France officially notified the drafts of regulatory texts defining the framework for the production and authorisation of cannabis for medical use to the European Commission!
This notification marks the culmination of a long process of maturation and elaboration in consultation with stakeholders. Above all, it is the first step towards the entering into force of a detailed legislative and regulatory framework with a defined timeframe, a crucial element for the flourishing of a national industry dedicated to the cultivation and production of medical cannabis.
The drafts include:
- a decree on cannabis for medical use, setting out the framework for cannabis-based medicines. This decree creates a new specific section in the Public Health Code for the authorisation of medical cannabis-based medicines and incorporates these medicines into the existing provisions relating to pharmacovigilance, manufacturing and wholesale distribution, and into provisions relating to poisonous substances;
- a ministerial order setting out the specifications of cannabis-based medicines and the therapeutic indications for their use;
- a ministerial order setting out the technical conditions for the possession, cultivation, import, export, transport and storage of cannabis plants for medical purposes within French territory.
Member States and the Commission now have 3 months to issue their opinions on the notified drafts. This standstill period imposed by the TRIS procedure provides stakeholders with the opportunity to submit comments on the draft texts and to start preparing for both regulatory and legal aspects (structures, contracts, etc.).
The Pharma Regulatory team of our Paris office, headed by Anne Servoir, is delighted with this important step forward and proud to have contributed to this success. It was part of this journey from the start, assisting stakeholders in developing the framework for medical cannabis in France.
Read the Government Press Release here.
