Delegated Regulation (EU) 2016/161 - Safety Features for Medicinal Products

What it says

Medicinal products within scope must bear a unique identifier, a machine-readable code enabling verification of the product's authenticity, and an anti-tampering device on the packaging, with manufacturers uploading unique identifier data to a central European repository system that pharmacies and other dispensers check at the point of dispensing.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This regulation is the EU's equivalent framework to the US DSCSA, though structured around a centralised European repository system that dispensers check against at the actual point of dispensing, rather than the more distributed transaction-history-based tracing model used under DSCSA.
• The unique identifier must be decommissioned, marked as used, in the repository system at the point of dispensing, meaning the system depends on consistent, accurate participation from pharmacies and other dispensers across the entire EU/EEA to function correctly.
• Anti-tampering device requirements work alongside the unique identifier system as a physical, visible complement to the electronic verification system, giving both a technological and a physical layer of protection against falsified medicines entering the legitimate supply chain.

What inspectors look for

• Whether unique identifier data is correctly and completely uploaded to the repository system at the time of manufacture and release.
• Whether anti-tampering device integrity is verified as part of standard release and distribution procedures.
• Whether a system exists for investigating and responding to verification failures or decommissioning anomalies detected through the repository system.

Related regulations