Project Status on European Level

  • The European project is developing very positively and almost all affected EU member states are connected to the productive system of the EU hub.
  • Further information on the European implementation project can be found at

Project status of the National data storage Switzerland-Liechtenstein (3 October 2018)

Together with the EMVO (European Medicines Verification Organisation), the SMVO assumed at the start of the project that the Swiss data storage system (SMVS System) could be connected to the EU hub for data exchange without further conditions. In July 2018, however, the European Commission issued a written instruction to EMVO to only connect test systems to the EU hub that are based in an EEA country. Since Switzerland does not belong to the EEA, the originally planned connection of a Swiss-Liechtenstein data storage to the EU hub is not possible.

The stakeholders and EMVO, have developed a solution which meets the EU criteria for the connection of a Liechtenstein-Swiss data storage system.

These are:

  • Compliance with the Delegate Regulation (EU) 2016/161 with regard to system functionality, governance and implementation schedule.
  • Compliance with the EMVO User Requirements Specification.
  • The operation of a supranational system Liechtenstein-Switzerland.
  • The establishment of a responsible governance organisation in Liechtenstein (EEA area).

Based on the above criteria and thanks to the existing customs union between Switzerland and Liechtenstein, the proposed solution is as follows:

  • The associations of the Liechtenstein-Swiss manufacturers, wholesalers, and the tax authorities establish the registered association "LiMVO Liechtenstein Association for the Verification of Medicinal Products" in Liechtenstein.
  • The association LiMVO is the contractual partner of the EMVO for the implementation and operative operation.
  • The association LiMVO is responsible for the implementation of the national blueprint testing system "Liechtenstein Medicines Verification System" (LiMVS) developed by Solidsoft-Reply.
  • SMVS GmbH remains the cooperation partner of the Swiss pharmaceutical companies and finances LiMVO and the operation of the LiMVS data storage with their contribution payments.

On September 20, 2018, the SMVO Board unanimously approved the proposed solution. Although the Federal Office of Public Health is not yet in a position to make a definitive statement until Art. 17a HMG and the associated ordinance come into force, it is generally in favour of the project. The consent of the Liechtenstein Ministry of Society is required for a short-term implementation of the SMVO Board Decision. An official request to the Ministry has already been made by the SMVO.

The connection of the LiMVS requires the completion of two assessments in order to guarantee the corresponding quality, user and IT requirements.

  • The Assessment I (proof of QM system) was passed.
  • For the Assessment II (proof of user and IT requirements) the LiMVO must first be founded and the license agreement with Solidsoft Reply signed.

What does this delay mean for the implementation project of the Liechtenstein-Swiss data storage system?

  • Software service providers who want to test their pharmacy, doctor's practice, hospital or wholesaler solutions with LiMVS can carry out these tests on the integrated test system (ITE) until the completion of Assessment II.
  • The quality (IQE) and the production system (PRD) are only activated after Assessment II

Important information for manufacturers

  • Serial numbers with the target market Liechtenstein-Switzerland that have already been uploaded to the EU hub are not automatically forwarded to the future LiMVS productive system and must be uploaded again as soon as the LiMVS is connected to the EU hub.
  • It is therefore recommended that manufacturers only upload serial numbers for the target market Liechtenstein-Switzerland to the EU hub after the Liechtenstein-Swiss data storage system is productive.

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