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EU Prescription Drug Anti-counterfeiting Legislation

Contributed by Joanne C. Kelleher

PharmaTech, a publication for pharmaceutical manufacturers, reports that the Council of the EU and the European Parliament are amending the current anti-counterfeiting directive to include a requirement for features that enable the identification, authentication and traceability of prescription medicines.

The only way a specific product can be identified, authenticated and traced effectively throughout the supply chain is to give it a unique identity. As such, serialisation, which assigns a unique identity via a unique identification number to each product through a vehicle such as RFID or 2D barcode, is the only solution that can comply with the directive.

The article does a nice job defining identification, authentication and traceability and how meeting these three requirements via serialization impacts the packaging process of pharmaceutical manufacturers.

If the EU would like to trace the movement of these drugs through each step of the supply chain, which includes distributors and wholesalers, they would also need an e-Pedigree system. Designing a successful anti-counterfeiting solution that tracks via e-Pedigree generates even larger issues beyond how manufacturers apply the serialized number. These issues include RFID security, maintainance and access to a centralized database and patient privacy. See E-Pedigree Implementation Issues at https://www.securerf.com/RFID-Security-blog/?p=109 for our insights.

PharmaTech.com’s article:

EU anti-counterfeiting legislation on its way
Jul 1, 2010
Pharmaceutical Technology Europe
http://pharmtech.findpharma.com/pharmtech/Manufacturing/EU-anti-counterfeiting-legislation-on-its-way/ArticleStandard/Article/detail/674915?contextCategoryId=40939