Advertising – DMOS – Transparency
The December 29, 2011 law, the so called “French Sunshine Act” (Bertrand law) upheaved the regulatory requirements for the exploitation of medical devices in France with its confirmed provisions and clarified by decree and orders. The January 26, 2016 law of modernization of the French healthcare system (Touraine law) broadens the application scope of these provisions and strengthens them.
WHITE-TILLET advises and assists you in:
- The assessment of the conformity of your advertising messages to the French regulation;
- The submission of advertising authorization requests to the ANSM & the follow-up files;
- The submission of your agreements with health professionals to the Responsible Authorities;
- The publication of links of interest on the Government’s site;
- Declarations of operator activity and placing the products on the market (mandatory in France);
Maillols-Perroy A.C. et Tillet Y. La loi de réforme de la sécurité sanitaire du médicament et des produits de santé en France : effet d’annonce, renforcement ou bouleversement ? Thérapie 2012 ;6(11) :1-10.
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