Swissmedic clarifies Validity of GMP Certificates during the COVID-19 Pandemic

The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic:

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 certificates 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.

In recent months, as a result of the corona crisis, a decision is taken in each individual case, based on a risk analysis with a slightly different approach depending the pandemic situation, as to whether a planned and due routine inspection is actually undertaken or not. This means that the usual frequency of inspections cannot always be guaranteed. Swissmedic would like to make it clear that GMP certificates issued by Swissmedic and based on a routine GMP inspection in 2017 or 2018 will remain fully valid until the end of 2021 (or until the next routine inspection), provided the scope of activities described in the certificates corresponds to the currently valid establishment licence.
Information about the currently valid establishment licence and the date of the last inspection - in respect of all companies that have an establishment licence in accordance with the new legislation - can be viewed on the Swissmedic website.

Source: Swissmedic press release

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