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ACVM Guidelines for Information Waivers (IW)

Background

The ACVM Group expects applicants to provide all applicable information specified in the ACVM Registration Information Requirements and Standards when an application is lodged. However, it is recognised that there may be technical justification for:

• less or different information to be provided; or

• deviation from the standard methodology for generating particular information.

To allow for such situations, the ACVM Group has established an IW system, whereby applicants can provide a justification, in the form of supporting argument or data, for deviation from the usual requirements. Currently, this request is made at the same time an application is submitted to the ACVM Group and is assessed as part of the review and evaluation process.

Applicants that intend to request an IW as part of their application are required to complete an IW application form along with the application form and product data sheet (available on the website www.nzfsa.govt.nz/acvm as well as relevant data sets (see next section for exceptions). This information should ensure the ACVM Group has sufficient information to determine the merits of the request.

IWs

In some instances IW requests are straightforward and do not require significant justification. Examples of such IWs are Type B1 applications or applications involving direct cross-reference to claims made on other similar products.

For these types of IWs, they can be incorporated into the covering letter accompanying the application for registration, or variation ie no application for an IW request is required. Processing of these simple IW will be included in the evaluation of the application.

Should an applicant be in doubt on whether their IW is considered a simple request, then they should contact the ACVM Group for guidance.

The Information Waivers are justified:

1 – where the applicant intends to indirectly cross-reference information on an existing trade name product. In these cases, the applicant’s proposed product is not identical to the existing trade name product to which reference is being made. Or

2- where the applicant is requesting a deviation from requirements in a registration standard and guideline.

Requests for IWs should be made prior to the application for registration or variation to a registration being lodged. However, where an IW request accompanies the application, then the application will not be accepted into the system until the IW request is processed.

Lodgement of IW Applications

A request for an IW will have an initial screening for completeness prior to being processed. Any deficiencies that prevent us from processing a request will be advised at that time. During the processing of the request, the ACVM Group may need to seek clarification or further information from the applicant.

Data Packages

Any data packages submitted with the request will be retained by the ACVM Group. It should be noted that Confidential Supporting Information provisions of the ACVM Act do not apply as this applies once an application for registration is formally lodged.

Fees & charges

A base fee of $324.00 + GST will apply for an IW request and is not refundable. If data volumes require assessment, then a charge of cost versus time basis ($108.00 + GST per hour) will apply. Also any disbursement costs will be charged. These charges will be invoiced separately. An estimate of the time to be taken for the evaluation will be given, prior to commencement of the evaluation.

The base fee must accompany the Information Waiver request unless you are an approved creditor.

Contact details

Approvals and ACVM Group

NZFSA
P O Box 2835
Wellington