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Self Monitoring Programme

Self Monitoring Programme. Foods and medicines in South Africa are controlled by 2 Acts of Parliament : Act 101 of 1965 – Medicines And Related Substances Control Act Act 54 of 1972 – Foodstuffs, Cosmetics & Disinfectants Act. Self Monitoring Programme.

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Self Monitoring Programme

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  1. Self Monitoring Programme Foods and medicines in South Africa are controlled by 2 Acts of Parliament : Act 101 of 1965 – Medicines And Related Substances Control Act Act 54 of 1972 – Foodstuffs, Cosmetics & Disinfectants Act

  2. Self Monitoring Programme History of Complementary Medicine • 1987 - A Homoeopathic Committee established by the MCC. • 1994 - This Committee changed name to be called the “Complementary Medicines Committee” - CMC. - To represent all the paradigms of CAMS

  3. Self Monitoring Programme History of Complementary Medicine • 1996 - Establishment of BBRG Committees. Development of the “lists of substances and indications”. • An electronic system for registration was envisaged. • 1998 - The lists of substances and indications were approved by the MCC for all CAM paradigms.

  4. Self Monitoring Programme History of Complementary Medicine • Sub-categories of CAMS • Anthroposophical medicines • Aromatherapeutic essential oils • Aryurvedic medicines • Chinese Medicines • Energy substances • Homoeopathic medicines • Herbal medicine • Nutraceuticals • Sowa Rigpa medicines • Unani Tibb medicine

  5. Self Monitoring Programme History of Complementary Medicine • In 2002 call up for audit of complementary medicine. • 12,000 applications received by MRA. • On 16 July 2004 – draft regulations were published Inappropriate for CAMS. • Complementary Medicines stakeholders Committee established – 30 June 2004. • Comments submitted on Draft Regulations (600 pages).

  6. Self Monitoring Programme Current situation : • No regulations established. • Hiatus in the market place. • Certain companies taking advantage of the situation (excessive claims, poor quality control, incorrect substances, false label disclosures). • Rigorous interaction with DOH to publish appropriate Regulations.

  7. Self Monitoring Programme Current situation : HPA has decided to introduce a self monitoring programme: • To assist the DOH. • To try and establish level playing fields. • To reduce unethical behaviour. • To retain credibility with the public regarding CAMS.

  8. Self Monitoring Programme Features of Self Monitoring Programme • Surveillance • Surveillance of defaulters in the marketplace. • Close co-operation with the ASA (Advertising). • Close co-operation with Law enforcement unit of DOH on substances and claims.

  9. Self Monitoring Programme Features of Self Monitoring Programme • Co-operation • Continued dialogue with DOH. • Co-operation with CMC. • Interaction on lists.

  10. Self Monitoring Programme Features of Self Monitoring Programme • Assistance • Assistance to members with regard to lists and claims. • The provision of technical expertise personnel for both surveillance and assistance.

  11. Self Monitoring Programme Support Structures • Technical Team • Give advice on indications, lists and labels. • Compile adverse effects data base. • Process complaints of non-compliance. 3.1 Internally 3.2 Externally. (ASA, Law enforcement, SAPS, SABS, Retailers, Wholesalers, Consumer Council, Media) • Referral to Consultants (Q.A., GMP, New Products & substances)

  12. Self Monitoring Programme Support Structures • New Executive Director Appointment For external function • Interaction with Government. • Media relationships on technical and political issues. • Relationships with other health organizations and structures.

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