Coronavirus: consequences for GMP and GDP inspections and certificates


The coronavirus outbreak also has consequences for the inspections of the production and distribution of medicines. The Health and Youth Care Inspectorate (IGJ) is not carrying out these so-called GMP and GDP inspections for the time being.

This applies only to routine inspections carried out periodically by the IGJ with regard to holders of a manufacturing licence for medicines. In urgent situations, for example after receiving a report, the IGJ can still carry out a GMP or GDP inspection. The Inspectorate evaluates on a case-by-case basis whether a GMP or GDP inspection is needed.

For every inspection scheduled up to and including 28 April, the IGJ will determine whether a GMP or GDP certificate of limited validity will be issued. These GMP or GDP certificates of limited validity will be entered into the EUDRAGMDP database. Manufacturers and wholesalers with licences will receive these certificates. As is the case for final reports, the inspectors will not, for the time being, sign these GMP or GDP certificates with a physical signature. A statement to that effect appears on the certificate.