Here’s a breakdown of the key serialization regulation guidelines under EU FMD:

1. Obligatory Safety Features:

• Unique Identifier (UI): Each individual saleable pack of a medicinal product must carry a unique identifier encoded in a GS1 2D DataMatrix barcode. This UI must contain four mandatory data elements:
  • Product Code: A Global Trade Item Number (GTIN) identifying the specific product.
  • Unique Serial Number: A randomized, unique number for each pack.
  • Batch/Lot Number: Identifying the specific batch of the product.
  • Expiry Date: The date beyond which the product should not be used.
  • Optional Fifth Element: A national reimbursement number (NHRN) may be added based on specific member state requirements.
• Anti-Tampering Device (ATD): The outer packaging of the medicinal product must have a device that allows verification of whether the packaging has been tampered with. The law does not specify which ATD must be used, allowing flexibility for manufacturers.

2. Serialization Level:

• Serialization is required at the secondary or saleable-unit level. This means each individual pack that is dispensed to a patient must have a unique identifier.
• Aggregation (case-level or pallet-level serialization) is NOT mandated by EU FMD, unlike some other regulations (e.g., US DSCSA). However, many companies choose to implement aggregation for business reasons (e.g., easier logistics, supply chain visibility).

3. Data Reporting to the European Medicines Verification System (EMVS):

• Marketing Authorization Holders (MAHs) and manufacturers are responsible for generating, applying, and uploading serialization data to the European Medicines Verification Organization (EMVO) Hub.
• The EMVO Hub then pushes this data down to the relevant National Medicines Verification Systems (NMVSs), which are operated by National Medicines Verification Organizations (NMVOs) in each member state.
• Data to be reported includes:
  • Product Master Data: Product codes, form, strength, doses per pack, pack type, and target market(s) for distribution. Any updates to this data must also be reported.
  • Serialized Product Pack Data: Product codes, lot/batch number, expiry date, and the unique serial numbers for each unit of drug product released into the supply chain. Updates to this data (e.g., in case of recall or decommissioning) are also required.

4. Verification Requirements:

• Point-of-Dispensation Verification: Pharmacists and other healthcare professionals dispensing medicines must verify the authenticity of the unique identifier by scanning the 2D DataMatrix code and comparing it against the data in the national repository. This verification is a key element of preventing falsified medicines from reaching patients.
• Wholesaler Verification: Wholesalers have specific verification responsibilities, particularly for products not received directly from the manufacturer or its official distributor, including returns. They must perform risk-based verification.
• Decommissioning: The unique identifier must be decommissioned (marked as dispensed or exported) from the system when the pack is legitimately supplied to a patient in the EU or exported outside the EU.

5. Record Keeping:

• Records related to serialization and verification must be available for a minimum of one year after the expiry date of the product, or five years after the pack has been released for sale or distribution, whichever is longer.

6. Quality and Technical Requirements:

• Printing Quality: The 2D DataMatrix code must be clearly printed and scannable throughout the product’s lifecycle.
• Randomization: Serial numbers must be generated using a sufficiently randomized algorithm to ensure uniqueness and prevent predictability. Best practices recommend a collision rate of less than 1 in 10 million.
• Data Management: Robust systems are required for the generation, management, storage, and exchange of serialization data.

7. Compliance and Penalties:

• Compliance with EU FMD is mandatory for all stakeholders in the pharmaceutical supply chain (MAHs, manufacturers, wholesalers, pharmacies).
• Member states are required to implement effective, proportionate, and dissuasive penalties for non-compliance.

Key Differences from other Regulations (e.g., US DSCSA):

• Harmonized vs. Standardized: EU FMD is a harmonized regulation, allowing for some country-specific requirements, whereas the US DSCSA aims for more standardization across states.
• Aggregation: EU FMD does not mandate aggregation, while DSCSA requires serialization at both the saleable unit and sealed homogenous case levels.
• Verification Point: EU FMD is a point-of-dispensation verification system, while DSCSA focuses more on verification during saleable returns processing and suspect product investigations.