8Special transitional arrangements for cornea only manufacturers

8 Special transitional arrangements for cornea only manufacturers

(1) In this section: cornea only manufacturer means a manufacturer who, in relation to a deceased donor: (a) collects human ocular tissue from the donor for the purpose of corneal transplantation and not any other purpose; and (b) does not collect any other tissue from the donor for any other purpose. repeal instrument means the Therapeutic Goods (Standards for Biologicals) Repeal Instrument 2021. special transitional requirements means the requirements specified in subsection (3) in relation to the testing of blood samples taken from a donor of human ocular tissue. special transition period means the period beginning on 30 September 2021 and ending on 30 September 2024. (2) The special transitional requirements apply to a cornea only manufacturer for the duration of the special transition period, such that those requirements may be complied with as an alternative to the blood sample testing requirements specified in paragraph 11(6)(b) and subsection 11(7) of this instrument. (3) Blood samples of a deceased donor of human ocular tissue collected in accordance with paragraph 11(6)(a) must be serology tested for HIV-1, HIV-2, HCV and HBsAg.