France

ANSM launches public consultation on advertising of medicinal products to public

Audrey Aboukrat

The French medicines regulator (ANSM) recently launched a public consultation concerning the warning message that pharmaceutical companies must include in all audio-visual advertising of medicinal products to the public, as part of the mandatory information required for medicine advertising by Articles L. 5122-6 and R. 5122-3 of the French Public Health Code.  The consultation concerns Read More

Majority of invented names for medicinal products rejected

Eveline Van Keymeulen

In 2016, more than half of the proposed invented names for centralised medicinal products were rejected (246 rejections to 241 acceptances), and this trend continues in the first half of 2017. Invented names for centralised medicinal products are reviewed by the Name Review Group (NRG) of the European Medicines Agency (EMA), which meets approximately every Read More

France envisages joining BeNeLuxA initiative

Eveline Van Keymeulen

According to recent statements of the Dutch Minister of Health, the French Minister of Health indicated during the last meeting of the Council of the European Union that France is considering joining the BeNeLuxA initiative, the collaboration between the Belgian, Dutch, Luxembourg and Austrian governments on pharmaceutical policy. If France joins the initiative, the new Read More

CJEU vaccine ruling: medical evidence not a prerequisite under the Product Liability Directive

Julie De Keukeleire

On 21 June 2017, the Court of Justice of the European Union (CJEU) issued its judgment in the product liability case N. W and Others v Sanofi Pasteur MSD and Others (C-621/15).  The CJEU found that a defect in a product and the causal link between the defect and the damage suffered may be proven Read More

French Competition Authority announces healthcare sector enquiry during presentation of 2016 Annual Report

Patricia Carmona Botana

The President of the French Competition Authority (FCA), Isabelle de Silva, recently confirmed in a radio interview the forthcoming launch of a sector-wide enquiry into the healthcare sector, with a special focus on hospital procurement, biomedical laboratories and pharmacies.  The enquiry aims to address the major economic and financial challenges that the sector entails for the Read More