Health products vigilance is SAHPRA’s term for safety monitoring across everything it regulates, not medicines alone. That scope is the useful thing to understand: it covers medicines, vaccines and medical devices, and problems with any of them can be reported.
People often assume reporting applies only to tablets. It also covers a vaccine reaction, a device that failed or behaved unexpectedly, and a product that was faulty rather than harmful in itself.
Quick answer: when and how to report a suspected side effect
What information to record
An adverse event is an unintended and sometimes harmful occurrence associated with using a health product. It includes side effects of medicines and vaccines, and incidents involving devices. Record the product, the dates, what happened and what else was being used.
Where reporting fits into medicine safety
An adverse event can also arise from how a product was used, or from two products that each work correctly but not together. The event occurring does not by itself mean the product is faulty.
Who can report a side effect or adverse drug reaction?
What information to record
Consumers and healthcare professionals alike. SAHPRA describes reports from both as important input to its monitoring programme. See who can report.
Where reporting fits into medicine safety
Clinical trials do not run long enough to find slow-developing effects, do not include enough people to find rare ones, and do not include everyone who will eventually use the product, including older adults, children, pregnant women and people with other conditions. Post-market vigilance exists to fill exactly those gaps.
What information should you collect before reporting?
What information to record
- The product. Name, strength, dose form, batch number and expiry date.
- The person. Age, sex and relevant history.
- The timing. When it started, when the reaction began, how long it lasted.
- The reaction and outcome, including whether hospital care was needed.
- Everything else taken, including supplements.
For a medical device, record the make, model, serial or lot number, and what the device was doing when the problem occurred.
Where reporting fits into medicine safety
Keep the product and packaging where possible. For a suspected device fault or quality problem, the item itself may be needed for investigation.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- SAHPRA’s online adverse drug reaction reporting, handled through the reporting routes listed on SAHPRA’s health products vigilance page.
- The Med Safety App, for reporting from a phone. See the Med Safety App guide.
- The adverse drug reaction and quality problem reporting form, a single SAHPRA form covering both. See the ADR form guide.
- Vaccine reactions through SAHPRA’s AEFI reporting system.
- Through a doctor or pharmacist, or through the company that markets the product.
Use one route only. SAHPRA’s overview is on its health products vigilance page.
Where reporting fits into medicine safety
Quality problems, including damaged, contaminated or suspected falsified products, go through the same combined reporting form as adverse reactions. See reporting a medicine quality problem and falsified medicines.
What counts as a serious or unexpected side effect?
Red-flag symptoms
A reaction is treated as serious when it results in death, threatens life, requires or prolongs hospital admission, causes lasting disability, causes a birth defect, or is otherwise judged medically important. Unexpected means it is not described in the approved product information.
Deal with the reaction first. Difficulty breathing, facial or throat swelling, chest pain, seizures or a blistering rash need emergency care, not a report. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
Reporting never replaces treatment. Get care first, report once the person is safe.
What happens after a report is submitted?
What information to record
Keep a copy of the submission and hold on to the product if a fault is suspected.
Where reporting fits into medicine safety
Reports are pooled and assessed for patterns. Outcomes range from updated product information through to rapid alerts and recalls, published on SAHPRA’s product recalls and safety alerts pages. See how to check safety alerts.
Medical Disclaimer: This content is for informational and educational purposes only and does not constitute medical diagnosis, prescription, or professional advice. Always read the patient information leaflet and consult a qualified doctor or pharmacist regarding any medicine or health concern.