Serialization and T&T requirements

There are a number of key trends in the pharmaceutical market causing the increase of the counterfeit problem.

Massive growth of Internet sales and also unlicensed markets, as well as the huge potential for producing copy medicines, all help to flood the market with counterfeits.

Technology-based devices can be an efficient means to tackle counterfeit if a unique identification number for each individual pack is created and maintained throughout all stages of the supply chain.

Two the strategies to face this threat: Mass Serialization and ePedigree.

Most of Pharmaceutical Companies identify Mass Serialization with DataMatrixECC200 codes (2D) as the best and easiest method which incorporates the main information to be traced in a much smaller space compared to the standard barcodes.

The coding solution provides an efficient and cost-effective method to meet the EC’s requirements for pack identification put forth in the recently adopted Falsified Medicines Directive (July 2011).

In short European industry is calling for:

A harmonized coding and serialization system across Europe for greater patient safety
A stakeholder governed point-of-dispense system for cost-effectiveness
A 2D data matrix based on international standard as unique identifier for interoperability.

According to the FDA Prescription Drug Marketing Act (2004) and the Florida Drug and Cosmetic Act (2005), any given prescription drug requires an electronic pedigree to accompany/validate drug distributions, in an attempt to prevent counterfeit developing standards for interoperability with unique identifiers

The e-Pedigree is a record in electronic form containing information regarding each transaction resulting in a change of ownership of the given prescription drug, including returns, thus to show the lineage of the drug from the manufacturer trough to the current point in the drug distribution channel (wholesaler, re-packager, pharmacy).

In order to discourage companies from developing their own incompatible proprietary systems of ePedigrees, they have to be created and maintained in an interoperable electronic system, to be more precise an electronic track & trace system that uses a unique identification number, established at the point of manufacture, contained within a standardized non-proprietary data format and architecture and uniformly used.

The unique serialized number will mostly likely be carried on either on a 2D bar code or an RFID chip placed on the saleable unit by the manufacturer and contains:

Prescription drug information
Transaction and source information
Ownership information
Certification.

Anyway, RFID is unlikely to be implemented below pallet level.

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Serialization and T&T Requirements

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