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AgVetLink August 2003

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PAR Class II conditions and label wording

As per section 28 of the ACVM Act, codes of practice may be approved by the Director-General as a risk management tool to control the use of any agricultural compound. Codes that have a sufficient degree of risk management to enable the use of Class II PARs by non-veterinarians when a veterinarian is not present at the time of administration have been approved.

The current PAR Class II condition reads as follows:

• The product must not be sold to any person other than a veterinarian or dealer.
• The product must not be administered except following a veterinary consultation.
• The product must be administered to an animal only by a veterinarian, or in the presence and under the control of a veterinarian, unless specified otherwise in the current approval.

The first two sentences of the condition are still applicable for PAR Class II veterinary medicines. However, in order to accommodate the use of this class of veterinary medicine within the bounds of a code of practice or under a set of operational instructions from a supervising veterinarian, the ACVM Group has modified the wording of the third sentence of this condition to read as follows:

• The product must be administered to an animal only by, in the presence of, or under the direct control of a veterinarian, unless specified otherwise in the current approval.

Where a PAR Class II condition is considered appropriate for a particular veterinary medicine but the risks associated with the product are such that they could be managed only by a veterinarian, the use of the medicine by a non-veterinarian when a veterinarian is not present will be specifically contraindicated in the current approval.

Consequent to this rewording of the condition, the PAR Class II statement used on product labels must also change.

Currently PAR Class II veterinary medicines have the following statement:

"For use only in the presence of a veterinarian".

The ACVM Group proposes changing the mandatory statement to the following:

"For use only by, in the presence of, or under the direct control of a veterinarian".

Comments are invited on the proposed statement and should be sent in writing to:

Jennie Yee, 
ACVM Group 
New Zealand 
Food Safety Authority 
PO Box 2835, 
WELLINGTON 
Email: jennie.yee@nzfsa.govt.nz.

 

PAR Class I Label Statement

An error is present in the current version of the ACVM New Zealand Labelling Guide for Veterinary Medicines Requiring Registration with respect to the mandatory label statement required for Class I Prescription Animal Remedies.

The statement that is required is provided in section 3.2.6 and reads:

"Prescription Animal Remedy (P.A.R) Class I For use only under the authority or prescription of a veterinarian".

The wording provided in section 2 of the annex is incorrect and should not be used. The labelling guide will be revised in the near future at which time the error will be rectified.

The ACVM Group apologises for any inconvenience this error may have caused.

 

Antibiotic resistance: Reporting on sales

We are collating the information that has been supplied for 2002 and, while the information is still in draft form and the support rationale is still being checked with the industries, we can advise that there appears to be an increase in sales in the region of 0.7% over last year. This is too small a difference to be of any significance.

Indications from the report are that no antibiotics of human health significance were sold for growth promotion purposes in the calendar year 2002 (although a recent ‘slice of life’ audit has shown that some were used in that way). There was a general trend in sales towards therapeutic use of products of greater significance – this was expected as treatment regimes were adjusted to minimise prophylatic treatment and with the removal of products like avoparcin. We are checking the figures with a number of groups and hope to publish the report shortly.