Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_5
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 5
Character Range: 551478–554983

5         Therapeutic goods, if:                                                                                                                                                                                                                                                                                                                                                                  (a) there are no listed goods or registered goods that, in all relevant respects, are substantially similar to the goods; and
          (a) the goods are not:                                                                                                                                                                                                                                                                                                                                                                  (b) the person:
          (i) biologicals; or                                                                                                                                                                                                                                                                                                                                                                          (i) manufactures the goods at premises in Australia; and
          (ii) goods referred to in item 3; and                                                                                                                                                                                                                                                                                                                                                        (ii) holds a licence, required by the Act, that authorises the manufacture, or a step in the manufacture, of the goods at those premises; and
          (b) the goods are manufactured by a person under a contract between the person and a private hospital, a public hospital in a State or Territory or a public institution (the relevant institution); and                                                                                                                                                                                (c) the person notifies the Secretary, in accordance with a form approved by the Secretary and within 15 days of the end of a quarter, of:
          (c) the manufacture is in accordance with a formulation specified by the relevant institution; and                                                                                                                                                                                                                                                                                      (i) the goods manufactured under the contract during that quarter; and
          (d) the goods are for use by, or in connection with, a patient of:                                                                                                                                                                                                                                                                                                                      (ii) the relevant institution that entered the contract
          (i) the relevant institution; or
               (ii) if the relevant institution is a public hospital in a State or Territory—another public hospital in the State or Territory