SOPREFERENCE OUTLINE

Suspected Falsified Medicine Procedure

Procedure for containing a suspect pack without destroying the evidence that identifies it: a do-immediately versus never table, batch and consignment quarantine rather than the single pack, trace back and forward, notification to the authority and marketing authorisation holder, system alerts treated as suspicion until resolved, and an investigation of your own controls afterwards. Maps to Delegated Regulation (EU) 2016/161.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

Checking your Professional access…

REGULATIONS MAPPED
Del. Reg. (EU) 2016/161
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

A falsified medicine misrepresents its identity, history or source; unlike a substandard product the failure is deliberate, and the pack may be inert or actively harmful. Most detections now arrive as a system alert, and the first decision is what not to do with the pack, because handling it destroys the evidence that identifies its route. Whether an alert is a technical fault or a genuine detection is your determination.

What's Inside

✓Detection record — how the suspicion arose, who raised it, and the pack’s exact physical state on receipt
✓A do-immediately versus never table, so the person holding the pack acts without needing a judgement call
✓Quarantine scope covering the batch and the whole consignment, not only the single pack that was detected
✓Trace back and forward through supply records, naming every partner the batch reached or came from
✓Notification routing to the competent authority, the marketing authorisation holder and the repository operator
✓System alert handling that treats every alert as suspicion until a documented resolution closes it
✓Own-control investigation asking how the pack entered your supply chain and what allowed it through

How to Use It

1Do not open, clean, relabel or repack the suspect pack — the packaging is the evidence that identifies where it came from.
2Quarantine the batch and the whole consignment before investigating; holding only the detected pack lets the rest ship while you deliberate.
3Trace back and forward from the supply records the same day, because onward recipients are dispensing while the trace is open.
4Notify the authority and the marketing authorisation holder as well as quarantining — an isolated detection left unreported stays outside the national picture.
5Treat every system alert as suspicion until resolved; dismissing alerts as technical is how a genuine detection drowns in routine noise.
6Close with an investigation of your own controls, recording what allowed the pack in rather than only what you did about it.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1What This Covers
2Immediate Actions — and What Not To Do
3Trace Back and Forward
4Notification
5System Alert Handling
6Own-Control Investigation
REGULATORY CONTEXT

Delegated Regulation (EU) 2016/161 establishes the safety features regime — the unique identifier, the anti-tampering device, verification at the point of supply, and the obligations that follow a suspected falsification, including notification. It does not tell you whether a given alert is a technical fault or a real detection, how wide to draw the quarantine, or what your own controls should have caught. Those determinations belong to your organisation. The procedure structure and the do-immediately table are SPEQ practitioner synthesis.

MAPPED STANDARDS
Del. Reg. (EU) 2016/161
Browse the standards catalog →