More than 60 pharmaceutical manufacturers from across Italy visited Pharmintech 2013 in Bologna to listen to coding and marking world leader Domino Printing Sciences’ expertise on the Falsified Medicines Directive (FMD).
Attendees heard how legislative changes associated with the EU Falsified Medicines Directive would affect their businesses at operational and commercial levels in a seminar hosted by Domino’s Italian distributor, Nimax.
During the seminar, speakers from coding body GS1, 3C Integrity and EFPIA, the European Federation of Pharmaceutical Industry and Associations, joined forces to advise attendees on how best to meet FMD requirements and deal effectively with the organisational and technical challenges of complying with the legislation.
A key part of the FMD legislation is that manufacturers must implement product serialisation at dispensing unit level for all pharmaceutical products dispensed or sold within the EU – a requirement that cannot be met by an estimated 70% or more of coding equipment currently in the field.
The exact specification of coded information will be definitive once the Delegated acts associated with the Directive are published in 2014 but broadly, it will consist of a unique serialised 2D datamatrix code combined with human-readable data and tamper evident features.
The FMD also presents a fundamental business challenge, as along with the need to update packaging lines with equipment capable of serialisation, manufacturers will also become responsible for acquiring and managing huge volumes of data, which will have an impact on businesses far beyond the packaging hall.
Hosting the event, Nicola Montanari, CEO of Nimax, explained why such seminars are crucial to pharmaceutical manufacturers. ‘The Falsified Medicines Directive will have a huge impact on multiple areas of a manufacturer’s business. It is imperative that they are given informed advice based on solid experience on how best to deal with the fact that along with the need to invest in new technology, they will also need to assess their business plans.
‘A whole new operational model will be required due to the FMD, so we are supporting our customers every step of the way in their journey to compliance.’
