Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008 (Cth)

Agricultural and Veterinary Chemicals Code

Amendment Instrument No. 3

(Multiple Applications) 2008

I, Eva Bennet-Jenkins, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, acting in accordance with my powers under subsection 32(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, make this instrument for the purposes of subsections 164(1A) and 165(1A) of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.

Eva Bennet-Jenkins

Chief Executive Officer

Dated this third day of January 2008

1.         Name of Instrument

This Instrument is the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008.

2.         Commencement

This Instrument commences on the day after it is registered.

3.         Amendments of the Agricultural and Veterinary Chemicals Code Instrument
No. 2 (Modular Assessment Fees) 2005

Schedule 1 amends the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005. 

Schedule 1        Amendments

1          Subsection 4(2)

add

multiple application means an application to vary the particulars or conditions of registration or label approval where the variation is to allow a minor label change (whether or not data of a technical nature is required) and the same type of variation is requested by the same applicant in respect of more than one chemical product;

2          Sections 17 and 18

repeal the sections and substitute

17.       Modular Assessment Fees

(1)        Subject to subsection (2), if as a result of this Instrument, a module, level or type of assessment is appropriate for a particular application then the fee payable in respect of that module, level or type of assessment is the fee set out in column 4 of Schedule 7 of the Agvet Code Regulations for that module, level or type of assessment. 

Note 1    For reference, the fee payable in respect of a module, level or type of assessment is set out (in brackets) in this Instrument beside that module, level or type.

Note 2    The method of working out the total modular assessment fee payable in respect of any particular application assessed by modular assessment is set out in regulation 71 of the Agvet Code Regulations.

(2)        For multiple applications made under Category 14 where no data of a technical nature is required, and:

(a)        for variations of up to five products, the fee is to be calculated from the following table:

Number of products in the application	The method of calculating the fee	Fee for the Application
2	$4601 + 2$1452	$750
3	$4601 + 3$1452	$895
4	$4601 + 4$1452	$1,040
5	$4601 + 5$1452	$1,185

¹     module 1 screening fee   ²     module 11.4 finalisation fee

(b)        for variations of more than five products, the fee is to be calculated as follows:

where:

N is the number of products in the multiple application; and

M is N divided by 5, but if the result is not a whole number the next highest whole number:

module 1 (screening fee) plus ([M minus 1] plus 5) times module 11.4 (finalization fee) — that is: $460 + ([M–1]+5)$145.

(3)        For multiple applications made under Category 14 where data of a technical nature is required, the fee is to be calculated as follows:

(a)        for multiple applications containing variations of up to five products, the fee is to be calculated from the following table:

where:

T is any technical assessment required by the APVMA that is included in modules 2 to 10 or module 12 of Schedule 7 of the Agvet Regulations; and

R is the number of each technical assessment required for all of the products in the multiple application:

Number of products in the application	The method of calculating the fee
2	$4601 + 2$1452 + (T X R)
3	$4601 + 3$1452 + (T X R)
4	$4601 + 4$1452 + (T X R)
5	$4601 + 5$1452 + (T X R)

¹     module 1 screening fee   ²     module 11.4 finalisation fee

(b)        for variations of more than five products, the fee is to be calculated as follows:

where:

N is the number of products in the multiple application;

M is N divided by 5, but if the result is not a whole number the next highest whole number;

T is any technical assessment required by the APVMA that is included in modules 2 to 10 or module 12 of Schedule 7 of the Agvet Regulations; and

R is the number of technical assessment required for all of the products in the multiple application:

module 1 (screening fee) plus ([M minus 1] plus 5) times module 11.4 (finalization fee) plus any technical assessment required times the rate of that technical assessment
 — that is, $460 + ([M–1]+5)$145 + (T X R).

18.       Modular Assessment Periods

(1)        Subject to subsection (2), if as a result of this Instrument, a module, level or type of assessment is appropriate for a particular application then the period within which the APVMA must complete that particular module, level or type of assessment is the period set out in column 3 of Schedule 7 of the Agvet Code Regulations for that module, level or type of assessment. 

Note 1    The method of working out the total modular assessment period within which the APVMA’s assessment of any particular application, which is assessed by modular assessment, must be completed is set out in regulation 77 of the Agvet Code Regulations.

(2)        The period within which the APVMA must complete a multiple application is three months.