The Falsified Medicines Directive published by the Council of the European Union in July is clear legislation aimed at securing the supply chain for pharmaceuticals. But how does this new Directive impact serialization?

First, let’s take at look at the Directive itself. It introduces a number of safety features including:

• Serial numbers and tamper-evident seals for safety packs
• Product traceability through the supply chain
• More stringent rules for the importation of active pharmaceutical ingredients (APIs), plus control and inspections of EU plants manufacturing APIs
• Extended control over the API and medicines supply chain, including improved scrutiny of brokers and traders
• Greater oversight of Internet sales, including an official logo for certified online pharmacies
• More stringent sanctions against counterfeiters

All EU member states have just 18 months to turn the Directive into national law. Manufacturers then have three years be compliant. Although the timetable has been set, there are still some details that need to be finalized. This includes specifics around the unique serial numbers that are required on medicine packs. There is some evidence that it will be the ECC200 2D Datamatrix barcode, but other barcode types and RFID are also being considered.

Whichever method is selected, having an identification and tracking system in place will be the foundation for success for the Directive. This will allow all parties – from manufactures to distributers to pharmacists – to check the authenticity of medication by scanning a unique serial number and checking it against a database. Any duplication of serial numbers or other discrepancies can be immediately flagged and investigated.

As with all previous measures, protecting patients is the fundamental goal of the new Directive. What are your thoughts around the new Directive? Do you think this will be a good way to enforce serialization?