Pharmaceuticals and medical devices are governed by various pieces of legislation and regulations arising from different sources. There is no uniform body of law, although there is an increasing number of rules being set at the European Union (EU) level, which tend to harmonise – although not completely – the regime applicable across EU member states.

In France, pharmaceuticals are mainly governed by the Public Health Code, which implements and complements the EU Directive on the Community code relating to medicinal products for human use (Directive 2001/83/EC) and the EU Regulation on the Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Regulation 726/2004). A new directive and regulation (collectively known as the “EU Pharmaceutical Package”) are currently being discussed to revise the EU regime of pharmaceuticals.

Medical devices are also governed by the Public Health Code, which implements and complements the EU regulations on medical devices (Regulations 2017/745 called “MDR” and 2017/746 called “IVDR” and, to some extent, the previous Directives). The medical device regulatory framework is also in the midst of a significant legislative reform.

Beyond the Public Health Code, relevant rules are also included in the Social Security Code, Environmental Code, and more generally the Civil Code, Commercial Code and Consumer Code, not to forget codes of conduct and guidelines set by trade associations.

In correlation with this diversity of legislative and regulatory sources, there are also several regulatory bodies that apply and enforce these rules.

For pharmaceuticals, the European Medicines Agency (EMA) and the French National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé, ANSM) would be key entities. The EMA is an EU institution and the ANSM is a public establishment under the authority of the French Ministry of Health.

With respect to medical devices, “notified bodies” are also essential as they are in charge of assessing compliance of medium- to high-risk medical devices prior to and post-market. These bodies are independent from central administration and must undergo a regulatory accreditation process.

Decisions made by the regulatory bodies are primarily administrative acts that can be challenged through the following avenues.

• Administrative appeal. This involves filing an objection with the regulatory body that issued the act (recours gracieux) or with its higher authority (recours hiérarchique). This administrative appeal is a complaint addressed to the authorities asking them to change a decision they have taken, whether explicitly (eg, refusal) or implicitly (eg, lack of reply). In certain cases, this appeal may be compulsory prior to lodging a judicial claim.
• Judicial appeal. This allows the regulatory decision to be challenged before the competent Administrative Court.

These challenge procedures also apply in general for administrative acts covering other regulated products (eg, food products).

There are multiple categories of pharmaceuticals and medical devices that are regulated differently. As health products, each of their characteristics affects the rules applicable to them.

For instance, pharmaceuticals may be subject to compulsory prescription. They require a doctor’s prescription to be issued. There may also be restrictions on the prescription process itself due to the level of risk of the product (eg, limited to hospital settings or requiring mandatory particulars).

Other pharmaceuticals may be subject to optional prescription. They require a doctor’s prescription only to be reimbursed by statutory health insurance (SHI). Medical devices may also be subject to optional prescription for reimbursement purposes.

In addition, there is a pharmacy monopoly on the dispensing of pharmaceuticals and certain medical devices (eg, most in vitro diagnostic medical devices). Some pharmaceuticals are offered over-the-counter, meaning that they are freely accessible by purchasers in the pharmacy, while others may only be within the pharmacist’s reach. In addition, some pharmaceuticals and medical devices may only be dispensed in hospital settings.

Pharmaceuticals are regulated differently depending on (i) their preparation (princeps, generic, hybrid or biosimilar pharmaceuticals) which determines the applicable marketing authorisation procedure and delivery conditions, (ii) their reimbursement status (which notably affects advertising requirements) and (iii) their therapeutic interest (pharmaceutical companies are required to maintain a minimum safety stock for products of major therapeutic interest).

Medical devices are classified according to the level of risk they present for users, which is set by law. They are also subject to various rules depending on their intended use (eg, implantable or sterile) or composition (eg, software-based).

Clinical trials of pharmaceuticals and medical devices are regulated both by EU law and domestic rules.

Clinical trials of pharmaceuticals are mainly regulated by the EU Regulation on clinical trials on medicinal products for human use (Regulation 536/2014), fully applicable since January 2025.

Clinical trials of medical devices, called investigational studies or performance studies, are mainly regulated by the MDR and IVDR and complementing provisions of the Public Health Code.

Clinical trials must also comply with domestic and international guidelines, such as the ANSM Guidelines on Good Clinical Practices, the International Conference on Harmonization Guidelines on Good Clinical Practice or the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.

