The Legal and Regulatory Landscape for Advertising of Medicinal Products and Medical Devices in France

Advertising and promotion of health products in France operate within a highly structured and intricate legal and regulatory framework. This framework includes both general provisions and highly specialised rules tailored to healthcare products.

The French Consumer Code and Criminal Code broadly prohibit and penalise misleading commercial practices. In parallel, the promotion of health products is subject to specific EU Regulations and Directives, and to French national laws, notably the French Public Health Code (FPHC) and the French Social Security Code (FSSC). These laws govern the promotion of a wide range of products, in particular:

• medicinal products for human use;
• medical devices (MDs);
• veterinary products;
• food supplements; and
• devices, objects and methods presented as beneficial to health.

Beyond this robust legislative framework, numerous additional instruments such as recommendations, guidelines, charters and ethical codes – some of which are non-binding – guide advertising practices in the health sector. These resources, issued by national, EU or international authorities and organisations, allow operators to align with best practices.

Key examples include the following authorities’ charters, guidelines and recommendations.

• Guidelines issued by the French National Agency for Medicines and Health Products Safety (ANSM):
1. recommendations on advertising of medicinal products, MDs and in vitro MDs, and objects and methods presented as beneficial to health; and
2. the charter for the communication and promotion of health products (medicinal products and MDs) on the internet and e-media.
• The Charter on Information through Canvassing or Prospection Aimed at Promoting Medicinal Products, concluded between the Economic Committee for Health Products (CEPS) and the French pharmaceutical industry organisation (Leem), applicable to operators marketing medicinal products reimbursed by the French health insurance scheme.
• The New Quality Charter for Professional Practices applicable to individuals responsible for the presentation, information or promotion of individual-use MDs, healthcare products other than medicines, and any associated services, which entered into force on 8 March 2022 (“New Charter for the Promotion of MDs”).
• Guidelines and reference documents issued by the High Authority for Health (HAS) for the certification of activities related to the presentation, information or promotion of healthcare products and associated services.
• General recommendations issued by the General Directorate for Competition, Consumer Affairs and Fraud Control (DGCCRF).
• Rules and recommendations set out in the French Advertising Standards Authority’s (ARPP) Code of Ethics governing general advertising practices.
• Self-regulatory guidelines and codes issued by industry organisations, such as EFPIA, MedTech, IFPMA, Leem and SNITEM (the French MD industry association), together with reference documents, ethical professional provisions and opinions.

While no major changes to the core rules governing health product advertising have been introduced since 2011, recent regulatory developments have significantly impacted promotional practices.

For example, the Social Security Financing Act (LFSS) for 2023 significantly strengthened the regulation of MDs, reflecting increasing alignment with the regulations applicable to medicinal products. The LFSS for 2024 introduced specific adaptations affecting the advertising of certain healthcare products.

Additionally, the New Charter for the Promotion of MDs encourages the sector to anticipate, certify and monitor its promotional activities more rigorously. However, its implementation will require additional regulatory and organisational adjustments once the final certification reference framework (the “HAS Referential”) for these activities is published, rendering it fully effective. This publication was expected to take place in March 2025 but is still pending.

Furthermore, a recent law aimed at regulating commercial influence and combating the excesses of influencers on social networks (the “Influencer Act”) became effective on 10 June 2023. This law has had an impact on advertising practices in the healthcare sector, as it formally prohibits the promotion of certain health products by e-influencers.

These changes underline the evolving need for the sector to anticipate, adapt to and rigorously monitor compliance with both regulatory and ethical standards.

Promotion of Medicinal Products for Human Use

High-level overview of the French legal framework

Article 86 of Directive 2001/83/EC, as implemented in the FPHC (Article L5122-1 and R5122-1 et seq), defines the promotion of medicinal products for human use as being any form of information, including that derived from canvassing, prospecting or inducement, designed to promote the prescription, dispensation, sale or consumption of medicinal products, except for information provided by hospital pharmacists.

According to French law, the following are not considered as promotional materials or activities:

• information provided by hospital pharmacists (as stated above);
• correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
• factual, informative announcements and reference materials relating, for example, to packaging changes, adverse-reaction warnings issued as part of general drug safety precautions, trade catalogues and price lists, provided that they do not contain any product claims;
• information on human health or human diseases that makes no reference to a medicinal product; or
• institutional information (ie, information documents of a scientific, technical or financial nature, issued by the establishment or company, which are not intended to promote a medicinal product).

