EU serialisation: Challenges facing pharma one year out
Friday February 9 marked twelve months until the EU Falsified Medicines Directive (FMD) – designed to prevent entry of falsified medicines into the pharmaceutical supply chain – demands serialisation legislation be adopted across Europe.
As a result of the impending deadline, Sharp Packaging Services’ Rick Seibert said he has observed an increase in customer interest and site audits.
A welcome reprieve?
The US serialisation deadline passed on November 26, 2017, but the US Food and Drug Administration (FDA) said it would delay enforcement to give MAHs and CDMOs more time to observe the regulations to avoid disruptions to drug supplies.
However, serialisation provider SEA Vision’s Marco Baietti said it was doubtful the EU FMD would offer a reprieve.
“While the FDA gave many businesses a welcome reprieve by extending the deadline, the EU’s pharma industry is not likely to be as lucky,” said Baietti.
“The most active segments appear to be those in speciality, injectable and biologic products but it is vital that pharma manufacturers across the sector now fully engage in their implementation projects,” he said.
However, serialisation provider TraceLink’s Manfred Voglmaier raised concerns with one year to go, an “uncomfortably large number” of businesses aren’t ready.
Not ready? Why not?
According to Voglmaier, a lack of understanding regarding the “complexity and resource intensiveness” of serialisation is a factor in firms’ lack of readiness.
“The implementation process is almost entirely new and a lot of uncertainty remains when it comes to understanding what is really needed to comply with different market,” he told us.
Further, companies believe vendors have sufficient amounts of delivery capacity, and that adopting serialisation later could lead to lower costs, he said.
But opposite is true: “A serialisation programme typically takes six to nine months to implement, meaning businesses looking to make the February 2019 FMD deadline should be starting their projects by the end of Q1 2018 at the latest.”
Timeline
Contract Development and Manufacturing Organisation (CDMO) Recipharm expressed concern that many Marketing Authorisation Holders (MAHs) are yet to implement the European Medicines Verification System (EMVS).
The EMVS is designed to guarantee medicines authenticity by end-to-end verification across Europe.
Recipharm’s director of corporate projects Staffan Widengren said adopting the EMVS is a timely process, adding: “The European Medicines Verification Organisation increased the fee for onboarding to the EMVS in January 2018 and this will increase again in June 2018, which is an incentive for companies to act sooner rather than later.”
Further, lead times for serialisation adoption is often longer than expected, said Widengren, due to “issues with equipment availability and the increasing scarcity of expert resources both inside respective organisations, and externally where third-party suppliers, consultants and vendors in the industry are in high demand.”
Italy-headquartered serialisation provider SEA Vision also expressed concern selecting, delivering and validating line systems can be a lengthy process.
“Some vendors are currently proposing timescales over 12 months to deliver line systems which will now take implementation beyond the EU deadline,” said commercial director Marco Baietti.
Contract packaging company (CPO) Tjoapack however said outsourcing serialisation can speed up the adoption timeline.
“Generally speaking, three to four months - depending on complexity – is a realistic timeframe to ensure a CPO can take the necessary steps to ensure a successful transfer and serialisation integration,” said head of corporate strategy, Dexter Tjoa.
“This is still considerably shorter than an in-house implementation project which can easily run twelve to eighteen months given current supplier lead times,” he added.
“An uphill battle”
Baietti said missing the deadline could be detrimental to the success and longevity of a business.
“If they [pharmaceutical manufacturers] are yet to begin their serialisation programmes, then they may find themselves facing an uphill battle to meet the deadline,” he added.
Widengren agreed getting on board early would be necessary to ensure firms had time to trial their serialisation programme.
“Realistically, if companies do not start onboarding until after June 2018 they will probably not be ready until the February 2019 deadline or later, leaving no time to test their solution,” he said.
