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Regulatory Process - Overview

The regulatory process consists of reviewing data assessments and evaluating risks which must be managed under the ACVM Act 1997 http://www.nzfsa.govt.nz/acvm/publications/information-requirements/index.htm. The regulatory review and evaluation can only be carried out by the ACVM Group and is subject to statutory timelines. Prior to an application being accepted into the regulatory process, a data assessment must have been carried out on the required data to standards set by the ACVM Group. http://www.nzfsa.govt.nz/acvm/topics/das/index.htm.

Where a data assessment has been undertaken by a third party, the CV of the data assessor must be provided with the application.

1. Making an application for registration

A request should be made to the ACVM Group for review and evaluation. The request should be accompanied by the completed data assessment reports, with CVs of expert assessors where applicable, summaries of results for all data assessed, proposed label content and the regulatory pre-screen fee. Raw data used in the data assessment is not required where trials are carried out to ACVM standards, but should be included for chemistry and manufacturing and any cases where trials were not carried out to ACVM standards. Where the data assessment was carried out by the ACVM Group, the relevant data assessment reference number should be quoted with all correspondence. Note: where an MRL is required in order to approve a particular claim, the MRL should be finalised before the application enters the regulatory system.

2. Review and evaluation of the application

The ACVM Group will carry out a review and evaluation of the data assessment, addressing the risk areas set out in the ACVM Act 1997. Conditions may be recommended in order to manage any risks identified. Additionally, a Technical Consultative Committee may review the proposed recommendations to provide further robustness to the evaluation.

The application is subject to statutory timeframes. However, if an issue is identified which is of sufficient weight to potentially cause the application to be declined if not resolved, with the applicant's agreement the ACVM Group can extend the time period for registration beyond the statutory 40 days ('stop the clock').

Once the application has been reviewed and evaluated, it is submitted to the ACVM Decision Making Committee with a recommendation. The applicant will be advised of the outcome in writing.

3. Registration

If approved, some changes to the label content and product datasheet may be required. Registration will occur when the final label content and product datasheet are approved, and when all obligations under other legislation specified in the ACVM Act are met (eg hazardous substances approval under the HSNO Act 1996). The product registration consists of the registration certificate, registration conditions, and copies of the final label content and product datasheet.

Last updated: 24-March-2003