Regulatory expectations from MAHs during COVID-19
Q&A about regulatory expectations for medicinal products for human use during the COVID19 pandemic.
EMA and the European Commission have published a Q&A document that aims to provide guidance for marketing authorisation holders of medicinal products (MAHs) in relation to regulatory expectations and flexibility during the COVID-19 pandemic.
The document is constantly updated in order to adjust the content thereof to the evolution of the pandemic. The document has no expiry date so remains valid until notice is given.
PDF Link: Q&A Regulatory Guidance during COVID-19