Document ID: chunk:federal_register_of_legislation:C2024C00632:section:25:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 25 (pt 1/3)
Character Range: 211747–214547

25  Evaluation of therapeutic goods
 (1) If:
 (a) an application is made for the registration of therapeutic goods in relation to a person under section 23; and
 (b) the application has passed preliminary assessment;
the Secretary must evaluate the goods for registration having regard to:
 (c) unless the application is one referred to in paragraph (d)—whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and
 (d) for an application for provisional registration of a medicine:
 (i) whether, based on preliminary clinical data, the safety and efficacy of the medicine for the purposes for which it is to be used have been satisfactorily established; and
 (ii) whether the quality of the medicine for the purposes for which it is to be used has been satisfactorily established; and
 (iii) if subsection 23AA(1) applies in relation to the application—whether, if the Secretary were to register the medicine, the Secretary is satisfied with the applicant's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence; and
 (da) if:
 (i) the applicant is applying for the registration of restricted medicine; or
 (ii) the applicant is applying for the registration of medicine (other than restricted medicine) and the applicant has been given a notice in writing by the Secretary requiring the applicant to give to the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine;
  the product information given by the applicant in relation to the medicine; and
 (e) whether the presentation of the goods is acceptable; and
 (f) whether the goods conform to any standard applicable to the goods; and
 (fa) whether:
 (i) the applicable provisions of the Therapeutic Goods Advertising Code; and
 (ii) the other requirements (if any) relating to advertising applicable under Part 5‑1 or 5‑1A or the regulations;
  are complied with in relation to the goods; and
 (g) if a step in the manufacture of the goods has been carried out outside Australia—whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable; and
 (h) if the goods have been manufactured in Australia—whether the goods have been manufactured in accordance with Part 3‑3; and
 (i) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—whether, if the Secretary were to register the goods, the Secretary is satisfied that imports into Australia, exports from Australia or supplies in Australia of the goods would contravene those prohibitions; and
 (ia) if there are one