News - April 14, 2020

Q&A Document on Regulatory Expectations during COVID-19

The European Commission, EMA and the European medicines regulatory network have developed a question and answer guidance document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. You can access the guidance online here

The Q&A document includes information on legal and regulatory guidance on

  • MAs/MAs procedures;
  • manufacturing and importation of Finish Product and Active pharmaceutical ingredients with an Exceptional Change Management Process (ECMP) being introduced;
  • quality variations;
  • product information and labelling.

This document is a living document which will be updated as required. EUCOPE will report any comments from its member companies at the weekly calls with the EMA and national authorities on the COVID-19 crisis and its impact on the regulatory environment for medicines in Europe.