The EC is seeking industry comments before implementing the serialisation aspect of the falsified medicines directive.
Adoption of the falsified medicines directive makes use of unique identifiers for verifying the authenticity of individual drug packages mandatory. However, the details are still to be decided and the European Commission (EC) is seeking input from industry before making its decision.
“The Commission has to assess the costs, benefits and costs-effectiveness [of possible approaches]”, the body wrote . Many details are still to be decided but most fundamentally the EC must choose between letting manufacturers choose their own system and harmonising through regulation.
Giving manufacturers freedom to choose technical specifications would minimise the burden on industry but subsequent fragmentation of product coding specifications may slow verification.
This is the approach the EC is taking with tamper-evidence. “With regard to tamper-evidence, the choice of the technical specification is left to the manufacturer: the manufacturer is best placed to establish how the outer packaging is made tamper-proof”, the EC wrote.
However, for unique identifiers there could be benefits to taking a harmonised approach. The EC would set details of the serialisation number and carrier and taking this more hands-on approach could “enable a smoother implementation”, the body wrote.
Choosing a carrier
If the EC imposes a system through regulation it must choose a carrier for the serialisation number. The three carriers discussed in the document are linear barcode, 2D-barcode and radio-frequency identification (RFID).
Linear barcodes are already used in Belgium, Greece and Italy for serialisation of medical products and readers are present in most European pharmacies. The EC thinks it could be difficult to fit linear barcodes featuring a pack number and manufacturer product code onto small packages though.
Using 2D-barcodes would get around space constraints. The carrier can fit a large amount of data on a small label but few pharmacies are currently equipped with readers. Pharmacy groups in the US and Europe have previously raised concerns about the costs of implementing serialisation systems.
A 2008 study in the US estimated a track-and-trace system incorporating 2D-barcodes and radio-frequency identification (RFID) would cost up to $110,000 (€82,000) per pharmacy. The EC is also considering using RFID but warns it is relatively expensive and may interfere with drug quality.
Another aspect under consideration is commercially sensitive information. The EC said information that could establish the number of packs manufactured and point of dispensation or re-packaging could be commercially sensitive.
Re-packagers are obliged to replace safety features with an equivalent system, such as another unique identifier which is checked into the repositories and replaces the original information.