Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.

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

Kaat Van Delm

On 1 June 2019, a new Royal Decree (dated 7 April 2019) altering the notification procedure for implants and certain invasive medical devices for long-term use entered into force. Previously, the Belgian Sickness and Invalidity Institute (RIZIV/INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical Read More

Dutch medicines regulator updates policy on how to carve out patented indications

Lars Braams

On 8 May 2019, the Dutch Medicines Agency (CBG/MEB) published a revised policy on generic manufacturers’ ability to carve out patented indications from their product information (that is, leaflet and summary of product characteristics). This new policy is a direct result of the CJEU’s preliminary ruling in Staat der Nederlanden v Warner-Lambert Company LLC (Case Read More

Medical cannabis in France: Latest state of play

Eveline Van Keymeulen

Following the penultimate meeting of the specialised committee on cannabis (CSST) established by the French National Agency of Medicine and Health Products Safety (ANSM) (see our previous blog posts “French ANSM temporary scientific committee pursues activities on modalities of medical cannabis availability” and “French ANSM recommends medical use of cannabis under certain conditions“), the French Senate Read More

EU agriculture ministers want to exclude crops created by targeted mutation methods from EU GMO legislation

Sophie ten Bosch

At the latest meeting of EU agriculture ministers, and following a report by the Danish Council of Ethics, 14 EU member states, led by the Netherlands and Estonia, called for the European Commission to re-evaluate the EU’s stance on genetically modified organisms (GMOs), in particular those created by new plant breeding techniques. In a ruling Read More

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