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
"complementary medicine" means a medicine that is
or intended to be used for, or manufactured or sold for use in
assisting the innate healing power of a human being or animal;
in accordance with the practice of the professions regulated
under the Allied Health Professions Act, 1982 (Act No. 63 of
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
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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