The Medicines Verification System is a pan-European system which aims to prevent falsified medicines from entering the legal supply chain. The requirement to build the system is based on EU legislation, namely The Falsified Medicines Directive (FMD) as well as the specifying Delegated Regulation.
The scope of the legislation is mainly with prescription medicines but the Delegated Regulation specifies some exceptions. The exceptions are listed in an annex to the Regulation. Special license products which are brought on the market from outside the EU, are not in scope.
The EU legislation clearly defines that data in the system belongs only to the supply chain actor that generates it. Different parties cannot access each other's data. Personal data is not handled within the system.
The Medicines Verification System consists of a European central repository, in which pharmaceutical manufacturers and parallel traders enter the unique identifier information about the medicine pack. All EU countries (+ EEA countries) have their own national repositories to which the EU Hub will feed information. The national systems are used by local actors in the pharmaceutical supply chain, i.e. wholesalers, pharmacies, hospital pharmacies and private dispensaries.
The EU Hub and national repositories contain information about the unique identifier on the medicines packs. The unique identifier consists of:
- product code (GTIN)
- unique serialised code
- batch number
- expiry date
Information on the pack is compared to the information in the repositories system to verify the pack is not falsified.
The national systems interact with each other via the EU Hub. This ensures the safety of multi-market packs. Also parallel traded packs can be correctly verified. In addition to this, a pan-European system is an efficient tool in case of a recall situation.
The National Agency for Medicines FIMEA supervises the system in Finland.
Timetable for setting up the system
The verification system is legally required to be operational by 09.02.2019. However, our aim is that the Finnish system will be fully operational in November 2018.
Governance of the system
The European legislation states that the system is governed by non-profit organisations.
The European Medicines Verification Organisation was formed to govern the central repository, the Hub. EMVO's members are organisations representing the pharmaceutical industry, pharmacies, wholesalers and hospital pharmacies.
A list of the national organisations i.e. NMVO's can be found on EMVO's website.