The specifications for future cannabis-based drugs, which will be used in an experiment from next year, were published on Sunday.
This is the last step before choosing suppliers.
Experimentation with therapeutic cannabis, voted by the National Assembly a year ago, was authorized by a decree published on October 9.
It must begin “no later than March 31”, “for a period of two years”, and will concern at least 3,000 patients.
The order published on Sunday in the Official Journal confirms which pharmaceutical forms will be authorized and in which cases they can be used.
Medicines will come in the form of oils, capsules and dried flower spray. They will only be administered to patients suffering from serious illnesses (certain forms of epilepsy, neuropathic pain, side effects of chemotherapy, palliative care or multiple sclerosis) and only “in the event of insufficient relief or pain. ‘poor tolerance’ with existing treatments.
For each form of drug, a main supplier and a secondary supplier “in the event of failure of the first” will be selected, indicates the specifications annexed to the order.
The text also details the characteristics of the products, and in particular the precise dosages authorized for the two active substances in cannabis (THC and CBD), the quality controls that will be carried out and the obligations incumbent on suppliers. These will be responsible in particular for the traceability of products and “securing their distribution circuit”.
The National Medicines Safety Agency (ANSM) must now publish the call for applications on its website to select the providers who will provide the medicines.
This experiment, eagerly awaited by patient associations, was initially to be launched in September 2020, but the ANSM had announced this summer a postponement to January 2021 due to unforeseen events linked to the Covid-19 epidemic.
Cannabis for medical use is authorized in around 30 countries. In Europe, the Netherlands were the pioneers in 2003. They have since been followed by 22 countries (out of 27), including France now.
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