Information for Marketing Authorisation Holders

      Marketing Authorization Holders (MAHs) are responsible for ensuring that prescription-only medicinal products marketed in the EU bear the safety features "Unique Identifier" (UI) and a so-called "Anti Tampering Device" (ATD).

      For products that are approved for the Swiss-Liechtenstein customs union market, the affixing of the two security features is currently not mandatory, but desirable.

      How manufacturers and marketing authorization holders (MAH) participate in the system

      • Manufacturers register with the European Medicines Verification Organization (EMVO) in order to connect to the European Hub (EU Hub). There they also define the MAHs for the respective target markets and upload the corresponding product and packaging information via the EU Hub to the National Medicines Verification Systems (NMVS) of the target markets. Further information can be found at https://emvo-medicines.eu.
      • MAHs conclude contracts with the National Medicines Verification Organizations (NMVOs) in the countries in which they market their products.
      • For Switzerland, MAHs conclude the contract with the operating company (SMVS GmbH).
      • Under a contract with SMVS GmbH, MAHs are obliged to pay fees to SMVS GmbH. The fee model can be found here.

      How the contract with SMVS GmbH is concluded

      1. Download sample cooperation agreement in advance
      Please note that only the German version is legally binding.

      2. Request and return the signed cooperation agreement
      Please request the cooperation agreement signed by SMVS GmbH. Based on the data provided, SMVS GmbH will send you two signed copies of the contract. Please return one signed copy to SMVS GmbH. Electronic signatures are accepted.

      Request cooperation agreement

       

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