What is SAHPRA? How to verify a registered medicine in South Africa

What SAHPRA is

SAHPRA stands for the South African Health Products Regulatory Authority. SAHPRA's own website describes it as a public entity of the National Department of Health. It reports to the Minister of Health through its Board.

SAHPRA took over the work of two bodies that sat inside the Department of Health: the Medicines Control Council and the Directorate of Radiation Control. Its main law is the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Amendments to that Act in 2008 and 2015 set up SAHPRA. The Hazardous Substances Act, 1973 adds radiation-emitting devices and radioactive nuclides to its work.

What SAHPRA does

• Registers medicines for people and for animals, including complementary medicines
• Regulates medical devices and in vitro diagnostics, the tests done on samples such as blood
• Licenses manufacturers, wholesalers and distributors of medicines and medical devices
• Oversees clinical trials
• Oversees radiation control in South Africa

SAHPRA says its work rests on three pillars: safety, efficacy and quality.

How to verify a registered medicine

SAHPRA lists its public tools on its e-services page. Two of them help you verify a medicine.

The Registered Health Products database

The Registered Health Products database lists the health products SAHPRA has approved and authorised. You can search it by applicant name, product name, active ingredient, registration number, application number, registration date or status.

1. Open medapps.sahpra.org.za:6006 in your phone browser.
2. Type the registration number from the label into the Registration # field. Then search again by the product name.
3. Open the record that matches.
4. Compare the record with your medicine: product name, active ingredient, applicant and registration number.

A notice on the database says SAHPRA found data inconsistencies in it. If you find no record, contact SAHPRA before you use the medicine.

The OTC Medicines Directory

SAHPRA launched the OTC Medicines Directory in June 2022. It covers registered over-the-counter medicines in Schedules 0, 1 and 2. Each entry has the patient information leaflet where one is approved, the professional information and a photo of the product. You can search by product name or by company name.

Compare the photo in the directory with the box in your hand. When SAHPRA launched the directory, prescription medicines were not in it.

What to look for on the label

Regulation 10 of the General Regulations under the Medicines Act lists what a medicine label must show. The list includes:

• The registration number SAHPRA allocated to the medicine, with the medicine's category just before it. A medicine still under application can show its application number followed by "Act 101/1965" instead.
• The letter S and the schedule number in a square border before the brand name, when the medicine contains a scheduled substance
• The brand name, the dosage form, and each active ingredient with its quantity
• The lot number and the expiry date
• A barcode for identification and tracking
• The name of the company that holds the certificate of registration
• Wording in English and at least one other official language

Complementary medicines must say "Complementary Medicine" on the label. If a complementary medicine is not registered, its label must say that SAHPRA has not evaluated it.

Look at the box and the medicine too. In 2025, SAHPRA named warning signs such as sediment in cough syrup, unfamiliar packaging and tablets that fall apart. For more signs, read how to identify fake drugs and batch numbers and expiry dates.

A registration number on a box shows that the medicine was registered. Counterfeiters can still print a real number on a fake box. Compare every detail with SAHPRA's record.

Some companies protect their products with anti-counterfeiting methods. You can verify a product protected with Batach with your phone at batach.io/scan.

Where fake medicines turn up in South Africa

SAHPRA's whistle-blower hotline logged about 130 reports in 2021, 297 in 2022 and 430 in 2023, TimesLIVE reported. By August 2025 it had logged about 507. SAHPRA's chief executive said these products reach the market mostly through spaza shops and online selling platforms. The same report covered the launch of a five-year National Action Plan on substandard and falsified medical products. Health Minister Aaron Motsoaledi announced it as a pilot backed by WHO.

In July 2026, SAHPRA's regulatory compliance manager told EWN that injectable peptides were the fakes SAHPRA found most often. They are sold for weight loss on social media and in beauty salons, health salons, IV bars and gyms. SAHPRA advises getting medicines only from authorised suppliers, with a valid prescription where one is required.

South Africa is one of many countries dealing with this. Read what the evidence says about fake medicines in Africa.

How to report a suspected fake

If the label or the record does not match, do not use the medicine. Keep it with its box and your receipt, and report it to SAHPRA:

• Call SAHPRA's 24-hour whistle-blower hotline on 0800 204 307.
• Fill in SAHPRA's complaint form for medicines and medical devices. You can upload photos of the product.
• If you had a side effect, report it through the Med Safety App.

SAHPRA publishes product recalls on its website. Search the list for the name on your box. More on reporting in how to report a fake product.

Other goods: the Counterfeit Goods Act and the NRCS

SAHPRA covers medicines and medical devices. For other branded goods, the Counterfeit Goods Act, 1997 lets the owner of the brand, or an importer or distributor of the goods, lay a complaint with an inspector. If you think a branded product is fake, tell the company that makes it.

The National Regulator for Compulsory Specifications (NRCS) enforces compulsory specifications for goods such as electrical products, vehicle parts and tyres, cleaning chemicals, building materials and some foods. In July 2026, the NRCS estimated that illicit or noncompliant products make up 10% to 15% of the market for fast-moving consumer goods.