Advertising for medicines: promoting while complying with French regulations

In France, advertising for medicines is regulated by the Public Health Code to ensure patient safety and the proper use of products. The regulatory framework distinguishes between several types of communication depending on the nature of the medicine and the target audience (healthcare professionals or the general public).

This article outlines the conditions that must be met for a promotional campaign to comply with the regulation.

Applicable regulatory framework

In France, advertising for human medicines is defined in Article L.5122-1 of the Public Health Code (“CSP: Code de la Santé Publique”) as any form of information, solicitation, or incentive aimed at promoting the prescription, dispensing, sale, or consumption of these medicines. Certain strictly informative exchanges are excluded, such as non-promotional correspondence or information on changes in packaging or pharmacovigilance.

Advertising must not be misleading or harmful to public health. It must comply with the data validated in the Marketing Authorization (MA), the recommendations of the ANSM and those of the Haute Autorité de Santé (HAS), and present the drug objectively, promoting its proper use (Article L.5122-2 CSP).

Promotional materials must comply with the summary of product characteristics (SmPC) and clearly indicate, where applicable, the nature of the medicinal product, its conditions of use, and warnings (Article R.5122-1 CSP). Specific rules apply to homeopathic and traditional herbal medicinal products, with mandatory information set out in Article R.5121-146 CSP.

All advertising for a medicinal product, whether aimed at the general public or healthcare professionals, requires prior authorization (known as an advertising visa) issued by the French National Agency for Medicines and Health Products Safety (ANSM), valid for a fixed period (two years).

All the rules applicable to advertising are set out in Articles L.5122-1 to L.5122-16 of the Public Health Code.

Role of the exploitant in promotion

The company marketing a medicinal product in France is responsible for promoting that medicinal product. In accordance with Article R.5122-2 of the Public Health Code, the exploitant must have a department responsible for advertising, under the supervision of the Chief Pharmaceutical Officer (“Pharmacien Responsable”). The latter ensures compliance with all regulatory provisions applicable to the advertising of medicinal products, in particular the scientific validity of the information disseminated.

The company is also required to keep a copy of each advertisement issued, accompanied by a sheet specifying:

The recipients of the message;
The method of dissemination;
The date of first dissemination;

These documents must be archived for three years from the date of last distribution and made available to the French National Agency for Medicines and Health Products Safety (ANSM) in the event of an inspection.

Advertising aimed at the general public

In France, advertising of medicines to the general public (GP) is strictly regulated. It is only permitted in the cases provided for in Article L.5122-6 of the Public Health Code, in particular for medicines that are not subject to mandatory medical prescription, provided that they are not reimbursed by health insurance and do not present a particular risk to public health.

When permitted, advertising to the general public (GP) must comply with several substantive and formal requirements, as defined in Articles R.5122-3 to R.5122-8 of the Public Health Code.

Mandatory information

The promotional message must be clearly identifiable as such and the medicinal product must be presented as a health product. It must include:

The name of the medicinal product and its common name;
The information necessary for the proper use of the medicinal product;
An explicit invitation to read the instructions for use or the information on the packaging carefully;
A warning message, a reference to the pharmacist’s advice, and an invitation to consult a doctor if symptoms persist;
For generic medicines: a statement indicating that they are generic, where applicable, accompanied by the name of the reference product and a reminder of the precautions associated with excipients with known effects.

Adaptations are provided for radio advertising: certain information, such as the common name, is only required if the medicinal product contains a maximum of two active ingredients.

Prohibited statements

Under no circumstances may the content include elements that could mislead the public, discourage them from consulting a healthcare professional, or promote inappropriate use. In particular, it is prohibited to:

Portray medical consultation or surgery as unnecessary.
Suggest that the drug has no adverse effects or that it is equal to or superior to another treatment.
Present the use of the drug as necessary to improve normal health, or implying that failure to treat could alter it (except for certain vaccination campaigns).
Address children primarily or exclusively.
Refer to recommendations from scientists, healthcare professionals, or public figures that may encourage consumption.
Equate the medicinal product with food, cosmetics, or any other consumer product.
Exaggerate the medicinal product ‘s effectiveness or use misleading representations of the human body.
Refer to testimonials of recovery or the granting of Marketing Authorization as proof of effectiveness.
Offer material benefits (gifts, bonuses, objects) linked to the purchase or use of the medicinal product.

Failure to comply with these rules exposes the exploitant to administrative or criminal penalties.

Advertising aimed at healthcare professionals

Advertising for medicines aimed at healthcare professionals is subject to strict requirements, both in terms of content and form. It is only authorized for medicinal products that have been granted Marketing Authorization (MA), in accordance with the conditions set out in that authorization.

In accordance with Article L.5122-9 of the Public Health Code, prior approval from the ANSM is required for any advertising aimed at professionals authorized to prescribe, dispense, or administer a medicinal product. This approval is granted for a maximum period of 2 years. It may be suspended or withdrawn by the agency in the event of a breach of regulatory requirements.

Mandatory information and substantive requirements

The information provided must be accurate, up-to-date, verifiable, and sufficiently comprehensive to enable healthcare professionals to form an informed opinion on the therapeutic value of the medicinal product.

Article R.5122-8 specifies that advertising must include at least the following information:

Name of the medicinal product;
Name and address of the exploitant;
Pharmaceutical form;
Qualitative and quantitative composition (active substances and essential excipients);
Marketing Authorization or registration numbers;
Pharmacological properties;
Therapeutic indications and contraindications;
Posology and method of administration;
Adverse effects, drug interactions, warnings, and precautions for use;
Classification of the drug in terms of prescription and dispensing;
Information on reimbursement or approval for local authorities;
Retail price (if applicable) and daily treatment cost;
Specific information for generic drugs.

Each material must also mention the date of creation or last revision of the advertisement.

Focus on medical visits

The dissemination of promotional information during medical visits is governed by a charter regulating the practices of medical representatives. This charter aims to guarantee the quality, objectivity, and compliance of the information provided to professionals, and to strengthen the role of medical representatives in promoting the proper use of medicines.

For vaccines, advertising aimed at healthcare professionals must include the full recommendations of the HAS (Haute Autorité de Santé), without referring to other documents.

Regulating medicinal product advertising: a strict regulatory requirement

Advertising a medicinal product in accordance with French regulations requires a thorough understanding of the Public Health Code and constant vigilance regarding changes in practices regulated by the ANSM.

With extensive experience in advertising control, Alhena Consult supports pharmaceutical companies at each stage of their campaigns. From detailed analysis of documents to drafting materials and approval requests, our expertise ensures rigorous, secure communication that complies with the strictest regulatory standards.

Promotional campaigns: regulatory requirements and support from Alhena Consult

Advertising for medicines in France is subject to strict regulations defined by the Public Health Code, with specific requirements depending on the nature of the product, its target audience (general public or healthcare professionals), and its regulatory status. Each campaign requires prior verification of applicable standards, full compliance with the Marketing Authorization and the opinion of the Haute Autorité de Santé (HAS), and the inclusion of mandatory information. This ultimately enables the exploitant to obtain approval from the ANSM.

Alhena Consult supports pharmaceutical companies throughout this process, from the regulatory analysis phase to the drafting of promotional materials and the management of authorization requests. Thanks to its in-depth expertise in regulatory affairs and communication under regulatory constraints, Alhena guarantees the security of the messages disseminated, while ensuring their scientific consistency and alignment with ANSM requirements. This integrated approach optimizes approval times and limits the risk of rejection in a context of increased regulatory oversight.

For a complete overview of market access procedures, find out how to market a drug in France (centralized Marketing Authorization and other cases).

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