The Australian Government recently introduced new manufacturing, labelling and packaging requirements for medicinal cannabis products manufactured or supplied in Australia, under amendments to the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Amendment Order 2022 (Amendment Order), effective as of 28 March 2022.
The Amendment Order:
- Creates a level playing field for imported and domestically produced medicinal cannabis products.
- Prohibits use of synthetic and modified cannabinoids in medicinal cannabis products.
- Brings much needed clarity on quality requirements for importers of plant material and overseas manufacturers of medicinal cannabis products.
- Clarifies labelling and child resistant packaging requirements.
- Promotes greater transparency regarding the active ingredients, reliability of information on labels and other important features of medicinal cannabis products.
The Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (Principal Order) is made under section 10 of the Therapeutic Goods Act 1989 (Cth) and establishes a ministerial standard that specifies the minimum requirements for the quality and safety of medicinal cannabis products, whether imported into Australia or manufactured domestically. The Principal Order intends to assure medical practitioners and patients that these products meet minimum quality standards.
The Amendment Order is geared towards addressing concerns regarding the safety and quality of medicinal cannabis products available for use by patients in Australia, whether manufactured in Australia or overseas. Prior to the Amendment Order, there was no uniformity in terms of the obligations imposed on imported and domestically produced medicinal cannabis products, particularly as only those products manufactured in Australia were required to be manufactured in accordance with a good manufacturing practice (GMP) requirements. Following the Amendment Order, there are now equivalent standards imposed on medicinal cannabis products imported into Australia for supply under the Special Access Scheme and Authorised Prescriber Scheme (SAS/AP Scheme). This means that medical practitioners and pharmacists can now be assured that all medicinal cannabis products supplied in Australia have been manufactured in a way that conforms with strict quality standards. Moreover this levels out the playing field between Australian and overseas manufacturers, holding overseas manufacturers to the same standard, and provides clarity for overseas manufacturers on the standards they need to comply with. These new requirements will apply to products released for supply in Australia after 1 July 2023.
It is important to note that for imported products, the relevant GMP standard that needs to be followed will depend on the equivalent GMP codes accredited by the national authority in each respective country of manufacture. For example, there are specific requirements in the Amendment Order that apply to manufacturing sites located in the UK, all EU member states, Canada, South Africa and Israel. If the medicinal cannabis product is to be manufactured at a facility in another country, an application can be made to the Therapeutic Goods Administration (TGA), requesting an inspection for compliance of the manufacturing facility, the cost of which is payable by the sponsor.
The Amendment Order also addresses a long debated issue on synthetics, and prohibits the use of synthetically produced cannabinoids in medicinal cannabis products, requiring that all cannabinoids in a medicinal cannabis product, whether an active ingredient or not, must be from the cannabis plant. The Amendment Order also prohibits use of cannabinoids that have been modified or transformed in any way, prohibiting the supply of naturally-derived cannabinoids that have had their chemical structure altered.
Another key change is the clarification that the manufacturing quality requirements under the Principal Order do not apply to:
- plant material, being defined as “dried or fresh material of the cannabis plant that has not undergone any refinement, including dried flos”; or
- medicinal cannabis products that are oil from the cannabis plant,
that are used as starting material to produce another medicinal cannabis product. This is welcome clarity for importers of such starting material for manufacture in Australia.
Finally, the Amendment Order introduces standardised labelling and packaging requirements for medicinal cannabis products, which will also apply to products released for supply in Australia after 1 July 2023. These requirements differ according to two main categories:
- Medicinal cannabis products that are extemporaneously compounded or repackaged by a pharmacist for a particular patient, where products must state the name and quantity of each active ingredient that is purported to be present.
- All other medicinal cannabis products, where products must be labelled with the product name, sponsor details, storage conditions, batch number, expiry date, the name and quantity of each active ingredient, dosage form and the quantity of the medicinal cannabis product.
All of the information that is displayed on the label of a medicinal cannabis product must be in English and it must be legible, visible (and not obscured) and durable.