Manufacture of Schedule 8 cannabis medicines requires a licence under the NSW Poisons and Therapeutic Goods Regulation 2008. To apply you need to submit a completed Application for a Licence to Manufacture and Supply by Wholesale, Drugs of Addiction.
Cultivation, production, or manufacture of cannabis medicines from the cannabis plant also requires licences under the Commonwealth Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989. Australian manufacturers must also operate in compliance with the Australian code of Good Manufacturing Practice (GMP) for medicines.
The TGA is responsible for the regulation of the quality aspects of cannabis medicines. The TGA's Therapeutic Goods Order No. 93 - Standard for Medicinal Cannabis (TGO 93) provides controls aiming to ensure acceptable quality of cannabis medicines from the cannabis plant, and ingredients used in their manufacture.
Detailed information on Commonwealth requirements can be found on the TGA website.
A company located in NSW may import unregistered cannabis medicines if:
Compliance with the conditions of any licence is mandatory.
An authorised prescriber or pharmacist may also import cannabis medicines when:
For further information on Commonwealth requirements, visit the websites of the Therapeutic Goods Administration and The Office of Drug Control.
Supply by wholesale is defined as supply for the purpose of re-supply to a third party. An example is the wholesale supply from a sponsor to a medical practitioner or a pharmacist so they can re-supply to a patient.
In NSW, a licence under the Poisons and Therapeutic Goods Regulation 2008 is required to:
To apply for a licence you must submit the relevant application form together with the cannabis supplementary pages. The application forms include:
Supply by wholesale of cannabis medicines must comply with NSW Licence conditions, the Commonwealth Licence conditions under the Therapeutic Goods Act 1989, and/or the Customs (Prohibited Imports) Regulation 1956, and/or the Narcotic Drugs Act 1967.
For more information on Commonwealth requirements refer to the TGA Medicinal cannabis: Information for sponsors, the TGA Supply and wholesaling of medicinal cannabis products (MCP) and the website for The Office of Drug Control.
Companies with existing wholesale licences for Schedule 8 drugs who want to supply cannabis medicines need to apply to NSW Ministry of Health for amendment of their existing licence. They must provide a revised procedure which may include refrigerated storage of Schedule 8 products, where required.
For further information on NSW licences see Licences under the Poisons and Therapeutic Goods Act 1966.
All cannabis medicines (including raw materials) supplied by wholesale in or from NSW must be packaged and labelled in accordance with the Poisons Standard (SUSMP).
It is illegal to label a product suggesting it is a cannabis product if it is not.
