Medical Cannabis

In France, cannabis and cannabinoids are regulated by a complex set of rules composed notably of laws, decrees and ministerial orders setting forth a general prohibition of cannabis, which is classified as a narcotic substance.

General Prohibition of Cannabis Under French Law

According to the French public health code, the production, manufacturing, transportation, importation, exportation, possession, sale, purchase and use of plants, substances or preparations classified as poisonous, including narcotic substances and psychotropic substances, are governed by regulatory provisions defined by ministerial orders. For the sake of clarity, ministerial orders (Arrêté in French) are administrative acts published by ministers and set forth certain rules regulating (for instance) specific sectors, products or activities.

The French ministerial order of 22 February 1990 (Appendix I) classifies cannabis and cannabis resin as narcotic (stupéfiants in French) substances. More specifically, French law strictly prohibits the production, manufacturing, transportation, importation, exportation, storage, supply, distribution, purchase or use of:

• cannabis, and its plant and resin, as well as products that contain it or that are produced from cannabis, its plant or its resin; and
• tetrahydrocannabinols (THC), their esters, ethers and salts, and the products containing them.

Exceptions to the General Prohibition Rule

Nevertheless, French law provides for several exceptions to the general prohibition.

The manufacturing, transportation, importation, exportation, possession, sale, purchase or use of medicines containing cannabis or one of the cannabis plant components is allowed if the product has been granted a marketing authorisation either from the French Medicines Agency (Agence nationale de sécurité du médicament et des produits de santé (ANSM)) or from the European Medicines Agency (EMA).

Other cannabis-based medicinal products that satisfy specific criteria (notably characteristics, composition, pharmaceutical forms, therapeutic indications) but do not hold a marketing authorisation are accessible as described below:

• the ANSM can grant specific authorisations for the production, manufacturing, transportation, importation, exportation, storage, supply, distribution, purchase or use of cannabis and/or its components for research and development purposes; and
• cultivation, importation, exportation and industrial and commercial use of hemp plants that do not have any narcotic properties, or of products containing or made out of such hemp strains, can be allowed by ministerial order upon proposition from the General Director of the ANSM.

To date, cannabis regulation remains a work in progress, since there is no fully established legal framework in France. Medical cannabis (other than medicines containing cannabis and holding a marketing authorisation) was authorised and therefore accessible to a very limited number of patients through a pilot programme until 25 March 2024, and is currently only accessible to patients that were enrolled in the pilot programme as part of a transition period and until the legalisation of medical cannabis becomes effective.

Medical cannabis is only allowed in France if:

• the product is a medicine holding a marketing authorisation or is accessible through early-access programmes (eg, Sativex, Epidyolex, Marinol) issued by the French or the European competent health authority (“medicines containing cannabis”); or
• the cannabis-based product is supplied, prescribed and administered to patients under the conditions of a pilot programme that started in March 2021, until the legalisation of medical cannabis (to be understood as cannabis-based medicinal products subject to a temporary use authorisation) enters into force.

In other words, any activities related to the cultivation, production, manufacture, transportation, importation, exportation, detention, supply, transfer, acquisition or use of cannabis for exclusively therapeutic purposes outside one of the above-mentioned frameworks are considered criminal offences related to drug trafficking, and are therefore prohibited in France.

The pilot programme on therapeutic cannabis, which began in March 2021, was designed to enrol up to 3,000 patients over an initial two-year period to assess the feasibility of the supply, prescription and delivery of medical cannabis to patients for whom no other therapeutic alternative is available. Because there is no domestic production line in France yet, supply was performed exclusively by foreign companies that were selected through a tender, and that were initially required to supply the products free of charge and at their own costs for the entire duration of the pilot programme.

The requirements related to the products, the supply chain, physician training, prescription and delivery as part of the pilot programme were set out in a statement of work published on 19 October 2020, as summarised below.

