Document ID: chunk:federal_register_of_legislation:C2024C00632:section:31:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 31 (pt 1/5)
Character Range: 360796–363488

31  Secretary may require information or documents
 (1) The Secretary may, by notice in writing given to a person:
 (aa) who is an applicant for the registration of therapeutic goods; or
 (ab) in relation to whom therapeutic goods are registered; or
 (ac) in relation to whom therapeutic goods were, at any time during the previous 5 years, registered;
require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:
 (a) the formulation of the goods;
 (b) the composition of the goods;
 (c) the design specifications of the goods;
 (d) the quality of the goods;
 (e) the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;
 (f) the presentation of the goods;
 (g) the safety and efficacy of the goods for the purposes for which they are to be used;
 (ga) whether the goods comply with conditions (if any) on the registration of the goods;
 (gb) the conformity of the goods to a standard applicable to the goods;
 (h) whether either of the following has not been complied with in relation to the goods:
 (i) an applicable provision of the Therapeutic Goods Advertising Code;
 (ii) any other requirement relating to advertising applicable under Part 5‑1 or 5‑1A or the regulations;
 (ha) if the goods are registered in relation to the person—whether the goods are being:
 (i) supplied in Australia; or
 (ii) imported into Australia; or
 (iii) exported from Australia;
 (hb) if the goods are registered in relation to the person and there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—whether any supplies in Australia, any imports into Australia or any exports from Australia of the goods contravene those prohibitions;
 (hc) if the goods are registered in relation to the person and there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—whether any supplies in Australia, any imports into Australia or any exports from Australia of the goods contravene those conditions;
 (j) the regulatory history of the goods in another country;
 (ja) if the goods are a reportable medicine and the medicine is registered in relation to the person:
 (i) whether or not there is a shortage of the medicine in Australia; or
 (ii) if there is a shortage of the medicine in Australia—the shortage; or
 (iii) any decision of the person to permanently discontinue the supply of the medicine in Australia;
 (k) any other