The procedure for securing authorisation to undertake a clinical trial of a pharmaceutical and a medical device is essentially as follows.

Pharmaceuticals

For pharmaceuticals, applications must be submitted to the ANSM via the Clinical Trials Information System (CTIS), a centralised EU-wide electronic platform introduced by the CTR, and must include all information listed in EU law.

Upon submission to the ANSM, the application undergoes a validation review completed within ten days from the date of receipt. If the application is incomplete, the sponsor is granted ten additional days to provide the missing information. Upon receiving additional documents, the ANSM has five days to review updates and notify the sponsor of validation or rejection.

Once validated, the application undergoes a scientific assessment by the ANSM and ethical assessment by the competent ethics committee in France, within 45 days. In the event of requests for additional information, the evaluation period is extended by a maximum of 31 days. For multinational trials, the scientific assessment is a joint decision among the health authorities of the involved EU member states.

The final decision is notified to the sponsor via CTIS within a maximum of five days following the later date between the scientific assessment report and the ethical assessment report.

Medical Devices

For medical devices, clinical trials are mandatory for Class III and implantable devices (unless exempt).

Applications must be submitted electronically to the ANSM, together with the documents referred to in EU law. The new application procedure under the MDR, which mandates submission via the European Database on Medical Devices (EUDAMED) using the Clinical Investigations and Performance Studies Module, is not yet applicable as the module remains non-operational. Until its implementation, national procedures remain in effect.

Upon submission, the application undergoes a validation review co-ordinated by the ANSM, completed within ten days from the date of receipt. If the application is incomplete, the sponsor is granted ten additional days to provide the missing information. Upon receiving additional documents, the ANSM and the ethics committee have five days to review updates and notify the sponsor of validation or rejection.

Once validated, the application undergoes a scientific assessment by the ANSM and ethical assessment by the ethics committee, within 30 to 65 days, depending on the category of clinical trial (which is determined primarily based on the purpose and status of the medical device). The final decision is notified to the sponsor.

Pharmaceuticals

Since January 2025, all clinical trials on pharmaceuticals must be registered in the CTIS. Sponsors are required to submit trial results within one year of completion, after which the data is published on CTIS. Clinical trial information was previously available in the EU Clinical Trials Register.

Medical Devices

On the other hand, there is currently no publicly accessible database for clinical trials on medical devices. However, once the Clinical Investigations and Performance Studies module of EUDAMED becomes operational, mandatory registration will be required. This requirement will take effect six months after the module is officially declared operational, as announced in the Official Journal of the EU by the European Commission.

The use of online tools to support clinical trials (eg, for recruiting or monitoring purposes) is not fully regulated in France, although there are guidelines at the EU level. Restrictions however apply on the processing of patient data (see 2.5 Use of Data Resulting From Clinical Trials and 2.6 Databases Containing Personal or Sensitive Data).

Data resulting from clinical trials usually relate to both participants and investigating personnel, thereby qualifying as personal data under Article 4 of the General Data Protection Regulation (EU) 2016/679 (GDPR). More specifically, data relating to clinical trial participants often reveals details about their health status and generally falls within the category of “data concerning health” (GDPR, Article 4(15)), which is part of the broader classification of sensitive data.

Even when pseudonymised, such data remains classified as personal data, as pseudonymisation does not irreversibly prevent the re-identification of individuals, unlike anonymisation, which is the determining factor for data to be considered non-personal.

The transfer of health data to affiliates or third parties may occur under the established GDPR framework, provided that participants are informed and that the processing is based on one of the exemptions outlined in Article 9 of the GDPR, which serves as the legal basis for processing sensitive health data. In the context of clinical trials, such processing generally relies either on consent or on public interest, as defined under Article 9 of the GDPR and Article 44, 3° of the French Data Protection Act (Loi No 78-17 du 6 janvier 1978 relative à l’informatique, aux fichiers et aux libertés, or LIL).

Where processing is grounded on consent, the transfer of data is permissible only if explicitly addressed in the consent form signed by the participants. Where the processing is based on public interest, the data controller must obtain prior authorisation from the French Data Protection Authority (CNIL) or adhere to a reference methodology. In addition, such authorisation or reference methodology must identify the third party or the affiliate as an authorised recipient.