Operators should be aware that, if certain content is portrayed as non-promotional or falls within the categories mentioned above, any positive, complimentary or comparative information may reclassify it as promotional material. This reclassification carries the risk of sanctions if the content does not comply with the applicable rules.

For example, in the fifth category listed above (institutional information), when a communication for a pharmaceutical company mentions a medicinal product, it is automatically subject to the legal framework governing promotional materials. Consequently, materials must be carefully analysed by internal advertising departments which are, by law, under the supervision and accountability of the responsible pharmacist.

French regulations establish two distinct sets of rules depending on whether the target audience is the general public (GP) or healthcare professionals (HCPs).

In both cases, advertising is strictly limited to content authorised for marketing or to registered medicinal products for which no benefit-risk reassessment is underway.

Promotion and advertising to the GP

Promotion and advertising of medicinal products to the GP is possible provided that the medicinal product is:

• not subject to medical prescription;
• not reimbursed by the French health insurance scheme; and
• not subject to a prohibition or restriction on advertising to the GP due to a possible public health risk noted in the marketing authorisation or registration.

Notwithstanding the above conditions, regardless of their prescription or reimbursement status, advertising for vaccines and smoking cessation products is authorised for public health purposes, provided certain conditions are met.

Advertising of medicinal products to the GP, including for vaccines, is subject to prior authorisation (namely a “Visa GP”) granted by the ANSM.

In addition, since April 2023, if advertising content is to be shared on social media, the Visa GP request must provide detailed additional and specific information to allow for a comprehensive review.

Promotion and advertising to HCPs

The promotion of medicinal products to HCPs (referred to as PM) is not limited by the product prescription or reimbursement status, but requires pre-approval from the ANSM in the form of a “Visa PM”.

Unlike GP advertising rules, the provision of free samples of medicinal products to HCPs is permitted provided that certain legal requirements are met.

Advertising application process and periods

Applications to the ANSM for a Visa GP or a Visa PM for authorised products are submitted online and must follow the respective filing periods (for 2026, there are four periods for a Visa PM, and eight periods for a Visa GP). In some cases, Visa applications may be submitted prior to the granting of the marketing authorisation or its amendment; however, they can only be made during the designated periods.

The only exception allowing submission outside the designated periods applies to medicines that have undergone a benefit-risk reassessment resulting in a change to the marketing authorisation or registration.

In a decision dated 22 October 2025, the ANSM set out the timetable and submission periods for 2026, including the form and content for applications seeking approval of advertisements for medicinal products for human use.

Application forms, along with the notice for applicants, are available on the ANSM website and were updated in January 2026.

If the ANSM does not issue an explicit decision on a Visa application within two months from the day following the end of the filing period, the Visa application is deemed to be accepted.

Both the Visa GP and the Visa PM are valid for two years.

Updating of guidelines and recommendations

The ANSM guidelines for advertising have not undergone any recent major modifications.

The only recommendation recently updated by the ANSM concerned “minor changes that can be made to a material with a valid PM Visa” in 2022.

However, the most recent working group sessions between the ANSM and the industry revealed some important insights, as follows.

The ANSM expressed its intention to review some of its recommendations such as:

• temporary recommendation “COVID19”;
• Paracetamol’s recommendation to reinforce messages on proper use and reduce the risk of overdose;
• recommendations regarding advertising for biosimilars and co-promotion of products with different statuses (PM and GP),
• updates announced in 2025 regarding PM recommendations on “generic medicines and substitution” and “mention of the indication and place in the therapeutic strategy (TS)” have not been implemented;; and
• the PM recommendation on advertising relating to “Low Molecular Weight Heparins”, which has been repealed.

The ANSM wishes to extend discussions on:

• the environmental impact of advertising for medicines, including identifying levers to reduce their environmental impact;
• the inclusion of the shelf life of medicines in advertisements; and
• a draft Q&A on the promotion of health products (medicines and MDs) on the internet and other e-media.

The ANSM has published its recommendations for updating its work programme and priorities for 2026.

Promotion of MDs and In Vitro Diagnostic MDs

High-level overview of the French legal framework

The FPHC (Article L5213-1) defines the promotion of MDs and in vitro diagnostic (IVD) MDs as being any form of information, including canvassing, prospecting or inducement, designed to promote the prescription, dispensation, sale or use of devices, except information provided by hospital pharmacists.

