regulations relating to the accreditation of foreign medical contingents and approval of medicines,...
TRANSCRIPT
![Page 1: REGULATIONS RELATING TO THE ACCREDITATION OF FOREIGN MEDICAL CONTINGENTS AND APPROVAL OF MEDICINES, SCHEDULED SUBSTANCES AND MEDICAL DEVICES PRESENTATION](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/1.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/2.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/3.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/4.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/5.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/6.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/7.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/8.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/9.jpg)
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](https://reader036.vdocuments.site/reader036/viewer/2022083011/5697bf9d1a28abf838c93e74/html5/thumbnails/10.jpg)
End of Presentation