6 February 2018 - Three rulings clarify the scope of commercial confidentiality with regard to authorised medicines

The General Court delivered today three landmark rulings for the 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. “We are very pleased that the General Court affirmed that the information contained in these documents cannot be considered commercially confidential in its entirety”, explained Stefano Marino, EMA’s Head of Legal Department. “We understand that with these rulings the General Court endorses our implementation of the Transparency Regulation that focuses on the interest of patients and public health”.

Read EMA press release