Codierung von Arzneimittelpackungen mittels Data Matrix Code zum Schutz vor Fälschungen
Wilfried Weigelt1 und Dr. Ehrhard Anhalt2
REA Elektronik GmbH1, Mühltal und Bundesverband der Arzneimittel-Hersteller2, Bonn
Coding of Medicinal Products Packaging using Data Matrix Code as a Protection against Counterfeiting
Counterfeiting of medicinal products has been increasing. In order to address this situation the EU has published the directive 2011/62/EU amending directive 2001/83/EC. The directive requires, among others, safety features for certain medicinal products to provide verification of the authenticity and identification of individual packs, and evidence of possible tampering.
The German stakeholders formed securPharm. SecurPharm is developing a system, in compliance with the requirements of the EU directive. Verification of authenticity and identification of individual packs will be realized by printing a 2-D-Code (Data Matrix) on each pack. The code contains a product number (Pharmacy-Product-Number, PPN), a serial number and also a lot number and expiry date. The PPN structure is designed to allow for the embedding of any other national medicinal product numbers. This allows for an easy upgrading of proprietary national systems into internationally unique product number systems.
The securPharm specification on PPN code is based on international ISO standards. The system meets all requirements for verification of the authenticity and identification of individual packs in a machine-readable form while being fully interoperable with existing systems.
The present article addresses the coding specified to verify the authenticity of medicinal products. More details on the specification and on securPharm are published in the internet (www.ifa-coding-system.org and www.securpharm.de).