• Medical cannabis is allowed for five therapeutic indications:
1. neuropathic pain that cannot be treated with available therapies (medicines and non-medicines);
2. certain serious and pharmaco-resistant forms of epilepsy;
3. as part of supportive care in oncology (eg, nausea, vomiting, anorexia);
4. palliative situations; and
5. painful spasticity related to multiple sclerosis or other central-nervous-system-related diseases.
• The products must be supplied as finished products only in their final packaging ready to be delivered to the patient.
• The authorised forms of medical cannabis were initially dried flowers for inhalation by vaporisation (smoking use was excluded from the allowed uses) and oil and capsules for oral use.
• The products use different ratios – the THC dominant ratio, cannabidiol (CBD) dominant ratio, or balanced THC and CBD ratio.
• The production of medical cannabis must comply with a certain number of industry standards, such as good agricultural and collection practices (GACP) for starting materials of herbal origin (EMEA/HMPC/246816/2005) and good manufacturing practices (GMP) set forth in the French public health code or any equivalent guidelines recognised at the international level, in addition to several other guidelines, including:
1. the Guidelines on Quality of HMPs/THMPs (CPMP/QWP/2819/00 Rev 2);
2. the Reflection Paper on Microbiological Aspects of HMPs and THMPs (EMA/HMPC/95714/2013); and
3. the ICH Q2 Guidelines for Validation.
• The plants used to make the products must meet the specifications of the monograph “Plant Drugs” (1433) of the European Pharmacopoeia. 
• Suppliers need to obtain both an importation authorisation for narcotic substances from the ANSM and an exportation authorisation for narcotic substances from the country of origin.
• Selected suppliers were required to enter into a partnership agreement with a pharmaceutical establishment located in France for the distribution of medical cannabis to pharmacies and hospital pharmacies that participate in the pilot programme.
• The pharmaceutical establishment located in France in charge of the distribution of the medical cannabis on the territory must have the status of operator and importer, if applicable, and must hold a narcotics authorisation relating to medical cannabis in the context of the pilot programme.
• The initial prescription of the products was reserved to physicians working at multidisciplinary reference centres specialised in the five indications for which treatment with medical cannabis was allowed. However, once the patient was stabilised, general practitioners were allowed to prescribe medical cannabis to them, upon agreement of both the specialist and the general physician.
• All prescribers involved in the pilot programme must have followed mandatory training (e-learning).
• The dispensing of medical cannabis initially occurred in hospital pharmacies and could later be carried out by retail pharmacies once the stabilisation of the patient had been reached. 

While legalisation of medical cannabis was initially expected at the end of the two-year programme, the French authorities decided to extend the pilot programme by one year (Decree No 2023-202 of 25 March 2023).

Subsequently, the pilot programme ended on 25 March 2024, and medical cannabis (“cannabis-based medicinal products”) was expected to be generalised on the French market by 1 January 2025 at the latest. However, the complex political situation in France since mid-2024 has resulted in major delays in the setting-up of the legal and regulatory framework. While the legal framework was set out in December 2023 and transposed into the French public health code, the relevant regulatory decrees and orders whose publication is necessary for the generalisation of cannabis-based medicinal products to become effective are still a work in progress at this date.

More specifically, the legal framework regarding cannabis-based medicinal products was set out in French Law No 2023-1250 of 26 December 2023, on the financing of social security for 2024. The law refers to the term “cannabis-based medicinal product” and defines it as “any medicinal product whose active substance is composed of a preparation based on cannabis sativa L (extract), manufactured in accordance with the good manufacturing practices set out in article L 5121-5 [of the French public health code] or any equivalent internationally recognised standard by establishments mentioned in Article L 5124-1 [of the French public health code] and meeting the specifications set by an order of the Minister for Health issued on the recommendation of the General Director of the French National Agency for the Safety of Medicines and Health Products”.

The law also sets out the following conditions for cannabis-based medicinal products to be placed on the French market.

• The cannabis-based medicinal products can only be manufactured and distributed by duly authorised pharmaceutical establishments.
• The cannabis-based medicinal products must obtain a temporary authorisation for use from the ANSM. The use authorisation is delivered for an initial period of five years, renewable for subsequent periods of five years.
• Only companies established in a member state of the European Union (EU) or a country party to the Agreement on the European Economic Area can apply for a use authorisation.
• The use-authorisation holder must collect follow-up data of patients treated at its own costs and provide the ANSM with an annual report.
• The cannabis-based medicinal products can only be prescribed as last-line treatment, with initial prescription required to be issued by hospital-based physicians trained and registered to prescribe under the framework. In other words, unlike other countries such as Germany, telemedicine will not be authorised in France for the prescription of cannabis-based medicinal products.
• The information delivered by the use-authorisation holder to healthcare professionals in relation to the use authorisation regarding cannabis-based medicinal products must not be considered promotional. While advertising to healthcare professionals is permissible for medicines holding a marketing authorisation, and must be consistent with that authorisation, cannabis-based medicinal products are subject to a total advertising ban that goes significantly further than the restrictions applicable to ordinary prescription medicines. The ANSM is expected to provide a specific framework for the information that operators will be allowed to provide to prescribers. However, the ANSM is yet to set out the framework for such information (for sanctions in the case of breach of this obligation, please see 1.7 Enforcement and Penalties).

The legalisation of medical cannabis can only become effective once the relevant decrees and orders setting out the specifications on cannabis cultivation, the specifications on products, prescription and delivery, as well as the criteria for price-fixing and reimbursement of the products, are published, which is yet to happen.

The draft regulatory documents notably provide specifications on the production line, the products that can be authorised for use, and the prescription and delivery requirements. According to these documents, the following applies.

