25 January 2018
Solidsoft Reply, who are the Reply group Company who specialise in creating solutions on the Microsoft Azure cloud platform, has signed a multi-year agreement with the newly incorporated, not-for-profit Croatian Medicines Verification Organisation; Hrvatska Organizacija za Provjeru Athenticnosti Lijekova (HOPAL) to implement and operate the Croatian National Medicines Verification system. The implementation of the National Medicines Verification System in Croatia represents a significant step forward in Croatia ensuring the safety of patients across the country by preventing falsified medicines from being dispensed.
“Croatia wish to be at the forefront of combating falsified medicines and thereby contribute to the European health policy. HOPAL was established with a view to set up the Croatian Medicines Verification System. Hopal has concluded an agreement with Solidsoft Reply in order to implement, develop, test and operate the Croatian Medicines Verification System. HOPAL choose Solidsoft Reply because Solidsoft Reply provided a good solution design, a pragmatic project management approach, predictable pricing and an ability to bridge gaps in a commercial and practical way, which is promising for a long term solution partner”, says Maja Drašković; HOPAL’s Chairman of the board.
In 2011, the European Parliament and European Commission passed the Falsified Medicines Directive (Directive 2011/62/EU) which states that medicine manufacturers must ensure all applicable medicines entering the supply chain have a unique identifier and tamper-evident seal. This allows each pack of medicine to be verified, for authenticity, at the point of dispense. The new system will apply to all applicable medicines dispensed throughout EU nations and from February 2019, all countries within the European Union must have a National Medicines Verification System connected to the European Medicines Verification Organisation’s central Hub to verify the authenticity of a medicine and prevent counterfeit drugs from being dispensed.
The European Medicines Verification Organisation (EMVO) represents the key stakeholders in the European pharmaceutical supply chain, EFPIA, Medicines for Europe, EAEPC, GIRP and PGEU. The EMVO engaged with Solidsoft Reply to implement and operate the European Medicines Verification Hub. The European Medicines Verification Hub is where all medicine manufacturers and parallel distributors within the supply chain can upload their product and pack data, which is circa. 10 billion packs per year. The pack data is routed to the appropriate National Medicines Verification System so that every pack can be verified regardless of which country they have been distributed to within the EU.
As the organisation that implemented the central European Medicines Verification Hub, Solidsoft Reply has designed a National Blueprint solution to meet the exact needs of the Falsified Medicines Directive, which has been rolled out across a number of EU nations to ensure compliance.
Built on the Microsoft Azure Cloud, the National Blueprint System is agile and flexible to respond to the requirements of the industry as they evolve over time and to utlise the new features and benefits of the Microsoft Azure stack. The solution automatically scales ensuring that the challenging response times can always be achieved.
As the ninth country to engage Solidsoft Reply to implement their certified National Blueprint Solution, Croatia joins an increasing list of Solidsoft Reply NMVO’s markets that include Sweden, Denmark, Ireland, Bulgaria, Slovenia, Lithuania, the Czech Republic, and Iceland.
The law firm Synch were acting as legal advisors to HOPAL in connection with the structuring, negotiation and execution of the Croatian National Blueprint Agreement. “Synch provided a pragmatic, business oriented approach. Henrik Hoyer provided commercial result driven advice and counsel of key legal issues, and contributed actively to strategic thinking and decision making for HOPAL and our stakeholders”, says Maja Drašković; HOPAL’s Chairman of the board.