The EMVO (European Medicines Verification Organisation) is stepping up the engagement with National Stakeholders as part of their effort to meet the requirements of the EU-FMD. 3C Integrity are pleased to announce we have signed a contract to support the EMVO with this important work.
As 3C Integrity’s lead, Christoph Krähenbühl will work with the EMVO’s Commercial and Partnership Management Team. The Team has been set up to provide guidance and support to national stakeholders whose task is to establish and run National Medicines Verifications Organisations. The team will also help the national stakeholders to implement the National Systems in each of the 32 EU member / EEA states that connect to the European Hub (which was established by the joint stakeholders in 2012/2013).
Christoph said: “I’m excited that we have been engaged to support this next phase of the European project. This appointment comes at a time when the adoption of the ‘Safety Features’ Delegated Act is imminent and all participants in the European healthcare supply chain are assessing the practical impact of this far-reaching legislation.
As we have commented before, it is clear that the task ahead is daunting, particularly for pharma manufactures who are obliged, over the next three years, to implement their serialisation systems across all their packing lines supplying Europe. On top of that, the law also stipulates that they have to fund the establishment and on-going operation of the European Medicines Verification Systems at European and also at national levels.”
To achieve Europe-wide compliance against the tight deadlines, the EMVO has been established as a non-profit organisation by the leading European healthcare supply chain stakeholders EFPIA (the European Federation of Pharmaceutical Industries and Associations), 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).
Through the engagement of the whole pharmaceutical supply chain, the EMVO will establish the infrastructure that allows the end point verification of medicine packs from the point of manufacture, through wholesale distributors, carrying out risk based verification and to pharmacies as the dispensing point for patients, thereby securing the entire supply chain as required by the EU-FMD.
3C Integrity will continue to deliver vendor-independent consultancy, training events, courses and resources while supporting the EMVO with its mission. We will keep you up to date with our EMVO involvement and continue to support our current and future clients in Europe and the rest of the World in implementing serialisation successfully.