26/04/2020
The European Commission and EMA have agreed 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.
Current national and international safety measures and travel restrictions affect or prevent the conduct of on-site inspections related to good manufacturing (GMP) and distribution practice (GDP). The mitigation measures have been taken to ensure the continued availability of medicines while making sure that good practice standards are being adhered to. This is achieved through proportionate approaches to verification of standards by enabling remote assessments of compliance.
For instance, 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.
If needed, inspections will be carried out remotely to support such extensions, with on-site inspections carried out as soon as feasible.
