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.

Preliminary assessment

Relates to preliminary assessment, what we mean by, and what we take into account in conducting, a preliminary assessment.

Permits

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.

Licences

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.

Recategorising applications

Covers the circumstances in which we will recategorise an application.

Altering applications

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.

Module Descriptors

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.

Formulation types

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.

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