Delayed but Not Denied: France Unveils Full Medical Cannabis Blueprint

Just weeks ago thousands of participants in Frances’ medical cannabis ‘experiment’, launched in 2021, were preparing to wean themselves off the treatment and had been instructed by the government to find alternative treatments.

In a stark turnaround from the government, which is only now emerging from months of political chaos, three separate documents detailing its proposed medical cannabis system have been submitted to the EU for approval, and should be passed ‘as a formality’.

These now public proposals appear to suggest, for the first time, that cannabis flower will be available to patients, but only in ‘single-use’ dosages and via specific devices.

On March 19, 2025, three documents were sent to the EU for approval, each detailing a specific part of the legalisation process.

Each decree had been finalised some time ago and were initially intended to be sent to the EU in June or July last year, but the collapse of the French government and subsequent turmoil has mean this, alongside many other bills, were significantly delayed.

As per the EU’s Technical Regulation Information System (TRIS), the first decree ‘defines the framework for the system regulating cannabis-based medicines’.

A further two ‘Arrêtés’, were published alongside this, helping flesh out the technical details, real world conditions and enforceable standards of 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 Business of Cannabis: “We’re just waiting for what I call ‘bureaucratic suspense’ to finalise, and then the government will sign the decrees once they’ve been signed off by the EU. That usually happens during the ministerial meetings every Wednesday at the presidential palace, but that’s usually a formality.”

“These laws are pretty common, and are enforced in many European countries, so I don’t anticipate any hold-up from the EU.”

Under the new generalised medical cannabis framework, only trained and certified physicians will be able to prescribe medical cannabis and training programmes are set to be created after consultation with Haute Autorité de Santé (HAS).

Cannabis will remain a treatment of last resort, as it has been in the experiment, and patients must be able to prove they have failed or are intolerant of all other standard therapies.

Prescriptions will only be legally available for neuropathic pain, drug-resistant epilepsy, spasticity associated with multiple sclerosis and other central nervous system disorders, for relief from the side effects of chemotherapy, and in palliative care when symptoms are persistent and unrelieved.

While these conditions remain largely in line with proposals we’d seen in the past, a key change that could open the market up to many more businesses is the inclusion of flower.

Although the flower is now included, patients will be strictly prohibited from smoking these via traditional methods and must consume via a CE-certified dry herb vaporisation device.

Flower must meet Ph. Eur. 3028 monograph standards and be presented as a finished product.

Other finished products, including oral and sublingual formulations, will be sought in three separate ratio profiles, THC-dominant, balanced and CBD-dominant.

In another key development, the Ministry of Health has also clarified that the 1,600 patients treated as part of the ongoing experiment will continue to be able to access their medicine until at least March 31, 2026, by which time it is expected the generalised framework could be in pla

One key provision in the decree is the establishment of a framework for ‘temporary use authorisations (ATUs)’, the process by which products entering the new market are approved.

As previously reported, France’s ANSM will oversee the process, which will validate products for prescription for five-year periods, with renewal available nine months before expiration.

The ANSM will have 210 days to respond to applications and will publish all decisions to authorise, refuse or suspend products on its website.

Applicants must provide evidence their product is EU GMP compliant and after approval must submit periodic safety update reports every six months for the first two years, then annually for the remaining three.

Crucially, only trained and certified physicians will be able to prescribe medical cannabis and training programmes are set to be created after consultation with Haute Autorité de Santé (HAS).

The first Arrêté delves into the requirements of each part of the supply chain. Alongside strict security protocols which are now standard in almost all medical cannabis markets, it states that any domestic cultivators must grow strictly indoors, with outdoor or greenhouse cultivation prohibited.

Notably, cultivators must have an existing binding contract with an authorised establishment before they can grow any cannabis and must cultivate for the sole purpose of selling to them.

In early January 2025, the extension of the medical cannabis experiment into a fully-fledged medical cannabis market seemed out of reach for patients and businesses alike.

This remained largely true until last week when the news broke that the EU had been asked to approve its proposals. As such, this has left little time for businesses to digest the potential opportunities, but given the potential size of the market, this will soon change.

Mr Jeanroy, who spoke to Business of Cannabis after the decrees were sent to the EU, but before the details were made public, said: “I think that there will be a lot of interest… we’ll have new types of products that are specifically made for France.

He continued that he expects the market to develop much more slowly than its German neighbour, seeing around 10,000 patients in the first year, before growing gradually to between 300-500k by 2035.

For foreign companies looking to break into the market, he said ‘one of the strengths’ of the French framework was that cannabis ‘fits into the broader pharmaceutical framework’.

“This means you avoid the kind of arbitrary restrictions you might see in the UK for example, where import licences can be restricted for no clear reason. That kind of political interference is unlikely in France because the licenses involved aren’t specific to medical cannabis.

“From an economic perspective, there are already actors forming partnerships with French companies that hold the necessary licenses and can handle manufacturing and processing. That said, I think the immediate opportunity lies more in shipping finished products into France and having them packaged and quality-controlled locally, rather than fully processed or manufactured there.”

This article was originally published by Business of Cannabis and is reprinted here with permission.