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THERAPEUTIC GOODS ACT 1989 - SECT 32HA

Public notification, and recall, of biologicals

             (1)  The Secretary may, by notice in writing, impose requirements, relating to a biological, on a person if:

                     (a)  any of the circumstances referred to in the 2nd column of an item in the following table occur in relation to the biological; and

                     (b)  the person is referred to in the 3rd column of that item.

 

Circumstances in which requirements may be imposed

Item

Circumstance relating to biological

Person subject to requirements

1

It is supplied while it is included in the Register, but the Secretary is satisfied that it does not conform with a standard applicable to it

The person in relation to whom it is included in the Register

2

It is a biological, other than a Class 1 biological, and it is supplied while it is included in the Register, but the Secretary is satisfied that the manufacturing principles have not been observed in its manufacture

The person in relation to whom it is included in the Register

3

It is supplied while:

(a) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); or

(b) it is exempt under section 32CB; or

(c) it is the subject of an approval under subsection 32CK(1); or

(d) it is the subject of an authority under subsection 32CM(1) or (7A); or

(e) it is the subject of an approval under subsection 32CO(1), (1A) or (2);

but the Secretary is satisfied that it does not conform with a standard applicable to it

The person supplying it

4

It is a biological, other than a Class 1 biological, and it is supplied while:

(a) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); or

(b) it is exempt under section 32CB; or

(c) it is the subject of an approval under subsection 32CK(1); or

(d) it is the subject of an authority under subsection 32CM(1) or (7A); or

(e) it is the subject of an approval under subsection 32CO(1), (1A) or (2);

but the Secretary is satisfied that the manufacturing principles have not been observed in its manufacture

The person supplying it

4A.

It is 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 it

5

It is supplied while:

(a) it is not included in the Register; and

(b) the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and

(c) it is not exempt under section 32CB; and

(d) it is not the subject of an approval under subsection 32CK(1); and

(e) it is not the subject of an authority under subsection 32CM(1) or (7A); and

(f) it is not the subject of an approval under subsection 32CO(1), (1A) or (2)

The person supplying it

6

It is supplied while it is exempt under section 32CB, and the Secretary is satisfied that it is not fit to be used for its intended purpose

The person supplying it

7

It is counterfeit goods (within the meaning of section 42E)

The person supplying it

8

It is a biological, other than a Class 1 biological, and it is supplied while it is included in the Register, but the Secretary is satisfied that there is a breach of the condition set out in subsection 32EA(5)

The person in relation to whom it is included in the Register

9

It appears to the Secretary that the quality, safety or efficacy of the biological is unacceptable or that the presentation of the biological is not acceptable

The person in relation to whom the biological is included in the Register

10

It has been suspended from the Register

The person in relation to whom it is included in the Register

11

Its entry has been cancelled from the Register

The person in relation to whom it is included in the Register

             (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 the biological that has been supplied;

                     (b)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, that the circumstances referred to in paragraph (1)(a) have occurred in relation to the biological;

                   (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)  the biological;

                             (ii)  the circumstances referred to in paragraph (1)(a);

                     (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 supply of the biological;

                     (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 the biological has been supplied.

             (3)  If the circumstances referred to in paragraph (1)(a) apply only to a batch of the biological, the Secretary may limit the imposition of the requirements to that batch.

             (4)  A requirement to recall a biological under this section does not apply to a biological that cannot be recalled because it has been administered to, or applied in the treatment of, a person.

             (5)  A notice under subsection (1) is not a legislative instrument.



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