Following the same approach as for medicinal products, the following are not considered to be promotional materials or activities:

• labelling and instruction leaflets (IFUs) for MDs and IVD MDs;
• correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular MD or IVD MD;
• information relating to warnings, precautions for use and adverse effects identified through vigilance, as well as trade catalogues and price lists, provided they do not include any product claims; and
• information relating to human health or human diseases, if there is no indirect reference to an MD or an IVD MD.

Since 2011, the general legal provisions for advertising MDs and IVD MDs, as outlined in the FPHC, have not undergone any major modifications. Ordinance No 2022-582 of 20 April 2022 adapted French legal provisions align with Regulation (EU) 2017/745 of the European Parliament and of the Council, dated 5 April 2017, concerning MDs.

However, the main principles remained largely unchanged. Respectively, Articles L5213-1 et seq and L5223-1 et seq of the FPHC regulate the advertising and promotion of such devices.

Accordingly, the promotion and advertising of MDs to the GP is permitted for reimbursed Class I or IIa MDs, and for MDs not reimbursed by the French health insurance scheme. Except for the derogation described below, prior authorisation is not required for such advertising. Advertising reimbursable Class IIb and III MDs to the GP is strictly forbidden.

The promotion of MDs to HCPs (which falls under PM) does not require pre-approval by the ANSM, except in the cases described below.

The ANSM has the authority to review GP and PM promotion material. If the advertisement does not comply with the applicable requirements, the ANSM is able to order the withdrawal of the promotional material through a specific administrative procedure.

By way of derogation, prior authorisation is required for the promotion of MDs that present a significant risk to human health. These MDs, listed in an Order dated 24 September 2012, include the following:

• for the GP – dermal depression fillers; and
• for the PM – implantable cardiac defibrillators and ankle, knee, hip and shoulder prostheses, etc.

The promotion of IVD MDs does not require prior authorisation, except in cases where their failure is likely to cause a serious health risk (eg, self-diagnosis IVD MDs for the GP and certain reagents and reagent products for PM advertising, as stated in the Order dated 24 September 2012).

Where prior authorisation is required by law, the GP and PM Visas for IVD MDs and other MDs are granted for five years, provided that the CE marking is valid.

Unlike medicinal products, applications to the ANSM for promotional materials are not subject to a particular calendar or timeframe.

What is new regarding MDs?

French Ordinance No 2022-582 adopted on 20 April 2022 to implement the Medical Devices Regulation (MDR)

The legal framework for MDs and IVDs has been reshaped by new Regulations (EU) 2017/745 and 2017/746 of the European Parliament and of the Council of 5 April 2017 on medical devices and on in vitro diagnostic medical devices (the MDR and the IVD MDR, respectively), which became applicable on 26 May 2021 and 26 May 2022, respectively.

An ordinance was adopted on 20 April 2022 by the French Parliament to adapt French law to the MDR.

This ordinance has an impact on the FPHC advertising provisions, in particular as follows.

• The ANSM will carry out post-marketing surveillance and market surveillance for MDs and their accessories, as well as for products not intended for medical purposes listed in Annex XVI of the MDR.
• Accessories to MDs that present a significant risk to human health are expressly subject to prior authorisation for their promotion. Violation of this provision, including for accessories, constitutes both a criminal offence and an infringement under the terms of the draft ordinance, subject, respectively, to a financial penalty and imprisonment, and an administrative fine.
• Advertising to the GP of MDs and their accessories that are reimbursed, covered or financed (even partially) by the French health insurance scheme (except for reimbursed Class I or IIa MDs) constitutes an infringement under the terms of the draft ordinance.
• The ANSM will be competent to control, after the fact, by all appropriate means, the advertising and promotion of products not intended for medical purposes listed in Annex XVI of the MDR. According to the ordinance, the ANSM’s general enforcement powers are extended to these products listed in Annex XVI of the MDR, including the advertising activities related to them.
• Misleading conduct regarding promotional materials for MDs and their accessories and for those products listed in Annex XVI of the MDR will constitute an infringement, subject to a financial penalty under the terms of the draft ordinance.

Accordingly, the ANSM and the DGCCRF will have a shared sanctioning power with respect to products regulated by the MDR (MDs and products listed in Annex XVI of the MDR).

To ensure the constitutional sustainability of the ordinance, a draft ratification law was introduced before the French Parliament on 13 July 2022.

