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RULES FOR STATEMENTS

Withholding period statement – no residue data

Historically, where applicants have provided no residue data in support of a withholding period, a statement such as 'Do not use' or 'Not for use' has been included on the label to counter the lack of an assessed withholding period.

This is most common in the case of veterinary medicines where only meat residue data has been provided, and a statement 'Not for use in animals producing milk for human consumption' appears on the product label instead of a milk withholding period. This effectively means that the product cannot be used for the productive lifetime of the milking animal and is an incorrect application of this statement.

The ACVM Group now requires that 'Do not use' and 'Not for use' statements are reserved for cases where a particular medicine is contraindicated for use in a certain species or class of animal for reasons other than a lack of data to set an assessed withholding period. 'Not for use' in bobby calf (pre-ruminant) statements that are currently in place are not affected by this decision.

The ACVM Group has adopted the following rule: Regulatory statements such as 'Do not use' must not be used in place of a label withholding period for any product bearing claims for use in animals that produce meat, milk or eggs for human consumption.

Where acceptable residue data or technical argument is not supplied to enable a withholding period to be set for each potential edible commodity, the relevant default withholding period must be stated on the label.

This rule will be enforced on all products at update or initial registration from 28 August 2002, and all products are expected to be compliant by 1 July 2004. Products that currently contain 'Do not use' statements or are completely silent on the issue of a withholding period for an edible tissue (this includes meat for horses, and milk for sheep and goats) must adopt the relevant default withholding period at update or provide data or technical argument for a reduced period.

Registrants are reminded that it is their responsibility to ensure that all the required information is included on product labels.

Use period statements for multi-use vaccine vials

The ACVM Standard and Guideline for Chemistry requires that in-use stability for multi-use products be addressed. There has been a growing trend for registrants of multi-use vaccines to elect a statement in lieu of providing data that directs consumers to dispose of unused vaccine within a certain time period following broaching of the vial.

The ACVM Group recognises that for products that are likely to be used in entirety upon opening it is inappropriate to insist upon costly supportive trial data. However, it is also recognised that the 'default' statement applied in the absence of data should provide a conservative and concise indication of the period for which the product can be reasonably assumed to remain efficacious once opened.

It is proposed that the following statement be a mandatory label statement for all multi-use vaccines where no in-use stability data is or has been provided:

     'Unused vaccine must be discarded within 10 hours of opening'.

Ten hours has been selected as a suitable time that best approximates an average day's work.

Where registrants wish to state a time period longer than the default, data must be supplied for assessment that is in compliance with the ACVM standard.

If you have any comments or concerns on this rule, please send them in writing by 31 October 2002 to:

Jennie Yee, Assessor (Technical Standards -Veterinary Medicines)
ACVM Group, New Zealand Food Safety Authority
PO Box 2835, WELLINGTON
E-mail: jennie.yee@nzfsa.govt.nz

Annual fees

We apologise for the delay in getting the annual fee invoices out to companies this year. Companies by now should have received the invoice for all veterinary medicine and plant compound products registered under the ACVM Act.

In addition to this, a letter has been sent out to all companies that have pesticides registered under the Pesticides Act. This letter asks each company to indicate whether the product is likely to be an agricultural compound under the ACVM Act or remain solely as a pesticide under the Pesticides Act. Companies are required to return their product lists to the ACVM Group by 11 October 2002. Annual fee invoices for these products will be sent out in late October.

If you have any queries please contact:

Sarah Smyth, Coordinator (Business Services)
Phone: 04 463 2553 or e-mail: sarah.smyth@nzfsa.govt.nz