Brief: EC publishes new safety features Q&A document

The European Commission has published the latest iteration of its questions & answers document on safety features for medicines.

Version 9 of the Q&A includes new information on: anti-tamper features for bundled packs; the positioning of human-readable headers and other data elements; 2D datamatrix shapes and colour; the use of stickers for unique identifiers on outer packaging; decommissioning; the role of the qualified person (QP) in the release process; and the requirements for free sample packs, amongst others.

The safety features regulations are part of the EU Falsified Medicines Directive and come into force in February 2019. They require the packaging of all medicinal products in the scope of the regulation to have an anti-tampering device and a unique identifier (in the form of a 2D barcode) to allow identification and authentication.

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