The European Project

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

From 9 February 2019, strict regulations will apply in the EU: all prescription medicines for human use must be provided with safety features. These ensure the uniqueness of a pharmaceutical package and ensure that counterfeit medicines cannot enter the legal supply chain. The safety 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.

Slider E Architektur 1System architecture and data flow of the complete European System (EU Hub and National Systems)

The Swiss Project

With Art. 17a HMG, Switzerland has a law that is equivalent to the European Directive 2011/62/EU, but it provides for voluntary application of the safety features on the one hand and testing and decommissioning on the other. In addition, the law is not expected to enter into force until the end of 2019, together with the corresponding ordinance. 

Furthermore, Switzerland is neither a member of the EU nor the EEA and therefore cannot, as originally planned, connect a Swiss Medicines Verification System (SMVS) to the EU hub as a national data storage system for the Swiss and Liechtenstein markets. 

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.

Against this background, on 4 April 2018 the representatives of the Swiss health care associations founded the SMVO Swiss Association for the Verification of Medicinal Products (SMVO) as a non-profit association.

The SMVO is committed to the binding implementation of Art. 17a HMG and will therefore play an active role in the consultation process of the implementing ordinance. The SMVO is also the point of contact for the competent Swiss authorities for questions concerning the establishment and operation of the national database storage system.

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.

Pharmaceutical companies and users of the future system can find further information on the current situation in Switzerland in the FAQ section.

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