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Cross-referencing and accessing information

The ACVM Group has had a number of queries about cross-referencing information recently. The following is intended to clarify the operational rules applied in this regard.

Any information that is not the subject of data protection and that is held by the ACVM Group may be cross-referenced to support another application. It is the responsibility of  the applicant to prove to the ACVM Group that there is a sound technical basis for cross-referencing information, especially where the information has been provided by another party.

Cross-referencing information can result in information waivers being granted. Information waivers can make the registration process faster and less expensive in that an information waiver is likely to reduce the number of trials needed to support an application.

However, it is not necessarily true that cross-referencing will reduce the actual cost of registration as the ACVM Group consideration of these requests is charged on an hourly basis.  A cross-reference request (usually in the form of an information waiver) may require the ACVM Group to consult with technical experts. In these cases the cost of obtaining advice is passed on to the applicant. It is always an option for the applicant to provide expert advice – where this happens the credentials of the expert should be included for consideration, and a statement covering independence and conflict of interest included.

Cross-referencing information in no way gives an applicant access to another company’s data without their permission – it simply allows the ACVM Group to access information provided by one company in support of an application from a second company, provided the basis for a cross-reference has been proved.

With the implementation of the ACVM Act, the Animal Remedies and Pesticides Acts have been replaced by a single piece of legislation. This has the potential to confuse the rules around cross-referencing further and was considered by the Boards some time ago. Where there is data protection for an active ingredient under either of the previous Acts, this will carry through until the end of the data protection period.

Further, a plant compound (pesticide)  application will not be able to cross-reference a veterinary medicine product where there is still data protection in place for the pesticide. This rule also applies to veterinary medicines (animal remedies) cross-referencing plant compounds.

ERMA NZ is also able to use data supplied to the ACVM Group for the purposes of considering the transfer of substances to the HSNO Act or for the approval of substances under HSNO. Data supplied to ERMA NZ carries with it the same protections afforded to it by the ACVM Group – either data protection under the ACVM and HSNO Acts, or commercial in confidence (protected under the Official Information Act).

Proposal to transfer animal remedies licences and pesticide registrations

On page 6 of the October issue of AgVetLink the ACVM Group proposed the development of regulations to transfer the existing licences and registrations of trade name products. There were no written submissions on the proposal, but the ACVM Group received verbal support for the proposal from a number of individuals and organisations. There were no objecting views.

Consequently, MAF will prepare the advice to Cabinet. MAF will propose that the Regulations come into force on 1 July 2002 to facilitate the change from the old licensing and registration annual fees to the new registration annual fees. The commencement date will also allow essential changes in licence or registration conditions to be made before the transfer, in particular the conditions on some in-feed antibiotic  products.