This content is current only at the time of printing. This document was printed on 21 September 2018. A current copy is located at https://apvma.gov.au/node/979
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Varying relevant particulars and conditions
1. What is this guideline about?
- This guideline is made pursuant to section 6A of the Agvet Code.
- The purpose of this Guideline is to set out our principles and processes in relation to performing our functions and exercising our powers relating to varying relevant particulars and conditions under Division 3 of Part 2 of the Agvet Code.
- It covers applications for variation of relevant particulars and conditions of approvals and registrations, and variation on our own initiative. It does not cover varying prescribed relevant particulars under Division 2A of Part 2 of the Agvet Code.
- The provisions of the Agvet Code and the Agvet Code Regulations covered by this guideline are outlined in the annexure to this guideline.
- This guideline commences on 1 July 2014.
2. Applying for variation
2.1. Preliminary assessment—where can I get more information?
- We expect applicants to lodge an application to vary relevant particulars or conditions of an approval or registration that contains or is accompanied by all relevant information such that the application ‘meets the application requirements’.
Note: Section 8A of the Agvet Code defines ‘meets the application requirements’.
- We will undertake a preliminary assessment of applications for variation in accordance with Section 6A guideline—preliminary assessment.
- For the purposes of section 28(4) of the Agvet Code, we may alter an application, after it has passed preliminary assessment, and with the written consent of the applicant, in accordance with Section 6A guideline—altering applications.
2.2. How will we determine applications for variation?
- We must be satisfied of the relevant matters in section 29 of the Agvet Code before we can vary the relevant particulars or conditions of an approval or registration.
- We will take into account Section 6A guideline—approvals and registrations in performing this function.
2.3. Varying on our own initiative
- Under section 29A of the Agvet Code, we may, on our own initiative, and with the written consent of the holder, vary the relevant particulars or conditions of an approval or registration.
- [These guidelines are still to be developed.]
3. Annexure—relevant legal provisions
- Division 3 of Part 2 of the Agvet Code provides for the variation of relevant particulars or conditions of an approval or registration. Holders of approvals or registrations can apply to us for a variation, or we may seek to vary the relevant particulars or conditions on our own initiative.
Note: Section 27 of the Agvet Code deals with applications to vary a relevant particular or condition. Section 28 deals with preliminary assessment of the application (see also regulation 19AD of the Agvet Code Regulations). Section 29 deals with assessment of an application for a variation. Section 29A gives us the power to vary a relevant particular or condition on its own initiative, with the consent of the holder. Section 29B sets out how a variation takes place.