No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier
On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application.
However, the CJEU indicated that certain information may be protected if the interested party can specifically show that the disclosure will cause it harm. This is the first time the CJEU has ruled on this matter, upholding the EMA’s approach to handling access to documents requests.
