What is SAHPRA Category D?
Category D is SAHPRA's category for complementary medicines in South Africa. It covers discipline-based medicines (such as homeopathic or Ayurvedic) and 'health supplements' like vitamins, minerals, amino acids and probiotics with low-risk claims. Makers need a SAHPRA licence and unregistered products carry a disclaimer, but as of August 2026 no complementary medicine had been registered.
- Category D covers discipline-specific complementary medicines and 'health supplements' (vitamins, minerals, amino acids, probiotics) with low-risk claims.
- Category D businesses need a SAHPRA licence; unregistered products carry a not-evaluated disclaimer.
- As of August 2026, SAHPRA had registered no complementary medicines; its list of about 117 entries is of licensed businesses.
- Supreme Court of Appeal, April 2022 ([2022] ZASCA 49): the 2017 regulations exceeded the Minister's powers for substances that are not medicines.
What does Category D mean?
Under the Medicines and Related Substances Act 101 of 1965, SAHPRA (the South African Health Products Regulatory Authority) groups medicines by category. Category D is complementary medicines, which SAHPRA splits into:
- Discipline-specific medicines: homeopathy, Ayurveda, traditional Chinese medicine and similar systems.
- Health supplements: vitamins, minerals, amino acids, probiotics and other substances making low-risk claims. The permitted substances, doses and claims are set out in SAHPRA Guideline 7.04 and its annexures.
Complementary medicine as a legal category dates from 2013, and a 2017 amendment created the discipline-versus-health-supplement split.
What does a company have to do?
- Hold a SAHPRA licence to manufacture, import or distribute Category D products; the application is attestation-based.
- Carry a prescribed disclaimer on unregistered products stating that they have not been evaluated by SAHPRA for quality, safety or intended use.
- Keep claims within low-risk boundaries. SAHPRA treats claims such as "clinically proven" as high risk.
Has anything actually been registered?
Registration is meant to happen through risk-based "call-ups" under section 14 notices. As of August 2026, according to an analysis in Spotlight, SAHPRA had registered no complementary medicines and the call-up process had not started. The roughly 117 entries on SAHPRA's published list are licensed businesses, not approved products. So a Category D disclaimer tells you the product is not approved, which is different from a product being unlawful.
Why is the status uncertain?
In April 2022 the Supreme Court of Appeal (Minister of Health v Alliance of Natural Health Products SA, [2022] ZASCA 49) upheld a finding that the 2017 General Regulations swept in substances that are not "medicines" in the legal sense, meaning those without a therapeutic purpose or claim. The Minister published draft amended regulations in March 2023, and in June 2023 SAHPRA said it would regulate only Category D products that meet the Act's definition of a medicine. Final regulations had not been published by mid-2026. The upshot: the boundary between a food and a health supplement for things like creatine or single amino acids is not clearly settled in law, and many sports nutrition products are sold as foods.
What does this mean for buyers?
| If you see... | It usually means... |
|---|---|
| "This product has not been evaluated by SAHPRA" | An unregistered Category D product. Normal for local supplements at present |
| A SAHPRA registration or approval number | Treat with caution; verify with SAHPRA, because no complementary medicine registrations had been made by August 2026 |
| "SAHPRA approved" | A red flag |
| No disclaimer on a protein or creatine tub | Often a foodstuff sold under R146 labelling |
Category D status says nothing about contamination or doping risk. If you are drug-tested, you need third-party batch testing (Informed Sport explained).
Where to read more
See are supplements regulated in South Africa for the full picture, and do supplements need SAHPRA registration for whether your product needs it.
Related questions
- Are supplements regulated in South Africa?
- Do supplements need SAHPRA registration to be sold in South Africa?
- What do South African labelling rules say about supplements?
- What is Informed Sport certification and who has it in South Africa?
Sources
- SAHPRA Guideline 7.02: Roadmap for complementary medicines (Dec 2021)
- SAHPRA Guideline 7.04: Complementary Medicines, Health Supplements safety and efficacy (Mar 2022)
- Supreme Court of Appeal media summary: Minister of Health v Alliance of Natural Health Products SA [2022] ZASCA 49
- SAHPRA communication to industry on the regulation of Category D medicines (2 June 2023)
- Spotlight (14 Aug 2026): Inside the Box with Dr Andy Gray, are complementary medicines effectively regulated in South Africa?
Educational information only, not medical advice. Speak to a doctor, pharmacist or registered dietitian before using supplements if you are pregnant or breastfeeding, under 18, taking medication, or living with kidney, liver or heart disease.
Cite this page: Healthnews24, “What is SAHPRA Category D?”, updated 27 October 2026, https://www.healthnews24.co.za/answers/what-is-sahpra-category-d-south-africa/. Plain-text version: /answers/what-is-sahpra-category-d-south-africa.md