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AgVetLink August 2004: Page 9

Cat and dog internal parasites

The cat and dog parasites listed in the box will be considered for inclusion on the labels of veterinary medicines registered in New Zealand. There is insufficient data to suggest that any other parasites not included on the list and known to infect cats and dogs overseas are present in New Zealand to the extent that products will be required to treat them.

A treatment or prevention claim will not be approved for any new or existing product for such parasites (except for Australia-New Zealand harmonised labels which come under separate ACVM policy).

Products updated with claims for unlisted parasite species are expected to remove the claims at the next reprint.

Efficacy data

Applications for approval of cat and dog roundworm, hookworm and dog whipworm treatment and control claims must be supported by efficacy data.

The applicable standards are the VICH documents Efficacy of Anthelmintics: Specific Recommendations for Canines and Efficacy of Anthelmintics: Specific Recommendations for Felines

(see http://vich.eudra.org/ htm/guidelines.htm#t2 ).

Efficacy data are not required to support a tapeworm treatment or prevention claim.

The negative animal welfare that results from tapeworm infection in cats and dogs does not breach the relevant ACVM threshold (at least moderate pain and distress). Furthermore, tapeworms are not currently subject to any Biosecurity Pest Management Strategies.

Veterinary medicine withholding periods

Registrants are reminded that it is a requirement for all veterinary medicines with claims for use in food-producing animals to state a withholding period (WHP) for all edible produce of the claimed species where one can be established.

Four different types of withholding periods may be approved:

Assessed WHP
The WHP determined by the ACVM Group after assessment of the trial data according to the rules and guidelines specified within the ACVM Residue Standard and evaluation of the various residue risks identified.

Allocated WHP
The WHP determined by the ACVM Group to be appropriate to a reduced or non-existent data set but also takes into account other evidence supplied as part of a waiver.

Default WHP
The set of predetermined WHPs that will be applied in the absence of any residue data (and a supportable residues information waiver).

Standardised WHP
A WHP assigned to a group of formulations with at least one active ingredient in common and with the same method(s) of administration. The standardised WHP will correspond to certain specifications. Future registrations of products within these specifications need supply no residue data if the registrant elects to take the standardised WHP. Standardised WHPs are included as an annex to the ACVM Registration Standard and Guideline for Determination of a Residue Withholding Period for Veterinary Medicines.

Any products that have previously been approved with a now superseded default, a ‘do not use’ statement in lieu of a WHP, or no WHP where one is applicable will be updated with the currently applicable default WHPs (see www.nzfsa.govt.nz/acvm/subject/vet/ withholding.htm).

Applicants are reminded that an application may be made to have a WHP other than the default approved (this may include retention of a superseded default).