South Africa - Draft amendment to complementary medicine regulations

In the next chapter on the regulation of complementary medicines in South Africa, a proposed amendment to the General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965 was published in the Government Gazette on 15 September 2014.

Surprisingly, the proposed amendment comes only 10 months after the publication of the amended Regulations which incorporated complementary medicines into the ambit of Medicines and Related Substances Act 101 of 1965.

The main import of the proposed amendment is the planned changes to the definition for a complementary medicine, which is now defined as:
any substance or mixture of substances that –

(a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by Council, and

(b) is used or purporting to be suitable for use or manufactured or sold for use –
      (i) in maintaining, complementing, or assisting the innate healing power or 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 Council, or

(d) is declared by the Minister, on recommendation by the Council, by notice in the Gazette to be a complementary medicine;

In a move that could be considered as a clarification on the Department of Health’s position on the regulation of vitamin products and sports supplements, it is noted that the definition now specifies, in addition to the other requirements, that the substance or mixture of substances is used as a health supplement.

In terms of the Notice, the Minister of Health has indicated his intention to promulgate Regulation 716 and all interested persons have been invited to submit any substantiated comments or recommendations on the amendment within three (3) months from the date of publication thereof. The current deadline for submitting comments on the proposed amendment is 15 December 2014.

Please feel free to contact our offices, if interested, for more information. Dirk Hanekom

Date published: 2014/09/22
Author: Dirk Hanekom

Tags: product regulatory advice news medicines health