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AgVetLink February 2004: Page 4

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Dry cow product labelling statements

In the current ACVM New Zealand Labelling Guide for Veterinary Medicines Requiring Registration (21 ACVM 10/03), section 13 of the annex is entitled ‘Labelling of Dry Cow Products’. The section lists four mandatory statements for dry cow products. They are as follows:

1. Dry cow therapy should be used at drying off only.

2. Lactating cow products should be used if retreatment is required during the dry period.

3. Milk (colostrum) from the first 8 milkings after calving should be prevented from directly entering the food chain.

4. Treatment to be at least 30 days before calving.

The first three statements remain current. The fourth statement is an historical requirement resulting from the Animal Remedy Board’s decision to approve a standardised pre-natal treatment interval (PNTI) of 30 days for all dry cow products (where the PNTI is equivalent to the treatment to calving interval). The other standardised withholding period of 8 milkings for dry cow products coincides with the required colostrum withhold period.

Under current policy, to prevent user confusion and maintain product market viability, when conducting residue assessments the ACVM Group uses the PNTI as the variable to ensure milk compliance with the relevant MRL by the ninth milking. With the advent of more diverse active ingredients and longer acting preparations, some dry cow products have been registered with PNTIs in excess of 30 days so that the fourth mandatory statement is untrue in those cases.

In addition, a mandatory label statement has not been established to direct users on the appropriate procedure when a cow calves within the regulated PNTI. There has been a determined move away from the use of individual cow testing as milk is regulated on a bulk vat and not individual animal level. Therefore, the statement that will replace the above mentioned fourth mandatory statement is as follows:

Treatment to be at least ‘x’ days before calving. 
If calving occurs within ‘x’ days of the last treatment, milk to be sold for human consumption may be taken only after the full ‘x’ days from treatment and a further 8 milkings have elapsed.

(Note: ‘x’ is the ACVM approved treatment to calving or pre-natal treatment interval). The labelling guide has been updated to reflect this change.

PAR condition wording

In the October 2003 issue of AgVetLink the ACVM Group advised that there had been changes to the wording of the PAR Class II condition to line it up with the management of PAR products. The wordings for the Class I and III conditions have now also been revised for the same reason. Changes have been made with respect to the wording regarding who may sell and buy the products but no changes have been made to the wording regarding who may use the products.

The wording that will now appear on the ACVM website and on all certificates of registration for veterinary medicines approved with the PAR Class I condition is:

Class I Prescription Animal Remedy The product must be sold only by an approved trader.

The product must be sold only to an approved trader, or to any person with a veterinary prescription or authorisation.

The product must be administered to an animal only by a veterinarian, or under and in accordance with the authority or prescription of a veterinarian.

The wording that will now appear on the ACVM website and on all certificates of registration for veterinary medicines approved with the PAR Class III condition is:

Class III Prescription Animal Remedy The product must be sold only by an approved trader.

The product must be sold only to an approved trader.

The product must be administered to an animal only by a veterinarian.

The ACVM Group is finding that for some groups of veterinary medicines it has become difficult to match the current structure of the PAR conditions with the controls necessary to achieve the management of risks as required under the ACVM Act. In consequence, the suitability of the current PAR class conditions is under review.

Importation of Materials of Animal Origin

The ACVM Group is requesting its inspectors to carry out specific checks of documentation concerning any materials or ingredients of veterinary medicines that have been imported and that are derived from ruminant animals. This is to confirm that no such materials or by-products have originated from countries that are known to have been exposed to BSE. It will mean that inspectors will pay special attention to raw materials of animal origin and will require to see a current MAF Biosecurity Permit for Importation in respect of every importation made. These checks will form part of all future regular GMP inspections.