1 October 2026
Swissmedic: Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances
As of 15 November 2026, the prior registration of active substances in the EMA SMS database (Substances Management Services) will become a mandatory requirement for their inclusion in establishment licences and GMP certificates. This requirement applies to initial applications, changes to existing establishment licences, and the issuance of documents following inspections. Manufacturers must therefore ensure that all active substances listed in their establishment licences or GMP certificates are registered in the SMS database and, for new or amended applications, submit the active substance name and corresponding SMS ID to Swissmedic in English.
For more information, see here.
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