• Increased safety for patients
    Increased safety for patients

    New EU-wide safety features for medicines also increase patient safety in Switzerland.

  • Efficient detection of counterfeits
    Efficient detection of counterfeits

    Using unique serial numbers and bar code scanners, drug packs are identified and counterfeits are safely detected.

  • Investment for more security
    Investment for more security

    For all stakeholders in the health care sector: drug manufacturers, pharmaceutical wholesalers, hospitals, pharmacies, doctors and patients.

  • Optimal protection of the supply chain
    Optimal protection of the supply chain

    New security features: Serialized packs and additional manipulation protection for legally produced medicines increase the supply chain security.

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Roles and tasks of the parties involved in the implementation of the "Falsified Medicines Directive" in Liechtenstein and Switzerland


Marketing Authorisation Holder

The Marketing Authorisation Holder (MAH) is responsible for ensuring that medicinal products marketed in the EU must have the safety features "Unique Identifier" (UI) and an "Anti Tampering Device" (ATD) from 9 February 2019. For products approved for the Swiss-Liechtenstein customs union market, the application of the two security features is not yet mandatory, but desirable. The MAHs must. The MAHs must

  • register with the European Medicines Verification Organisation (EMVO) to join the European Medicines Verification System (EMVS). The EMVS enables the upload of UIs via the European hub to the National Medicines Verification Systems (NMVS). Many MAHs have already connected to the EMVS or are in the process of completing this process. Further information can be found at https://emvo-medicines.eu.
  • MAHs must conclude contracts with the national organisations, the NMVOs, in which they market their products. The NMVOs are responsible for setting up and operating the national databases.

MAHs have no access to the NMVS or to the data contained therein. MAHs are obliged under their contract to pay fees to the NMVOs. Registration in Switzerland is still on a voluntary basis. The registration documents can be downloaded here: https://smvo.ch/en/about-smvo/application-documents-for-joining-the-smvs.html

It is important that all affected MAHs register in time with the EMVO and the NMVOs in order to avoid bottlenecks and to ensure market access and supply from 9 February 2019.


Manufacturing and Import Licences Holders

From 9 February 2019, manufacturers, including parallel importers, must have updated their production lines to ensure that products released for sale or distribution from that date have the required safety features. From the time that products are provided with safety features and these have been uploaded to the EMCS, manufacturers must also keep records of the activities they perform with the corresponding products.


Wholesalers and parallel traders

Wholesalers and parallel traders must update their computer systems so that they can connect to national databases in order to perform their tasks in the context of the overall process.

The tasks of wholesalers and parallel traders include, for example

  • the risk-based verification of packages purchased from wholesalers not designated by the MAH, the manufacturer or by the MAH
  • the decommissioning of packages, if they are exported
  • under certain circumstances, the decommissioning of packages on behalf of persons entitled to tax

 

Persons authorised to supply medicinal products to the public (end-users)

Pharmacies, hospital pharmacies and health care facilities, as well as self-dispensing medical practices (SDAs) play a crucial role in ensuring the authenticity of medicines delivered to patients. At the time of delivery (to pharmacies) or upon receipt of medicines (hospital pharmacies or health facilities), they must check the security features and decommission the package with the unique identifier in the national database.

The verification of the security features and the decommissioning of unique identifiers requires registration with the NMVS and the purchase of 2D barcode scanners to read the unique identifier, as well as the updating of the software to connect to the database system. Due to the large quantities of medicines they handle, hospital pharmacies must also ensure that they can check individual packs quickly and efficiently.

In the EU, persons entitled to dispense medicines with security features may only do so if they have checked the security features and decommissioned the unique identifier.

 

HinweisThe persons entitled to dispense medicines to the public must register for the Swiss-Liechtenstein database system. Further information on this will soon be published on our website https://smvo.ch .



Software Provider

Software providers also play an important role in updating the IT systems used by pharmacies, hospital pharmacies, healthcare facilities and other supply chain players. They ensure that the people involved in the supply chain are able to check and decommission medicine packs smoothly.

Hinweis

Software vendors wishing to link their applications to the Liechtenstein-Switzerland national database system should contact SMVS GmbH by e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it. After a registration process, software vendors can access the Liechtenstein-Switzerland ITE system to develop and test their application interfaces.

Das europäsiche Verifizierungsnetzwerk

The European Verification Network

 

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