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Guideline 1 - Medicines

  1. Medicines and Related Substances Control Act , Act 101 of 1965

    This Act makes all medicines liable for registration by the Medicines Control Council and contains specific provisions relating to labelling and advertising. Section 18 of the Act determines that no person shall advertise any medicine or scheduled substance for sale unless such advertisement complies with prescribed requirements. Section 20 deals with false advertising.

  2. Definition of "medicine"

    The Act defines medicine in the following terms: "Medicine" means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in-

    1. the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or
    2. restoring, correcting or modifying any somatic or psychic or organic function in man and includes any veterinary medicine.
  3. Homeopathic medicines

    Regulation 523 of 1986 03 21 made Homeopathic Medicines liable for registration in terms of the Act.

  4. Rulings received from the Medicines Control Council
    1. Bacteria

      The claim ".... removing the bacteria that cause ..."on the packaging of a soap will make the product liable for registration (MCC letter dated 1979 04 21).

    2. Pimple Treatment and Treatment of Blemishes

      MCC ruling on 1979 04 21:- "Claims in respect of antibacterial skin cleaners" - The Council resolved that the ASA be informed that pimple treatment and the treatment of blemishes are regarded as medicinal claims requiring registration of such products, in which case no cosmetic claims will be permitted.

    3. Stress Claims

      In a letter dated 1984 01 27 the Medicines Control Council confirmed that a product cannot claim to relieve stress unless it is registered as a medicine and the claim has been approved by the MCC.

    4. Clinical Trials

      At a meeting of the MCC and ASA held on 1977 08 02 it was agreed that:- "The results of clinical trials maybe used in advertisements provided such results do not contain claims additional to those registered with the Medicines Control Council in respect of the product concerned. Package inserts need to carry details of or reference to any clinical trials and/or results of such trials which are used in advertising in terms of this paragraph".

    5. Wording in Advertising

      As a result of certain proposals put forward by PASA, the Secretariat of the Medicines Control Council, in a letter dated 1987 12 07 advised that the Council had decided that certain words and/or claims would be permitted in advertising as follows:

      1. "Fast" and "Effective"

        The use of these words will be permitted in medicine advertising but the words may not be used in their comparative or superlative form unless approved by the MCC.

      2. Analgesic Advertising

        The indication for mild to moderate pain shall cover bodily aches and pains (headache, toothache, backache, period pains and those associated with coughs, colds and feverish conditions).

      3. Tonic Advertising

        Words and phrases which are indicated for tonic advertising are tonic, tone, run-down, energy, vitality, appetite, tiredness, fatigue, and lack of concentration and ability to work.

        The Council stressed that the conditions will be binding on registered as well as identical old medicines.

    6. Pictograms

      The MCC has ruled that pictograms may be used on packaging and in advertisements provided they relate to the approved claims on the product. Pictograms which are not related to the product or which depict or imply anything beyond the approved claims may not be used.

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