We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

EMA Publishes New Union Procedure on the Management of Pharmacovigilance Inspection Findings

July 2014

Focus on Regulation - Hogan Lovells Blog

On 20 June 2014, the European Medicines Agency (hereafter “EMA”) published a new European Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products (“new EU Procedure”). The new EU Procedure came into effect on 1 June 2014.

To read the full article please click here.

Loading data