Agricultural and Veterinary Chemicals Code Instrument No. 3 (Assessment Periods for Applications where Additional Information is Submitted Voluntarily) 2008 (Cth)

Agricultural and Veterinary Chemicals Code Instrument No. 3 (Assessment Periods for Applications where Additional Information
 is Submitted Voluntarily) 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 subsection 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

Part 1        Preliminary

1.         Name of Instrument

This Instrument is the Agricultural and Veterinary Chemicals Code Instrument No. 3 (Assessment Periods for Applications where Additional Information is Submitted Voluntarily) 2008.

2.         Commencement

This Instrument commences on the day after it is registered.

1. Object

The object of this Instrument is to set out criteria for working out which particular periods specified in the Agricultural and Veterinary Chemicals Code Regulations 1995 and within which the APVMA must determine an application are to apply to those applications where additional information is voluntarily submitted to the APVMA.

4.         Interpretation

(1)Unless the contrary intention appears, an expression used in the Agricultural and Veterinary Chemicals Code Act 1994 or the Agricultural and Veterinary Chemicals Code Regulations 1995 and in this Instrument has the same meaning in this Instrument as in the Agricultural and Veterinary Chemicals Code Act 1994 or the Agricultural and Veterinary Chemicals Code Regulations 1995.

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

additional information means, in relation to an application made to the APVMA, relevant information that is provided to the APVMA at a time after the original application has been made and where, for that application, the APVMA has already undertaken an assessment of the same type of information as the additional information yet the submission of that additional information:

(a)requires the APVMA to evaluate or assess that additional information;

(b)requires an existing assessment of the application to be revised or redone;

(c)was not in response to a notice given to the applicant by the APVMA under section 159 of the Agvet Code requesting the additional information; and

(d)was not in accordance with any agreement which the APVMA had reached with the applicant prior to the application being lodged with the APVMA that the information could be submitted to the APVMA after the application had been made.

Part 2        Criteria for working out a period for completion of an application with additional information

5.         The total period within which the APVMA is to determine an application containing additional information

Where the applicant provides additional information in relation to an application, then the total period within which the APVMA must determine the application is to be worked out by adding to the period within which the APVMA would otherwise be required to determine the application (that is, the period for that kind of application as specified in Column 3 of an item in Part 2 of Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995 including, if appropriate, any modular assessment period), the sum of:

(a)     the longest of any of the periods for the other modules, levels or types of assessment specified in Column 3 of Schedule 7 that the APVMA considers is necessary to be further undertaken, or needs to be revised or redone, by reason of the additional information; and

(b)     any period for the type of finalisation assessment module in items 11.1 to 11.4 in Schedule 7 that the application must undergo a second time.