EU Hub: Final Countdown for Onboarding
A new communiqué from the European Medicines Verification Organisation stresses the urgency for pharmaceutical companies to intensify compliance efforts regarding the Falsified Medicines Directive (2011/62/EU).
The European Medicines Verification Organisation urges pharmaceutical companies to get up to speed with their serialization compliance efforts.
June 2018 Deadline
According to the EMVO, “the end of June 2018 should be considered as the very last opportunity to on-board timely”. This means, pharmaceutical companies need to choose their level 4 serialization solution and their OBP-Gateway-Provider* within the next 6 months. “Any late on-boarding after that date may entail a risk to the company’s business” warns the organization.
Enterprise-level solutions to ensure correct data
Choosing a level 4 solution provider that is certified as an official OBP Gateway Provider for the European Hub can greatly facilitate onboarding as certified companies have experts who know all about the technical onboarding process. However, it is very important to first and foremost choose the right enterprise-level serialization solution to ensure that your unique serial numbers are centralized in one platform to avoid duplicates across lines and sites before even thinking of being able to report them to the EMVS. Only if you can ensure correct data you can ensure compliant reporting. Furthermore, your serialization solution needs to be able to export relevant serialization and product master data in the correct format required by authorities.
Your solution for clean data and compliant reporting
Certified for the European Hub, Adents Prodigi can ensure both: storage and indexation of all serial numbers across your production sites to avoid duplicates no matter whether the codes are generated – centrally with Prodigi or by your CMOs and production sites – and reporting of correct data in the correct format.
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*According to EMVO’s definition, an OBP (onboarding partner) “is a legal entity that is part of a Corporation or a Group and will send data to the EU Hub on behalf of Marketing Authorization Holders that are also part of that corporation”. In short, this means an entity of a pharmaceutical group or company that centralizes all serialization data and reports it in the required format to the relevant European authority (through the Hub).