Op 1 maart 2017 werd een nieuw koninklijk besluit met betrekking tot geneesmiddelen voor geavanceerde therapie in het Belgisch Staatsblad gepubliceerd. Onder “geneesmiddelen voor geavanceerde therapie” wordt verstaan een geneesmiddel voor gentherapie, een geneesmiddel voor somatische celtherapie of een weefselmanipulatieproduct dat een product is dat (gedeeltelijk) uit gemanipuleerde cellen of
The United States and the European Union have agreed to recognize each other’s drug inspections. This mutual recognition is based on the legal framework of their Mutual Recognition Agreement of 1998. More specifically, the Parties have amended the Pharmaceutical Annex to the Agreement. This amendment was adopted on 1 March
On 23 March 2017, the Belgian Council of Ministers approved the Multiannual Framework Agreement for Patients (Meerjarenkader voor de patient) that was signed by the Belgian Minister of Health and the Belgian pharmacists associations, APB and OPHACO, on 15 March 2017. The agreement aims to implement optimal pharmaceutical care for
Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the European Medicines Agency (EMA) has issued additional guidance and recommendations as part of its commitment to continuous process improvement. PSURs are reports that evaluate the benefit-risk balance
The Agreement allows EU and US regulators to rely on each other’s inspections in their own territories. A Party to the Agreement shall recognize pharmaceutical inspections and accept official GMP documents issued by a recognized authority of the other Party for manufacturing facilities located in their territory. The recognized authorities
The European Commission (the "Commission") published on 28 February 2017 a study on off-label use of medicinal products in the European Union (the "Study"). The Study is mainly descriptive in nature even though it offers a few recommendations. It provides information on the prevalence and incidence of off-label use; describes
The enforcement of second medical use patents is currently one of the hottest topics in European patent litigation. The dispute concerning Warner-Lambert’s patent for the use of pregabalin to treat pain has been very active in Europe and elsewhere since 2014 and has clarified a number of issues in relation
A complicating factor is that a product can have a different status between European member states. European case law, for example, confirms that what one member state could classify (and regulate) as a medicinal product, another could classify as a medical device. The implications for this is that it may
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health. The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices.
CJEU and Belgian Supreme Court on the interaction between free movement of goods and trademark rights. On November 7, 2016 the Belgian Supreme Court (Cour de cassation – Hof van cassatie) gave judgment in two cases regarding the repackaging of pharmaceuticals, wherein it ruled in favour of the parallel importer with