The Dutch firm – which owns contract packaging organisation (CPO) Tjoapack – said Meditraq will install and manage track & trace software solutions to ensure the safe and secure exchange of serialization data.
The service includes ongoing support and compliance options, including the management of master data and the transfer of data between relevant parties.
According to the Tjoa Group’s Dexter Tjoa, the serialization “data challenge” is looming for companies in Europe and the US yet to adhere to track and trace regulations.
“One of the greatest challenges of complying with global track and trace requirements is the complexity of managing and sharing huge volumes of data throughout the pharmaceutical supply chain,” he said.
The US serialization deadline passed on November 26, 2017, however in July the US Food and Drug Administration (FDA) said it would delay enforcement by one year.
In Europe, the EU Falsified Medicines Directive (FMD) will enforce separate yet comparable track & trace legislation on February 9, 2019.