With the publication of the Delegated Act on safety features, those who manufacture, sell, or dispense medications in the European Union have until February 2019 to comply with new track and trace regulations outlined in the Falsified Medicines Directive (FMD).
FMD compliance creates some unique challenges. The main requirements presented in the FMD involve serialization, compliance reporting, and verification. Medications in Europe are generally packaged and sold at the “unit of use” level, so the volume of product that needs to be serialized and the magnitude of transactions will be two to five times what companies will see in the U.S. where the saleable unit is in larger bulk quantities. Overall, the universe of data to be produced, managed, and reported on will be massive, with the added complexity that each EU Member State is provided flexibility to apply their own unique requirements.
Serialization: The FMD requires secondary-level (saleable unit) serialization only, with a GS1 standard serial number issued by the manufacturer. Product identifiers may include a GTIN or country-specific product code, and additional country-specific data elements may be required. In addition, business or trade requirements may mandate serialization at additional packaging levels and include aggregation, further adding complexity for the manufacturer.
Reporting: The manufacturer or marketing authorization holder has several types of reporting or notifications to make to the European hub. The two primary ones are for product master data and serialized product pack data. First, master data about the product including product codes, form, dosage, target market(s) for distribution and other data must be reported to the European hub. Serialized product pack data must also be reported, including product codes, lot, expiry data and serial numbers. If manufacturers have subsequent status updates about the product, those must be uploaded to the hub as well. Additionally, if manufacturers have downstream companies that act as agents on their behalf, they must publish a list of those companies within the master data submitted to the hub.
Product Verification: As the drug product moves through the supply chain prior to dispensation, EU FMD provides for verification of the product identifier. The regulations specify that dispensers verify product identity, but also that wholesalers and parallel importers do so in certain circumstances.
For dispensers, the law dictates that they verify product at some point prior to dispensation. Scanning the product’s barcode and verifying the information with a national system will validate serialization information and access any product updates from the manufacturer, including whether the product has been flagged as stolen or potentially counterfeit.
Wholesalers have their own unique set of risk-based verification requirements. If a wholesaler purchases product from another wholesaler, they must verify the product by interrogating its safety features, including scanning of the barcode to verify the product identifier, prior to resale of the product. Returned products that could re-enter the supply chain also have to be checked in a similar way to ensure the integrity of the product.
The FMD is an overarching guideline for manufacturing and distributing product in the EU, providing general harmonized standards across the EU while supporting the unique needs of individual Member States. Flexibility is afforded to each one of the Member States to apply their own unique requirements in areas such as product codes, national reimbursement numbers, etc. In addition, some drug products may be classified as prescription pharmaceuticals in one Member State and not in another.
TraceLink has crafted purpose-built solutions to provide the most comprehensive, end-to-end compliance platform for our customers to meet with FMD regulations.
Our European Union Compliance module supports traceability reporting requirements from a single platform, providing our customers with a tested integration to the European hub for reporting information about their product master data, serialized product pack data, and status changes for products targeted for distribution across all Member States. This is an important capability because it ensures that our customers can distribute their products into any market by supporting the target market data in our reporting so that the pack data is appropriately distributed to the right national system. In addition, EU Compliance manages notifications, receipts, and exceptions so that daily operations remain compliant.
TraceLink’s serialization applications provide a comprehensive solution for serialized product management, including the ability to generate and manage serial numbers, exchange serial numbers and events with packaging sites and line management systems, track serialized inventory operations across plant and warehouse operations, and automatically trigger compliance activities. For manufacturers who need to serialize product, our end-to-end serialization solutions support global standards as well as country-specific formats. So whether you serve a few countries in the EU or multiple countries across the world, TraceLink empowers you to meet evolving regulations.
|Government agency||Regulated at the country level|
|Regulatory scope||Serialization; reporting; product verification|
|Product scope||Most pharmaceuticals|
|Participants||All, with primary burden on manufacturers & dispensers|
|Next deadline||February 9, 2019|
|Serial # format||Random manufacturer-issued; GS1 format|
|Reporting flow||Manufacturer reports to European Hub|