• Only companies that are authorised as “pharmaceutical establishments” (as defined by the French public health code) can apply for a use authorisation for cannabis-based medicinal products.
• The cultivation of the cannabis plant for medical purposes can only be carried out by growers that have entered into an agreement for that specific purpose with a pharmaceutical establishment holding the use authorisation for cannabis-based medicinal products.
• Only indoors cultivation is allowed and the premises where the cannabis plant is to be cultivated must meet the strict requirements, notably in terms of security set out in the relevant order. Outdoors growing is strictly prohibited.
• The requirements for the use-authorisation dossier to be submitted to the ANSM are the same as those applicable to standard marketing authorisation dossiers for medicines, except for clinical study results that do not apply to cannabis-based medicinal products.
• Likewise, the pharmacovigilance requirements are the same as those applicable to medicines holding a marketing authorisation.
• Prescription of cannabis-based medicinal products can only be done as a last line treatment – ie, when other available therapies have failed, and in cases where other existing medicines offer little relief or are not tolerated well by patients, or when no suitable pharmaceutical speciality is available.
• Initial prescription must be hospital prescription only.
• Physicians must complete a specific training prior to being able to prescribe cannabis-based medicinal products. However, specifications on this mandatory training are yet to be defined.
• The five therapeutic indications in which cannabis-based medicinal products can be prescribed are the same as those authorised under the pilot programme (as described previously).
• Cannabis-based medicinal products can only be placed on the market as finished products and in accordance with the following requirements:
1. dried or granulated flowering tops are not authorised unless they are presented in secure, tamper-proof primary packaging;
2. the pharmaceutical forms of final products authorised are oral or sublingual forms;
3. other pharmaceutical forms can be authorised provided they are authorised by the ANSM;
4. smoking use of the cannabis-based medicinal products is prohibited; and
5. inhalation is permitted provided it is done by using a specific inhalation device that must hold a CE mark as a medical device.

While they have been validated by the French Council of State, these decrees and orders still need to be published to be in force. Their publication is now expected to occur in June 2026.

The decree related to pricing and reimbursement of cannabis-based medicinal products is still under discussion and is not expected to be finalised until at least June 2026.

Only once all the implementation decrees and orders have been published can the operators start submitting applications for use authorisation to the ANSM. The use authorisation should be delivered within 210 days from the date the application dossier is deemed complete, which in practice could take much longer as clock-stops due to incomplete dossiers or requests for additional information from the ANSM are expected.

Once the use authorisation is granted by the ANSM, critical pricing and reimbursement milestones will still need to be overcome. Therefore, the first cannabis-based medicinal products are realistically not expected to be placed on the French market until mid to autumn 2027.

In the meantime, in order to ensure that the patients who were enrolled in the pilot programme can still have access to medical cannabis, the French Minister of Health has decided to extend the pilot programme beyond 31 March 2026. During that extension period:

• only patients who were enrolled in the pilot programme and were still in it on 25 March 2024 can access medical cannabis;
• the products accessible to those patients are the same as those authorised under the pilot programme (with the exception of dried flowers, which have been removed from the list of authorised products);
• only suppliers elected under the pilot programme can supply the products during the transition period; and
• the conditions of prescription and delivery remain the same as under the pilot programme.

In other words, the transition period does not allow access for new patients, nor does it extend the list of products or suppliers. Therefore, access to medical cannabis remains limited until its effective legalisation.

Psychedelics

Psychedelics are classified as narcotics (stupéfiants) in France. Articles L.5132-1 and seq of the French public health code define poisonous substances (substances vénéneuses), which include narcotic and psychotropic substances.

Under the French Order (Arrêté) of 22 February1990 setting up the list of substances that are classified as narcotics, psilocybin and psilocin, LSD, MDMA, DMT and mescaline are all listed as Schedule I narcotics.

The ANSM’s Director General holds the power to add newly identified substances to this list by individual administrative decision, without parliamentary action (Article L.5132-7 of the French public health code). The list is therefore a living instrument capable of expansion whenever relevant.

Consequently, production (including cultivation), manufacture, transport, importation, exportation, possession, offer, transfer, acquisition and use (as well as all agricultural, artisanal, commercial and industrial activities relating to scheduled substances) are prohibited in France, and the prohibition covers the entire supply chain from cultivation to consumption.

Nevertheless, the prohibition is not absolute. Indeed, French law allows the use of psychedelic substances in limited and strictly regulated circumstances: where duly authorised medicines are concerned (ie, holding a marketing authorisation delivered by competent health authorities), under compassionate use frameworks established by the ANSM, or as part of duly authorised clinical research. Hence, the following applies.

• Ketamine medicines are reserved for hospital use and can be administered by any specialist in anaesthesiology-resuscitation or emergency medicine when intervening in emergency situations or within a medical mobile assistance structure. As of March 2026, the ANSM has also granted compassionate use access (Cadre de Prescription Compassionnelle (CPC)) for ketamine 10 mg/mL injectable solution in the indication of treatment of severe suicidal ideation in adults. Any other use is strictly prohibited.
• Esketamine can be used in a marketing authorisation-holding medicine reserved to hospital use for short-term psychiatric treatment.
• Any clinical trial involving psychedelic substances administered to human subjects requires a specific ANSM authorisation for use of the scheduled substance, combined with ethical approval from an ethics committee (Comité de Protection des Personnes (CPP)), and compliance with the EU Clinical Trials Regulation 536/2014.

