European Commission updates Q&A on safety features for human medicines

29th July 2026

Summary: Version 22 updates the Commission's guidance on the implementation of the EU Falsified Medicines Directive safety features, including the unique identifier and anti-tampering device required on medicine packaging. The revised Q&A provides further clarification on stakeholder responsibilities, requirements for anti-tampering devices, and access by national competent authorities to audit trail data within the European Medicines Verification System (EMVS). The update is intended to support the consistent application of safety feature requirements across the EU rather than introduce significant new regulatory obligations.

Link: https://health.ec.europa.eu/latest-updates/questions-and-answers-version-22-safety-features-medicinal-products-human-use-2026-07-10_en

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