# What is SAHPRA Category D?

Source: https://www.healthnews24.co.za/answers/what-is-sahpra-category-d-south-africa/
Publisher: Healthnews24 (South Africa's supplement answer desk)
Updated: 2026-10-27

> 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.

Key facts:
- 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](/answers/what-is-informed-sport-certification-south-africa/)).

## Where to read more

See [are supplements regulated in South Africa](/answers/are-supplements-regulated-in-south-africa/) for the full picture, and [do supplements need SAHPRA registration](/answers/do-supplements-need-sahpra-registration-south-africa/) for whether your product needs it.

## Sources

- [SAHPRA Guideline 7.02: Roadmap for complementary medicines (Dec 2021)](https://www.sahpra.org.za/wp-content/uploads/2021/12/7.02_Roadmap_for_CMs_Dec21_v2_3.pdf)
- [SAHPRA Guideline 7.04: Complementary Medicines, Health Supplements safety and efficacy (Mar 2022)](https://www.sahpra.org.za/wp-content/uploads/2022/03/7.04_CM_SE_Health_Supplements_Mar22_v4_3.pdf)
- [Supreme Court of Appeal media summary: Minister of Health v Alliance of Natural Health Products SA [2022] ZASCA 49](https://www.supremecourtofappeal.org.za/images/Media_Summaries_2022/sca2022-49ms.pdf)
- [SAHPRA communication to industry on the regulation of Category D medicines (2 June 2023)](https://www.sahpra.org.za/wp-content/uploads/2023/06/Communication-Industry-on-the-Regulation-of-Category-D-Medicines-02-June-2023.pdf)
- [Spotlight (14 Aug 2026): Inside the Box with Dr Andy Gray, are complementary medicines effectively regulated in South Africa?](https://www.spotlightnsp.co.za/2026/08/14/inside-the-box-with-dr-andy-gray-are-complementary-medicines-effectively-regulated-in-south-africa/)