The Therapeutic Goods Administration (TGA) of the Australian Government’s Department of Health has provided information about the highly anticipated changes to quality, packaging and labelling requirements for medicinal cannabis in the country, with these set to take effect from 1st July next year.
The background behind these important changes
It was reported as long ago as the autumn of 2020 that the TGA was considering reforms to Australia’s import quality standards.
Over the course of the ensuing consultation period, concerns were raised about the country’s medicinal cannabis firms having to deal with an uneven playing field, whereby the medicinal cannabis products they manufactured needed to conform to more stringent quality standards than was expected of imported products.
All products supplied in Australia are expected to adhere to Therapeutic Goods Order 93 (TGO93), for example, but only local products are also required to be produced in facilities that are certified for GMP compliance (those letters standing for ‘Good Manufacturing Practice’).
What has been done to help resolve this imbalance?
To help tackle the above difference in treatment between local and imported medicinal cannabis products, GMP requirements have been incorporated into TGO93.
Specifically, when the changes come into force, it will be expected that every batch of imported products is manufactured in facilities that fulfil one of a number of ‘equivalent’ GMP codes accredited by the national authority at the country of origin.
Included among those countries will be all member states of the European Union (EU), as well as the United Kingdom (UK), the United States (US), Israel, Canada, and South Africa.
The aforementioned list is additional to those countries – such as Switzerland and New Zealand – that already have mutual GMP recognition arrangements in place with Australia, as well as manufacturers in other countries that have independently sought and received Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP accreditation.
Australian sponsors of imported products will be legally obliged to make sure their products satisfy the new quality standards, and will be expected to supply and maintain evidence of this compliance for at least until the end of the shelf life of the given product batch.
New labelling and packaging requirements are also on the way
From the start of July 2023, new requirements in relation to labelling and packaging will also be introduced. These will include a need for all products – with the exception of flower – to include child-resistant packaging, the exemption understood to be due to flower products not presenting a serious risk to children in the event of accidental ingestion.
Labelling on products will also be standardised to include the product name and product sponsor, in addition to active ingredients, concentrations, batch numbers and expiry dates.
There will be an expectation that flower products specify the minimum weight per unit, as well as that extracted products specify the minimum amount of cannabis from which each given product is derived.
For further information on how compliance with TGO93 can be achieved, including the 2022 amendments, affected parties are advised to read the relevant guidance note on the TGA website.
As for if you are an individual or organisation active in the cannabis industry in Gibraltar, and would appreciate advice and support in relation to such key aspects as the creation of your business, GMP compliance, or something else entirely, you are very welcome to contact the Hempire team.
