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Data Assessment Service - Overview

From 1 April 2003, the ACVM Group is offering a discretionary data assessment service. This service assesses data in support of an application for registration, or variation to a registration, to standards set by the ACVM Group. Alternatively the assessment of any, or all, of the data may be carried out by an independent third party using the same data assessment templates and standards. All required data must be assessed by the ACVM Group or a third party before an application for registration or variation can be made into the regulatory system. See the Registration Requirements documents for further details on the data that is required .

Note 1: applicants may choose to do their own data assessment; however, they should be aware that the ACVM Group will have added concerns about possible bias if the reports are not made by independent assessors.

Note 2: It is the responsiblity of the applicant to ensure that the person undertaking the data assessment hs the appropriate qualifications to do the work.  The ACVM group requires data assessor's CVs to be provided with an application.

Note 3: *Note change in agricultural security threshold

1. Screening of the application for the ACVM Group's data assessment service

Before an application can be accepted for data assessment, it should meet a number of criteria via a screening process. These criteria include: payment of the appropriate fee, completion of a Registration and Product Datasheet and the submission of relevant data. The screen ensures that the application contains all information as identified on the application form checklist, and that this information is correct for the application type being sought. The screen does not check the quality of the data submitted.

If deficiencies are identified during screening the applicant will be advised and given the opportunity to resolve those deficiencies.

2. Accepting the ACVM Group data assessment service

The ACVM Group will inform the applicant of the estimated number of hours, cost, and likely time to complete the data assessment. If the applicant wishes to use the ACVM data assessment service, a signed copy of the Data Assessment Service Notice of Conditions and Disclaimer, which will be included with the estimate letter, should be returned to the ACVM Group. On receipt of this Disclaimer, the data assessment will then commence.

3. Data assessment of the application

The data assessment process is the most time consuming of the overall application evaluation. During data assessment, data submitted for the application are assessed and may be subjected to a review by experts.

If, during the data assessment process, it is noted that there are data deficiencies, or the ACVM Group requires further clarification on an application, then the applicant will be contacted. Work on this application will cease until the additional information or clarification has been supplied, or the end date stated to do so is reached. In effect, this means that incomplete applications may delay the data assessment process. A data assessment can be carried out with incomplete information or data submitted, however, any deficiencies and resulting implications will be pointed out in the finished reports.

Applications cannot be significantly modified during the data assessment process. If the applicant wishes to modify the application, the application should be withdrawn and a new application submitted.

On completion of the data assessment, completed data assessment reports will be returned to the applicant. The applicant then has the opportunity to review the finished data assessment reports before progressing the application through into the regulatory process. http://www.nzfsa.govt.nz/acvm/topics/regulatory-process/index.htm

Last updated 13-March-2006