The European Medicines Verification Organization (EMVO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, have signed an agreement on conformity asessments. 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 EMVO is a not-for-profit stakeholder organization incorporated in Luxembourg that was formed to combat the emergence of falsified medicines in the European Union's legitimate supply chain. Launched earlier this year, it represented the culmination of four years of work towards a dependable and secure pharmaceutical verification system. Through the engagement of the whole pharmaceutical supply chain, the EMVO seeks to reinforce the value of the European Stakeholder Model, allowing end-to-end verification of medicine packs from the point of manufacture, through to wholesale distributors, carrying out risk-based verification and pharmacies to the dispensing point for patients. The European Association of Euro-Pharmaceutical Companies, the European Federation of Pharmaceutical Industries and Associations, the European Generic and Biosimilar medicines Association, the European Association of Pharmaceutical Full-line Wholesalers, and the Pharmaceutical Group of the European Union, h announced the establishment of the EEMVO earlier this year. EDQM provides quality standards for medicines through the European Pharmacopoeia.
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 conformity assessments are intended as an useful support to member states for their future supervisory responsibilities under the Delegated Act.
With the support of EDQM, the EMVO is taking a step to secure the legitimate supply chain and to prevent falsified medicines from reaching patients.