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


Regulations relating to Human Stem Cells

Chapter 1

4. Suspension or withdrawal of authorisation


(1) If the Minister is of the opinion on the strength of an inspection, report and recommendation by an inspector of anatomy or an investigating officer that there are reasonable grounds to suspect that—
(a) any premises or equipment used by an authorised stem cell establishment are in any way hazardous to health;
(b) the stem cell establishment is not complying with any requirements, standards of practice, standard operating procedures or policies; or
(c) the rights of the donor or recipient are violated; and
(d) the stem cell establishment, after been afforded an opportunity by the inspector of anatomy or the investigating officer to rectify the situation referred to in paragraphs (a), (b) or (c), failed to rectify such situation,

the Minister may, suspend or withdraw the authorisation.


(2) The Minister, before suspending or withdrawing an authorisation as contemplated in subregulation (1), shall afford the stem cell establishment an opportunity to show cause why the authorisation should not be suspended or withdrawn.


(3) The suspension or withdrawal of authorisation in terms of this regulation shall have the effect that, the stem cell establishment shall cease to carry out any activities referred to in regulation 2(1)(a), (b) and (c).