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Supply chain opportunities for cannabis-based medicinal products in France suggests some relenting of the strict blanket ban France has imposed against both the production and culture of cannabis.
A new Decree, dated 17 February 2022 was published in the French Official Journal, relating to the culture and production of cannabis for medical use, with a view to create a specific supply chain for cannabis-based medicinal products in France.
While the general ban on the production (which includes culture, manufacturing, transport, import/export, detention, offer, transfer, acquisition and use) of cannabis and cannabis-based products remains in force, the decree sets out a new framework for the production and culture of cannabis (for medical use) in France.
The new decree introduces two exceptions to the ban:
- Production of cannabis can be authorised if it is to be used in a medicinal product which has obtained a marketing authorisation, an early access or compassionate use authorisation, or an import authorisation;
- It can also be authorised – save for supply and use, when it concerns medicinal products which meet specifications set by an order of the Ministry of Health (yet to be published) and are manufactured in compliance with Good Manufacturing Practices.
Only those companies with the status of pharmaceutical establishment under French law (i.e. pharmaceutical companies), or those allowed to manufacture, import and distribute active pharmaceutical ingredients or excipients are allowed to benefit from either of those two exemptions, in which case they must obtain an authorisation to that end.
In parallel, the French ANSM has indicated on their website that they have created a scientific temporary committee on the culture of cannabis for medical use in France.
The Committee (which held its first meeting just last week (w/c 14 February 2022)) will work on the technical specifications that will apply to this supply chain, from the plant to the medicinal product.