EC Aide-Memoire Aims to Help Drugmakers Comply With GMP Inspections Related to Falsified Medicines Delegated Regulation

Regulatory NewsRegulatory News | 25 June 2019 |  By 

As part of efforts to help drug manufacturers comply with a 2015 EU delegated regulation protecting against falsified medicines, which came into force in February, the European Commission (EC) has published an aide-memoire for good manufacturing practice (GMP) inspections of manufacturers.

The document features nine pages of questions that manufacturers can review to ensure they comply with the delegated regulation ahead of an inspection. The regulation deals with the safety features for medicinal products, with particular regard to the characteristics and technical specifications of the unique identifier (UI), the modalities for the verification of the safety features, and the establishment and management of the repository system containing information on the safety features.

In terms of general questions, the EC reminds companies to investigate whether all prescription products manufactured at a given site are required to bear safety features, as well as if any of the products are imported from India.

If products are manufactured by a contractor in India, the EC reminds firms to ensure that 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 also offers reminder questions on data flow, specifically with respect to how the serialization numbers are generated, to where the UIs are printed, to the hub where the UIs are uploaded.

“The information laid down in Article 33(2) of Commission Delegated Regulation (EU) 2016/161 needs to be present in the system at the time the batch is released for sale and distribution,” the EC says.

Other questions and reminders deal with packaging lines, composition of the UI, decommissioning of UIs, the human-readable format, quality of the printing of the 2D barcode, alert management and actions to be taken in case of tampering or suspected falsification.

Aide-Memoire for GMP Inspection of Manufacturers Compliance With Commission Delegated Regulation (EU) 2016/161 for Safety Features


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