This webpage is dedicated to the provision of, and support for, the regulatory framework for Category D medicines by the South African Health Products Regulatory Authority (SAHPRA).
In terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965):
(a) means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in-
(i) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or
(ii) restoring, correcting or modifying any somatic or psychic or organic function in humans; and
(b) includes any veterinary medicine.
Category D medicines are a category of medicine (and as such, those substances subject to regulation are either a "medicine" or "scheduled substance" defined in terms of section 1 of the Medicines Act).
Category D medicines may be identified as "complementary medicines", defined by way of the General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), published under Government Notice 859 in Government Gazette 41064 of 25 August 2017 (this definition is currently under review):
|“complementary medicine” means any substance or mixture of substances that-
(a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by the Authority;
(b) is used or purporting to be suitable for use or manufactured or sold for use-
(i) in maintaining, complementing or assisting the physical or mental state; or
(ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or mental state of a human being or animal; and
(c) is used-
(i) as a health supplement; or
(ii) in accordance with those disciplines as determined by the Authority;
Disciplines of CM include:
- Traditional Chinese Medicine
- Unani Tibb
- Western Herbal Medicine
- Combination Products
NOTE: Anthroposophical, Gemmotherapeutic, Spagyric Substances and Flower Essences are also provided for. See Guideline 7.01 - item 1.4.5.
The definition of "health supplement" is currently under review.
|“health supplement” means any substance, extract or mixture of substances as determined by the Authority, sold in dosage forms used or purported for use in restoring, correcting or modifying any physical or mental state by-
(a) complementing health;
(b) supplementing the diet; or
(c) a nutritional effect,
and excludes injectable preparations, medicines or substances listed as Schedule 1 or higher in the Act;
Health Supplements include those substances as listed in the Annexures to Guideline 7.04.
- Amino Acids
- Animal Extracts, Products and Derivatives
- Fats, Oils and Fatty Acids
- Other (as specified)