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COMMONWEALTHRegulation
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s 76

Period within which APVMA is to determine application

In force
Part 9Miscellaneous
Division 9.3Notification, assessment periods and review

76 Period within which APVMA is to determine application

(1)

For the purposes of subsection 165(1) of the Code, the period for determining an application of a kind specified in column 1 of an item of the table in clause 2.1 of Schedule 6 is the period (if any) specified in column 2 of that item, subject to regulations 76A and 76B.

(1A)

Without limiting subregulation (1), a period specified in column 2 of an item of the table may be expressed as a period specified in, or worked out in accordance with, a legislative instrument made by the APVMA.

(1B)

If:

(a)

an application is of the kind mentioned in section 10 or 27 of the Code (the primary application); and

(b)

the applicant makes another application of the same kind as the primary application (the secondary application); and

(c)

the secondary application is made at the same time as the primary application; and

(d)

the applicant nominates the secondary application as an application related to the primary application; and

(e)

the chemical products to which the primary and secondary applications relate would have, if the applications were approved:

(i)

the same identifying information for the holder of the registration of the chemical products; and

(ii)

the same manufacturer; and

(iii)

the same address at which the chemical products are manufactured; and

(iv)

the same active constituent on the label of the chemical products;

then, the period applicable under subregulation (1) and applicable to the primary application also applies to the secondary application.

(2)

A reference in column 2 or 3 of an item of the table in clause 2.1 of Schedule 6 to a modular assessment period, is a reference to the modular assessment period in respect of the application to which that item refers, worked out in accordance with regulation 77.

(4)

Despite subregulation (1), if:

(a)

the APVMA receives an application for a permit in respect of a chemical product; and

(b)

the application is in respect of an emergency use of the chemical product;

the APVMA must determine the application as soon as is practicable in the circumstances of the case.

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