15 August 2019

There are two licences that may be required if you are manufacturing medicinal cannabis. These licences are issued by the Office of Drug Control (ODC) and the Therapeutic Goods Administration (TGA).

Office of Drug Control Therapeutic Goods Administration
Narcotic Manufacture Licence Licence to Manufacture Therapeutic Goods (GMP)*

These licences are issued under separate legislation, and you may be required to hold both licences if you are manufacturing a therapeutic good that is also a medicinal cannabis product.

You will need to contact both the ODC and TGA separately for licensing requirements (see contact details below).

*Good Manufacturing Practice - a system for ensuring that products are consistently produced and controlled according to quality standards.

Need for both licences

A Narcotic Manufacture Licence and a Licence to Manufacture Therapeutic Goods (GMP) serve different purposes and operate under different legislation.

Narcotic Manufacture Licence Licence to Manufacture Therapeutic Goods (GMP)
Narcotic Drugs Act 1967 (ND Act) Therapeutic Goods Act 1989 (TG Act)

Although the terminology is similar (e.g. manufacture) the definitions are quite different under the respective legislation.

Term Therapeutic Goods Act Narcotic Drugs Act
Manufacture To produce a therapeutic good, or any process by which to bring the therapeutic goods to their final state. Any process by which a drug may be obtained, which includes refining and transformation of one drug into another drug.
Production The actual preparation of an active pharmaceutical ingredient or a finished medicinal product. As such, 'production' is considered a subset of 'manufacture'. The separation of cannabis and cannabis resin from the cannabis plant.

Difference between activities licensed under the Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989

Narcotic Manufacture Licence

A licence issued under the ND Act regulates factors such the quantities of and types of drugs that are manufactured from cannabis.

There is a difference between production and manufacture under the ND Act.

Drug Process Licensed Activity
Cannabis Physical separation of the cannabis flowers from the cannabis plant Production
Cannabis Resin Physical separation of the trichomes from the cannabis flowers or cannabis plant (e.g. sieving, ice water separation) Production
Extract of Cannabis Solvent extraction (including CO2, supercritical fluid extraction) of the cannabis flowers, cannabis resin or cannabis plant Manufacture
THC or CBD Isolation of cannabinoids from the extract of cannabis Manufacture

A Narcotic Manufacture Licence is required under the ND Act for any or all of the following activities

  • If you are making an extract (including tinctures) from cannabis or from cannabis resin.
  • If you refining the extract to obtain another drug, such as into Tetrahydrocannabinol (THC) or Cannabidiol (CBD).
  • If you are converting or transforming cannabinoids into another drug.

A Narcotic Manufacture Licence does not cover the following 'manufacturing' activities such as

  1. Manufacturing quality.
  2. The manufacture of an Active Pharmaceutical Ingredient (API).
  3. The manufacture of a preparation.
  4. Therapeutic Goods Order 93 (TGO93).

Licence to Manufacture Therapeutic Goods (GMP)

A licence issued under the TG Act regulates matters such as quality and compliance with standards.

A licence is required under the TG Act for activities such as:

  • Manufacture of an Active Pharmaceutical Ingredient (API)
  • Manufacture of a preparation, that is a therapeutic good
  • Market Authorisation (both domestic and exports*)
  • Production, processing, assembling, packaging, labelling, storage, sterilisation, testing, release for supply.
  • Clinical trials

*note that to export a substance which is also a narcotic drug will require separate licence and permit from the ODC under the Customs (Prohibited Exports) Regulations 1958.

Contact Details

Licence Type Regulator Contact

Narcotic Manufacturing Licence

Office of Drug Control (ODC)

Email: dcs@health.gov.au

Website: https://www.odc.gov.au/publications/medicinal-cannabis-manufacture-licences-and-permits

Licence to Manufacture Therapeutic Goods (GMP)

Therapeutic Goods Administration (TGA)

Email: gmp@tga.gov.au

Website: https://www.tga.gov.au/manufacturing-medicines

Licence to Export Narcotic Drugs

Office of Drug Control

Email: dcs@health.gov.au

Website: https://www.odc.gov.au/import-and-export