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AgVetLink August 2004: Page 7

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STANDARDS

Development of regulatory control for vertebrate toxic agent products

The ACVM Group received seven submissions on version 4 of the ACVM Standard for Vertebrate Toxic Agents.

In general the submissions reflected a level of concern that regulatory control in this area where two agencies have overlapping responsibilities may be redundant and possibly conflicting.

Respondents expressed concern over the consultation process, commenting that they have not been informed in an adequate and timely manner to allow them to make useful submissions.

The issues raised and the ACVM Group’s responses can be found in the summary of submissions on the Group’s website. However, to answer the concerns about the consultation process, the ACVM Group is still in the midst of consultation. It prepared a first draft of the standard to prompt discussion. It considered the submissions and modified the standard in light of the comments made. While it set a timeframe for submissions on version 4 of the standard to ensure the development process progressed, it has assured inquirers that any submissions received at any time in the process will be included in development of the standard.

The Group has adjusted the standard to make it clear that the conditions will be product specific. It has discussed the likely conditions with the product registrants. The proposed conditions are now in a form that the ACVM Group considers is specific enough to be used in the next and much wider round of consultation. The regulatory expectations and requirements for approved traders are also being prepared for consultation.

Regulatory expectations for approved users (comparable to the present vertebrate pest control licences) are being discussed with ERMA New Zealand. Until vertebrate toxic agents are transferred into the main framework of the HSNO Act (see box below), the ACVM Group will administer user approvals via the VPC licensing for itself and for ERMA New Zealand.

After transfer, the ACVM Group will maintain its own approval and will integrate with the ERMA New Zealand approved handler system as soon as it is operational.

It is intended to have another full round of public consultation on the management of vertebrate toxic agents.

The consultation will cover:

• version 4 of the Standard for Vertebrate Toxic Agents (which is already available);

• conditions on vertebrate toxic agent trade name products;

• approval of traders in specific vertebrate toxic agents; and 

• regulatory expectations for approval of users of specific vertebrate toxic agents.

This package of documents will be sent directly to product registrants as well as to local and central government agencies for comment. It will also be made available for wider public participation.

In the meantime all registrations for vertebrate toxic agent products have to be reissued as part of the ACVM registration updating process.

Registrants will receive limited-life registrations for their products and will be advised that as soon as the product conditions are finalised their registrations will be changed to incorporate any new conditions.

Unregistered veterinary medicines

Three submissions were received on the ACVM Draft Standard for the Management of Unregistered Veterinary Medicines Requiring Veterinary Overview.

Many issues concerning compounding were raised by submitters and other parties and agencies (both in New Zealand and abroad) consulted by the ACVM Group during the consultation period.

There were also questions about:

• controls on the use of human medicines;

• classification of horses as foodproducing animals;

• the scope of the standard;

• the ACVM Group’s authority to set standards in this area;

• default withholding periods;

• establishment of the veterinarian/client relationship;

• importing veterinary medicines; and 

• the decision rationale for preferentially choosing registered veterinary medicines over human medicines over specially compounded veterinary medicines.

The summary of submissions, which includes the ACVM Group’s responses to concerns expressed and suggestions made, will soon be available on the website.

 

 

VTA transfer

ERMA New Zealand has advised that vertebrate toxic agent products will be transferred to the HSNO Act on 1 November 2004.