When the recipient is located outside the European Union, additional requirements come into play. The data controller must ensure that the transfer is subject to an adequacy decision by the European Commission or, failing that, is governed by standard contractual clauses or binding corporate rules. Furthermore, the data controller may need to conduct an impact assessment to evaluate the adequacy of the third country’s legal framework in safeguarding the rights of data subjects.

In addition to the usual conditions for processing of sensitive data under the GDPR and French law (see 2.5 Use of Data Resulting From Clinical Trials), databases containing personal or sensitive data can be subject to the requirements applicable to Health Data Warehouses. The CNIL considers that databases designed for facilitating secondary use of health data (eg, research, studies and in some cases, AI training), named “Health Data Warehouses”, qualify as autonomous health data processing and should be grounded on one of the exemptions of Article 9 of the GDPR. In practice, the legal grounds for such Health Data Warehouses are either the explicit consent from data subject or a CNIL authorisation. A standard CNIL authorisation can be granted for organisations which comply with the framework on Health Data Warehouses – however, this framework is designed for Health Data Warehouses justified by a public interest mission.

The data protection requirements imposed by GDPR can be supplemented by health law requirements, mainly from the French Public Health Code (FPHC), if the databases contain medical data. Organisations hosting personal health data collected in the course of preventive, diagnostic, care or medico-social monitoring activities (“HDS data”) on behalf of a data controller must hold a specific Hébergeurs de données de santé or HDS certification (Article L.1111-8 of the FPHC). Processing of medical information is also frequently subject to a strong duty of confidentiality (“medical secrecy”) under Article L.1110-4 of the FPHC.

The classification of a product as either a pharmaceutical or a medical device is determined by its intended purpose and mode of action, in accordance with EU law. In essence, classifications are as follows.

• A product is classified as a pharmaceutical product if it is intended to be used for medical purposes through pharmacological, immunological or metabolic means. This includes substances or combinations of substances used to treat or prevent diseases, restore, correct or modify physiological functions, or make medical diagnoses.
• A product is classified as a medical device if it is intended to be used for medical purposes without relying on pharmacological, immunological or metabolic means. Medical devices include instruments, apparatus, appliances, software, implants, reagents, materials or other articles used alone or in combination for medical purposes.

Some products may have characteristics of both pharmaceuticals and medical devices, known as “borderline”, “hybrid” or even “combination” products. In such cases, the ANSM may assess the product on a case-by-case basis to determine the applicable regulatory framework. This assessment considers the product’s intended purpose, its mode of action and the claims made by the manufacturer.

French law does not provide for specific marketing authorisation procedures for biologic medicinal products (apart from the difference in supporting scientific data).

Marketing authorisations are granted for five years for pharmaceuticals.

• They may be renewed at the end of the first five years at the request of the marketing authorisation holder, for an unlimited period unless the ANSM decides on a five-year renewal, based on a reassessment of the pharmaceutical’s positive therapeutic effects in relation to the risks to patient health or public health, linked to its quality, safety or efficacy.
• They may be revoked if the product to which it relates has not been marketed for three consecutive years or if the marketing of the product already placed on the market is suspended for three successive years.

The ANSM may, in exceptional circumstances, grant a derogation from this rule:

• for public health reasons;
• when the pharmaceutical cannot legally be marketed during the period in question;
• when the pharmaceutical is exclusively intended for export to a state that is not party to the European Economic Area (EEA) agreement; or
• when the pharmaceutical is marketed in at least one other EU member state or party to the EEA, in which it has obtained an authorisation pursuant to a mutual recognition procedure or a decentralised procedure for which France is designated as the reference member state and at least one different dosage or pharmaceutical form of this medicinal product is marketed in France.

Marketing authorisations may also be suspended or revoked if legal requirements for the authorisations are not met or are no longer met. This includes, in particular, the following reasons:

• the pharmaceutical is harmful;
• the pharmaceutical does not produce therapeutic results;
• the risk-benefit balance is unfavourable;
• the pharmaceutical does not have the declared qualitative and quantitative composition; or
• the manufacturing process does not comply with the applicable good practices.

