European Medicines Regulatory Network (EMRN) COVID-19 Business Continuity Plan

The COVID-19 pandemic has been affecting the whole European Medicines Regulatory Network (EMRN) (regulatory network of National Competent Authorities (NCAs) of the Member States (MSs) of the European Economic Area (EEA), the European Medicines Agency (EMA) and the European Commission (EC)), albeit to a different extent and not necessarily at the same time. Several factors have to be taken into account, such as the resources needed to respond to the pandemic as well as the unavailability of staff due to illness or the need to look after children or sick family members.

The aim of this document is to describe

• the agreement reached within the EMRN as to the principles for the handling of regulatory procedures in a business continuity context in the frame of the COVID-19 pandemic;
• how these arrangements are implemented for both centrally (CAPs) and nationally authorized products (NAPs).

The arrangements for CAPs and EMA procedures are provided in Annex 1, for NAPs-human medicines in Annex 2, and for NAPs-veterinary medicines in Annex 3.