The European Union (EU) has mandated its member states and the countries of the European Economic Area (EEA) to implement verification for certain medicines through a Europe-wide interconnected database system.

Since February 9, 2019, strict requirements have been in force in the EU: all prescription-only human medicines must be equipped with safety features. These features ensure the uniqueness of a medicine pack and prevent counterfeit medicines from entering the legal supply chain. The verification of these safety features is carried out by scanning a Datamatrix code at dispensing points, such as pharmacies, medical practices with in-house pharmacies, or hospitals, before the medicine is dispensed.

For this process, a national data storage system (National Medicines Verification System, NMVS) must be set up in each participating country. All national data storage systems are connected to the EU Hub managed by the European Medicines Verification Organisation (EMVO), creating an interconnected network.

System architecture and data flows of the pan-European system (EU Hub and National Systems)

The EMVO, as well as the National Medicines Verification Organisations (NMVOs), are established as private, non-profit organizations.

As an operational organization, SMVO founded the "SMVS Swiss Medicines Verification Organisation GmbH" (SMVS GmbH). SMVS GmbH provides services related to the national verification system (NMVS) to all affected parties and organisations in Switzerland and Liechtenstein.

System status

• All affected EU and EEA member countries are connected to the productive system of the EU Hub.
• The CH-LIE system has been operational since February 15, 2019, and is connected to the EU Hub.
• End users can register with the NMVS and use the system.
• Software providers can connect their solutions to the NMVS.
• Marketing Authorization Holders (MAHs) can upload data for the target market "CH" if they have signed a contract with SMVS GmbH.
• For further information on the European system, please visit www.emvo-medicines.eu.