General Court confirms EMA approach to transparency

Three rulings clarify the scope of commercial confidentiality with regard to authorized medicines

The General Court delivered three landmark rulings for the European Medicines Agency (EMA), upholding EMA’s decisions to release documents requested in accordance with Regulation (EC) No 1049/2001, the so-called “Transparency Regulation”.

This is the first time that the Court of Justice of the European Union has had the opportunity to pronounce itself on the application of the Transparency Regulation to documents held by EMA.

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