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AgVetLink December 2002

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Updating registrations

The ACVM (Transition Provisions) Regulations 2002 came into force in July 2002. The Regulations deemed all applicable animal remedy licences and pesticide registrations to be ACVM registrations. The Regulations imposed a limited registration period with an expiry for all deemed registrations of 1 July 2004. This provided a period in which the products could continue to be marketed under their existing conditions and approved labels.Therefore, while the products are now registered under the ACVM Act, many of them still look like animal remedy or pesticide products.

To take advantage of the limited registration period provisions of the Regulations a registrant must not request any changes that would alter the identity of products or change how they are packaged or labelled. If such changes are requested, the ACVM Group considers that the products are no longer the products that were first deemed to have been registered under the ACVM Act, and new registrations will be issued.

All registrants must apply for new registrations before 1 July 2004 or the registrations of their products will lapse. In effect, the new registrations will be updates of the existing registrations, ensuring that the conditions on registration, product data sheets and label contents are made current and approved.

The ACVM Group has been processing a steady stream of applications where the applicants have either requested or been prepared to have new registrations issued. Applicants have provided the necessary updated information and the new registrations have been issued. However, some applicants have requested changes to existing registrations but have also requested deferral of the associated update at this time.

It is assumed that applicants have some commercial reason for wishing to maintain the existing conditions and labels, but the ACVM Group can see no benefit if the changes already prompt an immediate alteration in labels.

The ACVM Group has tried to be helpful in approving requests to change some aspects of the existing registrations while postponing the actual updates. However, the only changes that could be made are the ones that would not change the identity of products or the way they are packaged or labelled. Most registrants have been understanding of the situation and have restricted their requests to minor changes when they do not want to update their registrations yet. However, a few registrants have requested significant changes and have objected when the ACVM Group has required new registrations.

The purpose for the limited duration registration was to allow time so that registrants had to make changes only once to incorporate both new ACVM conditions and any controls imposed under the Hazardous Substances and New Organisms Act 1996. To make changes prior to this defeats that purpose of the ACVM (Transitional Provisions) Regulations 2002. To make significant changes in the existing registrations is also contrary to the other purpose of the Regulations which was to allow the product to be marketed as long as the product stays the same as it was approved at the time the Regulations came into force.

Therefore, in recognition of the fact that the time for applying for new registrations is getting shorter and to clear up any misunderstanding and further debate, the ACVM Group restates its updating policy as follows:

• If registrants wish to postpone the issuing of new registrations temporarily they should not request any variations in the existing registration until they are ready to update the registrations.
• If registrants must make changes in the existing registrations they must be prepared to accept that new registrations will be required (updated product data sheets and label content) at the same time if the changes requested alter the product itself, the claims made or the appearance of the product, i.e. any changes requiring changes in the label.

The ACVM Group recognises that it had provided advice that some minor changes in labels could be made without updating the product files and that some registrants are acting on that advice. The ACVM Group wishes to make it clear that any advice on this matter is no longer relevant. The current advice is: 

• As of 1 February 2003 no changes to the label of any kind will be approved unless the new registration is issued at the same time.
• As of 1 September 2003 no changes of any kind will be approved unless the new registration is issued at the same time.

All registrations must be reissued as new registrations before 1 July 2004. Initially the ACVM Group had suggested that registrants temporarily delay updating registrations to give ERMA NZ time to transfer substances and specify the new controls. This would have minimised the cost of compliance by facilitating only one label change. The ACVM Group now advises all registrants that, given that there are now less that two years before all registrations must be reissued, registrants should apply for new registrations as soon as they are ready to update their registrations.