Chapter II: Advertising.

Advertising for medicinal products for human use means any form of information, including canvassing, canvassing or inducement, which is intended to promote the prescription, supply, sale or consumption of such medicinal products, with the exception of information provided, as part of their duties, by pharmacists managing a pharmacy for internal use. This definition does not include : – correspondence, accompanied, where appropriate, by any non-promotional document needed to answer a…

The advertising defined in article L. 5122-1 must not be misleading or undermine the protection of public health. It must present the medicinal product or product objectively and encourage its proper use. It must comply with the provisions of the marketing authorisation and the therapeutic strategies recommended by the French National Authority for Health.

Only medicinal products for which the marketing authorisation referred to in article L. 5121-8 or the authorisation referred to in article L. 5121-9-1 or one of the registrations referred to in articles L. 5121-13 and L. 5121-14-1 or which benefit from a parallel import authorisation pursuant to article L. 5124-13 may be advertised. Advertising for a medicinal product is prohibited when this medicinal product is the subject of a reassessment…

A medicinal product may only be advertised to the general public if it is not subject to medical prescription, none of its various presentations is reimbursable by compulsory health insurance schemes and the marketing authorisation or registration does not contain any prohibition or restrictions on advertising to the general public due to a possible risk to public health, in particular where the medicinal product is not suitable for use without…

The electronic trade in medicinal products referred to in article L. 5125-33 is subject to the provisions of this chapter.

The therapeutic indications which may not be advertised to the general public are determined by an order of the Minister for Health issued on a proposal from the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products).

Advertising to the public for a medicinal product mentioned in article L. 5122-6 as well as advertising campaigns to the public for vaccinations are subject to prior authorisation from the Agence nationale de sécurité du médicament et des produits de santé, known as an advertising approval. This approval is issued for a period which may not exceed the duration of the marketing authorisation for medicinal products subject to this authorisation….

Advertising of a medicinal product to members of the health professions authorised to prescribe or dispense medicinal products or to use them in the exercise of their profession is subject to prior authorisation from the Agence nationale de sécurité du médicament et des produits de santé, known as an “advertising approval”. This authorisation is issued for a period which may not exceed the duration of the marketing authorisation for medicinal…

The requests for approval provided for in Article L. 5122-9 are made according to a timetable and during a period determined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

Free samples of medicinal products may only be given to persons authorised to prescribe or dispense medicinal products in the context of in-house pharmacies at their request. These samples may not contain substances classified as psychotropic or narcotic, or to which the narcotic regulations apply in whole or in part. They must be identical to the pharmaceutical specialities concerned and bear the words “free sample”. Samples may not be given…