EMA Q&A Document on Regulatory Flexibility: Updates on GMP/GDP

The European Commission, EMA and the national competent authorities 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. The measures are detailed in the latest version of the Q&A document.

We want to raise your attention to the following decision: the validity of GMP certificates and time-limited manufacturing and import authorisations, as well as the validity of GDP certificates and time-limited wholesale authorisations will be extended until the end of 2021.

More information is available on the EMA’s website: https://www.ema.europa.eu/en/news/update-guidance-regulatory-expectations-context-covid-19-pandemic