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REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION MADE TO JOINT PORTFOLIO COMMITEES ON SPORT AND RECREATION AND HEALTH ON 13/4/10

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Page 1: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND

APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND

MEDICAL DEVICES PRESENTATION MADE TO JOINT

PORTFOLIO COMMITEES ON SPORT AND RECREATION AND HEALTH ON

13/4/10

Page 2: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

SECOND 2010 FIFA WORLD CUP SOUTH AFRICA SPECIAL MEASURES ACT, 2006

Empowering provisions: Accreditation of foreign medical contingents

• Section 3(1): Minister of Health may accredit a foreign medical contingent if FIFA submits a written application in this regard

• Application must state full names, passport nos., countries of origin of team, period during their stay, names of each member of team to whom health services may be rendered and such other information as may be prescribed

Page 3: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

Empowering provisions cont’d

• Section 3(2): Minister of Health may accredit foreign medical contingent in writing by specifying the full names of members, the period of accreditation an any condition coupled with the accreditation.

Page 4: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

Empowering provisions cont’d

• Section 3(3): Minister of Health may approve medicines, Scheduled substances and medical devices to be used by accredited foreign medical contingents subject to FIFA requesting same in writing on behalf of contingent

• Request must state name and manufacturer of medicine, Scheduled substance and medical device, the quantity and number as well as any conditions which must be attached to it

Page 5: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

Empowering provisions cont’d

• The Minister of SRSA may, in consultation with the Minister of Health in terms of section 6 of the Second FIFA World Cup South Africa Special Measures Act, 2006 (Act No. 12 of 2006), make REGULATIONS RELATING TO THE (a) ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND (b) APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES

Page 6: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

DRAFT 2010 HEALTH REGULATIONS

REGULATION 2:An application for the accreditation of a foreign medical contingent referred to in section 3(1)(a) of the Act must be submitted in a form similar to Annexure “A” and must be accompanied by -

• a certified copy of the bio-information page of the passport of every member of the foreign medical contingent;

• a passport sized colour photograph of every member of the foreign medical contingent attached to the corresponding copy of the said bio-information page of the passport; and

• proof of registration as a health care professional in the country of origin in respect of every member of the foreign medical contingent.

Page 7: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

DRAFT 2010 HEALTH REGULATIONS • Regulation 3: Accreditation of foreign

medical contingent: The accreditation of a foreign medical contingent may be granted by the Minister of Health after consultation with the statutory health council in terms of section 3(1) of the Act, and the accreditation must be in a form similar to Annexure “B”.

Page 8: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

Request for approval of medicines, Scheduled substances and medical

devices

• Regulation 4: A request for approval of

medicines, Scheduled substances and medical devices that may be used by an accredited foreign medical contingent referred to in section 3(3)(a) of the Act, must be submitted in a form similar to Annexure “C”.

Page 9: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

Representations received

• Helen Blumenfeld (pharmacist): provision must be made for anti-malarial medication by visitors to SA by relaxing the law during the World Cup that compel visitors to first obtain a prescription in this regard

• SASCOC: Annexures B and C must be amended

Page 10: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION

End of Presentation