EU Releases New Rules Focused on Track-and-Trace Packaging

The European Medicines Agency and the European Commission have published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries.

The rule, which takes effect February 2019, mandates that manufacturers include a bar code as a unique identifier and an anti-tampering device in the packaging of most medicines.

The regulation also specifies interim compliance guidance for drug companies with existing or new marketing applications in the EU.

The regulation was hardly a surprise. Five years ago, the EU issued its Falsified Medicine Directive, and this action is part of the implementation of that directive.  “The EU requirements have been expected and most manufacturers that sell products in Europe have been waiting for the delegated acts to be published,” Bill Fletcher, managing partner with Pharma Logic Solutions, said.