Currently the Medicines and Related Substances Act ("the Act") only applies to, and regulates, allopathic medicines. However, on 22 July 2011 the Minister of Health, Dr. Aaron Motsoaledi, published draft amendments to the General Regulations in terms of the Act which will bring complementary medicines, or alternative medicines, into the ambit of the Act. This will result in the regulation of this industry by the Medicines Control Council of South Africa ("the MCC").
In particular, the proposed amendments to the regulations will introduce, into Regulation 1, a definition for "complementary medicine". The proposed definition for "complementary medicine" reads:
"complementary medicine" means a medicine that is used-
- or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal; and
- in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982)
Also, proposed new Regulation 25 introduces a "Category D" for complementary medicines, with proposed new regulation 25A stating that Category D will be subdivided into disciplines to be determined through consultation between the MCC and the Allied Health Professions Council of South Africa. Currently the allied health professions include the following:
Chinese medicine and acupuncture,
therapeutic massage therapy,
therapeutic reflexology, and
One of the consequences of the proposed new Regulations will be that complementary medicines will in future have to be registered with the MCC. Regulation 22(3)(e) requires an applicant for the registration of a medicine to provide data on safety, efficacy and quality of the medicine, whether positive or negative, as may be determined by the Council. The proposed new regulations do not deal specifically with the level of safety, efficacy and quality data for complementary medicines that will be deemed sufficient by the MCC. However, it has been reported that this and other issues will be dealt with in a Guidance Document that is expected to be available within three to four weeks.
A further consequence for manufacturers of complementary medicines is that they will be required to have a licence to manufacture in terms of Section 22C of the Act. Such a licence may be granted by the MCC upon such conditions regarding quality assurance, good manufacturing and distribution practices as the council may determine. Complementary medicines will also have to comply with the provisions and regulations relating to labeling, advertising, package inserts, patient information leaflets and sampling.
The Act read with the Regulations provides for the seizure of medicines that are unregistered and sold in contravention of the Act. Although it is envisaged that a phased in approach will be adopted, the failure to comply with the provisions of the Act and the new regulations, once finalised, could have severe consequences for those involved.
Interested parties were given a period of three months from publication, i.e. until 22 October 2011, to submit comments to the proposed new regulations to the Director-General Health.
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