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New judicial decisions at odds with EMA’s efforts to allow access to documents on medicines

The European Medicines Agency (EMA) has appealed two interim orders by the President of the General Court of the European Union (EU) to suspend the release of documents requested by third parties under Regulation (EC) no. 1049/2001, the so-called “Transparency Regulation”. The first order blocked the release of a clinical study report for Translarna, a centrally authorised medicine for the treatment of Duchenne’s muscular dystrophy, until a final ruling is given by the General Court. EMA was planning to provide access to the clinical study report in response to an access to documentsrequest, with appropriate redactions in accordance with the Regulation.

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