Pharma & lifesciences

Pharma & lifesciences

On 20 April 2017, the Law on clinical trials with medicines for human use was adopted...
What can be concluded from the ruling of the ECJ in Elisabeth Schmitt? The directive does...
Tout en soulignant que la responsabilité du fait d’un dispositif non conforme repose en premier lieu...
Op 1 maart 2017 werd een nieuw koninklijk besluit met betrekking tot geneesmiddelen voor geavanceerde therapie...
The United States and the European Union have agreed to recognize each other’s drug inspections. This...
Il existe plus de 500 000 types de dispositifs médicaux (y compris les dispositifs médicaux de...
In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose...
On 23 March 2017, the Belgian Council of Ministers approved the Multiannual Framework Agreement for Patients...
Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment...
Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation...
Yesterday, the 5th of April 2017, the EU Parliament has announced in its press release that...
In October 2016, we reported on Advocate General Sharpston’s Opinion in case C 219/15 Elisabeth Schmitt...
The Agreement allows EU and US regulators to rely on each other’s inspections in their own...
The European Commission (the “Commission”) published on 28 February 2017 a study on off-label use of...
The enforcement of second medical use patents is currently one of the hottest topics in European...
A complicating factor is that a product can have a different status between European member states....
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the...
While many of the details of the Regulations remain to be decided via so-called secondary legislation,...
CJEU and Belgian Supreme Court on the interaction between free movement of goods and trademark rights. On...
The Organisation for Economic Co-operation and Development (“OECD”) published on 16 January 2017 a 228-page report...