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


Regulations relating to Human Stem Cells

Chapter 1

10. Traceability


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.