Webinar video | Life Sciences Session #8: Global MAs and regulatory data protection a substantive and procedural challenge
Our speakers will explain the judgment’s impact on whether a new medicinal product is entitled to a separate initial marketing authorisation, or belongs to the same global marketing authorisation as an earlier medicinal product. In other words, can the new medicinal product benefit from its own regulatory data protection period or not?
The judgment is furthermore not only interesting from a substantive point of view, but also contains some interesting examples on the pitfalls that may arise under EU procedural law in challenging decisions from the European Commission, whether in this area or others.
Are parallel importers necessarily allowed to rebox medicines in case of visible traces from ATDs? The CJEU says NO
Pharmaceutical companies are obliged to affix an anti-tampering device (‘ATD’) on prescription-only medicines to enable verification of whether a medicine’s packaging has been tampered with. Parallel importers argue that this results in an overarching objective necessity to ‘rebox’ such medicines.Read on
If a branded medicine and its generic version are put on the EEA market by economically-linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? After the Brussels Court of Appeal had referred questions on this issue for a preliminary ruling two years ago, the CJEU has now clarified the limits.Read on
A new Act, which includes various provisions on incapacity for work, was published in the Belgian State Gazette on 18 November 2022.Read on