MEDICINES CONTROL COUNCIL SECTION 21 APPLICATION COUNCIL'S RESPONSIBILITIES AND LIABILITY WHEN PERFORMING ITS FUNCTION IN TERMS OF SECTION 21 OF ACT 101 OF 1965 In terms of this Section the Authority/Council may authorize the sale of unregistered orthodox medicine, complementary medicine, and veterinary medicine or device for certain purposes. 21. (1) The authority may in writing authorize any person to sell during a specified period to any specified person or institution a specified quantity of orthodox medicine, complementary medicine, veterinary medicine or device, is not registered. 21. (2) Any orthodox medicine, complementary medicine, veterinary medicine or device sold in pursuant to any authorization under sub-section (1) and in such a manner and during such period as the Authority may in writing determine. 21. (3) Authority may at any time by notice in writing withdraw the authorization granted in terms of sub-section (1) if effect is not given to any determination made in terms of sub-section (2) An applicant who wishes to sell an unregistered medicine must be fully informed and be able to respond if his request is not successful. Section 21 mandates the Authority to approve the use of unregistered medicine. The Authority, therefore, is required to address the following requirements of Section 21. - Authorise sales - Specify the period of sale - Specify the purchaser or institution - Specify the quantity of medicine - Determine the purpose for the use of such medicine - Determine the manner of use - Determine the period of use - Withdrawal of the authority to sell or use
MEDICINES CONTROL COUNCIL SECTION 21 APPLICATION COUNCIL'S RESPONSIBILITIES AND LIABILITY WHEN PERFORMING ITS FUNCTION IN TERMS OF SECTION 21 OF ACT 101 OF 1965 In terms of this Section the Authority/Council may authorize the sale of unregistered orthodox medicine, complementary medicine, and veterinary medicine or device for certain purposes. 21. (1) The authority may in writing authorize any person to sell during a specified period to any specified person or institution a specified quantity of orthodox medicine, complementary medicine, veterinary medicine or device, is not registered. 21. (2) Any orthodox medicine, complementary medicine, veterinary medicine or device sold in pursuant to any authorization under sub-section (1) and in such a manner and during such period as the Authority may in writing determine. 21. (3) Authority may at any time by notice in writing withdraw the authorization granted in terms of sub-section (1) if effect is not given to any determination made in terms of sub-section (2) An applicant who wishes to sell an unregistered medicine must be fully informed and be able to respond if his request is not successful. Section 21 mandates the Authority to approve the use of unregistered medicine. The Authority, therefore, is required to address the following requirements of Section 21. - Authorise sales - Specify the period of sale - Specify the purchaser or institution - Specify the quantity of medicine - Determine the purpose for the use of such medicine - Determine the manner of use - Determine the period of use - Withdrawal of the authority to sell or use
b88934766.12_section_21_application_form_feb04_v1_2.docx