Statistics Act, 1999
R 385
National Health Act, 2003 (Act No. 61 of 2003)RegulationsRegulations relating to Human Stem CellsChapter 13. Application for authorisation |
| (1) | A person desiring to be designated as an authorised institution shall apply for such authorisation to the Minister. |
| (2) | The application referred to in subregulation (1) shall contain the following information: |
| (a) | the name and nature of the applicant (whether an organisation, institution, medical scientist, etc); |
| (b) | location of the premises where business is to be conducted; |
| (c) | an indication of how records and data shall be kept; |
| (d) | the quality system to be used; |
| (e) | details of the responsible person; |
| (f) | qualifications and training for personnel; |
| (g) | standing operating procedures of the applicant; and |
| (h) | any other information the Minister may consider necessary for the consideration of the application. |
| (3) | The Minister may, on application in terms of subregulation (1) authorise the applicant concerned as a stem cell establishment, subject to such conditions as the Minister may determine. |
| (4) | An authorised stem cell establishment shall operate as a non-profit making entity. |
| (5) | Only a health organisation, health institution, medical scientist or human biological scientist can apply for authorisation in terms of this regulation. |
