The Q&A document provides guidance to MAHs (marketing authorisation holders) of medicinal products on regulatory expectations and flexibility during the COVID-19 pandemic. The document will be updated to address new questions and to adjust the content to the evolution of the pandemic.For queries related to specific products that arenot specifically addressed in this document, MAHs are invited to address the EMA (for centrally authorised products) or the relevant national competent authorities (for nationally authorised products).
Marketing authorisation holders are advised to regularly check the EMA-page on COVID-19 for any new information.
EMA: Task Force
EMA: COVID-19 page
> Do not hesitate, we look forward to your feedback!
Write a comment on this news.