In France, a first clinical trial using psilocybin-assisted therapy to study its effect in alcohol use disorder was launched in February 2024 at a university hospital in the south of France. Additional trials are now also under way at other centres in France.

Any use, possession or supply of a scheduled psychedelic substance outside a valid ANSM authorisation constitutes a criminal offence.

Regulatory Bodies Responsible for Enforcing Laws and Regulations Relating to Medical Cannabis

The medical cannabis sector is controlled by several competent authorities, each charged with specific missions.

The Ministry of Health

This sets the policy framework within which technical agencies act; it also issues ministerial orders that define the scope of permitted activities, and holds final political accountability for the regulatory system as a whole. The ministerial orders it is expected to publish define the therapeutic indications in which cannabis-based medicinal products may be prescribed, and which pharmaceutical forms are authorised for clinical use.

Unlike medicines holding a marketing authorisation, whose price fixing is normally the role of the French pricing committee (Comité Economique des Produits de santé (CEPS)), pricing of cannabis-based medicinal products is to be set by the social security branch of the Ministry of Health (Direction de la Sécurité Sociale (DSS)).

ANSM

The ANSM is charged with the control of health products governed by the French public health code. It is the control authority for:

• medicines containing cannabis and holding a marketing authorisation;
• medical cannabis (under the pilot programme and the transition period); and
• cannabis-based medicinal products that will hold a temporary use authorisation after the legalisation of medical cannabis.

Among its powers, the ANSM can:

• provide marketing authorisations;
• authorise pharmaceutical establishments;
• issue importation/exportation authorisations;
• control regulatory compliance of products;
• control advertising;
• verify compliance with narcotics operational requirements, and initiate administrative sanctions;
• co-ordinate pharmacovigilance; and
• allow clinical trials.

The High Health Authority (HAS)

This is an independent public body whose primary function is the evaluation of medicines’ therapeutic benefits, which in turn determines whether cannabis-based medicinal products will be reimbursed by the French Assurance Maladie, and at what rate.

Regulatory Bodies Responsible for Enforcing Laws and Regulations Relating to Psychedelics

ANSM

The ANSM oversees scheduling decisions, clinical‑trial authorisations and any potential medical use of psychedelic substances (notably compassionate use authorisations).

The Ministry of Health

This sets national drug‑control policy and implements legislative measures under the French public health code.

MILDECA (Mission interministérielle de lutte contre les drogues et les conduites addictives)

This is France’s interministerial body responsible for co-ordinating national drug-control strategy and prevention.

France does not allow industry‑led or self‑regulatory organisations to govern medical cannabis or psychedelics. Because these substances are classified as narcotics (stupéfiants), they are governed and controlled exclusively by state regulatory bodies with no delegation to private or industry bodies.

Medical Cannabis

Medical cannabis is currently only accessible to patients who were enrolled in the pilot programme and can be supplied only by suppliers selected for the pilot programme. Until it is generalised, access to medical cannabis remains very limited.

Psychedelics

Psychedelics are currently illegal in France and there is therefore no existing commercial market. The only legal pathways are medicines holding a marketing authorisation, compassionate use frameworks (currently limited to one related to ketamine) and authorised clinical trials.

Medical Cannabis

Until the generalisation of medical cannabis becomes effective, market opportunities in France remain structurally limited. Indeed, access is currently confined to the foreign suppliers and their French pharmaceutical operator partners who were selected to participate in the pilot programme launched in March 2021, and whose products were authorised under the experimental framework, as well as to the holders of marketing authorisations for medicines containing cannabis derivatives (such as Epidiolex and Sativex).

The biggest challenge faced by participants to the medical cannabis market in France is a political one. The delay in the publication of the regulatory texts, and therefore the implementation of the legal framework, is mainly due to France’s prolonged political instability following the dissolution of the National Assembly in 2024 and the succession of governments that followed. Until publication occurs, the permanent framework cannot enter into force, and the market remains effectively frozen for new participants.

Even once the implementing texts are published, significant uncertainty persists regarding the commercial conditions under which cannabis-based medicinal products will ultimately be available, as the pricing and reimbursement framework is still under discussion.

Consequently, companies cannot reliably forecast revenues, model their market entry costs, or make investment decisions in the French cultivation and distribution supply chain while both the clinical evaluation and the pricing framework remain unresolved.

Likewise, until all the texts related to cultivation and product specifications are formally published, the precise requirements governing cultivation licences, GMP compliance for the cannabis production chain, permitted pharmaceutical forms, THC/CBD ratios, and quality control standards cannot be definitively relied upon by prospective market participants – including French agricultural operators and pharmaceutical manufacturers seeking to build domestic supply chain infrastructure.

This uncertainty has necessarily tangible commercial consequences:

• investors and operators considering entry into French domestic cultivation and production are hesitant to commit capital to site development or manufacturing infrastructure without certainty as to the technical standards their facilities and products will need to meet; and
• companies that have been preparing for the generalisation for years are effectively ready to file authorisation applications but cannot formally submit them.

