Falsified medicines are a health risk.
The Medicines Verification System protects patients from falsified medicines and safeguards patient safety.
For a pharmacy to dispense or a pharma wholesaler to distribute medicines, they must be connected to the Finnish medicines verification system. The verification system is linked to the entire pharmaceutical supply chain and aims to prevent falsification from entering the legal supply chain.
When you buy medicines from a legal (online) pharmacy, you can be sure that the product is checked against falsification.
This is how it works
All prescription medicine packs must have safety features.
Pharmaceutical companies equip their packs with unique identifiers. The pack must also include features that reveal if the pack has been unlawfully opened (anti-tampering device, ATD). The unique information on the pack consists of the unique serial number and product code. This information can be found in the 2D code that is on the pack. In addition, the 2D code contains the batch number and the expiry date.
In a pharmacy, the information on the pack is compared with data in the verification system. When a pharmacist scans the 2D code on the pack, the system notifies if there is an alert that the information does not match. The pharmacist will also check the ATD (e.g. seal or tear band) is intact. After that, the medicines can be safely dispensed to the patient.
The National Competent authority monitors patient safety through legislation
The requirement for the verification system is based on EU legislation, i.e. the Falsified Medicines Directive, and a delegated regulation specifying it. The verification system mainly applies to prescription medicines, but there are some exceptions in the legislation.
The entire Finnish pharmaceutical supply chain has been closely involved in setting up the system. At FiMVO, we are responsible for managing and developing the system, and the Finnish Medicines Agency Fimea supervises the operation of the system in Finland.
FiMVO is part of a European wide database
The Medicines Verification System consists of a European central hub, 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 feeds data. The national systems are used by local supply chain actors, i.e. wholesalers, pharmacies, hospital pharmacies and private dispensaries.
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.
Governance of the system
The European legislation states that the system is governed by non-profit organisations.
The European Medicines Verification Organisation EMVO was formed to govern the central Hub. EMVO's members are organisations representing the pharmaceutical industry, pharmacies, wholesalers and hospital pharmacies.
A list of the all the national organisations i.e. NMVO's can be found on EMVO's website.
The legislation strictly defines, that data in the system belongs only to the entity producing the data. Actors in the supply chain do not have access to data created by other actors. The system does not hold personal data.
Additional information: European Commission's site on falsified medicines