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COMMONWEALTHRegulation
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s 19AEC

Limits on information that may be used for interchangeable constituent determinations

In force
Part 2Approvals and registration
Division 2.2Granting or refusing applications for variation of relevant particulars, or conditions, of approvals or registration
Subdivision 2.2.2Interchangeable constituent determinations

19AEC Limits on information that may be used for interchangeable constituent determinations

Overseas trials and experiments, consultation and information, reports or samples

(1)

The following provisions apply in relation to the making, variation or revocation of an interchangeable constituent determination as if the constituent to which the determination relates were an active constituent for a proposed or existing chemical product:

(a)

section 159 of the Code (requiring information to determine an application);

(b)

subsections 160(2) and (3) of the Code (overseas trials and experiments);

(c)

section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (consultation).

Limits on use of information

(2)

The APVMA must not use information given to it in connection with an application under the Code:

(a)

to assess an application made under regulation 19AEB; or

(b)

to make any other decision in relation to the making, variation or revocation of an interchangeable constituent determination;

unless the information was given to it in connection with the application mentioned in paragraph (a) or the decision mentioned in paragraph (b).

(3)

A person or body consulted under section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as that section applies under subregulation (1), must not, for the purposes of providing information or advice in relation to the making, variation or revocation of an interchangeable constituent determination, use information that the APVMA must not, under subregulation (2), use in relation to the interchangeable constituent determination.

(4)

The following provisions of the Code apply in relation to subregulations (2) and (3) in the same way as they apply in relation to subsections 34G(1) and (3) of the Code:

(a)

subsections 34G(1B) and (2);

(b)

sections 34H to 34M.

(5)

For subregulation (4), the condition in subsection 34J(4) of the Code is taken to be replaced by the condition that:

(a)

the information relates to the making, variation or revocation of an interchangeable constituent determination in relation to a constituent; and

(b)

the information shows that a matter mentioned in subregulation 19AEA(5) may not be satisfied in relation to the constituent.

(6)

For subregulation (4), if the APVMA relies on information to make, vary or revoke an interchangeable constituent determination, a limitation period is taken to apply to the information under section 34M of the Code that ends 3 years after the day the determination is made, varied or revoked.

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