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New application process for A1 (new active) applications

Since the commencement of the ACVM Act and the HSNO Act on 2 July 2001 it has become apparent that there are some operational obstacles for those applicants wishing to register a trade name product with a new active ingredient for use in New Zealand.

A significant hurdle for applicants is the time it now takes to pass through the combined regulatory systems of the ACVM Group and ERMA New Zealand to register a new active. The reasons for this are as follows:

• When an application is submitted to the ACVM Group, under the current operational system it must undergo prescreen and data assessment prior to formal acceptance. The ACVM Group must do this to comply with the legislative timeframes laid out in the ACVM Act.
• Under the HSNO Act, agricultural compounds only receive data protection by reference to section 73 of the ACVM Act. ERMA New Zealand does not have a formal acceptance process and if an application is sent to ERMA New Zealand prior to formal acceptance by the ACVM Group, data protection cannot apply. In essence, this means that applicants who wish to obtain data protection for their products can submit an application to ERMA New Zealand only after the ACVM Group has formally accepted their  application.

The result is that applications for new actives requiring data protection must go through the ACVM registration process and the HSNO process sequentially rather than going through both systems in parallel.

New administrative process for A1 applications

In order to allow a parallel application process through both agencies it is proposed that:

• The ACVM Group will formally accept A1 applications after the prescreen process on the request of the applicant. This will be carried out on the understanding that:
  1. The applicant agrees to the ACVM Group 'stopping the clock' (i.e. the ACVM Group will not carry out any work on the consideration of the application for a regulatory decision) until the data assessment has been completed and the data assessment report (DAR) has been produced.
  2. The applicant provides all the data required to complete the data assessment.
• On formal acceptance of an A1 application the ACVM Group will notify other government departments of formal receipt of the application and initiate public notification through the New Zealand Gazette as long as there is sufficient information to undertake the public consultation process effectively.*
• A letter confirming the successful passage through prescreen and the formal acceptance of the application by the ACVM Group will be sent to the applicant.
• On receipt of this letter, the applicant should be able to make a parallel application to ERMA New Zealand and receive the data protection provided under the ACVM Act.
• Following public notification, the ACVM Group ceases all work on processing the application (although work will continue on the data assessment) for the period of time required for submissions to be received (i.e. 30 days).
• Thirty days after notification, the ACVM Group will officially stop the clock on the consideration of the application (although work will continue on the data assessment) with the consent of the applicant.
• Consideration of the application will commence once the data assessment has been completed and the DAR has been submitted for review and evaluation. When this occurs, the ACVM Group will be obliged to make a decision to approve or decline the application within 40 days.
• Following a regulatory decision of the ACVM Group's Decision Making Committee (DMC) to register the product, the product will be registered if an approval has been provided by ERMA New Zealand or if  the product is non-hazardous.
• The new administrative approach will be carried out on a case by case basis.

* Where there is insufficient information (due to the lack of a data assessment report), the clock will be stopped prior to public notification. Public notification will then be undertaken as soon as the information is provided by the applicant or when the data assessment is completed.

Website update

Recent updates to the website are:

• Revised Report form for (Schedule 3) Exempt Agricultural Compounds
• Revised Annual Report form for (Schedule 3) Exempt Agricultural Compounds
• Minor revision to the Guiding Principles for Class Determinations