France’s decree sets out the conditions and procedures relating to the cultivation and production of medical cannabis.
France will now allow the creation of a legal medical cannabis supply chain, enabling cultivation for medical use. The decree has made amendments to the country’s public health code, articles L. 5132-1 and L. 5132-8.
Published in the country’s official journal, provisions to the decree entered into force on 1 March and 2 March. The Government has stated that the National Agency for the Safety of Medicines and Health Products (ANSM) will now begin working to define the specifications of cannabis-based medicines.
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France has been running a landmark medical cannabis pilot programme – overseen by the ANSM – which began in 2021 and will continue until March 2023. The pilot has seen 215 centres across the country prescribing medical cannabis to around 3,000 patients living with serious and painful medical conditions.
For the pilot, suppliers from Australia, Canada, Israel and the UK have partnered with French pharmaceutical distributers to supply the medicines. Due to the strict regulations on cannabis production in the country, non of the participating suppliers were French companies.
In August 2021, the first cannabis flowers were made available on the trail – provided by Aurora and distributed by Ethypharm.
The provisions to the code now mean that production – including cultivation, manufacture, transport, import, export, possession, transfer, acquisition and use relating to medical products – are lawful in the country. However, this will only be if cultivators and companies are authorised by the director general of the ANSM.
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This includes activities relating to synthetic and derivative products, and the decree outlines that all authorised products must be made in accordance with EU-GMP practices in order to guarantee quality and safety.
To enable the implementation of production in France, a temporary scientific committee – ‘Technical specifications of the production chain from the plant to the drug’ – has been set up by the ANSM, with its first meeting taking place on 18 February.
The committee is made up of representatives from the agriculture, health, economy, interior ministries as well as the National Research Institute for Agriculture, Food and the Environment (INRAE) and the Conseil Order of Pharmacists (CNOP).
The decree will also only allow cannabis growers who have agreed to supply their production to establishments authorised by the ANSM to hold and cultivate cannabis.
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