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France enters the medical cannabis industry

France is moving forward regarding medical cannabis cultivation and production. As of March 1, it is legal to cultivate cannabis for medical purposes in France. The change in the law was published in the official government register, the “Journal officiel de la République française“, on February 18 and came into force on March 1.  Decree still needs to be implemented by the regulators.

The legislation only specifies the conditions and procedures for the cultivation and production of cannabis for medical use. The decree has amended some parts of France’s Code of Public Health to allow cultivation, production, manufacture, transport, import, export, and possession of cannabis and its derivatives under medical authorization.

The following applies:

  • The (final) medicinal product meets the specifications set by the French Ministry of Health, issued based on a proposal from the National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)), relating to its characteristics, composition, pharmaceutical dosage form and indications.
  • The (final) medicinal product is manufactured in compliance with Good Manufacturing Practices (GMP), to guarantee its quality, safety and intended therapeutic use.

The ANSM will supervise the creation of the medical cannabis supply chain and has set up a temporary scientific committee made up of 11 members to define technical specifications for national medical cannabis (from the plant to the medicine) and examine several aspects of the supply chain, including the identification of the cannabis strains available for the medical treatment, the level of tetrahydrocannabinol (THC) and cannabidiol (CBD), track and trace systems, the methods of ingesting cannabis-based medicines, and the pharmaceutical quality criteria.

The decree follows a medical cannabis pilot project announced in 2020 and launched in March 2021, which is currently targeting up to 3,000 patients suffering from severe conditions, such as chronic pain and epilepsy, and it will continue to operate, supervised by the ANSM, until March 26, 2023.