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 have to
- 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). Further information can be found at https://emvo-medicines.eu.
- enter into agreements with the National Medicines Verification Organisations (NMVOs) in the countries where they market their products. The NMVOs are responsible for setting up and operating the national databases.
MAHs are obliged to pay fees to the NMVOs within the framework of their contract. Registration in Switzerland is still voluntary.
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.
The persons authorised to dispense medicines to the public must register for the NMVS.
Software providers play an important role in updating the IT systems used by pharmacies, hospital pharmacies, healthcare facilities and other supply chain partners. They ensure that the people involved in the supply chain are able to verify and decommission medicine packs smoothly.
Software vendors wishing to link their applications to the NMVS should contact SMVS GmbH. After a registration process, software vendors can access the NMVS systems to develop, test and self-certify their applications in the Integrated Qualification Environment (IQE).