The Commission’s Delegated Regulation (EU) 2016/161 describes in detail how the European system EMVS, with the aim of preventing falsified medicines from reaching patients via the legal distribution chain, should function, be managed and inspected.

EMVS consists of national database systems, in principle one for each member country, against which verification and decommissioning is done to ensure the authenticity of each package by checking its unique identifier. The national systems are linked via the EU-Hub.

SMVS is the Swedish system that end users in Sweden are connected to control packs unique identifier.

The main purpose of the EU-Hub is to serve as a gateway for the transmission of manufacturer and parallel distributor data to the national systems, and for communication between national database systems.