The Implementation of the Data Matrix System for Medicinal Products for Human Use in France and the EU Context
Dr. Alexander Natz and Marie-Geneviève Campion
Bundesverband der Pharmazeutischen Industrie e.V. (BPI), Brussels (Belgium)
Since the 31st of December 2010 two-dimensional (“2D”)-barcodes, Data Matrix, have replaced the former barcode and are mandatory on the outer-packaging of medicinal products for human use in France. The Data Matrix system, combined with batch-traceability, is already used for animal health products in France1). The measure is applicable to all medicinal products having a marketing authorization in France and is combined with a progressive switch of the marketing authorization number and the inclusion inter alia of the batch-number in the 2D-barcode. It aims at facilitating batch-recall and securing the supply chain. No serialization is planned for the moment by the French health regulatory authorities but it may evolve with future anti-counterfeiting measures, especially as a requirement resulting from the future adoption of the European Commission directive on the prevention of falsified medicinal products entering the legal supply chain2).
pharmind 2011, Nr. 2, Seite 291