Document ID: chunk:federal_register_of_legislation:C2024C00632:section:30ea:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 30EA (pt 1/3)
Character Range: 329563–334418

30EA  Public notification, and recall, of therapeutic goods
 (1) The Secretary may, in writing, impose requirements, relating to therapeutic goods, on a person if:
 (a) any of the circumstances referred to in the second column of an item in the following table occur in relation to the goods; and
 (b) the person is referred to in the third column of that item.

Circumstances in which requirements may be imposed
Item                                                Circumstance relating to therapeutic goods                                                                                                                                                                                            Person subject to requirements
1.                                                  The goods are supplied while they are registered goods or listed goods, but the Secretary is satisfied that they do not conform with a standard applicable to the goods                                                               The person in relation to whom the goods are included in the Register
2.                                                  The goods are supplied while they are registered goods or listed goods, but the Secretary is satisfied that the manufacturing principles have not been observed in the manufacture of the goods                                       The person in relation to whom the goods are included in the Register
3.                                                  The goods are supplied while:                                                                                                                                                                                                         The person supplying the goods
                                                     (a) they are exempt goods; or
                                                     (b) they are exempt under section 18A; or
                                                     (c) they are the subject of an approval or authority under section 19; or
                                                     (d) they are the subject of an approval under section 19A;
                                                    but the Secretary is satisfied that they do not conform with a standard applicable to the goods
4.                                                  The goods are supplied while:                                                                                                                                                                                                         The person supplying the goods
                                                     (a) they are exempt goods; or
                                                     (b) they are exempt under section 18A; or
                                                     (c) they are the subject of an approval or authority under section 19; or
                                                     (d) they are the subject of an approval under section 19A;
                                                    but the Secretary is satisfied that the manufacturing principles have not been observed in the manufacture of the goods
4A.                                                 The goods are supplied and the Secretary is satisfied that:                                                                                                                                                                           The person supplying the goods
                                                     (a) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—the supply contravenes one or more of those prohibitions; or
                                                     (b) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—the supply contravenes one or more of those conditions
5.                                                  The goods are supplied in contravention of subsection 19B(1), (4) or (4A) or 19D(1)                                                                                                                                                   The person supplying the goods
5A.                                                 The goods are supplied while they are registered goods or listed goods, but it appears to the Secretary that:                                                                                                                         The person in relation to whom the goods are included in the Register
                                                     (a) the quality, safety or efficacy of the goods is unacceptable; or
                                                     (b) in the case of registered goods—the