Medical devices are subject to pre-market certification, which is valid for five years. Every medical device must bear the CE-marking following a conformity assessment with the general safety and performance requirements set out by EU law. Lower risk devices may be self-certified but medium to high-risk devices must obtain a CE certificate from a notified body to bear the CE-marking and be placed on the French market.

The notified body may narrow the scope, suspend or withdraw a certificate if the conditions for its issuance are not fulfilled or are no longer maintained.

The procedure for obtaining a marketing authorisation for pharmaceuticals and medical devices is essentially as follows.

Pharmaceuticals

For pharmaceuticals, a marketing authorisation may be obtained through the following procedures:

• a centralised procedure to obtain an authorisation valid in all EU countries, co-ordinated by the EMA and its Committee for Medicinal Products for Human Use (CHMP), and ending with a decision by the European Commission;
• a mutual recognition procedure, which allows the extension of a marketing authorisation already granted by a member state to one or more EEA countries;
• a decentralised procedure, which allows a marketing authorisation to be granted simultaneously in two or more EEA countries on the basis of identical documentation; and
• a centralised procedure to obtain a marketing authorisation valid only for the French market.

To initiate one of these procedures, the applicant must submit an application to the competent authority (ie, the ANSM or the EMA), together with a dossier containing the information required by EU law.

The procedures for variations to the terms and conditions of a marketing authorisation are laid down in Commission Regulation (EC) No 1234/2008. These procedures differ according to the type of variation requested (variation types IA, IB and II).

• Type IA variations, which have little or no impact on the quality, safety and efficacy of the medicinal product (such as the change of contact details of the marketing authorisation holder) can be implemented even before being notified to the competent authorities (within 12 months of the implementation of the variation).
• Type IB variations (such as a change in the medicinal product name) must be notified by the marketing authorisation holder prior to implementation. The holder must wait 30 days to ensure that the variation is considered acceptable by the competent authority (by implicit authorisation) before implementing the variation.
• Type II variations (such as the addition of a therapeutic indication) require prior approval from the competent authority before implementation.

The transfer of a national marketing authorisation from one holder to another is possible and subject to the approval of the ANSM. In the case of a merger or a partial transfer of assets, the companies involved may submit an application for the transfer of marketing authorisations before the merger or transfer is finally completed. In support of their request, they must submit the letter of intent or agreement on the merger or contribution.

Medical Devices

For medical devices, these are classified into risk groups based on the risk during use, and their placing on the market requires the CE marking to be affixed to the device after the manufacturer has conducted a conformity assessment with all applicable general safety and performance requirements set out by EU law.

Manufacturers of Class I medical devices and class A in vitro diagnostic medical devices (the lowest risk class) can self-certify that their devices meet all applicable requirements. For all other Classes (and Class I medical devices that are supplied sterile, have a measuring function or are reusable surgical instruments), the involvement of a notified body is required to conduct the conformity assessment and issue the corresponding certificate of conformity.

In general, any variations to the approved device require a new approval by the notified body that issued the certificate of conformity, if they may affect the safety and performance of the device or the conditions of use prescribed for that device.

EU regulations do not provide for the transfer of the CE marking. The new manufacturer of the medical device must fulfil all the necessary requirements to obtain certification for the device under their own name.

The supply to patients of pharmaceuticals and medical devices that are not subject to a marketing authorisation is generally not permitted, unless they are a candidate in a clinical trial. However, derogations apply.

Pharmaceuticals

For pharmaceuticals, there are two main derogatory pathways:

• early access (accès précoce) for pharmaceuticals intended to treat serious, rare or disabling diseases when the following conditions are met:
1. the product addresses an unmet therapeutic need;
2. the product is presumed to be innovative;
3. the treatment cannot be delayed; and
4. the efficacy and safety of the product is strongly presumed in view of the results of therapeutic trials;
• compassionate use (accès compassionnel) for pharmaceuticals in specific therapeutic indications when the following conditions are met:
1. the product is not the subject of research involving human subjects for commercial purposes;
2. there is no appropriate treatment; and
3. the efficacy and safety of the product are presumed with regards to the available clinical data.

Medical Devices

For medical devices, the ANSM may authorise, by way of exception, the placing on the French market of a device which does not bear the CE marking, but whose use is in the interest of public health or in the interest of patient safety or health. Some derogatory pathways exist to facilitate access by patients to innovative devices (eg, Forfait Innovation).

