By early 2019, medicine packs sold in the EU will have to be serialised to the item level, and there are real concerns that some drugmakers will struggle to meet the deadline.
There is little doubt that big pharma companies will meet the safety feature requirements of the Falsified Medicines Directive - which focus on applying unique codes and tamper-evidence to each pack - as they have been investing in upgrading packaging lines and IT infrastructure for years.
There are still concerns that small- and medium-sized companies are at risk of missing the deadline - last year, a survey of manufacturers suggested that a quarter felt it would take more than three years to be compliant with the requirements - beyond the enforcement date.
Meanwhile, more than one source has suggested to SecuringIndustry.com that some of the larger players in serialization have all but closed their books on new orders, and as a result there is a danger that some manufacturers may find it hard to take projects through to their conclusion in the time available.
Against that backdrop, Domino Printing Sciences has launched a platform - called SerialTrac - that it hopes can assist pharma companies, contract manufacturing organisations who are at the start of their journey towards serialization and compliance with the FMD.
Critically, the intention is to allow customers to deal with just one company for the entire project, rather than having to bring multiple vendors to the negotiating table.
At the heart of SerialTrac is a random code generating system - called Codentify - that has already been deployed in the tobacco industry and allows individual packs to be tracked through the supply chain and helps combat counterfeiting and diversion.
Serialized Codentify codes are being applied to billions of tobacco products every year, well in excess of the numbers of medicine packs which enter the EU supply chain, and are applied to packs at speeds greater than those typically used in pharma printing.
The package is designed to be "parachuted in" to companies' primary packaging lines and covers all elements needed to comply with the FMD's coding requirements, according to Craig Stobie, director, global sector management and development at Domino.
That includes serial number generation, product handling, printing codes onto packs, verification using vision systems, and re-packaging where required. It also features a site-level repository and reporting system that meets the need to upload codes to the national medicines verification organization (NMVO), which in turn links to the European data hub.
SerialTrac's features have been designed to meet the requirements of not only the FMD but also other traceability requirements such as the Drug Supply Chain Security Act (DSCSA) in the US. As a result has some features - such as aggregation - are incorporated as standard.
The FMD does not mandate aggregation - linking each individual medicine pack to the carton or case in which it is shipped - but it is implicit in the regulation. The directive wants wholesalers to be able to check returns, for example, and being able to scan one code on the outside of a shipper box or pallet and infer the identities of all the unit packs inside without opening the box avoids the repacking and re-working step.
"We think aggregation is going to be fundamental even though it is not mandated in Europe," said Stobie. Using SerialTrac manufacturers can opt out of aggregation at the outset, but add it in if required later, he noted.
Domino says installation on a typical line can be completed in as little as five days, with minimal impact to the production environment, which "compares favourably with the install requirements for bespoke systems."
Jim Orford, commercial programme manager for SerialTrac at Domino, said that the company "recognises that small to medium-sized businesses are particularly hard hit."
"Typically these manufacturers do not have the infrastructure or resources readily available to create a bespoke solution or to integrate with an ERP system - yet they face exactly the same complexity challenges as operations 10 times their size."
One company that is in the final stages of negotiating a deal to implement SerialTrac is UK-based contract development and manufacturing organization (CDMO) Nova Laboratories.
According to Nova's David Edgar, the company looked at setting up a system using separate vendors to implement serialization on its single packaging line, but found that SerialTrac was less complicated and more cost-effective.
Domino's managing director Nigel Bond was reluctant to give any projections for the number of SerialTrac installations it hopes to ship, but did suggest that it was expecting "significant sales."
Given the large number of smaller companies that still need to get into compliance with the FMD, "we may have more orders than we can deal with," he suggested.
SerialTrac will be available to order in Spain from next month and in the UK from July, ahead of a wider rollout.
At the moment, it remains unclear what the consequences will be if, come February 2019, pharma manufacturers and other stakeholders such as contract manufacturing organizations (CMOs) are not ready to play their part.
While it is inconceivable that a situation resulting in medicine shortages could be allowed to arise, equally it is likely that regulators will give short shrift to non-compliant companies - particularly as the broad strokes of the security features requirements were pretty clear well before the publication of the Delegated Regulation.
Serialization expert Mark Davison of Blue Sphere suggested that it is clear that the momentum is too great to prevent the FMD being implemented. However, he suggested there may be an "enforcement holiday" - though likely no more than a few months - for companies that have shown they are committed to compliance but are not yet there.