News about GMP/cGMP

11.03.2022

Swissmedic: Validity of GMP certificates during COVID

Swissmedic: Validity of GMP certificates during COVID

Swissmedic announces the following regarding the validity of GMP certificates:

"The GMP certificates issued by Swissmedic list the date of the underlying inspection. They do not contain a validity date. However, following the practice for GMP certificates in the EU database EudraGMDP, it is often assumed by companies or other authorities that GMP certificates based on an inspection more than 3 years ago lose their informative value about the compliance status and therefore lose their validity."


Furthermore, the Swiss authority points out that the planned routine inspections in Switzerland were carried out despite Corona and that the usual inspection intervals could be observed. A general extension of the validity of GMP certificates is thus no longer needed. Information on the currently valid authorisation and the date of the last inspection is available on the Swissmedic website for all companies in possession of an operating authorisation under the new law.

Please note: GMP certificates of the EMA (European Medicine Agency) from the EU database EudraGMDP

EMA has granted an automatic, across-the-board extension for GMP certificates issued in the EudraGMDP database until the end of 2022. This is accepted by Swissmedic.


Source:

Swissmedic: News


 

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