Statistics Act, 1999
R 385
National Health Act, 2003 (Act No. 61 of 2003)RegulationsRegulations relating to Human Stem CellsChapter 120. Relationship between stem cell establishments and third parties |
| (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. |