One notable development from 2023 relates to the DGCCRF’s investigation prerogatives – this was recently highlighted by a case involving an MD operator that led to a EUR6.6 million penalty for a major breach of the anti-gift law by an MD group.

New charter governing the information and promotion of MDs, effective from 8 March 2022

The LFSS for 2018 introduced Article L162-17-9 of the FSSC, which mandates the establishment of a quality charter governing the professional practices of individuals involved in the presentation, information or promotion of single-use MDs, healthcare products other than medicines, and associated services, where applicable.

Negotiations between stakeholders – namely, relevant professional organisations and the CEPS – on the adoption of the charter were protracted and challenging. Ultimately, these negotiations failed to reach a consensus, leaving the French Ministry of Health and Social Insurance to define the terms of the MD charter. Consequently, the much-anticipated charter was adopted through an order dated 4 March 2022, and came into effect on 8 March 2022.

The charter aims to establish a comprehensive framework for the commercial, promotional and informational practices concerning all products and services listed in the reimbursement List of Products and Services (LPP) referred to in Article L165-1 of the FSSC. These products – whether subject to CE marking regulations or not – must not compromise the quality of care or lead to unjustified expenses for the French health insurance system.

According to Article L162-17-9 of the FSSC, the CEPS has the authority to impose financial penalties on companies that fail to comply with the charter’s provisions. To ensure adherence to the charter, Article L162-17-9 also required the development of a certification reference framework (the HAS Referential) by the HAS within one year of the charter’s publication – ie, by 8 March 2023. However, the HAS Referential has not yet been published, rendering the charter’s full implementation incomplete. The only related document issued to date is a guidance note published in July 2023 by the HAS. In March 2024, this guidance was updated to specify the extended scope of the charter and certification resulting from the 2024 Social Security Financing Act, which now applies to all operators and retailers of LPP products and services, whether registered under a brand name or a generic description. This guidance also outlines the procedure for developing and implementing a certification scheme for activities related to the presentation, information and promotion of products and services included in the LPP.

Additionally, certification bodies will receive notifications of any infringements observed and sanctioned by the CEPS, as well as financial penalties (up to 10% of turnover excluding tax) resulting therefrom.

Updated guidelines

The ANSM recommendations have not been updated since the application date of the new MDR and IVD MDR.

Recent Developments and Points of Attention

Pharmaceutical advertising figures

According to the ANSM Annual Report 2024, pharmaceutical companies submitted 10,923 advertising approval applications (combined for GP and PM).

Over a five-year period (excluding 2020 and 2021, due to exceptional measures related to the COVID-19 pandemic), a steady increase in the number of advertising approval applications was observed (+14% compared to 2017), despite updates to recommendations in 2019 and 2022 aimed at reducing them.

ANSM financial and administrative penalties

The ANSM has the authority to impose financial penalties on operators who fail to comply with legal provisions. Decisions in this regard are published on the agency’s website and are closely reviewed by sector operators, as they provide valuable insights into the ANSM’s enforcement policies.

Since 2021, the ANSM has not imposed any financial penalties or issued injunctions related to promotional and advertising infringements by French operators. It remains unclear whether inspections have shifted focus towards the promotional activities of healthcare operators.

According to the FPHC, breaches of advertising regulations can also result in financial penalties being imposed by the CEPS. However, successive CEPS annual reports from 2021 to date do not record any penalties having been levied for medicinal products or MDs.

Transfer of surveillance powers for tattoo and cosmetic products

As of 1 January 2024, tattoo and cosmetic products have been removed from the list of healthcare products under Article L5311-1 of the FPHC; consequently, they are no longer under the jurisdiction of the ANSM. The Finance Act 2023, dated 30 December 2022, stipulates the transfer of market surveillance and control responsibilities for these products from the ANSM to the French National Agency for Food, Environmental and Occupational Health and Safety (ANSES) and the DGCCRF. Therefore:

• declarations from establishments manufacturing or packaging cosmetics and tattoo products will now be submitted to the DGCCRF (Article L5131-2 FPHC);
• the ANSES and the DGCCRF will be responsible for market control, health and surveillance of these products; and
• the ANSM will continue to oversee the development of good laboratory practice principles applicable to non-clinical safety studies aimed at assessing the safety of cosmetic products (Article L5131-4 FPHC).

New rules for influencers

A law defining the status of influencers, regulating their practices and ensuring more transparency in their promotional activities, was adopted by the French Parliament on 9 June 2023.