France currently has no operational domestic cannabis cultivation and production industry for medical purposes. Products supplied during the experimental phase were imported from a small number of foreign suppliers. French regulation to be implemented includes provisions for domestic cultivation under strictly controlled pharmaceutical-grade conditions, which should create opportunities for French agricultural and pharmaceutical operators. However, building domestic production capacity will take time, and until domestic production becomes operational the French market will mostly remain dependent on importation.

The clock is ticking, and it goes without saying that market players are eagerly awaiting these regulations to be finalised and published.

Conducting business in an emerging sector – for which the legal and regulatory framework is not entirely developed – necessarily involves risks.

Medical Cannabis

Drug trafficking

The most common identified risk is that related to THC levels contained in products. Any product containing more than 0.3% of THC is considered a narcotic if:

• it is not a medicine containing cannabis and holding a marketing authorisation;
• it is not a cannabis product supplied as part of the pilot programme on therapeutic cannabis during said programme, and currently the transition period or a cannabis-based medicinal product duly authorised for use by the ANSM after the entry into force of the legalisation; or
• it has not been authorised for research and development purposes.

Any activity related to such product is therefore considered a drug trafficking offence.

Prohibition of Sale of a Medicinal Product Without a Prior Marketing Authorisation

A medicinal product (including a medicine by presentation and a functional medicine) can only be placed on the market if it has been granted a marketing authorisation from the French competent health authority (the ANSM or EMA for human medicines, and the ANMV for veterinary medicines). For instance, if a food or cosmetic product may be requalified as a medicinal product due to the prohibited therapeutic claims that were made in relation thereto, the selling of a medicinal product without a prior marketing authorisation would constitute an offence.

Prohibition of Activities Without Mandatory-Use Authorisation From the ANSM

Regarding prohibition of manufacturing, placing on the market, brokering or distribution of cannabis-based medicinal products without having obtained the mandatory-use authorisation from the ANSM, see the definitions in 1.1 Primary Laws and Regulations.

Prohibition of Advertising of Cannabis-Based Medicinal Products

French law prohibits the advertising of cannabis-based medicinal products not only to the general public but also to prescribers. This is a major difference with medicines holding a marketing authorisation, which can generally be advertised to prescribers provided that the promotional information delivered is in accordance with the scope of the marketing authorisation and promotional documentation has been duly approved by the ANSM beforehand. Operators (use authorisation holders and operating companies (exploitants)) of cannabis-based medicinal products will not be allowed to provide any message, information and/or documents that may be qualified as promotional to prescribers. Breach of such prohibition would entail criminal sanctions.

Psychedelics

The most acute criminal risk related to operation of a psychedelic business in France is drug trafficking. Because psychedelics are classified as narcotics under French law, production, manufacture, transport, importation, exportation, possession, offer, transfer, acquisition or use – and more broadly any agricultural, artisanal, commercial or industrial operations – relating to substances classified as narcotics or psychotropics are prohibited unless an express authorisation has been granted by the ANSM. Violation of this prohibition may give rise to a range of criminal offences of varying severity, from simple possession or use at the lower end, to drug trafficking at the most serious end.

Medical Cannabis

Various authorities oversee compliance of medical cannabis. Controls and administrative sanctions are applied by the ANSM for medicines and other health products, while the ANMV is the enforcement authority for veterinary products.

The competent authorities can apply administrative sanctions, such as by:

• issuing warnings;
• requiring corrective actions; and
• ordering the withdrawal of non-compliant products from the market.

They can also apply administrative fines to infringing companies.

In addition, several types of criminal penalties can apply. For criminal offences, enforcement is the responsibility of the public prosecutor, who can decide to prosecute either following police investigation or upon transfer of a report from the competent authorities mentioned above.

Key Criminal Sanctions

Of the common criminal sanctions that can apply in relation to the cannabis industry, the following are worth noting.

Drug trafficking

Drug trafficking can result in sanctions of between five years and life in prison (generally subject to a determined period of unconditional imprisonment) and a fine of between EUR75,000 and EUR7.5 million.

Placing on the market without prior authorisation

The placing on the market of a medicinal product without having obtained the requested prior marketing authorisation is a criminal offence punishable by up to five years’ imprisonment and a fine of up to EUR375,000.

Activities without use authorisation from the ANSM

Manufacturing, marketing, brokering or distributing, free of charge or against payment, wholesale or retail, a cannabis-based medicinal product (as defined in 1.1 Primary Laws and Regulations) without having obtained the required use authorisation from the ANSM is punishable by up to five years’ imprisonment and a fine of up to EUR375,000. Moreover, this criminal offence is punishable by up to seven years’ imprisonment and a fine of up to EUR750,000 when such offence is likely to:

• entail a serious risk to human health;
• have been committed as part of an organised gang;
• have been committed on a telecommunications network intended for a non-specified public; or
• have been committed by pharmaceutical establishments, brokers, dispensing pharmacists or hospital pharmacies.

These same sanctions also apply to the offence of advertising cannabis-based medicinal products subject to a use authorisation to healthcare professionals, in breach of the framework set out by the ANSM.

