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

Chapter 8 : Control of use of blood, blood products, tissue and gametes in humans

68. Regulations relating to tissue, cells, organs, blood, blood products and gametes

 

(1) The Minister may make regulations regarding—
(a) the post mortem examination of bodies of deceased persons;
(b) the preservation, use and disposal of bodies, including unclaimed bodies;
(c) the removal of donated tissue or cells from persons, tissue or cells obtained from post mortem examinations and the procurement, processing, storage, supply and allocation of tissue or human cells by institutions and persons;
(d) tissue transplants;
(e) the production, packaging, sealing, labelling, storage and supplying of therapeutic, diagnostic and prophylactic substances from tissue;
(f) the supply of tissue, organs, oocytes, human stem cells and other human cells, blood, blood products or gametes;
(g) the importation and exportation of tissue, human cells, blood, blood products or gametes;
(h) the withdrawal of blood from living persons and the preservation, testing, processing, supply or disposal of withdrawn or imported blood;
(i) the administering of blood and any blood product to living persons;
(j) the production, packaging, sealing, labelling and supplying of blood and blood products;
(k) the bringing together outside the human body of male and female gametes, and research with regard to the product of the union of those gametes;
(l) the artificial fertilisation of persons;
(m) the appointment and functions of inspectors of anatomy and investigating officers;
(n) the records and registers to be kept by persons and institutions;
(o) the returns and reports, including extracts from registers, to be submitted to specified persons and institutions;
(p) the acquisition, storage, harvesting, utilisation or manipulation of tissue, blood, blood products, organs, gametes, oocytes or human stem cells for any purpose;
(q) the appointment and functions of inspectors of the national blood transfusion service and progenitor cell transplant institutions; and
(r) any other matter relating to regulating the control and the use of human bodies, tissue, organs, gametes, blood and blood products in humans.

 

(2) The Minister, with the concurrence of the Cabinet member responsible for finance, may make regulations concerning the payment of persons or institutions in connection with procurement, storage, supply, import or export of human bodies, tissue, blood, blood products or gametes.

 

(3) The Minister may, if it is consistent with the objects of this Act and upon such conditions as the Minister may deem fit, by notice in the Gazette exempt any person or category of persons from any or all of the regulations made under this section.