France’s four-year campaign to establish a comprehensive, regulated framework for medical cannabis has finally borne fruit.
Just weeks ago, thousands of patients enrolled in France’s medical cannabis “pilot experiment,” launched in 2021, faced the distressing prospect of interrupted treatment as they were instructed by the government to seek alternative therapies. Now, after emerging from months of political turmoil, the French government has made a significant pivot. According to the latest reports, it has submitted three separate documents to the European Union for approval, detailing the proposed medical cannabis system, which should “procedurally” pass.
The now-public proposals appear to indicate, for the first time, that cannabis flowers will be available to patients—but only in “single-use” doses and administered via specific devices.
1. Event Recap
On March 19, 2025, three documents were submitted to the EU for approval, each outlining specific aspects of the medical cannabis legalization process.
In reality, each regulatory framework had been finalized some time ago, with initial plans to submit them to the EU last June or July. However, the collapse of the French government and subsequent political upheaval significantly delayed the passage of these decrees, along with many other legislative measures.
According to the EU’s Technical Regulations Information System (TRIS), the first decree submitted by France “defines the framework for the regulatory system of cannabis-based medicines.” Two additional decrees, known as “Arrêtés,” were submitted simultaneously to flesh out the technical details, practical conditions, and enforceable standards for what could become one of Europe’s largest medical cannabis markets.
Benjamin Alexandre-Jeanroy, CEO and co-founder of Paris-based consulting firm Augur Associates, told the media: “We are awaiting final approval from the EU, after which the government will sign the decrees during the weekly ministerial meeting held on Wednesdays at the presidential palace. These laws are universal and implemented in many European countries, so I do not anticipate any obstruction from the EU.”
2. Conditions and Products
Under the new universal medical cannabis framework, only trained and certified doctors will be permitted to prescribe medical cannabis products. A training program will be established in consultation with the French Health Authority (HAS).
Medical cannabis will remain a treatment of last resort, as in the pilot program. Patients must demonstrate that all other standard therapies have been ineffective or intolerable.
Legal medical cannabis prescriptions will be limited to treating neuropathic pain, drug-resistant epilepsy, spasms related to multiple sclerosis and other central nervous system disorders, alleviating chemotherapy side effects, and palliative care for persistent, unmanageable symptoms.
While these conditions align closely with previously proposed guidelines, a key change that could open the market to more businesses is the inclusion of cannabis flower.
Although flower is now permitted, patients are strictly prohibited from consuming it through traditional methods. Instead, it must be inhaled via CE-certified dry herb vaporizers. Medical cannabis flower must comply with the European Pharmacopoeia’s Monograph 3028 standards and be presented in finished form.
Other finished pharmaceutical products, including oral and sublingual formulations, will be available in three distinct THC-to-CBD ratios: THC-dominant, balanced, and CBD-dominant. Each category will offer primary strains and options for patients to choose from.
“The classification of medical cannabis products in France is indeed favorable for the industry, as there are no restrictions on strains or concentrations—only full-spectrum products are required. The THC/CBD ratio is the only mandatory information to be submitted. Additionally, providing details about minor cannabinoids and terpenes is encouraged to foster competition, though not obligatory,” noted industry experts.
Another significant development is the French Health Authority’s clarification that the 1,600 patients currently receiving treatment under the pilot program will continue to have access to cannabis medicines, at least until March 31, 2026, by which time the universal regulatory framework is expected to be fully operational.
3. Other Key Details
A pivotal provision in the new regulatory decrees is the establishment of a “Temporary Use Authorization (ATU)” framework—a pre-market approval process for new products.
As previously reported, the French National Agency for the Safety of Medicines and Health Products (ANSM) will oversee this process, which will validate medical cannabis prescription products for five years, renewable nine months before expiration. The ANSM will have 210 days to respond to applications and will publish all decisions—approvals, rejections, or suspensions—on its official website.
Applicants must provide evidence that their products meet EU Good Manufacturing Practice (GMP) standards. Upon approval, they must submit Periodic Safety Update Reports every six months for the first two years, then annually for the remaining three years.
Critically, only specially trained and certified doctors will be authorized to prescribe medical cannabis, with training programs to be announced in consultation with the French Health Authority (HAS).
The first decree also delves into requirements for each segment of the supply chain. Beyond the stringent security protocols now standard in nearly all medical cannabis markets, it stipulates that any domestic cultivator must strictly grow plants indoors or in greenhouses shielded from public view.
Notably, cultivators must enter into binding contracts with authorized entities before planting cannabis, and the sole purpose of cultivation must be to sell to these authorized entities.
4. Prospects and Opportunities
In early January 2025, the expansion of the medical cannabis pilot program into a full-fledged market seemed a distant prospect for both patients and businesses.
This outlook persisted until last week’s news that the EU had received France’s request for approval of its proposals. Consequently, medical cannabis businesses have had little time to digest this major opportunity, but given the market’s potential scale, this is likely to change soon.
Currently, while specifics remain undisclosed, medical cannabis companies have signaled their intent to seize this opportunity by launching new products tailored to the French market. Industry insiders predict that France’s medical cannabis market will develop much more slowly than neighboring Germany’s, with an estimated 10,000 patients in the first year, gradually growing to between 300,000 and 500,000 by 2035.
For foreign companies eyeing this market, a key “advantage” of France’s regulatory framework is that cannabis “falls under a broader pharmaceutical framework.” This means foreign firms can avoid arbitrary restrictions like those seen in the UK, where import licenses might be capped without clear justification. Such political interference is less likely in France, as the licenses in question are not specific to medical cannabis.
From an economic standpoint, some players have already formed partnerships with French companies holding the necessary licenses to produce and process medical cannabis.
That said, the immediate opportunity lies more in shipping finished products to France for local packaging and quality control rather than full-scale local production or processing.
Post time: Apr-01-2025