Document ID: chunk:federal_register_of_legislation:F2022C00276:clause:1_10:p2
Version: federal_register_of_legislation:F2022C00276
Segment Type: clause
Provision Reference: sch 1 cl 10 (pt 2/3)
Character Range: 16739–19235

of an export only medicine.

     Donors of HCT materials that are human ocular tissue only
 (6) The periods of ineligibility specified in column 3 of items 16 to 19 of the table in Schedule 1 do not apply in relation to a donor of HCT materials that are human ocular tissue only.

     Change in circumstances of donor
 (7) Where the circumstances of a donor of HCT materials used in the manufacture of an HCT product change in relation to the ineligibility criteria for donor selection specified in Schedule 1, the relevant aspects of the medical and social history of the donor must be reviewed by the manufacturer of the HCT product with respect to those changes, before the HCT product is released for supply.

     Screening requirements
 (8) An HCT product must not be released for supply, unless the medical and social history of a donor is reviewed and evaluated in accordance with this section.
 (9) Where a donor meets any of the medical and social history criteria specified in column 2 of an item of the table in Schedule 1, the donor must be subjected to the period of ineligibility specified in column 3 of that item, in relation to the collection of HCT materials from that donor for use in the manufacture of HCT products.

     Screening in relation to donors less than 18 months old
 (10) If the donor is less than 18 months old, a medical and social history in relation to the donor's birth mother, covering the ineligibility criteria for donor selection specified in column 2 of items 1 to 7, 11 to 13, 17 and 20 of the table in Schedule 1 must be obtained.
 (11) Where the donor's birth mother meets the medical and social history criteria specified in column 2 of item 1 to 7, 11 to 13, 17 or 20 of the table in Schedule 1, then the donor must be subjected to the period of ineligibility specified in column 3 of that item, in relation to the collection of HCT materials from the donor.

     Screening in relation to donors who have consumed breast milk
 (12) If the donor has consumed breast milk from a person (the relevant person) within the previous six months, a medical and social history in relation to the relevant person, covering the ineligibility criteria for donor selection specified in column 2 of the items 1 to 7, 11 to 13, 17 and 20 of the table in Schedule 1 must be obtained.
 (13) Where the relevant person meets the medical and social history criteria specified in column 2 of item 1 to 7, 11 to 13, 17 or 20 of the table in Schedule 1, then the donor