An initiative to protect the European pharmaceutical supply chain from the entry of falsified medicines.
Securing the European Pharmaceutical Market
The risk of falsified medicines is growing on a global scale. As a result, the European Union has stipulated a catalogue of measures in Directive 2011/62/EU to prevent falsified medicines from entering the legal supply chain. The EU Commission has published additional technical details for the further design of security features with the Delegated Regulation (EU) 2016/161 in the Official Journal of the European Union. Starting from February 9, 2019 only prescription medicines which bear the new safety features may be put into circulation.
The European Medicines Verification Organisation (EMVO) has taken responsibility for advancing the formation of the European Medicines Verification System (EMVS). The EMVS is in accordance with the EU’s Falsified Medicines Directive (FMD) and the Delegated Regulation (DR). It ensures the implementation of a functioning, secure, interoperable and cost-effective system across Europe.
Our aims, remit and mandate
The infiltration of falsified medicines in the European supply chain is a major and continuous threat for the patient health and security. Because patient health and safety are of the utmost importance to the pharmaceutical industry, a comprehensive strategy at European Level is required. Therefore, the European Medicines Verification Organisation (EMVO) was created as a joint initiative of EU stakeholders, representing manufacturers (Medicines for Europe, EFPIA, EAEPC), wholesalers (GIRP) and community pharmacists (PGEU).
Established in 2015, EMVO was mandated by our stakeholders with setting up and running the European Hub. The main purpose of the European Hub is to store master data and act as a gateway for the transmission of manufacturer data to the national systems.
EMVO has also established a system which enables supply chain actors to comply with the FMD and Delegated Regulation; and connected 28 EEA countris to the system.
What have we achieved to date?
In order to counter the threat of falsified medicines entering the legal supply chain, the European Parliament and Council have released a Directive on Falsified Medicines (2011/62/EU) (amending Directive 2001/83/EC). It aims at improving 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.