South Africa

Policy

Traditional medicine products are regulated under the Complementary and Alternative Medicines Regulation - Medicines and Related Substances Act (Act 101, 1965) under the jurisdiction of the Ministry of Health.

There is presently no institution of learning for Traditional Medicines and regulations are in the early stage of preparation.  The Republic of South Africa participates in the WHO Survey on Traditional Medicines.

Contact

Department of Health

Website: http://www.doh.gov.za

 

Laws & Regulations

The Medicines Control Council (established in 2001, under  the Ministry of Health) published a list of categories which  they recognized as complementary medicines in 2002.  This list includes the following: Anthroposophical medicines; Aromatherapeutic medicines; Ayurvedic medicines; Chinese Traditional medicines; Energy Substances; Homeopathy; Nutritional substances; Western Herbal Medicine; Unani-Tibb medicines; Combination Homeopathic and Flower Remedies; Combination Complementary Medicine.

Products manufactured for use as dietary supplements and/or traditional medicines must comply with GMP standards and must be registered with the Government.  GMP for all herbal products is the same as that of GMP for pharmaceuticals and manufacturers must submit to the Medicine Control Council for evaluation for classification or to maintain classification of their products.  Unsubstantiated claims on these products are not allowed.  WHO monographs are used as guidelines for herbal products while a National Pharmacopoeia is in its development stage.

Traditional herbal medicines are sold in pharmacies as over the counter medicines and are also are available from local healers as a part of treatment.

An adverse events reporting program is in its beginning stage of being drafted.

Traditional medicine products are regulated under the Complementary and Alternative Medicines Regulation - Medicines and Related Substances Act (Act 101, 1965) under the jurisdiction of the Ministry of Health.

There is presently no institution of learning for Traditional Medicines and regulations are in the early stage of preparation.  The Republic of South Africa participates in the WHO Survey on Traditional Medicines.

Contact

Republic of South AfricaHealth Department,
Complementary Medicines Unit
Private Bag X828
PRETORIA, 0001

Tel: 0123120390

http://www.doh.gov.za

http://www.mccza.com