France

CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?

Eveline Van Keymeulen

In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive. Read More

France issues guidance on reporting non-compliant prescribing or use of medicinal products

Eveline Van Keymeulen

On 22 December 2017, the National Agency for Medicines and Health Products Safety (ANSM) published guidelines to assist pharmaceutical companies when reporting intentional non-compliant prescribing or use of medicinal products. Non-compliance can in particular relate to the indication, patient characteristics, administration route or posology of the products. French law requires pharmaceutical companies to report to Read More

French court confirms that pharmacists can sell non-prescription medicinal products on Doctipharma e-platform

Patricia Carmona Botana

In December 2017, the Court of Appeal of Versailles ruled  that retail pharmacy websites can sell non-prescription medicinal products on the online platform doctipharma.fr, thus overruling the May 2016 first instance decision of the Court of Nanterre. The Court of Appeal confirmed that Doctipharma does not act as an illicit “intermediary” in the sale of Read More

France: ANSM publishes Q&A for medical device manufacturers in case of notified body denotification

Eveline Van Keymeulen

The French National Agency for Medicines and Health Products Safety (ANSM) recently published a Q&A providing guidance for medical device and in vitro medical device manufacturers headquartered in France in case their notified bodies ceased operations, either voluntarily or following a denotification decision by the competent authority. The Q&A is particularly helpful in the absence Read More

French Competition Authority launches sector inquiry into medicinal products and biomedical laboratories

Patricia Carmona Botana

On 20 November 2017, the French Competition Authority (FCA) launched a sector inquiry into medicinal products and medical biology (biomedical) laboratories in France.  As previously announced, the inquiry aims to address the challenges that the sector entails for the French insurance system and public health and to assess the feasibility of more competitive conditions with Read More