The Therapeutic Goods Administration (TGA) is reminding businesses involved with medicinal cannabis products of their regulatory obligations under the Therapeutic Goods Act 1989 (the Act). Regulatory controls on medicinal cannabis minimise the risk of harm from inappropriate use while ensuring that product is available to patients where appropriate. The amount of regulatory control needed to manage risks depends on the product and determines how consumers access the product.
Supplying medicinal cannabis
Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied to the general public in Australia. With the exception of a small number of products, existing medicinal cannabis products are not entered in the ARTG.
Access to unapproved medicinal cannabis products that are not entered in the ARTG is only available to patients on the written instruction of a registered medical practitioner via the Special Access Scheme (SAS) or the Authorised Prescriber Scheme.
Medicinal cannabis products that contain substances in Schedule 4 (Prescription Only Medicine) and Schedule 8 (Controlled Drug) of the Poisons Standard require a prescription. Certain low dose cannabidiol (CBD) products have been down-scheduled from Schedule 4 to Schedule 3 (Pharmacist Only Medicine) for over-the-counter supply. However, to date there are no approved products of this type.
The TGA website includes information for sponsors and manufacturers about regulatory requirements, including medicinal cannabis product quality and manufacturing standards.
Advertising of medicinal cannabis
Advertising medicinal cannabis products to consumers is illegal.
The Act prohibits advertising to the general public for a substance or a therapeutic good containing a substance included in Schedule 4 or Schedule 8 of the Poisons Standard. Schedule 3 CBD products also cannot be advertised to consumers as they are not included in Appendix H of the Poisons Standard.
Under the Act, it is also illegal to promote medicines to consumers if they are not in the ARTG. This requirement also prohibits the advertising of most medicinal cannabis products to consumers.
The use of prohibited or restricted representations in advertisements for therapeutic goods is unlawful, unless there has been prior authorisation from the TGA. Under the Act, representations relating to the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to neoplastic diseases (including all types of cancer), sexually transmitted diseases, HIV/AIDS, Hepatitis C virus and mental illness are prohibited representations. Representations concerning a serious form of a disease, condition, ailment or defect (e.g. epilepsy) are restricted representations under the Act. Given the prohibitions on advertising medicinal cannabis products to consumers, the TGA has not authorised the use of prohibited or restricted representations in consumer advertising for these products.
The TGA website has specific advertising guidance material for businesses involved with medicinal cannabis products.
The TGA takes action against illegal activity
The regulatory scheme is critical to the safety of Australian consumers, and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial fines and or imprisonment.
The TGA will review complaints of alleged non-compliant advertising of medicinal cannabis products to the public. In December 2020, a man was issued with four infringement notices totalling $10,656 for alleged unlawful advertising of cannabidiol (CBD).
If you suspect non-compliance in relation to medicinal cannabis, you can report illegal or questionable practices online to the TGA. The TGA also encourages people to report suspected non-compliant advertising via its advertising reporting form.
If you have concerns about health practitioners, notify the Australian Health Practitioner Regulation Agency (AHPRA).
