Your questions, our answers. What are the regulations governing drug advertising?

Advertising (by press or radio advertisements, posters, displays, window panels or films) for a medicinal product for human use to the general public is strictly regulated (articles L5122-1 to L5122-16 of the Public Health Code). It is limited to certain products.

The products concerned

Advertising is only possible after obtaining a marketing authorization (MA). It is subject to prior authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM). This authorization results in the issuance of a GP (general public) visa valid for two years.

It can only concern:

▶ medicines not subject to mandatory prescription and not reimbursable by compulsory health insurance schemes;

▶ certain vaccines, if they appear on a list established for public health reasons by order of the Minister responsible for health, taken after consulting the High Authority for Health (HAS);

▶ smoking cessation products, for public health purposes.

An objective presentation

Advertising must present the drug objectively and encourage its proper use.

The elements contained in the promotion must comply with the information contained in the summary of product characteristics (SPC) as well as with the therapeutic strategies recommended by the High Authority for Health.

According to Article R5122-3 of the Public Health Code, the advertising campaign must clearly indicate the following information:

- the name of the medicine,

- indications for proper use of the medication,

- a reference to the instructions in the user manual,

- a message of caution, a referral to a pharmacist for advice and, if symptoms persist, an invitation to consult a doctor.

- where applicable, mention of generic quality.