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Global Compliance

European Union

Meet traceability reporting requirements with a proven solution, partnering with the same provider chosen by 358 companies to meet their EU Hub integration requirements. Report information about product master data, serialized product pack data, and status changes to the right national system for products targeted for any Member State, ensuring your ability to distribute product into any market. Manage notifications, receipts, and exceptions so that daily operations remain streamlined and compliant. Reduce the time, cost, and risk associated with achieving compliance in Europe.

EU FMD includes serialization, verification, and compliance reporting requirements:

  • Serialization. Manufacturers must mark packages with four data elements — a product identifier, serial number, lot or batch number, and an expiry date. A fifth data element, such as a national reimbursement number, may also be required for some markets.

  • Verification. Serialization must happen at the secondary or saleable-unit level to enable product verification at one or more stops along the supply chain. By law, pharmacy dispensers must verify drug product identity prior to dispensation. Safety features such as anti-tampering devices also need to be verified.

  • Compliance reporting. Information such as product code, lot or batch number, expiry date, doses per pack, target markets, and serial number information must be reported to the European Medicines Verification System (EMVS) to verify the identity of medicines for sale in EU markets. In some cases, such as for parallel importation, reporting is also required by supply chain partners.
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