Thank you for your enquiry to the Therapeutic Goods Administration (TGA) regarding producing medicinal or Therapeutic Cannabis. (Mar 2, 2015)
The TGA is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods for human use including medicines, medical devices and biological products under the Therapeutic Goods Act 1989 (the Act).
The information provided below relates to the role of the TGA in the regulatory process for medicines under the Act only.
Broader decisions about decriminalisation and access to Cannabis are the subject of other Commonwealth and state and territory laws that apply to possession, use, trade in, distribution, import, export, manufacture, cultivation and production of Cannabis.
The term ‘medicinal Cannabis’ may be used in reference to a range of preparations including raw Cannabis, hashish and pharmaceutical Cannabis preparations such as tinctures and other extracts.
In relation to the TGA approval of medicines for supply in Australia, unless exempt or otherwise authorised by the TGA, therapeutic goods lawfully supplied in Australia must appear as an entry in the Australian Register of Therapeutic Goods (ARTG).
On the TGA website you can search the ARTG using product details or sponsor details.
To gain approval to supply a medicine in Australia, the sponsor of a product would need to submit an application together with supporting data on the safety, quality and efficacy of the product to the TGA for evaluation.
The TGA is unable to compel a sponsor to submit an application to register a medicine in Australia.
Approval for marketing in Australia cannot be given in the absence of an application. In addition, the Act requires, with certain exceptions, that manufacturers of therapeutic goods in Australia hold a licence.
It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt from this requirement.
The TGA website provides further information regarding manufacturing therapeutic goods in Australia.
The TGA is not involved in issuing medicinal Cannabis growers/cultivation licences.
The issuing of a licence for cultivation would be a state and territory responsibility and it is suggested that you contact the drugs and poisons units in your state/territory.
However, please note that Cannabis is currently listed in the SUSMP as a schedule 9 substance.
Scheduling is a national classification system that controls how medicines and poisons are made available to the public (see Scheduling Basics). Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison, required to protect public health and safety.
In Australia, medicine schedules are legislated in the Poisons Standard (the SUSMP).
As stated in the SUSMP, schedule 9 classification is:“Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.
Please note that this is a general description of the schedule. For the legal definitions, it would be necessary to check with each relevant authority as each state and territory has its own laws.
The TGA hopes the above information is of assistance. www.tga.gov.au
Therapeutic Goods Act 1989
Registered and listed medicines
Australian Register of Therapeutic Goods (ARTG)