French Cannabis Framework Intact
First Rx still unlikely in 2026.
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The Eight-Month Reality
France has chosen a unique pathway for medical cannabis integration, learning from the issues experienced in neighboring markets and avoiding many of the pitfalls Germany, the UK and Australia are tackling today, but bringing with it a new set of challenges.
Its proposed framework will integrate cannabis medicines directly into the country’s existing pharmaceutical framework, as opposed to pigeon-holing it into its own unique category, as seen in almost every other market.
While this should significantly streamline the process, providing well-understood and established rules for patients, doctors, and businesses, it also means that cannabis medicine will be subject to the same rigorous standards, approval processes, and oversight as any other controlled drug.
“The med agency over here, the team and the authorities, they don’t want to hear about buds to be distributed anywhere for patients,” Péribère explains. “They look at it with a pharmaceutical eye, not as it is done in many countries.”
This, according to Péribère, is also precisely why it could take until 2027 for the first prescriptions to be received, with the dual phases of evaluation and commercial preparation both taking months to complete.
“When we speak with [ANSM], they will go very deeply into the evaluation,” Péribère explains, stating that the regulator has indicated that reviewing medicinal cannabis product applications will take ‘six months minimum,’ with the standard timeline reaching up to nine months.
These applications must also be completed to exacting standards, requiring complete pharmaceutical files that demonstrate EU GMP compliance, including comprehensive drug substance and drug product documentation, stability data, and rigorous safety assessments.
Every aspect will be scrutinised to pharmaceutical standards before the ANSM will grant a product the five-year temporary use authorisation (ATU), which is set to govern market access.
“After that, you need to have the results to be able to begin the production and the fabrication of the packaging that has to be approved as a medicine. That will take a minimum of two months to be organised and be able to come to the supply chain.”
With this in mind, the whole process should take eight to 11 months from the day the framework is published. Despite the bill being ‘complete’, there is little indication from the government on when publication will take place, further extending the potential timeline.
Extracts over flower
Another key part of the pharmaceutical focus is the omission of raw cannabis flower, a controversial choice for many, but one that is becoming increasingly common in emerging markets such as Spain’s incoming framework.
While flower is technically permitted, it is heavily restricted to sealed, single-use vape cartridges for use with CE-approved medical devices.
Given the pharmaceutical framing, requiring controlled, repeatable, measured dosing, this makes sense in a purely medical market.
While this is a clear plus for regulators, effectively futureproofing the market against accusations of a pseudo-recreational market as seen in Germany, Australia and the UK, it once again presents new challenges and opportunities.
When the market is eventually rolled out across France, Péribère believes these inherent barriers to flower will see extracts and oils dominate ‘in the beginning’.
“The future in France is really focused on quick assimilation methods from an extract, full extract, not isolate… They don’t want patients to grind their products, manipulate them. They don’t want that in the chain of distribution.”
He also questions whether CE-marked medical vaporisation devices are readily available to be rolled out across the market in bulk, presenting a major opportunity for any manufacturers able to fulfil this demand.
“When we look at the registration numbers, it seems that they are not there. So are they really CE mark approved?”
Slow, but sustainable
While Péribère concedes France’s unique framework presents some significant barriers for businesses hoping to break into the market, the EU’s second most populous country presents a major opportunity for those that do.
“I don’t have the feeling that we will have a lot of actors in France,” he acknowledges candidly. The pharmaceutical file requirements, coupled with the need for either an existing pharmaceutical exploitation license or a partnership with a licensed entity, will drastically limit the field.
“You need to have a complete pharmaceutical organisation with a pharmaceutical laboratory,” he added. Without an existing French pharmaceutical entity, companies from outside France must partner with licensed importers or manufacturers capable of handling the regulatory burden.
As such, Péribère notes that companies who’ve already invested heavily in the pilot, including Aurora Cannabis, Tilray, Little Green Pharma, and Panaxia, should have first-mover advantage.
“They didn’t make this investment to get away now. They are very motivated to come, and they have a good position to begin with.”
Overseed counts itself among this group. “As soon as the publication is made, we will be able to ask for the evaluation of this file,” he says, emphasising the company’s readiness to enter from day one.
The market will start small, likely around 10,000 patients in the first year, according to estimates from Augur Associates and Prohibition Partners, before gradually expanding. With 300,000 to 800,000 potentially eligible patients across France’s five approved indications, and a projected annual turnover of €806m by 2035, the long-term opportunity is clear.
But Péribère emphasises that regulatory approval is only the beginning. The real challenge will be prescriber adoption.
“In every country, the question is always the education of the prescribers, the quality of the information we will be able to provide them. This will have a considerable impact on the accessibility of these medicines to the patient.”
France currently has a base of 2,000-3,000 healthcare professionals trained through the experimentation programme, a head start most markets lack. Yet scaling beyond early adopters will require sustained education efforts.
This is Third-Party content and does not reflect (or not not reflect) the views of Cannabis Confidential or CB1 Capital.
Ben is the editor of Business of Cannabis. Since 2021, they have researched, written, and published the vast majority of the outlet’s content, delivering agenda-setting journalism on regulation, business strategy, and policy across Europe.
These challenges and opportunities will be central topics at Cannabis Europa Paris on February 19, where Péribère and other industry leaders will examine whether France’s unique approach justifies the countless delays in the eyes of patients.








Insightful breakdown of France's pragmatic approach. The pharma-first strategy sidesteps alot of the pseudo-recreational pitfalls Germany and UK face, but that 8-11 month evalution timeline for product approval is gonna limit early market entry significantly. Suspect the extract-heavy market will favor established pharma partnerships over startups.