactured to Good Manufacturing Practice (GMP).
The Therapeutic Goods Administration (TGA) is responsible for licensing GMP. Refer to the TGA good manufacturing practice overview.
While it is not a prerequisite to hold a GMP licence before applying for a Commonwealth manufacturing licence, you must provide evidence that you hold a GMP licence when applying for a permit to manufacture.
- Supply is controlled.
Supply of medicinal cannabis products is limited to clinical trials, Special Access Scheme and Authorised Prescribers (AP). State and territory governments may also have additional requirements for supply, such as patient cohorts or specific indications.
Manufacturing licences will be refused if the applicant cannot demonstrate that supply will be in accordance with all pre-requisites.
- State/Territory Licences.
It is not a prerequisite to hold a state/territory licence authorising activities related to Schedule 8 (Controlled Drugs) before applying for a Commonwealth Manufacturing Licence. However you must provide evidence that you hold the necessary licences/approvals (if required by the State or Territory where the manufacturing site is located) when applying for a manufacturing permit.
- Export of medicinal cannabis is limited.
The export of medicinal cannabis (plant material, extracts and preparations) is not permitted unless the product is registered on the Australian Register of Therapeutic Goods (ARTG) and the exporter holds a licence and permit to export drugs from the Office of Drug Control.
An Export Only Listing under the Therapeutic Goods Act 1989 is not sufficient under the ND Act to allow for exportation.
- Import of cannabis material is permitted for manufacture of medicinal cannabis products.
A person holding a Commonwealth licence to manufacture narcotic drugs involving cannabis and a Commonwealth licence and permit to import drugs, may import cannabis material, including extracts, for use in manufacture.
However, the importer must:
- hold a state/territory licence allowing possession of cannabis material before import approval may be granted.
- only import from countries where cannabis for medicinal use is approved at the federal level.
Persons licensed under the ND Act to manufacture medicinal cannabis products will be able to enter into contractual arrangements with cannabis cultivators/producers to produce cannabis.
Cultivation of cannabis may not commence until both parties (cultivator and manufacturer) hold permits.
A permit may not be issued if the manufacturer does not hold the appropriate state/territory licences/authorisations or if the manufacturer does not hold a GMP licence from the TGA.
Applicants will be subject to a fit and proper test. This may be in addition to any test undertaken by a state/territory Government.
A licence issued under the ND Act does not compel a state or territory to issue any applicable licences required (i.e. licence to manufacture, wholesale, supply) under their respective legislation.