On Jan. 28, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued a press release outlining details for the medical cannabis trials in France. Suppliers who want to apply for distribution will have to present their plans on how they plan on growing cannabis, while health professionals will have to undergo mandatory training for prescribing cannabis.
On Oct. 25, 2019, France’s National Assembly voted in favor of trials for medical cannabis. Although the dates and duration are set, the conditions necessary for approving medical cannabis in France remain unclear.
On Jan. 28, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued a press release explaining that this has finally been determined.
The experts at the Temporary Scientific Committee (TSC) explained that the Implementation of medical cannabis in France relies on the training of health professionals, the specifications of the products that will be used, and the conditions for monitoring patients.
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Suppliers who want to apply for distributing medical cannabis in France will have to present their plans on how they plan on growing cannabis (cultivation method, selection method, compliance with good agricultural practices, THC/CBD content, etc.) and specifications on their finished products.
In particular, the analytical procedures of the control methods and the results of these controls must be provided.
Patient follow-ups will be carried out through an “electronic register,” which will include various modules to assess its patients such as scheduling an appointment, and how easy it is to find a pharmacy that carries medical cannabis in France.
The ANSM adds that the registry will also make it possible to collect data on the dosages dispensed, efficacy, adverse effects and its impact on the patients’ quality of life. Both pharmacists and patients will have access to this information.
As for health professionals, they will have to have undergo mandatory dedicated training before they can prescribe medical cannabis in France. The validation of this online training, which lasts over three hours, will be a mandatory condition for doctors and pharmacists to be registered in the experimental patient monitoring register.
The ANSM guarantees “the independence of health professionals vis-à-vis the laboratories supplying the products and the control of the messages delivered.”
As outlined in the narcotics regulations, medical cannabis in France and its derivatives will be prescribed on a “secure prescription” and stored in locked containers.
The Agency specifies that the treatment may only be initiated by doctors working in voluntary referral structures, taking charge of the indications selected by the CST and approved by the ANSM.
However, once the patient has been entered into the system, the renewal of prescriptions may be carried out by any doctor in town.
As with all narcotic and psychotropic substances, cannabis will also be subject to an import permit issued by the ANSM.
The supply of French pharmacies during the experiment of medical cannabis in France will include the compulsory administrative procedures for narcotics. Distributors are limited in number and are all located in France.
“City and hospital pharmacists, in addition to ordering and dispensing medical cannabis, will have an advisory role with patients,” said the ANSM.
They will also have to fill in the register at the time of dispensing, which will make it possible to follow the path of patients and name any adverse effects that may appear during treatment.
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First published in Doctissimo Santé, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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