COVID-19

Regulatory expectations during COVID-19 pandemic

Guidance is available for marketing authorisation holders, manufacturers and importers of human and veterinary medicines on adaptations to the regulatory framework to address challenges of the COVID-19 pandemic, including with GMP certificates and inspections:

• Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic
• Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic

In this context, for sites in the European Economic Area (EEA), GMP certificates and time-limited manufacturing and import authorisations are automatically extended until the end of 2021.

This does not waive manufacturers’ and importers’ obligations to comply with GMP standards.