Legalization Is Coming Soon, France Announces Complete Regulatory Framework For Medical Marijuana

France's four-year campaign to establish a fully regulated framework for generic medical cannabis has finally come to fruition.

 

Just a few weeks ago, thousands of patients in France's medical cannabis' pilot experiment', which is due to start in 2021, were facing the agony of having to discontinue their treatment because the Government had told them to look for alternative therapies.

 

The French Government has just emerged from months of political turmoil and has made a major shift. According to the latest news, the French Government has submitted three separate documents detailing its proposed medical marijuana system to the European Union for approval, which should be adopted 'by the procedure.'

 

The proposals, which are now public, appear to indicate for the first time that cannabis flower will be available to patients, but only in 'one-time' doses and through specific devices.

 

 

On 19 March 2025, three documents were sent to the EU for approval, each detailing specific parts of legalizing medical cannabis.

 

Each regulatory framework was finalized some time ago and was initially planned to be submitted to the EU in June or July last year. Still, the collapse of the French Government and its subsequent political upheaval meant that the passage of these decrees, along with many other bills, was significantly delayed.

 

According to the EU's Technical Regulation Information System (TRIS), France's first decree 'defines the framework of the regulatory system for cannabis medicines'. Two other decrees, 'Arrêtés,' have been submitted simultaneously to help 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 consultancy Augur Associates, told the press: 'We are waiting for final approval from the EU, after which the Government will sign the decree at the ministerial meeting every Wednesday at the presidential palace. These laws are universal and implemented in many European countries and I don't anticipate any blocking measures from the EU.'

 

 

Under the updated universal medical cannabis framework, only trained and certified doctors will be able to prescribe medical cannabis products and a training program will be developed in consultation with the French Ministry of Health (HAS).

 

Medical cannabis will still be recognized as a treatment of last resort, and, as in the pilot project, patients must be able to demonstrate that they are ineffective or intolerant to all other standard treatments.

 

Legal, medical marijuana prescriptions are only indicated for the treatment of neuropathic pain, drug-resistant epilepsy, associated spasticity due to multiple sclerosis and other central nervous system disorders, relief of the side effects of chemotherapy, and palliative care when symptoms persist and do not resolve.

 

While these conditions are largely consistent with those proposed in the past, one key change that could open up the market to more businesses is the inclusion of dried cannabis flowers.

 

While dried flowers are now included, patients are strictly prohibited from ingesting them through traditional methods and must inhale them through a CE-approved dried herb vaporization device.

 

Dried medical cannabis flowers must comply with the European Pharmacopoeia 3028 monograph standard and be presented in finished form.

 

Other finished medicines, including oral and sublingual formulations, will be presented in three different configurations of THC and CBD ratios - THC-dominant, a balance of the two, and CBD-dominant - with each category offering the main strains and options available to patients.

 

The categorization of French medical cannabis products is good for the industry as there are no restrictions on strains and concentrations, only full-spectrum products. The CBD/THC ratio is the only information that must be presented. It is also welcome to provide information on minor cannabinoid components and terpenes, which will help competition but is not obligatory.'

 

In another important development, the French Ministry of Health also clarified that the 1,600 patients treated as part of the ongoing pilot project will be able to continue to access cannabis medicines until at least 31 March 2026, when the universal regulatory framework is expected to be in place.

 

A key provision of the new regulatory decree will be establishing an 'Authorisation for Temporary Use (ATU)' framework, which is approving products before they enter new markets.

 

As previously reported, the French National Drug Administration (ANSM) will oversee this process. Medical cannabis prescription products will be validated for five years and can be renewed nine months before their expiry date. The ANSM will have 210 days to respond to an application and publish all decisions on a product's approval, rejection, or suspension on its official website.

 

Applicants must provide evidence that their product complies with EU GMP standards and, following approval, must submit regular safety updates every six months for the first two years and then annually for the remaining three years.

 

Crucially, only specially trained and certified doctors will be able to prescribe medical cannabis, and a training program will be published in consultation with the French Ministry of Health (HAS).

 

The first decree also delves into the requirements for each part of the supply chain. In addition to the strict security protocols that are now in place in almost all medical marijuana markets, it stipulates that any grower in the country must strictly adhere to growing only indoors or in greenhouses out of sight of the public.

 

Notably, growers must enter into a current binding contract with an authorized body before cultivating cannabis plants and cultivating cannabis for the sole purpose of selling it to an authorized body.

 

 

At the beginning of January 2025, the expansion of the medical marijuana pilot program into a full-fledged medical marijuana market seemed out of reach for both patients and businesses.

 

This was the case until last week's news that the European Union had received a request from France to approve its proposal. As a result, medical marijuana businesses appear to have not had time to digest this important opportunity. Still, given the market's potential size, this is expected to change soon.

 

For now, although details have not been made public, medical marijuana companies have said that they will seize this opportunity to launch new medical marijuana products specifically for the French market. Industry sources claim that the French medical cannabis market will grow much more slowly than neighboring Germany, which is expected to receive around 10,000 patients in the first year before gradually increasing to between 300,000 and 500,000 by 2035.

One of the 'advantages' of France's regulatory framework for foreign companies looking to enter the market is that cannabis 'fits into the broader pharmaceutical framework.' This means that foreign companies can avoid the kind of arbitrary restrictions that exist in the UK, where, for example, import licenses may be restricted without clear justification. Such political interference is unlikely to happen in France, as the permits in question are not specific to medical cannabis.

 

From an economic point of view, several participants have already established partnerships with French companies that hold the necessary licenses and can produce and process medical cannabis. That said, the immediate opportunity lies more in shipping the finished product to France, with local packaging and quality control, than in producing or processing it entirely locally.