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European Commission consults on unique identifiers for medicines

Seeks comment on concept paper that outlines anti-counterfeiting options, including a new barcode for pharma packaging

The European Commission is considering introducing new pharma packaging elements to guard against counterfeit drugs entering the supply chain.

Its concept paper describes various options to tackle the counterfeit threat through the use a unique identifier, such as a barcode, on the outer packaging of human medicinal products.

The move is in line with the EU falsified medicines legislation – Directive 2011/62/EU – which obliges the Commission to adopt implementing legislation (a so-called “delegated act”) setting out the details of the unique identifier safety feature, such as its characteristics and technical specifications. Adoption of the act is scheduled for 2014.

Under the Directive the unique identifier must allow for verification of a medicinal product's authenticity and for identification of an individual pack.

To achieve this, a randomised serialisation number must be affixed to the packaging on a barcode or other 'carrier'. That number is then checked against a repositories system for verification.

The Commission wants industry feedback on whether the technical solution for the serialisation number and its carrier should be decided by each manufacturer or whether this should be harmonised via regulation.

As a minimum requirement, the Commission says that the number should have a manufacturer product code and a pack number, but it asks whether other details such as the batch number, expiry date and national reimbursement number should be included as well.

As for the best type of carrier to use, the paper asks for comments on the pros and cons of linear barcodes, 2D barcodes and radio-frequency identification.

The repositories system is the other key element in the process of ensuring the detection of falsified medicines. As such, the Commission wants to determine where barcode verification should occur. This could be at the dispensing point alone or additionally at random points throughout the supply chain (i.e. at the level of wholesale distributors). 

The concept paper also seeks stakeholder input on the logistics of establishing and running the repositories system, and on how to determine which products should be exempt from the unique identifier requirements.

The comment deadline for the paper is 27 April 2012.

2nd December 2011

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