The introduction of delegated Ordinance 2016/161 has created more stringent framework conditions for the pharmaceutical industry by imposing new reporting requirements. Additional European regulations for protection against medication fraud affect all the parties involved in the transport chain. The “European Medicines Verification Organisation” (EMVO) and the “National Medicines Verification Organisations” (NMVOs) were introduced to enable the status tracking of packaging data and the storage of data on all the medicinal products licensed and produced within the EU using an end-to-end comparative system.
Since evidence of “good distribution practice” will no longer be sufficient once the new regulations come into force in February 2019, d-fine will support transport providers with implementing current requirements. Technically this involves developing a system for comparison, status validation, as well as the activation and deactivation of the individual identification characteristics (IDs in the NMVOs and the EMVO.
Additional information about the integration of the reporting process, the technical conditions and options for implementation can be obtained by e-mail from logistics(at)d-fine.de, keyword “pharmalogistics”.