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

Regulations

Regulations relating to Human Stem Cells

Chapter 1

20. Relationship between stem cell establishments and third parties

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(1)A stem cell establishment shall evaluate and select third parties on the basis of their ability to meet the requirements standards laid down in these regulations.

 

(2)A stem cell establishment shall enter into written agreements with a third party each time an external activity takes place which influence the quality and safety of stem cells processed in co-operation with such a third party, and in particular in the following circumstances:
(a)where a stem cell establishment entrusts one of the activities in regulation 2(1)(a), (b) and (c) to a third party:
(b)where a third patty provides goods and services that affect stem cells quality and safety assurance, including their distribution;
(c)where a stem cell establishment distributes stem cells obtained by a third party;

 

(3)A stem cell establishment shall keep a complete list of the agreements referred to in this regulation.

 

(4)Agreements between stem cell establishments and third parties shall specify the responsibilities of the third parties and detailed procedures.

 

(5)A stem cell establishment shall provide copies of agreements with third parties on request to the Director-General, the Inspector of Anatomy or an investigating officer.