The EU Falsified Medicines Directive: Serialization and Track & Trace requirements

The European Falsified Medicines Directive or EU FMD was enacted in 2013 to fight against falsified medicines and counterfeit drugs entering the European pharma supply chain. To harmonize the fight against counterfeit medicines on a European level, Directive 2011/62/EU as the Falsified Medicines Directive is officially called, sets out serialization, track and trace and reporting requirements which need to be put in place in EU member states by February 2019.

Falsified Medicines Directive requirements in detail

Serialization

As from February 2019, product identifier, serial number, lot or batch number, and expiry date have to be printed in human-readable format and encoded in a 2D data matrix on the secondary packaging of saleable units of prescription medicines to be FMD compliant. Some EU member states might require a fifth data element, such as a national reimbursement number.

Tamper-evident packaging

Although the Falsified Medicines Directive doesn’t specify by which means tamper-evidence should be achieved, drug manufacturers and packagers need to ensure to put a system in place that makes it immediately evident if anyone has tried to open a drug package.

See an Overview of the Global Serialization Landscape

End-to-end verification

Serialization and unit identification allow for risk-based verification all along the supply chain and mandatory verification and authentication at dispenser-level.

Compliance reporting

As per Falsified Medicines Directive, product master data and serial number information must be reported by licence holders to the European Medicines Verification System or EU Hub to verify the identity of medicines for sale in EU markets. In some cases, such as for parallel importation, reporting is also required for supply chain partners.

Impacts of the EU Falsified Medicines Directive at all levels of the pharma supply chain

The Falsified Medicines Directive impacts all levels of the EU pharma supply chain:

Licence holders

To be compliant with the Falsified Medicines Directive, manufacturers will have to print unique serial numbers on secondary packaging. Therefore, pharma companies have to prepare production lines accordingly with print-and-verify systems and software able to ensure unique serial numbers or integrate with CMO partners to ensure EU FMD serialization requirements are met. Further, they need a system capable of managing the huge amounts of master and serialization data these new track&trace processes generate. As the Falsified Medicines Directive generates an unprecedented necessity for connectivity, serialization solutions like Adents Prodigi that are certified gateways to the EU Hub can help licence holders solve 3 challenges at once: scalable data management capacities and unique serial number management, easy supply chain partner onboarding and secure connection to the European Medicines Verification System (EMVS).

Supply Chain partners

To ensure patient safety aimed at by the Falsified Medicines Directive, all supply chain partners will need to somehow connect to their National Medicines Verification Systems to be able to verify products that seem not legit to them. They will also need to report decommissioning activities to the European Hub to ensure that a serial number that has been taken out of the supply chain cannot be re-used for a falsified medicine.

Dispensers

Whether high street pharmacists or hospital pharmacies, product authentication and verification as well as subsequent decommissioning before dispensation is mandatory to be FMD compliant. Therefore, all dispensers in the EU will need scanning equipment as well as a connection to their respective National Medicines Verification Systems to be able to query each and every saleable unit before handing them over to a patient.

The Falsified Medicines Directive

TWO LEVELS OF COMPLIANCE

Timely compliance with the Falsified Medicines Directive

At Adents, we are committed to ensure you get the best in class equipment and software to ensure lasting compliance with the Falsified Medicines Directive. Our powerful, centrally configurable Level 3 serialization solution helps ensure compliance at manufacturing level. Adents Prodigi helps you manage unique serial numbers and the immense amount of data track & trace processes create across all your entities. With EU FMD requirements calling for unprecedented connectivity, our Cloud solution is the ideal way to onboard all your supply chain partners easily and connect you to The EU Hub.

LEARN MORE ON THE FALSIFIED MEDICINES DIRECTIVE

The European Medicines Verification Organisation urges pharmaceutical companies to get up to speed with their serialization compliance efforts.

Webinar: How to speed up the implementation of serialization processes at your sites to meet approaching deadlines and ensure long-term compliance

The current UK regulations following the Falsified Medicines Directive (FMD) will probably not change before the UK has actually left the Union, however, there might be a gradual shift in the UK’s relationship with European regulators.

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