The illegal practice of pharmacy

The illegal practice of pharmacy is punishable by up to two years in prison and a fine of up to EUR30,000.

Incitement to use narcotics

Incitement to use narcotics is punishable by up to five years in prison and a fine of up to EUR75,000, even if the incitement does not result in actual use of recreational cannabis by a consumer.

Placing on the market and distribution of non-compliant products

The placing on the market and the distribution of non-compliant products (eg, in breach of requirements relating to product composition, labelling and safety) can result in a fine of up to EUR1,500 multiplied by the number of non-compliant products. Under French law, the amount of the fine applied to an individual is multiplied by five when applied to a legal person.

Psychedelics

Trafficking, manufacture or organisation of supply chains involving psychedelics can entail sentences of up to life in prison and fines of EUR7.5 million for natural persons, with significant multipliers (x5) for legal persons under Article 131-38 of the French criminal code. Corporate criminal liability is fully applicable under French law. Consequently, directors, officers and the legal entity itself may be simultaneously prosecuted.

Medical Cannabis

France has no operational domestic medical cannabis production industry. All products supplied during the experimental phase – and continuing through the current transitional period – have been imported from a small number of foreign suppliers. Every import operation requires a specific narcotics import authorisation issued by the ANSM, and must clear customs with the required documentation. This creates a cumbersome, permit-by-permit import regime that adds cost, lead time and supply security risk to every transaction. 

Companies sourcing products internationally must therefore maintain meticulous regulatory affairs resources to ensure that their supply chains remain compliant at all times.

Countries such as Germany legalised medical cannabis in 2017, allowing products such as raw flowers and magistral preparations and much less strict prescription by physicians. France, on the contrary, has opted for an ad hoc legal framework for medical cannabis, excluding raw flowers and setting up very strict and limited prescription conditions. These divergent national frameworks create significant cross-border complications. The absence of EU-level harmonisation of medical cannabis regulation means that companies must navigate entirely distinct regulatory regimes in each member state, with no mutual recognition of national cannabis medicine authorisations.

The French implementing decree and orders, yet to be published, set out detailed quality and safety specifications for cannabis-based medicinal products eligible for authorisation in France, including GMP requirements aligned with EU pharmaceutical standards. Foreign suppliers whose products were manufactured to the standards of their home jurisdiction and seeking French authorisation must therefore demonstrate equivalence with French and EU requirements on a product-by-product basis – a process that may prove particularly onerous in practice.

Psychedelics

Unlike medical cannabis, classical psychedelics (psilocybin, LSD, MDMA, DMT, mescaline) are subject to prohibition with no commercial market access pathway whatsoever. The only lawful activities involving them in France are ANSM-authorised clinical research and pre-clinical scientific work (both subject to specific ANSM narcotics authorisations for possession and use). Cross-jurisdictional issues for psychedelics therefore currently arise in the contexts of clinical trial co-ordination, importation of investigational substances, and the regulatory influence of foreign evidence and policy frameworks on France’s own evolving position.

Current French clinical trials involving psychedelic substances rely on investigational medicinal products manufactured abroad. Every import of a scheduled psychedelic substance into France for clinical trial use requires a specific ANSM narcotics import authorisation. The substance must be manufactured to EU GMP standards for investigational medicinal products, and the entire import chain must be covered by the relevant authorisations.

France’s domestic prohibition of psychedelics may become increasingly isolated within the European regulatory landscape. Within the EU itself, some member states have introduced regulated pathways for access to certain psychedelic substances such as psilocybin, whether through compassionate use schemes or other controlled access mechanisms. The possible multiplication of these regulated pathways in neighbouring countries is likely to generate both political and scientific pressure on France, particularly as it may give rise to an inequality of treatment for French patients, who may be tempted to seek access to these products abroad – exposing themselves to the legal and safety risks of unregulated medical tourism.

Although regulation of medical cannabis and psychedelic substances in France is a matter of national competence, French regulators must monitor regulatory developments abroad and the evolution of international scientific evidence, as external developments can become relevant to future policy choices. For medical cannabis, EU law has already had a direct impact on French patient access: in 2025, France was required to notify the European Commission of its draft medical cannabis framework through the TRIS procedure before adopting implementing decrees, allowing the Commission to assess compatibility with internal‑market rules.

For psychedelic medicines, France remains firmly prohibitionist, and foreign reforms have not yet translated into domestic change. However, significant scientific advances and authorisations abroad may generate pressure for reassessment. While formal regulation of medical psychedelics has so far occurred mainly outside Europe, several neighbouring countries have begun introducing limited access pathways (for example, a compassionate‑use programme in Germany and a legislative proposal in the Czech Republic). These developments, although not legally binding on France, are shaping the wider European policy debate and clinical research landscape in ways that could ultimately support movement towards EU‑level harmonisation or centralised marketing authorisation.

