The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.

Guidance is available for marketing authorisation holders, manufacturers and importers of human medicines on adaptations to the regulatory framework to address challenges of the COVID-19 pandemic.

A questions and answers document is created on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. The Questions and Answers document deals among other things with GMP certificates and manufacturing/import authorisations, a “distant assessment” conducted by an EU/EEA competent authority, the role and responsibilities for Qualified Persons (QP) (remote batch certification and remote audits),….


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