With 18 months to go, FMD readiness ‘still a concern’

Just 10 per cent of pharma manufacturers will be able to meet their EU serialization obligations on their own without relying on outsourcing partners – making the readiness of those partners critical.

That is one of the findings of the latest annual GS1 serialization readiness survey, which also reveals that – with less than 18 months to go before the EU Falsified Medicine Directive safety feature deadline comes into effect on February 9, 2019 – more than a quarter of all respondents still have no serialized packaging lines up and running.

For companies with a smaller number of packaging lines (one to nine) – 48 per cent of the total – the situation is worse, with almost half (45 per cent) yet to serialize a line which according to Liam O’Brien, managing director of Enterprise System Partners (ESP) which collaborated with GS1 on the survey, is “a big concern this close to the regulatory deadline.”

Larger organizations with 20 or more lines to upgrade also have some way to go, with more than half (53 per cent) indicating they have nine or fewer lines completed. On the plus side, more than 70 per cent of respondents have the processes in place to handle serialization master data, while 90 per cent are budgeting for the sign-on fees that will have to be paid to the European medicines verification organization (EMVO) and national medicines verification organizations (NMVOs), and 80 per cent have plans in place for the massive task of updating packaging artwork.

41 per cent of those surveyed said they did not have enough EU regulatory information to support their business needs, which is not a surprise, according to the report, as most countries still do not have not national legislation in place. More than half (56 per cent) are also building aggregation capability – linking the individually coded packs with the codes used on cartons, cases, and pallets used in shipping – into their FMD strategy.

“With the FMD deadline looming, companies big and small should be nearing completion at this stage, but that is not reflected in the industry responses to our survey, which is of concern,” commented Alan Gormley, head of industry and engagement solutions at GS1 Ireland.

Added benefits of serialization ‘not being considered’

The survey also reveals that while there are recognised benefits of serialization beyond compliance with the FMD – such as improved patient safety and service and greater visibility and control over the supply chain – this is not at the forefront of many companies’ minds.

“It is clear that a majority of participants are reasonably well versed on the requirements and on the change management and financial implications of implementation, [but] it is also clear that most have not given due consideration to the non-regulatory benefits of serialisation,” said.

The 2017 survey is available to download from the GS1 Ireland website.