Swissmedic: Validity of GMP Certificates
Swissmedic announced on 23 January that companies with a valid manufacturing licence for the manufacture of medicinal products can apply for a GMP certificate. The certificates do not contain a validity date, but the date of the GMP inspection.
Following the practice for GMP certificates in the EU database EudraGMDP, however, it is often assumed by companies or other authorities that GMP certificates which are based on an inspection more than 3 years in the past lack informative value about the compliance status and therefore lose their validity.
Scheduled routine inspections were carried out even during the pandemic and therefore the usual inspection intervals could be adhered to.
On the Swissmedic website, all information on the currently valid authorisations and the most recently conducted inspections for companies with an operating license under the new law can be viewed.
The EMA has automatically extended the GMP certificates issued in the EudraGMDP database on a general basis until the end of 2023, which is accepted by Swissmedic.
Source:
Swissmedic: News
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