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28th February 2017
Solidsoft Reply, the Reply group company creating enterprise strength solutions on-premises and utilising the Microsoft Azure cloud platform, has signed a contract to implement and operate the Danish National Medicines Verification System with the Dansk Medicin Verifikation Organisation A/S (DMVO). The DMVO is a not for profit organisation set up specifically to implement the requirements of the EU Falsified Medicines Directive (FMD; Directive 2011/62/EU) in Denmark.
Denmark are in the first wave of European member states to engage a certified blueprint supplier; Solidsoft Reply. Martin Jordt Andersen, the DMVO’s representative and Commercial Director of the Danish Association of the Pharmaceutical Industry said that “it was important that the DMVO engaged with a supplier (Solidsoft Reply) that had a future proofed technical solution, a pragmatic project management, predictable pricing and a willingness to adapt, as he was looking for a long term solution partner”.
The implementation of Denmark’s National Medicines verification system is in direct response to the growing problem of falsified medicines with Europe. The Falsified Medicines Directive (FMD; Directive 2011/62/EU) published by the European Parliament and the European Commission states that each eligible medicinal product must have a unique identifier and tamper-evident seal to allow for the authentication of each medicine pack at the point of dispensing. A European Delegated Act was then passed in February 2016 which requires the full implementation of the European Medicines Verification System by February 2019.
Solidsoft Reply was previously selected by the European Medicines Verification Organisation (EMVO) to implement the European Medicines Verification Hub, enabling medicine manufacturers and parallel distributors to upload their pack data which is then routed to appropriate national systems. There are potentially 32 markets in which National systems will be required to be implemented. Markets are also able to combine creating Supra-nations.
The European Medicines Verification Organisation (EMVO) represent the key stakeholders in the European pharmaceutical supply chain, EFPIA, EGA, EAEPC, GIRP and PGEU. The EMVO have established the centrepiece of the system’s infrastructure, the European Hub that connects all national systems and ensure their interoperability. The European hub together with the individual National systems form the entire European Medicines Verification System.
The Solidsoft Reply National system has been built with state of the art technology and is built upon Microsoft’s public cloud platform Microsoft Azure.
The law firm Brandt & Lauritzen were acting as legal advisors to the DMVO in connection with the structuring, negotiation and execution of the Danish National Blueprint Agreement. “They have proven to be an important asset in order to facilitate the negotiations processes and make sure that all stakeholders needs have been met”, says Martin Jordt Andersen, the DMVO’s representative and Commercial Director of the Danish Association of the Pharmaceutical Industry.