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AgVetLink April 2004: Page 6

Draft Standard for Management of Unregistered Veterinary Medicines Requiring Veterinary Overview

The ACVM Group has developed a standard for management of some veterinary medicines that are not registered as prescription animal remedies (PARs) but still require veterinary overview. This includes human medicines and specially compounded medicinal preparations that are prescribed by veterinarians for the treatment of animals.

These products are exempt from registration (ref: ACVM Regulations 2001) so they cannot be registered as prescription animal remedies. Nevertheless, they can be used on animals only under the prescription or authority of a veterinarian. This is because they have not been assessed by the ACVM Group in regard to the risks they pose and, consequently, veterinarians play an important part in managing those risks.

The draft standard states the regulatory expectations in regard to the discretionary use of these products and the level of veterinary overview that is expected. For specially compounded medicinal preparations the standard also states the responsibilities of veterinarians when they are either compounding or contracting a third party to compound preparations on their behalf and to their instructions.

The draft is on the ACVM Group website for public consultation. If you wish to comment send your submission by 24 May 2004 to: 
Chris Boland Programme Manager (Technical Policy) ACVM Group NZFSA PO Box 2835, WELLINGTON or christopher.boland@nzfsa.govt.nz

Controls on VTAs

The ACVM Group is working on procedures and processes to handle the changes on controls for vertebrate toxic agents (VTAs). With the transitional provisions covering VPC licences and controls on sale and/or use of VTA products under the Pesticide (Vertebrate Pest Control) Regulations 1983 coming to an end in July 2004, historical and interim conditions of these products will require changes, including labels. Once the first draft of procedures and processes has been completed, affected parties will be consulted on them and on how to proceed forward to minimise time and costs to registrants and the ACVM Group. A letter giving more details on this topic will soon be sent to registrants of VTA products.

International scene

VICH future

ACVM Group Director Debbie Morris attended the VICH meeting in Paris in March. The purpose of the meeting was to consider the future of VICH from 2005 when the current five-year workplan finishes. Some key discussion areas were:

• How can existing guidelines be maintained, monitored and reviewed to provide information on costs/ benefits and to ensure continuing credibility of the process?

• What are the existing gaps where the development of VICH guidelines could produce a benefit for industry?

• What ICH (human medicine) processes are applicable to the VICH?

• How can the Steering Committee process used to confirm new topics be re-engineered to ensure that the feasibility consideration is carried out adequately?

Conclusions reached at the meeting were:

• The present objectives still apply — the scope (to provide a forum for constructive dialogue between regulatory authorities and the veterinary medicine product industry on real and perceived differences in technical requirements for product registration in EU, Japan, USA...) in the original charter should not be expanded or reduced.

• Any important new topic should be evaluated in accordance with proposed procedures, whether guidance in the area exists or not.

• The general decision-making process should remain as consensus (VICH meaning is ‘without opposition’) achieved by all parties.

• The level of guidance for production, marketing and control of high quality veterinary medicines should be that which is necessary and sufficient to protect public health, animal health and welfare. There is a risk of driving standards to highest level —providing additional costs with no additional benefits.

• All parties are required to commit the necessary human and material resources for groups and work to proceed to agreed plans. Experts should be chosen for scientific merit, ability to work in a multi-cultural team environment, and skill in negotiation/ finding compromises.

• Cost/benefit analyses of the VICH process should include the basis for the analysis including number of companies, geographical distribution, size, responses, numbers of products, guidance involved.

• The Task Force agreed its mandate did not include lists of new topics.

There was some discussion about the frequency and type of meeting required. The preferred option was face-to-face meetings every 6 to 9 months.