PCI to tackle ‘wait and see’ approach with serialization suite in Ireland
The firm announced completion of installation and validation of the site – located near Dublin – which was purchased as part of PCI’s Millmount Healthcare acquisition last year.
The facility offers machine and human-readable coding, tamper evident services and aggregation capabilities, to support clients in their serialisation, anti-counterfeiting, and aggregation strategies, PCI’s Justin Schroeder told us.
The EU Falsified Medicines Directive (FMD) is designed to prevent entry of falsified medicines into the pharmaceutical supply chain, and requires serialisation legislation be adopted across Europe by February 9, 2019.
Schroeder said he has observed a passive approach from industry in the lead up to the deadline, which raises concerns for ‘readiness’ in Europe.
“Generally the ‘wait and see’ approach that has plagued the US market and its readiness for the DSCA deadline compliance has also been evidenced in the European market,” he said.
The separate, but comparable US Drug Supply Chain Security Act (DSCSA) passed its deadline in November last year, but a one year reprieve was granted to drugmakers in order to provide “additional time and avoid supply disruptions,” we were told at the time.
“Resource demands continue to present a challenge for companies to commence their readiness preparation,” Schroeder told us.
A Brexit move?
The firm has received a strong response to the acquisition from the Republic of Ireland’s “thriving pharmaceutical and biotech community,” said Schroeder, who highlighted that PCI operates several sites in the UK as well.
“This added capacity and strategic geography provides our clients a comprehensive solution to help address any uncertainty brought upon by ongoing negotiations between the UK and EU,” we were told.
Last month, PCI announced plans to acquire Australia-based clinical trial services company Pharmaceutical Packaging Professionals (PPP), marking its fifth acquisition outside the US in five years.
