The aim of Delegated Regulation (EU) 2016/161 is to provide reliable protection for medicines against counterfeiting by introducing new safety features for pharmaceutical packaging and a comprehensive data storage system for all EU and EEA member states.

Since 9 February 2019, national data repositories connected to the EU hub have been in operation in allmost all EEA countries (except in Italy and Greece, which are to be connected from 2025) and Switzerland. This will make it impossible for counterfeiters to smuggle their - sometimes life-threatening - imitation medicines into the legal supply chain.

The legal situation in Switzerland

The adoption of the motion by Councillor of States Erich Ettlin 22.3859 "Masterplan for digital transformation in the healthcare sector. Use of legal standards and existing data" of 26 September 2023 by the Federal Parliament, the affixing and verification of safety features and devices on the packaging of prescription-only medicinal products for human use was declared mandatory. You can find out more about the legal situation here.

SMVO and SMVS

The "SMVO Swiss Association for the Verification of Medicines" (SMVO) was founded on 4 April 2018 with the aim of introducing counterfeit protection for medicines in Switzerland. The association works in coordination with all stakeholders to ensure that the mandatory serialisation of all prescription medicines in Switzerland is implemented in a profitable and resource-efficient manner.

The SMVO has founded "SMVS Schweizerische Gesellschaft für die Verifizierung von Arzneimittel GmbH" (SMVS GmbH) to operate the national medicines database system. The SMVS offers services and implementation support to all relevant bodies and organisations in Switzerland and Liechtenstein.

You can find out more about how the database system works here.