Delegates from the French pharmaceutical industry heard recently how legislative changes associated with the EU Falsified Medicines Directive will affect their businesses at operational and commercial levels.
At a seminar held during Emballage 2012, France’s premier event for the packaging industry, speakers from coding body GS1 and EFPIA, the European Federation of Pharmaceutical Industry and Associations, joined forces with Domino’s Life Sciences team to explore the requirements and potential implications of the Directive.
A cornerstone of the 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 clear once the Delegated acts associated with the Directive are published in 2013 but broadly, it will consist of a unique serialised 2D datamatrix code combined with human-readable data and tamper evident features.
Opening the event, Yann Gorrity, managing director of Domino France, explained that the Directive is the next step in legislation for the French market, following the adoption of the CIP 13 standard at the end of 2010. 'We are used to change in this market but this doesn’t mean that we can afford to be complacent about the Falsified Medicines Directive, since it will require a whole new operational model,' he commented.
GS1’s Christian Hay then spoke about traceability standards for healthcare products, before Jean-Marc Bobée, EFPIA board member and director of anti-counterfeiting for Sanofi, outlined the vision for serialisation and product authentication across Europe as it applies to all stakeholders.
Craig Stobie, global life sciences manager for Domino
In his closing remarks, Craig Stobie, global life sciences manager for Domino, urged manufacturers to pay close attention to the coding requirements of the Falsified Medicines Directive and to begin planning now. 'Until now, the term variable data has implied from batch to batch but in the future it will be from pack to pack. Apart from the need to update packaging lines with equipment capable of serialisation, producers will become responsible for acquiring and managing huge volumes of data, which will have an impact way beyond the packaging hall,' he said. 'Manufacturers must realise that this is a fundamental business challenge: managing the requirements of the Falsified Medicines Directive will call for a cross-functional team and senior management commitment.
'Customers that have started serialisation projects are telling us that it is taking longer than current expectations allow, something that should be factored into planning for FMD compliance,' Stobie concluded.
The event is the second in a series being rolled out by Domino across Europe, with Spain, Germany and the Netherlands on the itinerary early in 2013. For more information, please contact fmdevents@domino-uk.com.
About EU Falsified Medicines Directive
Adopted in 2011 and aimed at stemming the flow of falsified medicines reaching the open market within the European Economic area, the EU Falsified Medicines Directive (FMD 2011/62/EU) will, within a few years, completely change the landscape of the European pharmaceutical business model.
The scope of the Directive places new obligations on all branches of the industry – manufacturers, generics producers, contract packers, re-packers and importers – among which is the unique identification of products at unit of sale level. In 2011 Domino established a European Group dedicated to helping manufacturers comply with the Directive. The Group consolidates Domino’s industry-leading expertise in pharmaceutical legislative compliance solutions and comprises specialists in all the critical disciplines, including legislative standards, validation of automated manufacturing good practice, code formats and serialisation.