Marketing authorisation (or CE-marking) holders are bound by strict post-market surveillance obligations.

Pharmaceuticals

For pharmaceuticals, marketing authorisation holders must conduct pharmacovigilance by recording suspected adverse reactions in detail and reporting those classified as serious with the highest degree of urgency. This information must be collected and submitted to competent authorities in the form of periodic safety update reports.

The holder is also required to implement a pharmacovigilance system and, in particular, to:

• respect the good practices on pharmacovigilance;
• have an adequate pharmacovigilance system and a risk management system;
• have a suitably qualified person responsible for pharmacovigilance in both the EU and France;
• monitor the results of risk mitigation activities;
• monitor pharmacovigilance data; and
• conduct periodic audits of the pharmacovigilance system.

The ANSM may also require the MA holder to conduct:

• a post-authorisation safety study if there are concerns about the safety risks posed by an authorised product; and
• a post-authorisation efficacy study when the understanding of the disease or clinical methodologies indicate that previous efficacy assessments may need to be significantly revised.

More generally, the holder must contribute to the product’s proper use, in particular by ensuring that it is prescribed in accordance with its MA. In the event of prescriptions that do not comply with proper use, it must take all appropriate measures to inform health professionals and immediately inform the ANSM.

The holder is further required to inform the ANSM immediately of any prohibition or restriction imposed by the competent authority of any country in which the product is marketed and of any other new information that may influence the evaluation of the benefits and risks.

Lastly, the holder must immediately inform, specifying the reasons, the ANSM of any action taken in France or in another EU member state to suspend or terminate the marketing of the medicinal product, to request the withdrawal of the authorisation or not to apply for the renewal of the authorisation for the medicinal product.

Medical Devices

For medical devices, economic operators and in particular manufacturers are required to submit vigilance reports to the ANSM for all the incidents of which they have become aware in France involving their devices.

Manufacturers must also take appropriate safety action when required and communicate on all the corrective actions that have been undertaken to avoid or reduce the risks associated with the use of a medical device.

In addition, manufacturers of medical devices are subject to a number of obligations under the EU legislation, such as keeping the technical documentation of the device up to date, appointing a person responsible for regulatory compliance and complying with vigilance reporting obligations.

Third parties may access certain pieces of information about pending applications for marketing authorisations for pharmaceuticals and medical devices.

Pharmaceuticals

At the EU level, the EMA issues every month a list of “pharmaceuticals under evaluation” by the CHMP.

At the national level, pending applications for marketing authorisation are not made publicly available. Third parties only have access to information on pharmaceuticals published by the ANSM on the database Répertoire des spécialités pharmaceutiques and the relevant documents (ie, the summary of product characteristics and the patient information leaflet). Otherwise, the ANSM publishes the summary report of the assessment carried out for each new medicinal product as well as the decisions to grant, suspend or withdraw marketing authorisation. The ANSM also publishes the agendas and minutes, with details and explanations of votes (including minority opinions), of the meetings of its commissions, committees and expert collegial bodies, excluding any information covered by business or medical secrecy.

Medical Devices

For medical devices, information may be publicly accessed via EUDAMED, which is currently being deployed by gradual roll-out. Once fully functional, EUDAMED will ultimately be composed of six modules:

• actor module;
• unique device identification (UDI) and device module;
• notified bodies and certificates module;
• market surveillance module;
• vigilance and post-market surveillance and vigilance module; and
• clinical investigations and performance studies module.

The French regulatory framework does not specifically foresee fast-track registration routes for pharmaceuticals and medical devices. Only pharmaceuticals subject to the centralised procedure (at EU level) may benefit from expedited reviews, namely those of major public health interest for public health and therapeutic innovation or those addressing diseases with a high unmet need, based on less comprehensive clinical data than normally required.

France has not exactly embraced the notion of regulatory reliance.

Nevertheless, the ANSM is participating in pilot programmes of mutual regulatory reliance managed by the EMA designed to assess the impact of using the results of regulatory inspections carried out by the regulatory authorities of third countries that are members of the Pharmaceutical Inspection Co-operation Scheme and by the United States Food and Drug Administration.

