Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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 |
The goods are supplied while: (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 | The person supplying the goods | |
4. | The goods are supplied while: (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 | The person supplying the goods |
4A. | The goods are supplied and the Secretary is satisfied that: (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 | The person supplying the goods |
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: (a) the quality, safety or efficacy of the goods is unacceptable; or (b) in the case of registered goods--the presentation of the goods is not acceptable; or (c) in the case of listed goods--the presentation of the goods is unacceptable | The person in relation to whom the goods are included in the Register |
6. | The goods are supplied while they are registered goods or listed goods, but one or more steps in the manufacture of the goods has been carried out by a manufacturer while the manufacturer did not hold a licence that was in force | The person in relation to whom the goods are included in the Register |
The registration or listing of the goods has been suspended under this Part | The person in relation to whom the goods were included in the Register | |
The registration or listing of the goods has been cancelled under this Part | The person in relation to whom the goods were included in the Register | |
8. | The goods are counterfeit (within the meaning of section 42E) | The person supplying the goods |
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within such reasonable period as is specified, to recall therapeutic goods that have been distributed;
(b) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to therapeutic goods;
(ba) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:
(i) therapeutic goods;
(ii) the circumstances referred to in paragraph (1)(a) in relation to therapeutic goods;
(c) to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of therapeutic goods;
(d) to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom therapeutic goods have been supplied.
(3) If the circumstances referred to in paragraph (1)(a) apply only to a batch of therapeutic goods, the Secretary may limit the imposition of the requirements to the therapeutic goods included in that batch.
(4) A requirement to recall therapeutic goods under this section does not apply to therapeutic goods that cannot be recalled because they have been administered to, or applied in the treatment of, a person.