Swissmedic: SMS Registration Becomes Prerequisite for GMP Certificates
As of 15 November 2026, active substances must be registered in the EMA's Substance Management Services (SMS) database before Swissmedic can include them in establishment licences and GMP certificates for active substance manufacturers. The new requirement results from modifications to the EudraGMDP database.
It applies to first-time issuance as well as changes to existing licences and certificates issued following inspections. Affected active substance manufacturers should therefore verify now that all active substances listed in their establishment licences or GMP certificates are correctly registered in SMS. For new or amended applications, the active substance name as registered in SMS and the corresponding SMS ID must be submitted to Swissmedic in English.
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