(1) The Medicines and Related Substances Act, 1965 (Act 101 of 1965) controls the sale of medicines. In accordance with Regulation 25 of the Act, medicines are categorised into four categories of which category D refers to Complementary Medicines intended for use in humans and animals.
The Council has identified 5 disciplines of Complementary medicines of which Chinese Traditional Medicines is but one.
The Medicines Control Council (MCC) regulates the use of any active ingredient to be used in a medicine by means of the registration process of the medicines. During the registration process, the MCC will consider the quality, safety and efficacy of the active ingredient/herb to be included in the medicine.
The MCC will allocate a Schedule status to the active substance contained in the herb. The scheduling status of the substance will determine the import requirements that the Chinese medicine practitioner needs to comply with. In the event that the substance is listed as a specified Schedule 5, Schedule 6 or Schedule 7 substance, the importing practitioner requires an import permit from the Director-General: Health (Section 22A (11) of the Act). Substances listed as S0, S1, S2, S3 or S4 may be imported by a practitioner without any restriction.
(2) Labelling requirements: in terms of the MCC requirements relating to Good Manufacturing Practices (GMPs) for the manufacture of a medicine, the guidelines specify the requirements to be included on the label of any raw material. The following information is the minimum information required:
(3) Prohibition on the importation of a herbal substance relates to the scheduling status of the substance. See response in (1) above.
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