National Health Act, 2003 (Act No. 61 of 2003) Regulations Regulations relating to Human Stem Cells Chapter 1 1. Definitions

 

In these regulations, "the Act" means the National Health Act, 2003 (Act No. 61 of 2003), and any word or expression to which a meaning has been assigned in that Act, shall have that meaning and unless the context indicates otherwise:

 

"competent person"

means—

 

"clone"

means an organism that is a genetic copy of an existing organism;

 

"distribution"

means transportation and delivery of tissue and cells intended for human applications;

 

"donor"

means a person who has donated tissue in terms of the Act;

 

"embryonic stem cells"

means specialised or undifferentiated cells that can divide indefinitely in culture and can develop into specialized or undifferentiated cells;

 

"high risk family"

means a family with history of genetic or haematological disorder;

 

"human application"

means the use of tissues or cells on or in a human recipient and extracorporal applications;

 

"inspector of anatomy"

means the inspector of anatomy as contemplated in the Regulations Regarding the General Control of Human Bodies, Tissue, Blood, Blood Products and Gametes;

 

"investigating officer"

means the investigating officer as contemplated in the Regulations Regarding the General Control of Human Bodies, Tissue, Blood, Blood Products and Gametes;

 

"muffipotent"

means a cell that is specialized for specific tissue;

 

"pluripotent"

means a cell that is able to develop into most tissues of an organism;

 

"procurement"

means a process by which tissue or cells are made available;

 

"processing"

means all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications;

 

"preservation"

means the use of chemical agents, alterations in environment conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissue;

 

"quarantine"

means to isolate retrieved tissue or cells physically or by other means whilst awaiting a decision on their acceptance or rejection;

 

"authorised organisation, institution or person"

means an organisation, institution or person authorised in terms of regulation 3(3)(a) to conduct the activities referred to in regulation 2(1)(a), (b) or (c);

 

"responsible person"

means any person registered in terms of the Health Professions Act, 1974 (No 56 of 1974) and who is in charge of the activities referred to in regulation 2(1)(a), (b) and (c);

 

"serious adverse event"

means any untoward occurrence associated with the procurement, testing. processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, death or life threatening, disabling or incapacitating condition for patients or which might results in, or prolong, hospitalisation or morbidity;

 

"serious adverse reaction"

means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity;

 

"stem cell"

means any embryonic stem cell, circulating progenitor cell, bone marrow progenitor cell including haemopoietic progenitor cell, umbilical cord progenitor cell, or any cell that is capable of replicating (proliferating) and giving rise to a differentiated cell;

 

"storage"

means maintaining the product under appropriate controlled conditions until distributed;

 

"totipotent"

means a cell that is able to form an entire organism;

 

"transplantation transmittable disease"

means a disease that can be transmitted by the transplantation of tissue or a tissue product donated by a person, into the body of another person, including a genetic disease.