Market Surveillance and Control
What this domain tests
Market surveillance tests post-market detection of substandard, falsified and recalled medicines, and the regulatory actions that follow.
Core rules and concepts
- Surveillance uses sampling, laboratory testing, inspection, complaints and adverse-event signals.
- Suspected products may be seized, quarantined or recalled. Recall classes reflect the health hazard: a defect likely to cause serious harm is the most urgent.
- A recall plan covers traceability, notification, retrieval, reconciliation and destruction.
- Falsified medicines mimic identity; substandard medicines fail specifications. The response differs but both are regulatory concerns.
- Risk communication to health professionals and the public must be accurate and timely.
Worked example
A batch of paediatric syrup is found to contain a precipitate. Reasoning: this is a quality defect with potential patient harm. The batch should be quarantined, distribution traced, a recall initiated at the appropriate class, and users notified. The manufacturer provides a root-cause investigation. Reconciliation checks whether all units were retrieved. Testing alone does not close the case; the recall and corrective action do.
Traps that cost marks
Calling every quality failure “counterfeit”. Recalling without tracing distribution. Failing to reconcile returned stock. Assuming a recall ends when the notice is issued. Ignoring the difference between falsified and substandard products.