French National Agency for Medicines and Health Products Safety (ANSM)

The French National Agency for Medicines and Health Products Safety (ANSM) is the State public body, under the supervision of the Minister for Health, that is responsible in France for the assessment, authorisation and monitoring of medicinal products and other health products. Created by the Law of 29 December 2011 on strengthening the safety of medicinal and health products, adopted after the Mediator scandal, it succeeded the French Agency for the Safety of Health Products in 2012. It is the French competent authority within the meaning of EU law.

Tasks of the Agency

The ANSM grants national marketing authorisations and takes part in European procedures, as reference State or as State concerned. It is involved, together with the research ethics committees, in authorising clinical trials, authorises and inspects pharmaceutical establishments, controls advertising of health products through the advertising approval (visa de publicité) and organises pharmacovigilance and medical device vigilance. It grants compassionate access authorisations and gives an opinion on the presumption of efficacy and safety in early access applications, the decision on which lies with the French National Authority for Health (HAS). Finally, it monitors supply tensions and shortages.

Health policing and sanctioning powers

The Agency has extensive health policing powers. It may suspend, vary or withdraw an authorisation, prohibit the placing on the market of a product, order its withdrawal or recall and take any interim measure justified by a risk to public health. It may also impose financial penalties on companies that breach their obligations, in particular on advertising, shortage reporting or pharmacovigilance. Its decisions are subject to review by the administrative courts, including in summary proceedings.

The ANSM and patent litigation

The ANSM decides on applications for authorisation of generics and biosimilars without examining the patents covering the reference medicinal product, and a patent holder cannot ask it to defer grant on that ground. Public information on medicinal products, in particular the public medicines database, does however reveal the authorisations granted and their holders. It is an essential source for detecting an imminent launch and for preparing an infringement action or an application for provisional measures.

Key points

The ANSM is the French authority for medicinal and health products. It authorises, inspects, monitors and sanctions, and its decisions fall within the jurisdiction of the administrative courts. It takes no account of patents when it authorises a generic, but the information published on authorisations makes it possible to track the arrival of competitors. Regular monitoring of authorisations granted and of their variations should be put in place, so as not to discover a generic only when it is launched.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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