- Print Friendly - Help

AgVetLink June 2003

Previous page  | Contents |  Next page

---

Applications made by a third party for additional uses on registered products

Under the ACVM Act, applications for additional claims on registered trade name products are not restricted to the registrant. Applications can be made by third parties where they are supported by sufficient data.

Minor uses

It is likely that this will be most useful for minor uses of plant compounds, where grower groups may have access to residue and Good Agricultural Practice information and where there is an interest in having a registered product to deal with known pests and diseases.

In many of these instances the potential market value to the registrant is not high. This makes the costs of additional claims unattractive to the initial registrant, but provides the opportunity for interested third parties to make an application.

There are similar possibilities in the veterinary medicines area for the addition of claims relating to minor species such as goats and ratites.

Approved uses

Uses that are approved through this route may subsequently be added to relevant product labels (by the registrant and only with their approval) or an information sheet can be produced (supported by a regulatory approval) by the user group concerned.

Trial applications

The ACVM Group has worked through some trial applications with a user group to test the process. It is our preference that the registrant company is involved in the application.

Where they are not, the registrant will be advised of the application and the ACVM Group will make a request for the supply of any relevant information held by the registrant company. The information, either in support or against the addition of the claim, will be part of the consideration of the application by the ACVM Group.

The ACVM Group is in the process of developing an application form and further information on ‘Third Party Applications’ will be available on the website shortly.

Product Data Sheets – Why do we need them for old compounds?

There have been some recent enquiries as to why the ACVM Group requests companies to complete product data sheets for products that are already registered and will be transferred without changes to the HSNO Act. The reasons are as follows.

When many of these old compounds were registered, the information required was minimal – a one page application form was all that was required. Since the implementation of the ACVM Act 1997, criteria set in the legislation requires more information, such as additional details for inclusion in the public register. There are also different risks being managed. In addition, ERMA NZ has started work on the transition of products to the HSNO legislation and further details on trade name products are required in relation to the hazardous substance assessment.

Therefore, to prevent an applicant filling out two different forms – one for ERMA NZ and one for the ACVM Group – a single form was developed to capture both sets of information requirements. During the updating of products to the ACVM Act, using the current Product Data Sheets, ERMA NZ is able to review product files to seek the updated information, or alternatively request the Product Data Sheet for their reference.

We believe this is an effective and efficient time saving process to deal with the wide range of criteria required under the ACVM and HSNO Acts.