European Union Falsified Medicines Directive (FMD)
The FMD went into effect on February 9, 2019. It’s goal is to prevent counterfeit or substandard medicines from entering the supply chain. As we discuss below, it has strict serialization, traceability, verification, and compliance reporting requirements for pharmaceutical manufacturers, wholesalers, distributors, and contract manufacturers.
EU FMD Requirements
Serialization Requirements
The FMD requires serialization at the saleable unit or the secondary packaging level. Although the FMD does not yet require serialization at other packaging levels, many companies are considering or already implementing multi-level serialization and related aggregation activities.
Manufacturers must affix a GS1 2D Data Matrix code to every unit of a drug product. The code must contain the following information, which must also be printed on the packaging in human-readable form:
- A unique serial number
- The manufacturer product code in the form of a global trade item number or GTIN
- Batch number
- Expiration date
- A fifth data point, such as a national reimbursement number, may be required in certain countries.
Manufacturers (and licensed parallel traders) must report data to a central EU Hub run by the European Medicines Verification Organization (EMVO), which also onboards users into the Hub. This will push data down to appropriate data repositories run by corresponding National Medicines Verification Organizations (NMVOs), which are responsible for end-user onboarding and for the operation of the national systems
Compliance Reporting Requirements
Marketing authorization holders are required to submit product master data and serialized product pack data.
Master data includes:
- Product codes
- Form
- Strength
- Doses per pack
- Pack type
- Target market(s) for distribution
- Future and any updates to product master data
Serialized product pack data includes:
- Product codes
- Lot/batch number
- Expiry date
- Serial numbers
- Any updates to serialized product pack data
How rfxcel can help you with EU FMD compliance
When it comes to maintaining EU FMD compliance, rfxcel can help. Our serialization, verifications and track and trace technology not only safeguards your products, guarantees you comply with the EU FMD, but also creates a digital supply chain that transforms business value.
Our EU support team can help you increase supply chain visibility
rfxcel has more than 17 years of experience increasing supply chain visibility. Our team in Europe will walk you through every step of the implementation process, ensuring full integration with our pre-configured, pre-validated compliance, serialization, and track and trace solutions.
You’ll also benefit from 24/7 growth-driven support. You’ll be assigned a dedicated rfxcel support team member who will resolve issues promptly and effectively.
Secure your supply chain with rfxcel Traceability System
rfxcel Traceability System (rTS), our award-winning track and trace system, increases visibility and improves scalability by allowing you to quickly add new features. Contact us to learn how rfxcel helps companies simplify and accelerate their processes and comply with the EU FMD.
Your value beyond compliance with rfxcel
- Digitize and centralize your entire supply chain in one elegant, easy-to-use, intuitive platform
- Enhance performance and reduce processing time in multiple languages
- Leverage IoT technology to gain new real-time insight into and control of your supply chain
- Trace your products forward and backward
- Maintain historical information for a batch or individual product with continuous review and supply chain optimization
- Drive growth by lowering costs and risks, eliminating inefficiencies, and tracking all activity anywhere in your supply chain, including among suppliers, distributors, and 3PLs
- Integrate with any trading partner
