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


Regulations relating to Human Stem Cells

Chapter 1

16. Stem cell processing


(1) A stem cell establishment shall include in its standard operating procedures and guidelines—
(a) all processes that affect quality and safety and ensure that these are carried out under controlled conditions;
(b) special provision for the handling of stem cells to be discarded, in order to prevent the contamination of other cells, processing environment or personnel.


(2) Any modification to the process used in the preparation of stem cells shall also meet the criteria laid down in its standard operating procedures.


(3) The stem cell establishment shall ensure that the equipment used, the working environment and process design, validation and control conditions are in accordance with its standard operating procedures.