Moreover, the EU has entered into a number of mutual recognition agreements with non-EU countries that define the conditions under which the EU member states will accept conformity assessment results (such as testing or certification) performed by conformity assessment bodies designated by another non-EU member state and vice versa.

Manufacturing plants of pharmaceuticals are subject to an authorisation, while plants manufacturing medical devices are generally not.

Pharmaceuticals

Manufacturing plants of pharmaceuticals must be licensed as pharmaceutical establishments (établissement pharmaceutique) by the ANSM. Any company that includes at least one pharmaceutical establishment must be owned by a pharmacist or a company in which a pharmacist participates in the management or general direction.

• Manufacturers must submit a detailed application covering all manufacturing operations, including raw material procurement, production, quality control, batch release, and storage, in compliance with Good Manufacturing Practices (GMP).
• Applications must be submitted via an online platform (Démarches Simplifiées). The ANSM reviews the application and conducts an on-site inspection. If all regulatory requirements are met, the authorisation is granted and published in the EudraGMDP database. If the Director General of the ANSM does not issue a decision within 90 days of receiving the application, the request is automatically considered denied by default.
• Each authorisation is issued per facility, requiring separate applications for each production site. However, a single authorisation may cover multiple manufacturing activities within the same establishment.
• The authorisation remains valid indefinitely, provided the facility complies with GMP regulations and updates its authorisation in case of major modifications. In cases of non-compliance with the applicable regulations, the ANSM has the authority to suspend or revoke the authorisation.
• Each manufacturer must also appoint a qualified person (pharmacien responsable) responsible for ensuring continuous compliance with quality and safety standards.

Medical Devices

Manufacturing plants of medical devices are generally not subject to prior authorisation, but they are required to register themselves on EUDAMED. However, pending the full operability of EUDAMED, manufacturers can use a national form provided by the ANSM. In this case, national declarations are only valid in France. Manufacturers of custom-made medical devices must also declare their activity to the ANSM before making such devices available on the national market. This declaration must include details of the type of activity performed and the devices concerned.

The establishments engaged in wholesale of pharmaceuticals are subject to an authorisation, while those engaged in wholesale of medical devices are generally not.

Pharmaceutical Wholesalers

Pharmaceuticals wholesalers (including acquisition, storage, supply or export, but excluding direct sales to the public) must be licensed as pharmaceutical establishments by the ANSM.

The license process follows the same steps as for manufacturers (see 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices). The applicant must submit a detailed application describing its distribution activities and demonstrating compliance with Good Distribution Practice (GDP), which is then reviewed by the ANSM and followed by an on-site inspection.

However, unlike for manufacturers, the absence of a decision from the ANSM within 90 days of receiving the application results in tacit approval, meaning that the authorisation is considered granted.

Medical Devices Wholesalers

Medical devices wholesalers generally do not require prior authorisation or specific registration. Distributors making medical devices available on the French market, excluding direct sales to the public, must however declare their activity to the ANSM.

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

Importation and exportation of pharmaceuticals are mainly regulated by dedicated provisions of the Public Health Code.

Importation and exportation of medical devices are mainly regulated by EU law (MDR and IVDR) and dedicated provisions of the Public Health Code.

The ANSM is responsible for applying and enforcing regulations on the import and export of pharmaceuticals and medical devices.

Companies or organisations licensed as pharmaceutical establishments by the ANSM may act as importers of record of pharmaceuticals (see 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices).

With respect to medical devices, any natural or legal person can act as an importer of record. EU law assigns specific regulatory obligations to importers, particularly when the manufacturer is located outside the EU and has not appointed an authorised EU representative.

The importation of pharmaceuticals and medical devices is subject to prior authorisations.

Pharmaceuticals

The importation of pharmaceuticals into France, including from another EEA country, requires prior authorisation from ANSM, which may be granted for:

• a single import operation (valid for up to three months); or
• a series of imports over one year for a specified quantity.

Import authorisation requests must be submitted via an online platform (Impexweb). If the ANSM does not respond within 45 days, the request is considered rejected. The ANSM may suspend or revoke an authorisation at any time. Except in urgent cases, such decisions can only be taken after allowing the authorisation holder to submit observations.

