27 November 2018

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 will likely be required to hold both licences if you are manufacturing a medicinal cannabis product.

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

Narcotic Manufacturing Licence

A Licence issued under the ND Act regulates factors such as probity of licence holders, security of the facilities and quantities of drugs that are manufactured.

A 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 an extract from cannabis resin.
  • If you are purifying or refining the extract.
  • If you are concentrating the extract.
  • If you separating, or obtaining cannabinoids (e.g. Cannabidiol, THC) from the extract.
  • If you are converting or transforming cannabinoids present in the extract into another drug.

A Narcotic Manufacturing licence does not cover matters such as

  1. Manufacturing quality.
  2. Therapeutic Goods Order 93 (TGO93).

If you have been granted a Narcotic Manufacturing Licence under the ND Act, you are likely to also need a Licence to Manufacture Therapeutic Goods (GMP) under TG Act.

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)
  • Market Authorisation (both domestic and exports)
  • Production, processing, assembling, packaging, labelling, storage, sterilisation, testing, release for supply.
  • Clinical trials

Need for both licences

A Narcotic Manufacturing Licence and a Licence to Manufacture Therapeutic Goods (GMP) serve separate 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.

If you are involved in manufacturing medicinal cannabis you will likely need both licences. A licence issued under the ND Act does not remove the requirement for a licence under the TG Act and vice versa.

For further information:

Licence Type Regulator Contact

Narcotic Manufacturing Licence

Office of Drug Control (ODC)

Email: dcs@health.gov.au

Website: Medicinal cannabis manufacture licences and permits

Licence to Manufacture Therapeutic Goods (GMP)

Therapeutic Goods Administration (TGA)

Email: gmp@tga.gov.au

Website: Manufacturing medicines