As the compliance date for the EU Falsified Medicines Directive edges closer, pharmaceutical manufacturers need to ensure all implications on production lines are fully understood.
Coding and marking specialist Domino Printing Sciences will deliver bite sized advice on the FMD at Pharmapack Europe 2016, with Craig Stobie, head of the Global Life Sciences team set to speak about what manufacturers can do now to ease their path to serialization ahead of the January 2019 deadline.
“While the original deadline anticipated when the Directive was first published back in 2011 has moved, the clarification last summer of all compliance requirements would suggest no further delays are likely. For manufacturers who are still unclear, the first step is to fully acknowledge the implications the Act will have on production. This means understanding what timescales are in place for EU Member States, which products will be affected, and having the capability to achieve onsite coding, reading and data management requirements in line with the new regulations,” Stobie says.
“Visitors to the Domino booth at Pharmapack will be able to take away tangible advice and recommendations to help them develop serialisation schemes that accord with the Delegated Acts,” he adds.
Stobie recommends that manufacturers look beyond 2019 in their planning to anticipate aggregation. “While not currently mandated by the FMD, aggregation does form part of similar schemes elsewhere in the world and we believe it is the next logical step for the industry – whether mandatory or not. Building aggregation into planning now will ensure that when the time comes, manufacturers have a straightforward upgrade route,” he advises.
Domino’s Partner Programme is a unique initiative through which the company certifies the legislative compliance capabilities of Original Equipment Manufacturers’ packaging machines based on compatibility with the Domino i-Tech range of serialization-ready printers. Primarily focused on the requirements of the Falsified Medicines Directive and the general global trends in legislation, the Programme is a valuable resource for OEMs as well as end customers looking to source serialization-compliant equipment.
Craig Stobie will be presenting at the Pharmapack Track & Trace Symposium at 10.10 AM on 10 February. The title of his paper is “Compliance Waits for No One. What Should You Be Doing Now to Ensure You Comply?”