However, there are exemptions from the prior authorisation requirement, namely for:

• individuals importing medicines for personal use;
• medicines with a valid marketing authorisation in France, provided they are presented in compliance with the approved authorisation (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices);
• homeopathic and traditional herbal medicines registered in France, provided they are presented in compliance with their registration;
• medicines authorised under early access or compassionate use;
• medicines required for an authorised biomedical research study in France;
• medicines imported from an EU member state and stored in a licensed pharmaceutical facility, provided they are intended exclusively for export to non-EU countries;
• medicines imported by a sports team physician for team use, whether transported personally or through other means; or
• medicines in external transit or moving through French territory as part of intra-EU exchanges.

Medical Devices

The importation of medical devices from non-EEA countries into France does not require prior governmental authorisation. However, imported devices must fully comply with EU regulatory requirements, including a valid CE marking and an EU Declaration of Conformity, which confirm compliance with essential safety and performance standards and enable free circulation within the EU.

If the manufacturer is based outside the EEA and has not appointed an authorised representative, the importer assumes regulatory responsibility for ensuring the device’s conformity, traceability and compliance with post-market obligations.

The import of products into the EU is governed by a standardised classification system that categorises products based on their tariff codes (Harmonised System, Union Combined Nomenclature and Community Customs Tariff). This classification helps to identify and regulate products that are being imported, ensuring that duties, taxes and restrictions are properly applied. Additionally, the applicable non-tariff regulations depend on whether an imported product meets the statutory product definition (medical devices or pharmaceuticals).

The types of products subject to import regulations in the EU are outlined in various laws and regulations such as EU Regulation No 952/2013 laying down the Union Customs Code or Regulation No 952/2013 laying down the Union Customs Code.

France, as a member of the EU, participates in the EU’s free trade agreements and applies the principle of free movement of goods and services within the EU single market.

Prices for pharmaceuticals and medical devices are strictly controlled in France if such products are reimbursed by SHI.

The rules governing price setting are mainly outlined in the French Social Security Code and Framework Agreements entered into between the governmental body in charge of fixing prices (Comité économique des produits de santé or CEPS) and industry trade associations.

Pharmaceuticals

The price of products used in hospitals is negotiated between the pharmaceutical company and the hospital, within the framework of the Public Procurement Code. France has implemented and activity-based tariff system for hospitals.

However, the price of (i) expensive and innovative pharmaceuticals included in the list of pharmaceuticals chargeable in addition to hospital stays (liste en sus), for which payments are made in addition to the hospitalisation price, and (ii) pharmaceuticals available in pharmacy hospitals for direct sale to outpatients, included in the list of pharmaceuticals prescribed on a retrocession basis (liste de restrocession), is negotiated between the CEPS and the pharmaceutical company. The ministers responsible for Health and Social Security may set a maximum sale price for pharmaceuticals with a risk of unjustified spending or for pharmaceuticals that are particularly costly for institutions.

The price of reimbursed pharmaceuticals prescribed to outpatients is determined through negotiations between the pharmaceutical company and the CEPS, based on various factors, including:

• the improvement in medical benefit of the pharmaceutical;
• the results of health economic assessment;
• the prices of other pharmaceuticals in the same therapeutic field;
• the expected or actual sales volumes;
• the expected and actual conditions of use of the pharmaceuticals; and
• the security of supply to the French market guaranteed by the location of production sites.

If no agreement is reached between the CEPS and the pharmaceutical company, the CEPS has the authority to unilaterally set the price. The Ministers of Health, Social Security and the Economy may oppose this decision within 15 days.

When generic or biosimilar pharmaceuticals enter the market, specific discount rates are applied by the CEPS to determine their price, and the prices of the reference pharmaceuticals are reduced accordingly.

The Ministers of Economy and Health may also control the margins of reimbursed pharmaceuticals. Discounts, rebates and any other commercial and financial benefits, including service fees, on reimbursed pharmaceuticals, granted by a supplier to pharmacists, cannot exceed, per calendar year and per product line for each pharmacy, 2.5% of the manufacturer price excluding tax. For generic pharmaceuticals, this is capped at 40% of the manufacturer’s price.

Medical Devices

Rules applicable to medical devices used in hospitals are the same as for pharmaceuticals used in hospitals or healthcare institutions.

