Romania, connected to the EU Medicines Verification System (EMVS)

Romanian authorities have taken an important step in combating trade with falsified medicines. Romanian Medicines Verification System has been connected to the EU Hub production environment, which is the European Medicines Verification System (EMVS).

Measure is one step in the process of implementing the European Falsified Medicines Directive (FMD), which should be transposed into Romanian legislation by February 9, 2019.

According to the European Commission, falsified medicines are “fake medicines that pass themselves off as real, authorized medicines”. World Health Organization says that a falsified medicine “contains no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient.”

European Falsified Medicines Directive (FMD) was approved by the EU in February 2011, and became law in 2013. In details published in the Official Journal of the European Union, EU Parliament and EU Council said the directive had been adopted in response to an “alarming increase of medicinal products detected in the Union, which are falsified in relation to their identity, history or source.”

Brussels emphasized that falsified medicinal products have reached patients through the legal supply chain as well as through illegal channels.

To combat this, the directive introduced two new safety features that must be present on each individual pack or bottle of medicine: a unique identifier (a 2D barcode containing a unique 20-digit pack number, as well as other data), and a physical anti-tampering device (ATD).

The delegated regulation also set out who, in the medicines supply chain, is responsible for verifying the safety features on each pack.

Source:RRA,European Commission.Translated by Miruna Matei