(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 worldrenowned 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
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