Tag Archives: disclosure

The Court of Justice of the EU Adopts a Broad Interpretation of the Information on Emissions into the Environment that Authorities Must Disclose to the Public

Last week the Court of Justice of the European Union (“CJEU”) upheld a broad interpretation of the concept of “information that relates to emissions into the environment” that EU and Member State authorities (e.g., ECHA, EFSA, Commission, national environmental agencies) must disclose to the public.  According to the CJEU, the information that must be disclosed … Continue Reading

EMA Publishes Proactive Disclosure Guidance

On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070).  The latest Proactive Disclosure Guidance can be found here and focuses on: Procedural aspects of submitting clinical reports. The anonymisation of clinical reports. The identification and redaction of commercially confidential information … Continue Reading

General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case

Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post. On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation … Continue Reading
LexBlog