Regulatory & compliance

Belgium adopts new Royal Decree on biobanks

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

Innovators can protect data exclusivity in Concerned Member States following a decentralised procedure

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

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

Dutch cabinet approves proposal for reimbursement of replacement medicines

Iradj Nazaryar

On 9 February 2018, the Dutch government issued a press release announcing the Council of Ministers’ approval of a proposal for the reimbursement of medicines from abroad that are not (yet) registered in the Netherlands (i.e., replacement medicines). In case of any shortage of a certain medicinal product in the Netherlands, an equivalent medicine approved Read More

Belgium to strengthen role of e-health apps in patient healthcare

Veerle Pissierssens

The Belgian Minister of Health has announced in a press release that she is seeking to integrate mobile medical applications (e-health apps) into the Belgian healthcare system. In order to ensure the quality of such e-health apps and the safety of patients, these apps will be evaluated under a specific scheme (Evaluation Scheme) and some Read More