Medical Cannabis

To date, and until the entry into force of the legalisation of cannabis-based medicinal products in France, access to medical cannabis remains very limited in the country. Indeed, very few medicines containing cannabis and holding marketing authorisations are available on the market, and they are only prescribed to a limited number of patients for very specific therapeutic indications.

Until the end of the extended transition period, medical cannabis (ie, cannabis-based medicinal product) is only accessible to patients who were enrolled in the pilot programme and who were still in it on the date the programme ended in March 2024 (please see 1.1 Primary Laws and Regulations).

The regulatory framework is still being set up. In particular, decrees and orders setting out the following aspects are yet to be published:

• the requirements related to medical cannabis cultivation and processing;
• the definition of cannabis-based medicinal products’ specifications;
• the definition of the criteria for the fixing of product-pricing and reimbursement; and
• conditions and modalities of prescription and dispensing to patients.

Time is of the essence, and France is being watched closely by market players anxious to enter the market once medical cannabis is legalised. In the meantime, most players are trying to navigate the practical and legal uncertainties around the legalisation.

A major challenge will be for the relevant players and the French government to find agreement on market access conditions and prices that satisfy all the parties concerned, especially considering the major investments required from industry players to meet the legal requirements regarding cannabis-based medicinal products and production thereof. Otherwise, this may discourage new players from venturing into the French market, and may eventually frustrate the purpose of facilitating access to these new medicines for patients in need.

Psychedelics

In France, access to psychedelic medicines remains highly restricted, as substances such as psilocybin, MDMA, LSD and DMT are classified as narcotics and cannot be prescribed or used therapeutically outside tightly controlled ANSM‑authorised clinical trials. Ketamine and esketamine are the only psychedelic‑adjacent treatment currently available in medical practice, the former through a recently established compassionate use framework and the latter under a marketing authorisation for treatment-resistant depression. While France is participating in some clinical trials, to date neither regulators nor the legislature have proposed any formal reform of the legal framework applicable to classical psychedelics.

Broadly speaking, food products can be placed on the market provided they meet the general safety requirements set out by applicable laws and regulations, notably Articles 14 and 15 of Regulation (EC) 178/2002.

The Novel Food Regulation

However, as in other EU member states, cannabinoids (including CBD) are considered a novel food and must therefore be authorised prior to being placed on the market as such or used in a food product as per Regulation (EU) 2015/2283 (the “Novel Food Regulation”). Cannabinoids are therefore registered as novel food in the Novel Food Catalogue.

Novel foods are products for which the history of safe consumption before 1997 has not been demonstrated. These products must therefore obtain an authorisation from the European Food Safety Authority (EFSA) prior to being placed on the market. The prior authorisation requirement applies both to cannabinoid extracts and to finished products containing cannabinoid extracts as an ingredient, regardless of whether the extract is natural or synthetic.

Consequently, some food products that are derived from the hemp plant (eg, hemp seed oils, hemp seed flour and hemp seeds) are not considered novel food and can legally be placed on the market.

However, hemp extracts and any products to which hemp extracts have been added as an ingredient (eg, hemp seed oil, drinks, waters and chewing gum enriched with CBD) are considered novel food, and as such may not be placed on the market until a risk assessment has proved that they are safe for consumption and a novel food authorisation has been granted for CBD or another cannabinoid, as the case may be.

In addition, it should be noted that French Decree No 2006-352 of 20 March 2006 on food supplements expressly prohibits the use of novel food in the manufacturing of food supplements. Consequently, according to this regulation, only hemp seeds can be used in the manufacturing of food supplements (eg, cold-pressed hemp seed oil, grounded hemp seeds).

The EFSA’s most recent assessment of cannabinoids as novel foods (February 2026) concludes that persistent data gaps – concerning liver toxicity, gastrointestinal effects, endocrine disruption, neurological impacts and potential drug interactions – continue to prevent a complete toxicological characterisation. However, the EFSA was able to establish a very low provisional safe intake level of approximately 2 mg/day for a 70 kg adult, derived using an uncertainty factor of 400 applied to available animal data. This level applies exclusively to high-purity CBD isolates (>95% purity) and does not extend to broader cannabinoid preparations. This provisional intake level does not constitute an authorisation and carries no binding legal force. To date, no CBD product has been authorised as a novel food in the EU.

Enforcement of the Novel Food Regulation in France

In recent years, the enforcement of the Novel Food Regulation regarding CBD has apparently been handled very differently from one member state to another. More specifically, while some countries’ competent authorities have adopted a clear position on the implementation of the Novel Food Regulation and are taking restrictive measures accordingly, it appears that enforcement in France has been quite different. Indeed, it remained quite limited until 2023, with frequency of controls varying depending on region. This has resulted in a very large number of CBD food products being placed on the French market. These products can be found at CBD stores, pharmacies, supermarkets and online.

Although the number of controls appears to have increased since 2023, the French competent authorities had not, until recently, taken any official position on the placing on the market of CBD food products and dietary supplements. It has been reported that certain informal, never-published criteria had guided enforcement practice during this period, resulting in controls that appeared to be selectively targeted rather than systematic. In practice, CBD food products not only remained widely available on the French market but continued to multiply, reinforcing among operators a reasonable perception of institutional tolerance. Whether or not such informal criteria existed in any formalised sense, they provided no legal certainty for operators, who remained exposed to sanctions at the discretion of controlling authorities.

