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AgVetLink February 2003

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Standard for 'operational procedures'

During the pre-consultation process for the prescription animal remedy (PAR) operational policy, it has been brought to our attention that a number of aspects of the risk management process rely on the use of 'operational procedures', and that it would be useful to have these given formal status.

The ACVM Group developed a Model for Operational Procedures for use in the code of practice covering the use of veterinary medicine and human medicine products in research, testing and teaching. This is effectively an ACVM standard.

The organisations involved in the development of the code of practice were the Ministry of Health, the New Zealand Veterinary Association, Massey University Veterinary School and the ACVM Group, so the model has already been extensively discussed by most of the relevant parties in this context.

While this standard was developed for a specific purpose, it contains the components that would need to be covered in other operational procedures – for instance where a veterinarian was delegating to personnel for a specific purpose, or where a vertebrate pest control operator had people performing functions under supervision. It may also have some application under the Good Manufacturing Practice standard.

The ACVM Group has used the original model to develop a further model covering the general requirements for the use of veterinary and human medicines by non-veterinarians from the perspective of the ACVM Act. We expect that other standards will be developed as needed either by the ACVM Group or as part of a code of practice.

Both of these draft standards are on the website for consultation, and will be discussed by AVMAC at the next meeting on 27 February 2003.

Standards update

The revised ACVM Registration Standard and Guideline for Determination of a Residue Withholding Period for Veterinary Medicines is now available on the website and through Manor House Press (see enclosed order form). The residue standard for plant compounds is nearing completion of the internal comment stage.

The public consultation period for ACVM Registration Standard and Guideline for the Chemistry of Plant Compounds has finished. Comments and suggestions are being considered and the final document should be available this month.

The public consultation period for the updated registration information packages and the New Zealand Labelling Guide for Plant Compounds Requiring Registration has also finished. These documents will be available soon.

Currently on the website for public discussion are:

• ACVM Model for Operational Procedures:
  Model 1: The Use of Veterinary and Human Medicines by Non-veterinarians for Research, Testing and Teaching Purposes
• ACVM Model for Operational Procedures:
  Model 2: The Use of Veterinary and Human Medicines by Non-veterinarians Generally

The following standards have been updated to include NZFSA details. No substantive changes have been made.

• ACVM Registration Standard and Guideline for Efficacy of Antibloat Products
• ACVM Registration Standard and Guideline for Efficacy of Emetics
• ACVM Registration Standard and Guideline for Efficacy of Vertebrate Pesticides

Annual Fees

Annual fees for plant compounds for 2002/2003 are due for payment by 28 February 2003. If payment of these fees is not received by this date, registrants will be contacted and advised of the additional steps (likely to be suspension or revocation of existing registrations) that will be taken.

If you have any queries, contact:

Sarah Smyth phone 04 463 2553 email sarah.smyth@nzfsa.govt.nz