Gearing up for FMD in the European Union
On 2 January, 2013, member states must begin implementing the European Union Falsified Medicines Directive 2011/62/EU, which requires obligatory identification and authentication features on the outer packaging of medicines. Once transposed into national law, manufacturers have three years to comply with the Directive, which for many will entail upgrading production lines to accommodate sophisticated coding and image-recognition systems capable of working at high speeds
Craig Stobie, Lifesciences Sector Manager for Domino Printing Sciences, looks at European serialisation regulation and timings
In less than a year, on 2 January, 2013, member states must begin implementing the European Union Falsified Medicines Directive 2011/62/EU, initially by transposing it into national laws. Manufacturers then have a further three years to comply with the Directive, the principal demands of which include obligatory identification and authentication features on the outer packaging of medicines.
Given that the Directive was only adopted in July last year, the timetable was always going to be tight, particularly as the European Commission has still to decide on the precise form of the identification and authentication process. For example, what will be the characteristics and technical specifications of the ‘unique identifier’ each pack must carry? How much data will the serialisation number hold, and will it be carried on a linear barcode, an EC200 2D Datamatrix barcode, or an RFID tag? And how will the unique identifier be verified against the ‘repository’ (ie, the database) of numbers?
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