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  1. pharma services oehler
22 October 2018

Serialisation: CH Requirements

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

A: Swissmedic does not provide any specific guidelines in this respect. According to the new Swiss Medicinal Products Act (HMG) Article 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 corresponding organisation Swiss Medicines Verification Organisation (SMVO) to serialise Swiss medicinal products.

The SMVS system to be implemented in Switzerland will be connected to the EU Hub 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.

This white paper highlights what it takes to bring a drug to the Swiss market, including the marketing authorisation application MAA), preapproval and launch preparation...
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