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


Regulations relating to Human Stem Cells

Chapter 1

2. Use of stem cells


(1) No person, shall—
(a) acquire or import human stem cells from any living or deceased person;
(b) preserve, screen, test, process. store, separate, label, pack, supply or distribute or export or in any other manner dispose of human stem cells whether in its original form or in any altered form; or
(c) release any stem cell products for therapeutic use, unless—
(i) it is authorised in terms of section 54 of the Act;
(ii) laboratory tests, according to latest scientific information for infectious agents and genetic diseases which may cause transplantation transmitted diseases, for the following, have, with informed consent, been completed and the results of the tests on each stem cell are available:
Hepatitis B
Hepatitis C
Human Immunodeficiency Virus type 1 and 2
p24 HIV antigen
Genetic disease traits
Card blood gases before umbilical cord stem cells are harvested
(d) use stem cells or its products for therapeutic, research or educational purpose unless it, he or she—
(i) is registered with the Department in terms of regulation 3(3)(a);
(ii) conducts any activity referred to in paragraph (a) or (b), as the case may be, in accordance with the provisions of these regulations:
(iii) has obtained informed written consent of the donor even in the case of residual tissue/cells; and
(iv) has obtained the donation voluntarily; and
(e) use stem cells for any reason other than therapeutic, teaching or research purposes.


(2) The provisions of subregulation (1) are not applicable to a person transporting human stem cells in the usual course of business as a carrier; if special transport requirements are adhered to.