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Protection of the medicines supply chain: The EMVO and the EDQM, Council of Europe, have signed an agreement on Conformity Assessments

(26 October 2015 – Brussels – Strasbourg): EMVO and EDQM have come to an agreement on the performance of periodic conformity assessments of the European Medicines Verification System ("EMVS") and its governance.

The purpose of these conformity assessments will be to determine whether the EMVO European Hub and blueprint systems are designed, managed and operated in accordance with the standards described in the “Delegated Act on the Unique Identifier” supplementing the Falsified Medicines Directive 2011/62/EU and other relevant state of the art standards.

The EDQM is world renowned for its quality standards in the field of medicines and healthcare. Its experience, neutrality and independence make it a primary trusted source for assessing medicines verification systems that will be deployed to protect the medicines supply chain. The conformity assessments will provide a useful support to Member States for their future supervisory responsibilities under the Delegated Act.

With the support of EDQM, the EMVO is taking a major step to secure the legitimate supply chain and to prevent falsified medicines from reaching patients. According to Andreas Walter, EMVO Director General ad-interim, “The signature of the agreement is a major step for our organisation to ensure compliance with state of the art standards.”

Susanne Keitel, EDQM Director, added: “I am convinced these conformity assessments will be an excellent basis for the future supervision by Member States in line with the Delegated Act”.

Andreas M. Walter                                           Caroline Larsen Le Tarnec
EMVO - Director General a.i.                          EDQM - Public Relations Division
Rue de la Loi 26                                                  7 allée Kastner – CS 30026
B-1040 Brussels                                                  F-67081 Strasbourg
Email: andreas.walter@efpia.eu                     Email: caroline.letarnec@edqm.eu                                 

About EMVO

The European Medicines Verification Organisation (EMVO) is a Luxembourgish non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines. Its founding members are EFPIA, the European Federation of Pharmaceutical Industries and Associations, the EGA, the European Generic and Biosimilar medicines Association, PGEU, the Pharmaceutical Group of the European Union, GIRP, the European Association of Pharmaceutical Full-line Wholesalers and EAEPC, the European Association of Euro-Pharmaceutical Companies. 

About EDQM

The EDQM is a leading organisation that protects public health by enabling development, supporting implementation, and monitoring the application of quality standards for safe medicines and their safe use. EDQM’s standards are recognised as a scientific benchmark world-wide. The European Pharmacopeia is legally-binding in its Member States. Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.

About CoE

A political organisation set up in 1949, the Council of Europe works to promote democracy and human rights continent-wide. It also develops common responses to social, cultural and legal challenges in its 47 member states.