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National Health Act, 2003 (Act No. 61 of 2003)


Regulations relating to Human Stem Cells

Chapter 1

3. Application for authorisation


(1) A person desiring to be designated as an authorised institution shall apply for such authorisation to the Minister.


(2) The application referred to in subregulation (1) shall contain the following information:
(a) the name and nature of the applicant (whether an organisation, institution, medical scientist, etc);
(b) location of the premises where business is to be conducted;
(c) an indication of how records and data shall be kept;
(d) the quality system to be used;
(e) details of the responsible person;
(f) qualifications and training for personnel;
(g) standing operating procedures of the applicant; and
(h) any other information the Minister may consider necessary for the consideration of the application.


(3) The Minister may, on application in terms of subregulation (1) authorise the applicant concerned as a stem cell establishment, subject to such conditions as the Minister may determine.


(4) An authorised stem cell establishment shall operate as a non-profit making entity.


(5) Only a health organisation, health institution, medical scientist or human biological scientist can apply for authorisation in terms of this regulation.