The European Medicines Agency has issued new guidance to industry on Brexit, warning that all products under review by the UK regulatory authority will need to be transferred to rapporteurs or co-rapporteurs from the other EU member states. The rapporteur is the leader of the scientific team that evaluates applications from companies for marketing authorisations. The activities of this team are supported by the EMA secretariat. Once outside the EU, the UK’s Medicines and Healthcare products Regulatory Agency will no longer be eligible to participate in these evaluations.
