A dictionary of the Falsified Medicines Directive

The new European databased Medicines Verification System (MVS) will be implemented 9th February 2019. The aim of MVS is to prevent falsified medicines from entering the legal supply chain. According to estimates, about 2 500 pharmaceutical companies should be connected to the European wide database, EU Hub, when the implementation takes place.

There are many terms related to Falsified Medicines Directive (FMD) and sometimes it is hard to remember the meaning of each term. That is why we compiled a FMD dictionary for you. We hope you find it useful!

2D-matrix
A package-specific unique identifier. Contains key data elements such as product code, unique serial number, batch number, expiry date.

ATD       

Anti-tampering device. A tamper evidence mechanism which indicates if the package has been unlawfully opened before dispensing.

EU Hub

European central repository. The unique identifier information about the medicine packs is uploaded to EU Hub by pharmaceutical manufacturers. The data transforms from EU Hub to National Medicine Verification systems.  

EMVO

European Medicines Verification Organisation. A Belgian non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines.

EMVS

European Medicines Verification System

e-VIS                 

e-Verification i Sverige. The Swedish association who manages the Swedish Medicines verification System.

FMD    

Falsified Medicines Directive. EU directive which aimis to improve patient safety by mandating the Marketing Authorisation Holders and manufacturers to put a system in place that is preventing falsified medicines from entering the legal supply chain, the European Medicines Verification System.

FiMVO      

Finnish Medicines Verification Organisation. FiMVO manages the Finnish Medicines Verification System

FiMVS  

Finnish Medicines Verification System

GLN

Global Location Number. GLN can be used to identify companies´ locations.

GTIN     

Global Trade Item Number. GTIN can be used to uniquely identify all of companies´ trade items (unique identification per package)

MAH         

Marketing Authorisation Holder

NTIN

National Trade Item Number. NTIN is a GTIN, which prefix is owned by the Nordic Vnr administrator.
(Nordic prefix regardless of the MAH). NTIN contains the Vnr and is only changed when the Vnr is changed. NTIN does not separate, for example, packages with PLs in different languages or packages with different measurements. NTIN is therefore not necessarily a unique identifier.

OBP     

On-boarding partner. Pharmaceutical companies must upload their product data onto the European hub. A prerequisite to this is to enter a contract with the European Medicines Verification Organisation (EMVO). This is called Onboarding, and partners are referred to as Onboarding Partners.

PC

Product Code

SR

Serial number

SMVS

Swedish Medicines Verification System

VNR

Nordic article number. A unique number for all pharmaceuticals in the Nordic countries (unique per article / package).

For more information about the implementation of Medicines Verification System in Finland visit the website of FiMVO Finnish Medicines Verification Organisation and in Sweden visit the website of Swedish Medicines Verification Organisation (e-VIS).