Chapter II: Advertising

The application to obtain the endorsement referred to in Article R. 5122-19 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the manufacturer or distributor of the product. It must be accompanied by 1° The draft advertisement, whatever the medium, and in particular a copy of the draft labelling appearing on the primary and secondary packaging of the…

The following information is exempt from advertising approval when it appears on labels, leaflets or brochures relating to the products referred to in Article L. 5122-14: 1° The name and composition of the product ; 2° Instructions for use and precautions for use, if applicable.

For a product mentioned in Article L. 5122-14, the advertising approval for professionals mentioned in Article L. 5122-9 is issued and may be suspended or withdrawn under the conditions set out in Articles R. 5122-13 to R. 5122-16. The provisions of article R. 5122-20 are applicable to the application for an advertising visa. The advertisement also mentions the date on which it was last drawn up or revised. This information…