This content is current only at the time of printing. This document was printed on 20 February 2017. A current copy is located at http://apvma.gov.au/node/957
How we make decisions
The APVMA can make guidelines under section 6A of the Agvet Code in relation to decisions we make. If we make guidelines under section 6A of the Agvet Code we must have regard to them when performing our functions or exercising our powers. Current 6A guidelines are included in this section.
Background to the reforms and the section 6A guidelines
Section 6A of the Agvet Code states that we may make written guidelines for performing our functions and exercising our powers under the Agvet Code and the Agvet Code Regulations.
Overarching principles and processes for the effective and efficient regulation of agricultural and veterinary chemical products
Outlines our principles and processes for effective and efficient regulation of chemical products and their constituents.
Approvals and registrations
Relates to approvals and registrations and covers preliminary assessments, determining applications (including the information we take into account), restrictions on our power to approve or register, conditions on approvals and registrations, and notices of proposed decisions.
Relates to preliminary assessment, what we mean by, and what we take into account in conducting, a preliminary assessment.
Relates to issuing permits and covers applying for permits and what we take into account in determining permit applications. It also covers the conditions we impose on permits and the duration and extension of permits.
Relates to issuing licences and covers exemptions from licensing, the process of applying for and determining applications for licences, the particulars and conditions of licences, and suspensions and cancellations of licences.
Covers the circumstances in which we will recategorise an application.
Covers the circumstances in which we will consider altering applications, and how we will obtain consent.
Section 159 in the context of applications under the Agvet code
Relates to the operation of section 159 of the Agvet Code in the context of the applications under the Agvet code and covers the circumstances in which we will issue a section 159 notice, the reasonable period within which to respond, when we will allow a further period to respond and what happens if an applicant fails to comply with a section 159 notice.
Limits on use of information
Relates to our powers under Division 4A of Part 2 of the Agvet Code and covers general rules concerning limits on use of information and the exceptions to the limits on use of information.
Reconsidering approvals and registrations
Relates to reconsidering approvals and registrations and covers initiating reconsiderations, giving notice and obtaining information for the purposes of the reconsideration, and the process of reconsideration
Varying relevant particulars and conditions
Relates to varying relevant particulars and conditions and covers applications for variation of relevant particulars and conditions of approvals and registrations, and variation on our own initiative.
The purpose of this Guideline is to set out descriptors for working out the appropriate modular assessment level for certain applications and reconsiderations as set out in Schedule 7 to the Agvet Regulations.
The purpose of this Guideline is to set out, for agricultural chemical products, formulation types recognised by the APVMA pursuant to reg 3 of the Agvet Regulations.