Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005

Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005

as amended

made under subsection 32 (1) of the

Agricultural and Veterinary Chemicals (Administration) Act 1992

This compilation was prepared on 10 January 2008
taking into account amendments up to Agricultural and Veterinary Chemicals Code Amendment Instrument No. 2 (Multiple Applications) 2008

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Contents

Part 1 Preliminary 

 1 Name of Instrument [see Note 1]

 2 Commencement 

 3 Object 

 4 Interpretation 

Part 2 Criteria for Working out which Application Category Applies             

 5 Category 1 (application fee $48,860) 

 6 Category 2 (modular assessment fee) 

 7 Category 3 (application fee $31,750) 

 8 Category 11 (application fee $14,260) 

 8A Category 12 (application fee of $560) 

 8B Category 14 (modular assessment fee) 

 9 Category 15 (application fee $23,430) 

 10 Category 17 (application fee $1,435) 

 11 Category 18 (application fee $915) 

 12 Category 20 (application fee $320) 

 13 Category 25 (modular assessment fee) 

Part 3 Fees 

 14 Fees 

Notes   

Part 1 Preliminary

1 Name of Instrument [see Note 1]

  This Instrument is the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005.

2 Commencement

  This Instrument commences on 1 July 2005.

3 Object

  The object of this Instrument is to set out criteria which more fully describe some of the 25 items in Part 2 of Schedule 6 to the Agricultural and Veterinary Chemicals Code Regulations 1995.  A more detailed description of the items will allow applicants to work out which fee applies to a particular application. 

4 Interpretation

 (1) Unless the contrary intention appears, an expression used in the Agvet Code Act or the Agvet Regulations and in this Instrument has the same meaning in this Instrument as in the Agvet Code Act or the Agvet Regulations.

 (2) In this Instrument, unless the contrary intention appears:

Category in relation to an application means an item in Column 1 of Part 2 of Schedule 6 of the Agvet Regulations.

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.

new active constituent means an active constituent that, at the time an application in respect of that active constituent is lodged with the APVMA, has not been approved.

new chemical product means a chemical product that, at the time an application in respect of that chemical product is lodged with the APVMA, has not been registered.

Part 2 Criteria for Working out which Application Category Applies

5 Category 1 (application fee $48,860)

 (1) A Category 1 application includes only applications for agricultural chemical products for use on food‑crops where the new active constituent in the agricultural chemical product is synthetic or is semi‑synthetic or is highly purified or is produced by genetic engineering. 

 (2) In the context of a Category 1 application, a full assessment means that to grant the application the APVMA must undertake an assessment of the application that is equivalent to the following Schedule 7 modules — 1, 2.1, 3.1, 4, 5.1, 6.1, 7.1, 8.1, 11.1, and 12.

6 Category 2 (modular assessment fee)

  A Category 2 application includes applications for:

 (a) agricultural chemical products where the active constituent is a commonly used household or industrial chemical with a history of safe use; or

 (b) veterinary chemical products.

7 Category 3 (application fee $31,750)

  In the context of a Category 3 application, a full assessment means that to grant the application the APVMA must undertake an assessment of the application that is equivalent to the following Schedule 7 modules — 1, 2.3, 3.3, 4, 5.1, 6.1, 7.1, 8.1, 11.1, and 12.

8 Category 11 (application fee $14,260)

  A Category 11 application does not include an application to vary the particulars or conditions of registration where the variation is an extension of use of a chemical product from a non‑food‑producing use to a food‑producing use for the first time for any chemical product containing the active constituent which the chemical product contains.

8A Category 12 (application fee of $560)

  A Category 12 application does not include a multiple application.

8B Category 14 (modular assessment fee)

  A Category 14 application includes multiple applications.  The modular assessment fee for multiple applications is to apply in the manner described in subsections 17 (2) and (3) of the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005.

9 Category 15 (application fee $23,430)

  In the context of a Category 15 application, a full assessment means that to grant the application the APVMA must undertake an assessment of the application that is equivalent to either of the following Schedule 7 modules — 2.1 and 3.1; or 2.1 and 3.2.

10 Category 17 (application fee $1,435)

  A Category 17 application includes an application for a new source of manufacture for the active constituent that is the subject of the application.

11 Category 18 (application fee $915)

  Category 18 applies to applications to vary the particulars or conditions of an approved active constituent where a chemistry assessment is the only assessment required.  Variations to the particulars or conditions of approval of biological active constituents (which also involve efficacy and safety assessment, at least) are not included in this Category.

12 Category 20 (application fee $320)

  In the context of a Category 20 application, a previous assessment would remain valid where the application is for the purposes of extending or renewing the duration of a permit.

13 Category 25 (modular assessment fee)

  A Category 25 application includes an application for assessment of a trial protocol.

Part 3 Fees

14 Fees

  Subregulation 70 (2) of the Agricultural and Veterinary Chemicals Code Regulations 1995 provides that the fee payable in respect of an application of a kind specified in Column 2 of an item in Part 2 of Schedule 6 of the Regulations is the fee (if any) specified for the item in Column 4 of that Schedule.

Note   For reference, the fee payable in respect of an application of a particular kind specified in Column 2 of an item in Part 2 of Schedule 6 of the Regulations is included (in brackets) in this Instrument beside that item or Category.

Notes to the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005

Note 1

The Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005 (in force under subsection 32 (1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Table of Amendments