The European System

The European Union (EU) obliges its member states and the states of the European Economic Area (EEA) to introduce a verification system for certain drugs via a Europe-wide networked database system.

Since 9 February 2019, strict regulations have been in force in the EU: all prescription medicines for human use must be provided with safety features. These ensure the uniqueness of a pharmaceutical package and prevent counterfeit medicines from entering the legal supply chain. The security features are checked by scanning a Datamatrix code at the points of sale, such as pharmacies, doctors' surgeries or hospitals, before dispensing the medicine.

For this process, a National Medicines Verification System (NMVS) must be established in each participating country. All national data storage systems are connected to the EU hub of the European Medicines Verification Organisation (EMVO) and thus networked with each other.

System architecture and data flow of the complete European System (EU Hub and National Systems)

The Swiss System

Although art. 17a of the TPA gives Switzerland a law equivalent to the European Directive 2011/62/EU, until now it still provided for the optional application of safety devices on the one hand and verification or decommissioning on the other. On 26.9.2023, the Federal Parliament passed the motion of Council of States member Erich Ettlin 22.3859 "Master plan for digital transformation in healthcare. Use of legal standards and existing data".

Among other things, the Federal Council was instructed to make the application and verification of safety features and devices - the same as in the EU - mandatory in the ordinance on individual identification features and safety devices on the packaging of medicinal products for human use.

For the Swiss stakeholders (representative associations of the pharmaceutical industry, pharmacies, doctors, hospitals and hospital pharmacists, as well as pharmaceutical wholesalers), both the timely implementation and the connection of the national data storage to the EU hub are important for the following reasons, among others:

• For pharmaceutical manufacturers, the time-consuming on-boarding process only takes place once for the EU and for Switzerland and Liechtenstein.
• Thanks to the so-called "intermarket queries", the persons entitled to supply medicines can check the authenticity of medicinal products imported from the EU which are missing in Switzerland and Liechtenstein - e.g. due to supply shortages - but can not decommission them, since they must be decommissioned when they are exported from the EU.
• Switzerland, as an important player in the development and manufacture of medicines, must not remain inactive in the fight against the penetration of counterfeit medicines into Switzerland and Europe.

The SMVO has founded the "SMVS Schweizerische Gesellschaft für die Verifizierung von Arzneimittel GmbH" (SMVS GmbH) as an operational organisation. SMVS GmbH offers all affected bodies and organisations in Switzerland and Liechtenstein services related to the establishment of a national data storage system and its connection to it.