National Health Act, 2003 (Act No. 61 of 2003)
Regulations relating to Human Stem Cells
A stem cell establishment must ensure that—
|(1)||all its activities referred to in regulation 2(1)(a), (b) and (c) can be traced from donor to the recipient and vice versa.|
|(2)||it has a unique donor identification system which assigns a code to each donation and to each products associated with it.|
|(3)||all stem cells are identified with a label that contains the information or references allowing a link to the information referred to in regulation 5(1)(b).|
|(4)||data necessary to ensure traceability at all stages is kept for a minimum of 30 years after donation or clinical use and such data storage may be in electronic form.|
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