Brexit, AIFA on non compliant MAs

Following the exit of the United Kingdom from the European Union, the Italian Medicine Agency has informed that for medicinal product with MA holder, PSMF, QPPV, batch control and release sites for the finished product still located in the UK, and for which variations were not submitted nor pertinent actions were taken to ensure the compliance with the European regulations, […]

New EFSA regulation for transparency

The new Regulation EU 2019/1381, also known as “Transparency Regulation”, applicable as of 27 March 2021, will introduce important changes in the operational procedures of the European Food Safety Agency (EFSA). The scope of the new Regulation is to increase the transparency of risk assessment in the food chain, strengthening the reliability and objectivity of the studies submitted to EFSA, […]