The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector.
Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.
After a 15-month prison sentence, the owner of Immuno Biotech is now threatened with the seizure of GBP 1.4 million in connection with the manufacture, sale and supply of an unlicensed drug.
EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.