This situation came to an abrupt end in April 2026. On 15 April 2026, the DGAL (Direction Générale de l'Alimentation), the French authority responsible for food safety, informed the main professional trade associations of the hemp industry of its decision to strictly enforce the EU Novel Food Regulation ((EU) 2015/2283) with respect to food products and dietary supplements containing CBD or other cannabinoids. A national control plan, mobilising departmental food safety services (DDPP) across the entire French territory, was announced with an effective date of mid-May 2026, without any transitional period. This was subsequently confirmed by the Ministry of Agriculture in a press release dated 20 May 2026. At the time of writing, no information is publicly available regarding the actual deployment of controls on the ground or their practical outcomes.

This announcement marks a significant shift in the French authorities’ approach. For several years, operators had developed their business in a context of de facto tolerance – a grey area which, while legally precarious, had provided a degree of operational stability. The abrupt enforcement of rules that had technically been in force since 2019, with no grace period and no advance notice beyond a few weeks, raises serious concerns from the standpoint of legal certainty and operators’ legitimate expectations. It remains too early to assess the full practical and economic impact of these measures on a market that has developed, in part, in reliance on the apparent acquiescence of the French authorities.

Beyond the immediate economic disruption – which may affect thousands of producers, retailers and distributors – there is a further structural concern: by targeting products on the basis of labelling, the control plan may primarily affect operators who have transparently declared the cannabinoid content of their products, while leaving outside its scope other products – often containing undeclared synthetic cannabinoids, some of which are classified as controlled substances – that pose a significantly greater risk to consumer safety.

The announcement of the DGAL control plan has made the following sanctions a concrete and immediate risk for operators:

• products’ withdrawal from the market and prohibition from selling the products;
• destruction of products at the cost of a non-compliant company; and
• a fine of up to EUR1,500 per non-compliant product.

Medical Cannabis

The most immediate and consequential route to wider access for medical cannabis is administrative. The implementing texts have been technically finalised and approved. The only remaining step is ministerial signature for publication in the French Official Journal. Once published, the ANSM will be able to open its call for product authorisation applications, the HAS will be able to complete its reimbursement evaluation, and the price of products can be fixed.

Once cannabis-based medicinal products are generalised on the French market, other routes could be considered to widen access to these products.

• Additional therapeutic indications could be authorised by ministerial order, as is already the case in many other neighbouring markets.
• Prescription requirements could be relaxed. If initial prescription of cannabis-based medicinal products is restricted to hospital-based physicians who have completed the mandatory ANSM training, renewal prescriptions could be issued by trained general practitioners. This is already the case under the pilot programme, and physicians are pushing to obtain a similar route as part of the generalisation.

Psychedelics

The sole currently operative route through which psychedelic substances may lawfully be administered to patients in France is through ANSM-authorised clinical trials.

French law already contains a framework for early or exceptional access to medicines that have not yet obtained a conventional marketing authorisation (early access and compassionate use).

Neither of these pathways is currently available for classical psychedelics (psilocybin, LSD, MDMA, DMT, mescaline). Early access requires an ongoing clinical development programme aimed at a marketing authorisation, while compassionate use requires a recognised therapeutic benefit – thresholds that are not yet met under current French regulatory doctrine for these substances. This therefore does not seem a plausible route in the short term.

Another route could be similar to that for medical cannabis – ie, the creation of an experimental framework for medical use of psychedelics. A government or parliamentary amendment to a future law for the financing of the social security could, for instance, authorise a formal experimentation of psychedelic-assisted therapy, mirroring the cannabis model: a defined patient population, named authorised prescribers, ANSM oversight, mandatory data collection, etc.

The most powerful legislative route to psychedelic access in France would be if a psychedelic medicine obtains a centralised marketing authorisation from the EMA, since that authorisation is automatically valid in all EU member states, including France. However, this scenario is not plausible in the short term.

While France is often described as Europe’s largest consumer of cannabis, it also has some of the toughest laws against drugs. Although the conversation regarding whether cannabis should be legalised has arisen several times over the past few years, with lobbying actions being engaged or public consultation being launched, cannabis remains a major stigma in France.

To date, and despite the change in position of some neighbouring EU member states, there has been no discussion as to whether or not cannabis for recreational purposes should be legalised in France. Based on the current government’s firm position on narcotics (particularly cannabis) which suggests even more enforcement of narcotic laws, and its decision to prohibit the use of dried raw flowers as cannabis-based medicinal products in order to (according to the French Ministry of Health) avoid any risk of confusion with recreational cannabis, it is very unlikely that any change will occur until at least the next Presidential elections, which will take place in 2027.

Likewise, there is no ongoing discussion regarding a potential legalisation or decriminalisation of psychedelics for adult use in the near future in France.