Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_1a
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 1A
Character Range: 520249–523613

1A        Therapeutic goods imported into Australia and held under the direct control of the sponsor, until a decision is made under section 25, 26, 26A, 26AE, 32DB, 32DC, 32DF or 32DG of the Act about the goods                                                                                                                                                                               (a) the sponsor must:
                                                                                                                                                                                                                                                                                                                                                                                                       (i) keep records about the source of the goods; and
                                                                                                                                                                                                                                                                                                                                                                                                       (ii) if requested by the Secretary, give the records to the Secretary; and
                                                                                                                                                                                                                                                                                                                                                                                                       (iii) have lodged an application under section 23, 32DA or 32DD of the Act for the goods before their importation; and
                                                                                                                                                                                                                                                                                                                                                                                                  (b) if the goods are not registered, listed, or included in the Register under Part 3‑2A of the Act:
                                                                                                                                                                                                                                                                                                                                                                                                       (i) in the case of therapeutic goods other than biologicals—the goods must be destroyed; or
                                                                                                                                                                                                                                                                                                                                                                                                       (ii) in the case of biologicals—the biologicals must be destroyed or returned to the consignor of the biologicals within 1 month of the decision not to include the biologicals