Enough information available for companies to begin their preparations now
The need for pharmaceutical manufacturers to act now to meet the requirements of the EU Falsified Medicines Directive (FMD) and still be able to sell their products throughout Europe after 2017, will be the key theme of a seminar at the Total Processing & Packaging exhibition at the NEC, Birmingham, UK in June.
Presented by 3C Integrity managing director Christoph Krähenbühl in association with pharmaceutical coding specialist Sunala, the seminar will demonstrate how, although certain aspects of the directive will not be known until 2014, there is enough information available for companies to begin their preparations now and that those who delay for too long run the risk of not being ready in time.
The threat of falsified medicines penetrating the European pharmaceutical supply chain is substantial and growing and the FMD has been established as an important step in protecting patients from counterfeit medicines. While the exact outcome of the Delegated Acts is not expected until next year, there are clear indications of what will be required, in particular the need for all companies to participate in a systems-based, Europe-wide medicines verification process.
The seminar will provide an update on the European Stakeholders’ European Medicines Verification System (EMVS) and examine the options available for establishing effective serialisation technology, emphasising the need for flexibility; equally important, it will also highlight the many other wider preparations that manufacturers will need to implement, such as data management, pack artwork, data quality and internal organisation, processes and communication, both during the initial set-up and once the system is established.
‘The work we have done with clients to date has already highlighted the need to start early and to be as flexible as possible,’ explains Krähenbühl. ‘With so much detail to get right, companies must begin preparations now in order to identify unforeseen problems and complexities and manage the implementation in a controlled way; making sure the system is adaptable will help to avoid the need to re-engineer or re-design completely if requirements do change substantially.’
In addition, as Krähenbühl will point out, there will be huge demand on equipment suppliers, which means capacity will be severely strained and could lead to a ‘first come, first served’ situation.
The reality is that without the right preparation, pharmaceutical companies will not be able to trade in Europe after 2017
‘My aim is to take manufacturers through all the key actions that they need to undertake to be ready for the FMD,’ concludes Krähenbühl. ‘The reality is that without the right preparation, pharmaceutical companies will not be able to trade in Europe after 2017 and time to make those preparations is running out.’
The seminar will take place at 11am on Wednesday, 5 June at the Total Processing and Packaging Exhibition at the NEC. It is presented in association with Sunala, a leading supplier of coding & vision equipment for the pharmaceutical sector and part of product handling solutions specialist the Travtec Group.
Krähenbühl is recognised for his extensive experience in the field of product security, coding and serialisation solutions in the pharmaceutical industry, including project managing the implementation of the global serialisation system in AstraZeneca. He is also one of the original experts on EFPIA’s Coding and Serialisation team. He is currently managing director of 3C Integrity, which specialises in the design and implementation of product security, coding and serialisation solutions in the pharmaceutical industry.