Market Surveillance and Control
Market Surveillance and Control tests post-marketing detection of substandard, falsified and unsafe medicines, and the recall and enforcement actions that follow.
Core activities
PPB samples medicines from ports, warehouses, pharmacies and clinics; tests them through the National Quality Control Laboratory (NQCL); and issues rapid alerts where necessary. Product quality complaints, adverse findings, illegal imports and unregistered products are investigated. Recall classification reflects health risk: Class I for products likely to cause serious harm or death, Class II for temporary or reversible harm, and Class III for lower-risk violations. A recall requires notification to PPB, quarantine, distribution tracing, customer notification, reconciliation of returned stock, effectiveness checks and a final report. Traceability systems are essential because a failed batch must be located quickly.
Worked example
A market sample of paracetamol tablets fails assay at 80% of label claim. The batch is already distributed. The risk is subtherapeutic treatment, so the distributor and PPB initiate a recall, trace the batch, quarantine remaining stock and investigate manufacturing and storage causes. Waiting for PPB to discover the distribution gap is not acceptable: the licence holder has its own recall and notification responsibilities.
Traps that cost marks
- Confusing expiry with substandard quality.
- Treating counterfeit and substandard as identical categories.
- Failing to keep batch traceability records.
- Recalling without notifying PPB or documenting effectiveness checks.
- Ignoring a rapid alert or market sample failure.
- Leaving recalled stock in the active dispensing area.