Complementary medicines enter Medicines Act

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The amended Regulations define a 'complementary medicines' as:

• any substance or mixture of substances that -
  1. originates from plants, minerals or animals;

  2. 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
     
  3. 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, complementary medicines will in future be scrutinised by the Medicines Control Council of South Africa (MCC) for safety, efficacy and quality," explains Dirk Hanekom, candidate attorney, Spoor & Fisher.

"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 coming into 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 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.'