- PDF Version (121K) - Print Friendly - Help

AgVetLink December 2004

Processing remaining applications to update registrations

The ACVM Group advised registrants that it was unlikely that all the applications for updating registrations could be processed by 1 July 2004. Consequently, the Group would continue to recognise the existing registrations until applications could be processed.

Most trade name product registrations have now been updated and have been reissued with revised conditions. However, about 300 applications have not been processed yet. There are some applications where the data assessment parts of the applications are unacceptable. Many of the applications still to be processed are ones in which some additional information must be provided by the applicant.

Transitional registration policy

For compliance reasons unprocessed applications cannot be left open indefinitely, recognising registrations that are technically not valid. To manage this situation, the ACVM Group’s Decision Making Committee (DMC) has promulgated the following transitional registration policy:

1. The ACVM Group will continue to recognise the registration that was current at 1 July 2004 for any agricultural compound or veterinary medicine that was required to be updated by the transfer date of 1 July 2004 (that has not been updated) for which an update application has been received.

2. The registration of an agricultural compound or veterinary medicine to which 1 above applies will cease to be recognised as the current registration on:

• an ACVM Group decision to update the registration; or

• a decision to decline the registration; or

• the close of business 16 November 2005 (whichever occurs first).

3. Conditions or requirements imposed under the Animal Remedies, Pesticides or ACVM Acts prior to 1 July 2004 will continue to apply to affected products in the interim period.

This means that over the next 12 months all pending applications will be sent to the DMC for a decision in time to have final decisions before 16 November 2005.

Deficient applications

Deficient applications that are sent to the DMC are likely to be declined. If this happens in regard to a product that had been registered, that product will no longer be registered and it will no longer be legal to import, manufacture, sell or use the product unless this is specifically allowed in the DMC decision. A new application to register the product will have to be lodged with the ACVM Group if a registrant wants the product to be registered in New Zealand.

If applications are deficient, applicants will be advised before their applications are sent to the DMC so that they have an opportunity to address the deficiency, thus avoiding a DMC decision to decline the registration. The timeframe for addressing the deficiency should be discussed with ACVM Group staff.

VTA products

Special arrangements will be made for vertebrate toxic agent trade name products. In most cases, updating the registrations of these products has not been delayed because of a lack of information. They have not been updated because the ACVM Group does not want to force dual regulatory control systems as a result of the ERMA decision not to transfer 1080 along with the other vertebrate toxic agent substances into the main framework of the HSNO Act (see article on page 7).

Unless it is necessary, applications to register these products will not be sent to the DMC until all VTA products can be regulated in a coordinated manner. It is hoped that a decision on 1080 will be made in sufficient time to update registrations before 16 November 2005. However, if there are further delays, a new deadline will be set for updating the registrations of VTA products.