SAHPRA, the South African Health Products Regulatory Authority, is the body responsible for monitoring the safety of medicines, vaccines and medical devices in South Africa after they reach the market. Pharmacovigilance is the part of its work concerned with detecting, assessing and acting on unwanted effects.
Two separate streams feed it. Companies holding a registration are legally obliged to collect and submit safety data on their products. Alongside that, spontaneous reports come from health professionals and directly from the public, and it is the second stream this page is mainly about.
Quick answer: when and how to report a suspected side effect
What information to record
Report whenever you suspect a health product caused an unwanted effect. Record the product name and batch number, the dates, what happened, and everything else being taken.
Where reporting fits into medicine safety
SAHPRA is explicit that a report is not an accusation. An adverse event occurring alongside a product does not establish that the product caused it, and sorting association from causation is precisely what the assessment process is for.
Who can report a side effect or adverse drug reaction?
What information to record
Consumers and healthcare professionals both report into the same system, and SAHPRA treats reports from the public as a meaningful part of its monitoring rather than as supplementary. See who can report.
Where reporting fits into medicine safety
Licence holders carry mandatory obligations with defined timelines, particularly for serious reactions. Public reporting is voluntary, which is why encouraging it matters.
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.
Where reporting fits into medicine safety
The batch number is what allows a manufacturing fault to be distinguished from a property of the medicine, and it is the detail most often lost once packaging is discarded.
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
South Africa participates in the World Health Organization’s international drug monitoring programme, coordinated by the Uppsala Monitoring Centre, which is why the public reporting portal is hosted there. Reports contribute to a global database as well as the national one.
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
SAHPRA does not provide clinical advice on individual cases. For advice about your own situation, contact a pharmacist or doctor.
What happens after a report is submitted?
What information to record
Keep a copy and any reference number in case further detail is requested.
Where reporting fits into medicine safety
Where assessment confirms a concern, SAHPRA can require changes to the professional and patient information, issue a safety alert, restrict use, trigger a rapid alert, or require a recall. These appear publicly through safety alerts, the rapid alert system and product recalls.
See SAHPRA safety alerts and SAHPRA product recalls.
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.