Advertising approval (visa de publicité)

The advertising approval (visa de publicité) is the prior administrative authorisation issued by the ANSM before an advertisement for a medicinal product is disseminated. The Public Health Code distinguishes the approval for advertising to the general public, known as the GP visa, and, since the 2011 Act on strengthening the safety of medicinal products, the approval for advertising to healthcare professionals, known as the PM visa, which replaced a system of a posteriori filing. A comparable prior control applies to advertising for certain medical devices presenting a significant risk to health.

Procedure for obtaining approval

The application is filed by the undertaking that exploits the medicinal product, together with the proposed material and the references supporting the claims. The ANSM examines applications during filing periods set by an annual timetable and checks that the message is consistent with the summary of product characteristics, objective, not misleading and in line with the recommendations on proper use.

Duration and challenge

The approval is tied to a specific item of material and to the state of the authorisation at the time it is granted. Any variation of the marketing authorisation affecting the information reproduced, in particular a restriction of indication or a new warning, requires the material to be revised. The ANSM may suspend or withdraw the approval where the advertising no longer meets the legal requirements, and impose financial penalties where advertising is disseminated without approval or after withdrawal. These decisions are subject to review by the administrative courts.

Scope of the approval in litigation

The approval merely attests that the message complies with public health rules. It does not prejudge the lawfulness of the advertising with regard to third-party rights, so that a competitor may bring proceedings before the civil courts for unfair competition, disparagement or trade mark infringement against advertising that has been approved. Production of the approval file and of the scientific references submitted to the ANSM then becomes central to the evidential debate.

Key points

The advertising approval is a precondition for any dissemination of advertising for a medicinal product in France, whether aimed at the public or at professionals. It is granted item by item and must be revisited whenever the authorisation changes. When planning a launch, the ANSM filing periods should be anticipated, and the approval should never be regarded as protection against action by a competitor.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation