Swissmedic specifies Requirements for EU-GMP Certificates

The European Medicines Agency (EMA) has granted an automatic, across-the-board extension for GMP Certificates issued in the EudraGMDP Database until the end of 2023. This is accepted by Swissmedic.

Background

For companies with a valid establishment licence for the manufacture of medicinal products and transplant products, Swissmedic issues GMP Certificates on request. GMP Certificates from Swissmedic show the date of the inspection on which the certificate is based. They do not contain an expiry date. However, in accordance with the practice for GMP Certificates in the EU database EudraGMDP, it is often assumed by the companies or by other authorities that GMP Gertificates based on an inspection which took place more than 3 years ago are no longer meaningful in terms of compliance status and therefore lose their validity.

Swissmedic GMP Gertificates

Although the coronavirus crisis created a complicated situation for inspections, the planned routine inspections in Switzerland were carried out, and the usual inspection intervals were maintained. Consequently, there is no longer any need to generally extend the validity dates on Swissmedic GMP Certificates.

Information about the currently valid establishment licence and the date of the last inspection is available on the Swissmedic website for all companies that have an establishment licence in accordance with the new legislation.

Swissmedic refers to licences issued under the new legislation.

Source: Swissmedic