This law aims to prohibit influencers from promoting pharmaceutical products, MDs and surgical procedures on social networks unless the influencer is simply relaying government public health campaigns.

An Order dated 6 November 2024 amends the Influencers Act 2023 in order to ensure the alignment of French law with the EU legal framework, and to respond to the observations made by the European Commission in its letter to the French authorities following the notification of 12 May 2023 (pursuant to Directive (EU) 2015/1535).

The Order’ ratification project law was submitted to the French Parliament on 15 January 2025. Its adaption will enable the full implementation of the Order’s measures.

Ad hoc temporary authorisation for use of cannabis-based medicinal products

As part of the conclusion of the medical cannabis experiment, scheduled for 31 December 2024, cannabis-based medicinal products will now be subject to a temporary, ad hoc authorisation for use granted by the ANSM for a renewable period of five years, pursuant to the LFSS for 2024, which also legally defines cannabis-based medicinal products.

According to new applicable rules, promotion or advertising to the GP is prohibited. Additionally, any information relating to this ad hoc authorisation intended for PM must comply with specific rules implemented by the ANSM.

The MedTech code of ethics and its importance for MD operators

In 2015, the European trade association representing the medical technology industry (ie, IVD and MD manufacturers operating in Europe) published the MedTech Europe Code of Ethical Business Practice (the “MedTech Code”).

This Code, which became binding for MedTech Europe corporate members on 1 January 2017, “regulates all aspects of the industry’s relationship with healthcare professionals (HCPs) and healthcare organisations (HCOs), to ensure that all interactions are ethical and professional at all times and to maintain the trust of regulators and – most importantly – patients”.

In France, since 1 January 2022, all provisions of the MedTech Code are applicable to SNITEM member companies (ie, over 602 members with a significant market presence in France), which includes non-corporate members of MedTech Europe.

The MedTech Code lays down stricter rules than those governing interactions between HCPs/HCOs and IVD MD/MD operators in France.

As such, relevant operators subject to the MedTech Code will no longer be able to provide direct financial support for individual HCPs to attend third-party organised educational events.

With the new French anti-gift scheme set to come into force following the publication of the long-awaited Decree dated 1 October 2020, the IVD-MD and MD industries have had to anticipate every interaction with HCPs, including the expected delays for the competent authority to authorise or respond to declarations of such interaction.

It should be noted that the anti-gift law prevents companies manufacturing or marketing healthcare products or providing healthcare services from granting benefits, particularly to HCPs and HCOs. This framework has existed under French law since 1993 and was frequently updated, until being completely reshaped by Ordinance No 2017-49 of January 2017 (later ratified by Law No 2019-774 of 24 July 2019).

This new framework redefines the strict conditions under which certain benefits can be granted to HCPs and HCOs by healthcare companies. The regulation requires either a prior declaration or a prior authorisation to be submitted to the relevant professional board or relevant competent authority (regional health agency) depending on the amount of benefit to be provided to the recipients.

In any case, feedback from the authority is considered prior to the implementation of the regulated interaction.

The MedTech Code requirements represent a real challenge for operators governed by its provisions. The process for granting an indirect sponsor must start well in advance, and the SNITEM estimates that the delay between the signing of the grant agreement with the third-party beneficiary and the event date is between four and eight months.

Detailed processes are required to be implemented internally within relevant operators in order to comply with all the ethical and legal requirements.

Conclusion

The legal and regulatory landscape for the advertising of medicinal products and MDs in France is characterised by a complex framework of laws and regulations, such as the French Consumer Code, FPHC and FSSC (among others), as well as relevant EU Regulations and Directives.

One key takeaway is the consistency and stability in the rules governing health product advertising over many years. However, recent changes – such as the early access schemes, the anti-gift law and the EU Regulation on MDs – have introduced significant changes to advertising practices in this sector.

Operators in the healthcare industry need to navigate this intricate regulatory landscape with precision. They must be vigilant in adhering to the evolving rules and guidelines. The requirement for prior authorisations, the scrutiny of content on social media and the influence of industry-specific codes of ethics further emphasise the need for compliance.

Moreover, the transfer of surveillance powers for tattoo and cosmetic products underscores the dynamic nature of healthcare advertising regulations in France.

In summary, while the core principles of health product advertising remain consistent, recent developments and changes in the legal framework necessitate careful attention and adaptability from industry operators to ensure that they comply with the evolving rules and maintain ethical practices in the promotion of medicinal products and MDs in France.