Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_1b
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 1B
Character Range: 523613–527010

1B        Therapeutic goods imported into Australia that are needed for dispensing as a medicine prescribed for persons who are seriously ill with a condition from which premature death is reasonably likely to occur in the absence of early treatment                                                                                                                                         (a) the goods must be supplied to a person covered by column 2 in circumstances where subparagraphs 12A(2)(a)(ii) and (iii) and paragraph 12A(2)(b) of these Regulations are satisfied; and
                                                                                                                                                                                                                                                                                                                                                                                                  (b) until the goods need to be so supplied, either or both of the following apply:
                                                                                                                                                                                                                                                                                                                                                                                                  (i) the goods are kept in a warehouse or a properly secured area under the control of the sponsor;
                                                                                                                                                                                                                                                                                                                                                                                                  (ii) the goods are kept at a hospital or other healthcare facility after being delivered to the hospital or facility by, or on behalf of, the sponsor; and
                                                                                                                                                                                                                                                                                                                                                                                                  (c) the sponsor must:
                                                                                                                                                                                                                                                                                                                                                                                                       (i) keep records relating to the source, and delivery, of the goods; and
                                                                                                                                                                                                                                                                                                                                                                                                  (ii) if requested by the Secretary, give the records to the Secretary