The FMD went into effect on February 9, As we discuss below, it has strict serialization, traceability, verification, and compliance reporting requirements for pharmaceutical manufacturers, wholesalers, distributors, and contract manufacturers.
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.
The code must contain the following information, which must also be printed on the packaging in human-readable form:. 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.
Marketing authorization holders are required to submit product master data and serialized product pack data. 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 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. Contact us to learn how rfxcel helps companies simplify and accelerate their processes and comply with the EU FMD. Learn more about rfxcel products. 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.
