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Registration for limited periods for further data collection

A number of applications to use vaccines in farm animals have been made using the ‘Application For Approval To Import Animal Remedies Or Pesticides For Special Use’ mechanism. The use of an unregistered product in food animals for domestic consumption, or for export, creates a very real problem for the verification of New Zealand’s primary produce. This is not an option that can be considered because of the risks it poses to trade in particular, and to the whole philosophy of the need for registration to manage identified risks.

The intent of the ‘special use’ import approval mechanism is to provide a mechanism for people to import products for the following purposes:

• repacking/relabelling of a licensed/ registered product;
• importation under a provisional licence or experimental use permit;
• re-export;
• analysis only;
• other research;
• use in quarantine;
• veterinary discretionary use.

In each of these cases use of product is very limited, risks can be managed adequately by means other than registration, and the treated animals do not enter the food chain. It was never the intention that the mechanism be used as an alternative to registration.

However, there are occasions in which products that have no New Zealand equivalent need to be used on a larger scale then the special use mechanism was designed to manage. It is considered that these products would have to be registered before they could be used to combat a disease problem because registering the product ensures proper product stewardship. Ongoing assessment of the risks associated with the use of the product in food producing animals is also covered.

While registration is possible, there is usually limited data available concerning the specific New Zealand details of the disease to be treated (e.g. farming practices, bacterial strains etc.).

One possible solution is to provide for a registration with strict conditions, including in this instance registration for a limited period of time, and with a limited quantity to enable the collection of data while still limiting the risk to the appropriate level. Registration would be reviewed and the conditions relaxed to reflect the additional data if available.

Alternately, if there are products registered in the interim with more robust and complete data, the registration of the original product would lapse unless the equivalent data were supplied to support the continuation of registration.

Therefore it is proposed that registration can be issued based on the following:

1. The disease being treated must be charcterised by severe pain or distress using the welfare thresholds, as outlined in the Guidelines For Risk Assessment And Hazard Analysis Under The Agricultural Compounds And Veterinary Medicines Act 1997 section 5.2.
2. No alternative therapy and or/ preventative treatment exists that adequately manages the risks to welfare.
3. The registration will be issued for a specific and restricted period.
4. During the period of registration data for full and permanent registration must be sought.
5. There must be a full data package (minus the New Zealand specific information) available for the product to allow registration.
6. The product will be supplied only to veterinarians as a PAR.
7. Data collected must be supplied to the ACVM Group prior to the review of the registration.
8. The registration will be issued on the condition that if another similar product with more robust and complete data becomes available, then the registration will be reviewed.
9. The licensed remedy could not be advertised or promoted in any way until the data deficiencies were addressed.

Code of practice condition in schedule 1

Schedule 1 of the Agricultural Compounds and Veterinary Medicines Regulations 2001 lists groups of agricultural compounds that are exempt from the requirement to be registered. Even though they do not have to be registered, trade name products that fit the definition of any of these groups must comply  with an applicable code of practice, i.e. one that relates to that group of agricultural compounds and that has been approved under section 28 of the Agricultural Compounds and Veterinary Medicines Act 1997.

At this stage there are no codes of  practice approved. Consequently, there are no codes that require compliance. In effect, until there is a relevant code, these trade name products do not have to be registered and do not have to comply with any particular condition.

The ACVM Group is aware of development of only one code of practice that would affect any agricultural compounds in schedule 1. If the code is ever approved it may place limitations on fertilisers and fertiliser additives that are raw or composted biological wastes if they are used on agricultural land.