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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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.