On April 21, EMA has released a document providing recommendations to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders – Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic published by the European Commission and the guidance regarding COVID-19 related terms published by the MedDRA MSSO.
Brexit updates for human use medicinal products approved via MRP/DCP
December 21, 2020
As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.
