Originally published as Covington E-Alert on October 3, 2012

French Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products has been inserted into the Public Health Code (‘Code de la santé publique’ or CSP). It includes new advertising rules for medical devices (MDs) and in vitro diagnostic medical devices (IVDs). See our previous e-alert (France – A Revolution for the Medical Devices Industry New Advertising Rules). The Law has been supplemented by the implementing Decree No 2012-743 of 9 May 2012 that details the prior approval system for advertisements for certain MDs (those carrying an important risk to human health) and IVDs. The approval (so-called ‘visa’) is granted by the French Medicines Agency (ANSM), for a maximum of five years. The MDs and IVDs concerned had to be determined by the Ministry of Health. This is done – the Ordinances listing the MDs and IVDs the advertising of which is subject to prior approval have been published today in the French official journal.

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