Complementary Medicines Amended Regulations | News | Spoor and Fisher

The much anticipated 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 November 2013.

The amendment of the General Regulations is largely aimed at bringing complementary medicines into the ambit of Act 101, however, there are also consequences for the manufacturers of allopathic medicines. The amended Regulations define a ‘complementary medicines’ as: any substance or mixture of substances that –
(a) originates from plants, minerals or animals;
(b) 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 to mitigate, modify, alleviate or prevent illness or the symptoms thereof or abnormal physical or mental state; and
(c) is used in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982).

As a result of the amendment to the Regulations complementary medicines will in future be scrutinised by the Medicines Control Council of South Africa (“the MCC”) for safety, efficacy, and quality. Furthermore, all manufacturers, distributors, importers, and exporters of these products will now require licences for these activities, while the products will in future have to comply with the prescribed requirements including those relating to labelling, package inserts, and patient information leaflets.

The amended Regulations will come into operation in phases, with the Regulations relating to labelling, package inserts, and patient information leaflets in operation on 15 February 2014. Deadlines for the registration of specific categories of complementary medicines have been set at 6 months, 24 months, and 30 months from the date of publication of the Regulations.

In addition to the other requirements relating to labelling, inserts and leaflets, and until such time as the product is successfully registered with the MCC, these products will also have to include the following notice:

"This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease."

Date published: 2013/11/19
Author: Spoor & Fisher

Tags: product regulatory advice news medicines medicines control council of south africa