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 https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic.
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.