Chapter III: Advertising

I. – Advertising for the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 means any form of information, including canvassing, canvassing or inducement that is intended to promote the prescription, supply, sale or use of these devices, with the exception of information provided as part of their duties by pharmacists managing an in-house pharmacy. II –…

The advertising defined in Article L. 5223-1 shall relate to the devices referred to in Article 1 of Regulation (EU) 2017/746 which have the EU declaration of conformity provided for in Article 17 of that Regulation. Advertising shall objectively define the device and, where applicable, its performance and its compliance with the general safety and performance requirements, as attested by the declaration referred to in the previous paragraph, and shall…

The advertising of certain devices mentioned in Article 1 of Regulation (EU) 2017/746, the failure of which is likely to cause a serious risk to health and the list of which is set by order of the Minister for Health, is subject to prior authorisation issued by the National Agency for the Safety of Medicines and Health Products. This authorisation is issued for a renewable period of five years. This…

The Agence nationale de sécurité du médicament et des produits de santé and the administrative authority referred to in II of article L. 5221-2, within their respective areas of competence, may, under the conditions set out in article L. 5312-4-1, give formal notice to the person concerned to withdraw the advertising, to present their observations and to rectify the situation, if necessary by imposing a fine on the formal notice….

The procedures for applying this chapter shall be laid down by decree in the Conseil d’Etat.