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.
French IPO allows extension of the duration of SPCs on the basis of the MA notification date
01 April 2018 - Posted by: Laëtitia Bénard
The French Intellectual Property Office (IPO) recently issued a notice (French language) advising that the expiration date of French supplementary protection certificates (SPC) can be extended upon request of the registered SPC holder. The notice applies the 2015 Seattle Genetics ruling of the European Court of Justice (ECJ) which held that the relevant date for the › Read More
Getting ready for the EU MDR: Classification of medical devices
27 March 2018 - Posted by: Eveline Van Keymeulen
In this second post of our “Getting ready for the MDR” series, we look at how the MDR will affect manufacturers in classifying their devices according to the newly introduced rules and classification criteria. Rules on medical device classification will not radically change under the upcoming regulatory system, which will apply as of 26 May › Read More
Belgium adopts new Royal Decree on biobanks
23 March 2018 - Posted by: Veerle Pissierssens
The new Royal Decree on biobanks was published on 5 February 2018 in the Belgian Official Gazette. A biobank stores human tissue and makes it available for scientific research only (that is, not for human use). The decree, which implements the Law of 19 December 2008 in relation to obtaining and using human tissue in › Read More
20 March 2018 - Posted by: Jacqueline Bore
The Court of Justice of the European Union has ruled that the holder of a marketing authorisation for a reference medicinal product in a decentralised procedure does have the right the challenge in the courts of the concerned Member States the grant of a marketing authorisation for a generic medicinal product on the basis that › Read More
Getting ready for the EU MDR: Timelines for manufacturers
14 March 2018 - Posted by: Marco de Morpurgo
In the first post of our “Getting ready for the MDR” series, we have a look at the key timelines that manufacturers need to be aware of as they prepare for the application of the EU Medical Devices Regulation (MDR). Time is going by fast and the new MDR will soon become applicable. Its application › Read More