Serialisation: CH Requirements

Are there any requirements for the introduction of serialisation in Switzerland yet?

Swissmedic does not provide any specific guidelines in this respect. According to the new Swiss Medicinal Products Act (HMG) Art. 17a, this will continue to be on a voluntary basis. However, large pharmaceutical companies and the vips (Association of Pharmaceutical Companies in Switzerland) have established a corresponding organisation (Swiss Medicines Verification Organisation, SMVO) to serialise Swiss medicinal products. The system to be implemented in Switzerland (Swiss Medicines Verification System (SMVS)) will be connected to a European system, the European Hub (EU Hub), in order to ensure complete tracking of the individual pharmaceutical packages all over Europe. Delivery of serialised packs is planned for February 2019, at the same time as delivery to the EU.

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Dr. Katharina Oehler
Scientific and Managing Director

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