French Public Health Code
In forceA 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 intervention of a doctor for the diagnosis, initiation or monitoring of treatment.
Advertising to the public of a medicinal product for which a marketing authorisation has been granted by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, or whose marketing authorisation has been varied by means of the procedure provided for in that Regulation, may be prohibited or restricted on the grounds set out in the first paragraph, by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
By way of derogation from the first paragraph, advertising campaigns for the medicinal products mentioned in Article L. 5121-2 or for vaccines subject to medical prescription or reimbursable may be aimed at the public.
Non-institutional advertising campaigns aimed at the public for the vaccines mentioned in the third paragraph of this article are only authorised if the following conditions are met:
1° They appear on a list of vaccines drawn up for public health reasons by order of the Minister for Health after obtaining the opinion of the High Authority for Health;
2° The content of these advertising campaigns complies with the opinion of the Haute Autorité de santé and is accompanied, in a clearly identified manner, by the minimum compulsory information determined by this body. This information is reproduced in full, is easily audible and legible, depending on the medium of the advertising message concerned, is not cross-referenced and complies with the characteristics defined by order of the Minister for Health.
Advertising of a medicinal product to the public must be accompanied by a message of caution and a reference to the need to consult a doctor if symptoms persist.
