Making prescription medications safer against counterfeiting – this is the objective of the delegated regulation (EU) 2016/161. It is accompanied by new security features for pharmaceutical packaging and a data storage system for all EU and EEA member states.

All EEA countries are connected to the EU-Hub

Since February 9, 2019, national data storage systems have been implemented in all EU countries. This is intended to prevent counterfeiters from clandestinely introducing their potentially deadly imitations of medications into the legal supply chain.

Legal situation in Switzerland

On September 26, 2023, the Federal Parliament adopted the motion by Councilor Erich Ettlin (The Center, OW) 22.3859 "Master Plan for the Digital Transformation of the Healthcare System. Use of Legal Standards and Existing Data."

The Federal Council has been mandated to make the application and verification of security features on human medication packaging mandatory, in line with the EU, through the ordinance on unique identifiers and anti-tampering devices.

More about the current legal situation can be found here.

The SMVO is responsible for implementing the system in Switzerland

The Swiss Association for the Verification of Medicines (SMVO) was founded on April 4, 2018, with the aim of establishing a national database for Switzerland and Liechtenstein. The association is also committed to promoting a binding implementation of Article 17a of the LPTh.

For the operation of the NMVS, SMVO has founded the «SMVS Schweizerische Gesellschaft für die Verifizierung von Arzneimittel GmbH» (SMVS GmbH). The company offers services related to the national verification system (NMVS) to all relevant parties and organizations in Switzerland and Liechtenstein.

Responsibilities of the participants

Concerned participants, such as pharmacies, hospital pharmacies, doctors, pre-wholesalers, wholesalers, blister packaging service providers, and software suppliers, play important roles in the implementation process.