APVMA chemical review process

Changes to the Agvet Codes effective from 8 October 2003 mean that the APVMA can no longer finalise a reconsideration (review) which results in label variations, until the APVMA has received varied labels from product registrants which reflect the changes set out in the Review Findings.

The previous review process was that the APVMA would publish a Draft Review Report for public comment after evaluation of data and information submitted to the review. The APVMA would revise the Draft Review Report, taking public submissions into account, and would then publish a Final Review Report which contained the final regulatory decisions.

Under the new process, the APVMA will normally publish for public comment a document titled Preliminary Review Findings. After public comments and submissions have been taken into account, the APVMA will publish a document titled Review Findings. This document will be the basis on which the APVMA proposes to make its regulatory decisions, however the final regulatory decision is not taken by the APVMA at this stage.

The final regulatory decision takes place after varied labels, consistent with the Review Findings, are submitted to the APVMA by relevant product registrants. If varied labels are not submitted, the APVMA can suspend or cancel the label approvals.

The APVMA may also make other regulatory decisions in respect of an active constituent or registration encompassed by the review, including cancelling product registrations, or label or active constituent approvals. The APVMA may also vary conditions of product registration or label approval or active constituent approval. A notice will be published in the APVMA Gazette when all regulatory actions have been taken and the review is finalised.

Summary
Under the previous review process, a review was concluded when the Final Review Report was published. Under the new system, a review is not concluded until the APVMA has taken actions which may include:

· varying relevant product labels according to the Review Findings; and/or
· varying conditions of product registration; and/or
· varying conditions of active constituent approval; and/or
· cancelling or suspending labels as indicated by the Review Findings; and/or
· cancelling or suspending product registrations; and/or
· cancelling or suspending active constituent approvals.