European Commission releases aide-memoire to help medicine manufacturers comply with GMP inspections related to falsified medicines delegated regulation

In order to help medicine manufacturers comply with the 2015 European Union (EU) delegated regulation protecting against falsified medicines, which came into force in February 2019, the European Commission has released an aide-memoire for good manufacturing practice (GMP) inspections of manufacturers.

The aide-memoire for GMP inspection of manufacturers’ compliance with commission delegated regulation (EU) 2016/161 for safety features contains questions that manufacturers can review to ensure compliance with the delegated regulation ahead of an inspection. The regulation outlines the safety features for medicinal products, in particular the characteristics and technical specifications of the unique identifier (UI), the modalities for the verification of the safety features and the management of the repository system containing information on the safety features.

The European Commission have reminded companies that they need to investigate whether all prescription products manufactured at a given site are required to contain safety features, including if any of the products are imported from India. The European Commission have stated that, if products are manufactured by a contractor in India, the companies need to ensure that the contract manufacturer obtains an exemption from the Indian traceability system so that Indian barcodes are not applied to medicine packs exported to the EU.

The aide-memoire includes reminders regarding data flow, specifically regarding how the serialisation numbers are generated, to where the UIs are printed and the hub where the UIs are uploaded. Also detailed in the aide-memoire are reminders related to packaging lines, structure of the UI, decommissioning of UIs, the human-readable format, quality of the printing of the 2D barcode, alert management and actions required in case of tampering or suspected falsification.

To read the European Commission’s aide-memoire for GMP inspection of manufacturers’ compliance with commission delegated regulation (EU) 2016/161 for safety features, please click here.