Title II: Medicinal products for human use

When the application is submitted, the applicant assigns an internal reference number to each of the advertising media, in accordance with the rules defined by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé. Advertising distributed to healthcare professionals must mention this number, except in the case of advertising on a radio broadcast medium.

Withdrawal of the approval provided for in the third paragraph of Article L. 5122-9 is decided by the Director General of the Agence nationale de sécurité du médicament et des produits de santé after the beneficiary of the approval has been invited, by any means capable of proving the date of receipt of this notice, to present its written or oral observations within a period set by the Director General,…

For reasons relating to the protection of public health, the measures provided for in article R. 5122-15 may be taken in the event of misuse, as defined in article R. 5121-153, or drug dependence or abuse, as defined in article R. 5132-97, of the medicinal product being advertised.

I.-The provision of free samples referred to in article L. 5122-10 is only permitted during the two years following the first effective marketing in France of : 1° a proprietary medicinal product that has been registered or authorised for the first time; or 2° A medicinal product which has already been registered or authorised and which has obtained a registration or a marketing authorisation for a new strength or a…