WEBINAR VIDEO | Life Sciences Session #8: Global MAs and regulatory data protection – a substantive and procedural challenge


Visuals YOUTUBE lss 8


During this session, our speakers Philippe de Jong and Kirian Claeyé will discuss the interesting judgment of the General Court in Polpharma v. EMA.

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.


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