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Medicinal cannabis manufacture

Technical guidance on the interpretation of the PIC/S Guide to GMP

10 December 2019

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Roles and responsibilities

It is your responsibility to ensure you are compliant with all relevant legislation. Failure to comply may result in sanctions and penalties from the relevant federal or local government agency.

Medicinal cannabis is subject to the Therapeutic Goods Act 1989 as well as the Narcotic Drugs Act 1967, which are administered by the Australian Government Department of Health (through the TGA and ODC respectively).

State and Territory health departments also have requirements regarding how controlled substances, including medicinal cannabis, may be authorised for use in their jurisdictions.

For more information, contact your local State or Territory health department.

Role of the TGA

The TGA administers the Therapeutic Goods Act 1989 and regulates the quality, safety and efficacy of medicines as well as access to medicines that have not been approved for general use (unapproved therapeutic goods).

The TGA is also responsible for issuing Australian manufacturing licences and overseas manufacturing certification and clearances.

The TGA has developed a series of medicinal cannabis guidance documents to assist patients and health professionals, particularly those who prescribe medicinal cannabis in Australia under current access pathways.

Regulation of medicinal cannabis

Medicinal cannabis products are not included in the Australian Register of Therapeutic Goods (ARTG) unless registered. For a product to be subsidised through the Pharmaceutical Benefits Scheme (PBS), it also needs to be included in the ARTG.

Most medicinal cannabis products can only be accessed through access pathways available for unapproved therapeutic goods:

Unapproved therapeutic goods are those goods not included in the ARTG, but are available through the special access pathways.

When medicinal cannabis is included in the ARTG, it is classified as a 'registered' prescription medicine.

Classification in the Poisons Standard

Classification is based on how medicinal cannabis ingredients are controlled through the Poisons Standard. Ingredients from medicinal cannabis are included in either schedules 4 (prescription only), 8 (controlled drug) or 9 (prohibited drugs) of the current Poisons Standard.

Role of the ODC

The Office of Drug Control administers the Narcotic Drugs Act 1967 and regulates controlled substances to prevent diversion and illicit use.

The ODC regulates and provides advice on the cultivation, production, import and export of controlled and narcotic drugs including medicinal cannabis, in accordance with Australia's obligations under international drug conventions. This also includes the fit and proper persons requirements, security and inspections and controlling the import and export of narcotics.

In addition, the ODC regulates how much of a particular drug may be obtained and used in Australia. Australia may not import, cultivate or manufacture controlled drugs in excess of these requirements.

Differences between TGA and ODC legislation

Terminology and definitions used under the Therapeutic Goods Act 1989 can differ from those used in the Narcotic Drugs Act 1967. The same word can have different meanings in the two different Acts.

For example:

  • In the context of the Therapeutic Goods Act 1989, 'production' refers to the preparation of an active pharmaceutical ingredient or a finished medicinal product. As such, 'production' is considered a subset of 'manufacture'.
  • In the context of the Narcotic Drugs Act 1967, 'production' refers exclusively to the harvesting of the specified plant parts, separating resin from plant by physical/water extraction (e.g. physical separation of the cannabis flowers from the cannabis plant, physical separation of the trichomes from the cannabis flowers or cannabis plant such as sieving, ice water separation). The plant or separated resin might then undergo a processing step (e.g. solvent extraction) which is termed 'manufacture'. As such, 'production' is an initial step that is usually followed by 'manufacture'.

More information regarding TGA definitions used in relation to the manufacture of medicinal cannabis can be found at:

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