EMA appeals interim measures under Transparency Regulation

The European Medicines Agency has appealed two interim orders by the President of the General Court of the European Union to suspend the release of documents requested by third parties under Regulation (EC) no 1049/2001, the so-called “Transparency Regulation,” saying that new judicial decisions are at odds with EMA’s efforts to allow access to documents on medicines.

The first order blocked the release of a clinical study report for Translarna (ataluren), a centrally-authorized medicine for the treatment of Duchenne 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 documents request, with appropriate redactions in accordance with the Regulation.

The second order, issued at the same time, blocked the release of three toxicity studies for Bravecto, a veterinary medicine used to treat flea and tick infestations in dogs and cats.