How to Handle a Suspected Falsified Medicine
Contain a suspect pack and notify, without destroying the evidence that identifies it.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
A falsified medicine is one that misrepresents its identity, history or source, and it is distinct from a substandard one: the failure is deliberate and the product may be entirely inert or actively harmful. The EU scheme places verification at the point of supply through a unique identifier and an anti-tampering device, so most detections now arrive as a system alert rather than as a visual suspicion, and the first decision is what not to do with the pack.
- 1
Stop and segregate immediately
Quarantine the suspect pack and everything associated with it — the same consignment, the same batch, the same supplier. Speed matters more than certainty at this point, because a pack that continues down the chain while you investigate may reach a patient.
- 2
Preserve the pack and its packaging exactly as received
Do not open, clean, re-scan repeatedly, or discard the outer packaging and transport documents. The packaging, the identifier and the paperwork are what let an authority establish the entry point, and they cannot be recovered once handled.
- 3
Establish where it came from and where else it went
Trace the batch through your receipt and despatch records: who supplied it, what else arrived with it, which customers received the rest. The question is never one pack, it is what else moved on the same route.
- 4
Notify the authority and the marketing authorisation holder promptly
Reporting is an obligation and it is what connects your isolated detection to a national picture. A distributor who quarantines and does not report has protected its own stock and left the network blind.
- 5
Treat a system alert as suspicion until it is resolved
Where verification returns an alert, the pack is not supplied until the alert is investigated and closed. Many alerts turn out to be technical, and dismissing them as technical before investigating is how a genuine detection is lost in the noise.
- 6
Investigate your own controls afterwards
Ask how it entered — which supplier, which qualification step, which check would have caught it earlier. A falsified pack reaching your stock is evidence about your supplier qualification, and treating it purely as an external event forgoes the one thing you can control.
- !The pack opened, cleaned or the packaging discarded, destroying the evidence of its origin.
- !Only the one pack quarantined, while the rest of the batch and consignment continue moving.
- !System alerts dismissed as technical before being investigated, so genuine detections drown in noise.
- !Quarantine and no notification, leaving an isolated detection out of the national picture.
How to Handle a Suspected Falsified Medicine: frequently asked questions
Common questions on handle a suspected falsified medicine.
What makes a medicine falsified rather than substandard?
Falsification is deliberate misrepresentation of identity, history or source — the packaging says something untrue about what is inside or where it came from. A substandard medicine is a genuine product that failed to meet its specification. One is a crime and the other is a quality failure, and they route to different responses.
What do the EU safety features consist of?
A unique identifier carried in a two-dimensional barcode and an anti-tampering device on the packaging. The identifier is verified and decommissioned at the point of supply to the public, and wholesalers verify in defined circumstances, so an alert is generated when a pack does not match the repository.
Is an alert proof of falsification?
No, and most alerts are not. They arise from data errors, scanning problems and upload timing as well as from genuine falsification. But the pack is not supplied while the alert is open, because the cost of investigating a technical alert is trivial next to the cost of supplying a falsified pack.