CJEU upholds withdrawal of orphan designation based on increased availability

Jacqueline Bore

The EU’s General Court, whose jurisdiction includes the judicial review of decisions made by the EU institutions such as European Medicines Agency, has recently considered an interesting application in relation to a medicinal product that had been granted orphan designation on the little used basis that its significant benefit lay in its potential authorisation in Read More

French medicines agency announces action against “short-liner” wholesale distributors

Eveline Van Keymeulen

On 6 May 2019, the French National Agency of Medicine and Health Products Safety (ANSM), facing the challenges of stock shortages and the risks of introducing falsified medicines into circulation, published an announcement on action against “short-liner” wholesale distributors. Wholesale distributors, holding authorisations granted by the ANSM, carry out the purchase, sale, storage and distribution Read More

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 7 April 2019, a law altering the notification procedure for implants and certain invasive medical devices for long-term use was adopted. Previously, the Belgian Sickness and Invalidity Institute (INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical devices were required to register with the Read More

AI in health: the launch of the French Health Data Hub

Laurie-Anne Ancenys

The French Office parlementaire d’évaluation des choix scientifiques (the Office) has published a report on artificial intelligence and health data following the public hearing organised in February 2019, in the form of two round tables on artificial intelligence and health data. The hearing, attended by AI researchers, entrepreneurs, public and private stakeholders of the health Read More

French ANSM temporary scientific committee pursues activities on modalities of medical cannabis availability

Eveline Van Keymeulen

On 15 May 2019, the French Temporary Specialised Scientific Committee (CSST) met to continue its work on the modalities of making cannabis for therapeutic purposes available during the initial experimental phase. The CSST was created in September 2018 for one year by the French National Agency of Medicine and Health Products Safety (ANSM) to assess Read More