Medicinal cannabis products (being therapeutic goods that contain, or are manufactured from, any part of the cannabis plant) and any ingredients used in the manufacture of those products (including, but not limited to, the cannabis plant). For the purposes of this notification, 'cannabis plant' means any plant, or part of a plant, of the genus Cannabis, including, but not limited to, the flowers, fruiting tops, seeds, stems and leaves of the plant.; PHARMACEUTICAL PRODUCTS (HS 30)
Reforms to medicinal cannabis manufacturing, labelling and packaging requirements.
The Therapeutic Goods Administration (TGA) is seeking comment on a package of reforms in relation to the manufacturing, labelling and packaging requirements for Medicinal Cannabis Products made available in Australia or supplied to Australians.
In recent years, Australian Governments at Commonwealth, State and Territory levels have implemented legislative and policy changes to allow the cultivation, manufacture and supply of medicinal cannabis for patients in Australia.
The TGA administers Australia's national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. Typically, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG). If they are not included in the ARTG, these goods can only be lawfully supplied in, imported into, or exported from Australia if they are subject to an exemption, approval or authority. Therapeutic goods not on the ARTG are referred to as 'unapproved products'. Currently, most medicinal cannabis products are unapproved products.
Unapproved medicinal cannabis products can be accessed via the Authorised Prescriber Scheme (AP), Special Access Scheme (SAS) or clinical trials.
The TGA requires certain standards for medicinal cannabis products accessed in Australia, as set out principally in TGO 93. At present, Australian manufacturers must comply with Good Manufacturing Practice (GMP) standards, whereas a similar requirement does not apply to product imported into Australia.
There has been a significant increase in the supply and use of medicinal cannabis products in Australia. In light of this, the TGA recently undertook a review of the regulation of medicinal cannabis products manufacturing, labelling and packaging, which included a public consultation held between December 2020 and January 2021. The TGA has subsequently developed a package of reforms, described below.
TGO 93 and the Regulations are proposed to be amended to require the following:
· Imported medicinal cannabis products will be required to be manufactured on sites with acceptable GMP standards. Sponsors (the companies importing the goods) must maintain evidence to show compliance for each batch of medicinal cannabis products. The TGA will provide sponsors with clear guidance on the GMP practices and evidence required, which will be in accordance with existing recognised global standards and/or accreditation. This measure provides greater certainty on the quality and safety of products available to Australian patients. It extends broadly the same standards to offshore manufacturers currently required of Australian manufacturers. For the avoidance of doubt, the TGA will not be requiring sponsors of offshore manufacturers to comply with a unique Australian manufacturing standard. Sponsors will be able to rely on a manufacturer's adherence to an internationally accepted GMP standard (of a type acceptable to the TGA) that may be specific to that manufacturer's country.
· Extemporaneous compounding by medical practitioners and pharmacists will require approval from the TGA under the Special Access Scheme (SAS). Medicinal cannabis manufactured outside of Australia can still be used in extemporaneous compounding.
· TGO 93 will be amended to include requirements for (a) a child resistant closure on high risk goods, which is normal practice for medicines that present a poisoning risk (b) labelling that better identifies the active ingredients and (c) clarity on microbiological testing requirements. Clear guidance on the requirements – and a reasonable transition period – will be provided.