For medical devices prescribed to outpatients, the maximum price that the public can be charged and the tariff on which SHI reimbursement is based are determined through negotiations between the pharmaceutical company and the CEPS. The determination of the tariff primarily takes into account:

• the medical benefit or the improvement in medical benefit of the medical device;
• if applicable, the results of the medico-economic assessment of tariffs of comparable products or services;
• the planned or observed sale volumes;
• planned or observed amounts reimbursed by SHI, and
• the estimated conditions of use.

If no agreement is reached between the CEPS and the pharmaceutical company, the CEPS has the authority to unilaterally set the price. The pricing of reimbursed medical devices may be reviewed at the initiative of the CEPS.

The Ministers of Economy and Health may set the margins of reimbursed medical devices. Discounts, rebates and any other commercial and financial benefits, including service fees, granted by any supplier to retailers of reimbursed MDs, may soon be capped under French law. A ministerial order is expected to limit such discounts, rebates and benefits, per calendar year and per product line, to a percentage of the product price (excluding tax) for each retailer, not to exceed 50% of the operator (exploitant) price. The implementing act for this provision is expected to be issued by the end of the year.

When setting and reviewing the price of reimbursed pharmaceuticals and the tariff of reimbursed medical devices, the CEPS may take into consideration the existence of lower prices or tariffs in Germany, Spain, Italy and the United Kingdom.

The Framework Agreement between the trade association representing the pharmaceutical industry and the CEPS establishes the possibility of benefiting from a pre-tax list price that cannot be lower than one of the prices applied in Germany, the United Kingdom, Italy and Spain for a pharmaceutical providing an ASMR I, II or III (see 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices) and whose main manufacturing stages (active ingredient, finished product, packaging) are carried out in France.

The costs of pharmaceuticals and medical devices may be reimbursed from public funds at a variety of levels and under different pathways.

Pharmaceuticals

Pharmaceuticals used in hospitals are primarily financed through hospital stays. However, expensive and innovative pharmaceuticals, for which payments are made in addition to the hospitalisation price, are included in the list of pharmaceuticals chargeable in addition to hospital stays (liste en sus) and are reimbursed by the SHI based on invoices issued by hospitals.

Pharmaceuticals used in ambulatory settings are reimbursed subject to registration on a positive list (liste des spécialités pharmaceutiques remboursables). Access to reimbursement and reimbursement rate defined by the National Union of Sickness Insurance Funds (Union nationale des caisses d’assurance maladie) are based on the therapeutic value of the pharmaceutical (service médical rendu) assessed by the HAS (see 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices). The final decision on reimbursement is taken by the Minister of Health by legal order.

Medical Devices

Medical devices for individual use in hospitals are primarily financed through hospital stays. Expensive and innovative medical devices are financed separately, in addition to the hospitalisation price. In such cases, they are included in the list of products and services chargeable in addition to hospital stays (liste en sus) and are reimbursed based on an invoice issued by hospitals.

Medical devices for individuals used in ambulatory settings may be reimbursed subject to registration on a specific list called “List of Reimbursable Products and Services” (Liste des Produits et Prestations Remboursables or LPPR). Access to reimbursement is based on the therapeutic value of the medical devices assessed by the HAS (see 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices).

In France, cost-benefit analyses play a significant role in determining both the price and the reimbursement status of pharmaceuticals and medical devices.

The HAS (Transparency Committee for the pharmaceuticals and The National Committee for the Evaluation of Medical Devices and Health Technologies for medical devices) is responsible for conducting such health technology assessment.

After reviewing the dossier submitted by the company and the other available scientific data, the HAS publishes a scientific opinion evaluating the actual clinical benefit and the clinical added value of the product.

Reimbursement decisions are based on the rating and, while the rating is not the only factor, it is the primary criterion which supports the pricing by the CEPS (see 8.1 Price Control for Pharmaceuticals and Medical Devices).

To ensure cost efficiency in pharmaceutical prescribing and dispensing:

• physicians are required to prescribe pharmaceuticals using the Non-Proprietary Name, which is the globally recognised name for the active substance; and
• pharmacists are allowed to substitute branded pharmaceuticals with generic/biosimilar pharmaceuticals, under certain conditions, unless the physician writes on the prescription that the pharmaceutical cannot be substituted for medical reasons.