Craig Stobie, head of the global life sciences team at Domino Printing Sciences, will be presenting at the Pharmapack Track and Trace Symposium on 10 February, at Paris Expo, in Porte de Versailles, Paris
Craig Stobie, head of the global life sciences team at Domino Printing Services
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, according to Domino.
Stobie said: “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.
“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.
Stobie said that manufacturers should look beyond 2019 in their planning to anticipate aggregation. He said: “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.”