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QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC

The current COVID-19 pandemic has a considerable impact on citizens, patients and businesses. It may force marketing authorisation holders of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. Moreover, public health needs may require quick actions or re-prioritisation of operations.


The ultimate aim of the EU legislation on medicinal products is to ensure a high level of public health.

The COVID-19 pandemic is posing unprecedented challenges and ensuring continuity of supplies of medicines is a priority for public health. Therefore, it is necessary to articulate appropriate measures to minimise risks of shortages while ensuring that the high standards of quality, safety and efficacy of medicines made available to patients in the EU are maintained.

This document provides guidance to marketing authorisation holders of medicinal products for human use (“MAH”) on regulatory expectations and flexibility during the COVID-19 pandemic. The document will be updated to address new questions and to adjust the content thereof to the evolution of the pandemic. For queries related to specific products that are not specifically addressed in this document, MAHs are invited to address the European Medicines Agency (for centrally authorised products) or the relevant national competent authorities (for nationally authorised products).

This document remains valid until further notice. It has been developed in cooperation between the European Commission, the Coordination group for Mutual recognition and Decentralised procedures – human (“CMDh”), the Inspectors Working Group and the European Medicines Agency (“EMA”).

The ultimate responsibility for the interpretation of EU legislation is vested on the European Court of Justice and therefore the content of this document is without prejudice to a different interpretation that may be issued by the European Court of Justice.

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