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AgVetLink April 2003

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Draft policy on PAR products

The 49 submissions received on the draft operational policy on PAR products covered a broad range of views. A high number of the submissions were from veterinarians or organisations representing veterinarians; there were also submissions from user significant groups (such as Federated Farmers, Fonterra, and a combined submission from the Feed Manufacturers Association and the Poultry Industry Association) and from registrant companies. A summary of the submissions is available on the website.

There have been suggestions made that some of the assumptions used by the ACVM Group in developing the draft policy are incorrect. The NZFSA Compliance and Investigation Group is in the process right now of undertaking 'slice of life' audits covering a number of issues related to PAR products. We will take the opportunity to follow up on these suggestions to make sure that any assumptions used are supported in practice.

It appears that there are a number of areas of confusion where more communication is required. This confusion covers such points as:

• Why a PAR policy needs to be developed at all - unlike the Animal Remedies Act, the ACVM Act does not have any provision for assigning PAR status to products or providing for veterinary discretionary use. This is done by putting conditions of registration on products or via the use of codes of practice.
• The proposed code of practice for traders - there was a high level of concern over users being able to set up as traders, the lack of training, the controls, and how the system might work. These comments are all being considered carefully.
• How the 'cascading' system might work in relation to veterinary discretionary use of products - there were suggestions that this might force veterinarians to use inappropriate treatments just because they are registered. This is not the intended outcome so clarification will be provided.

There were also significant concerns expressed over how the proposal could damage animal welfare and biosecurity over time. Other submitters expressed concerns over the trade impacts of the implementation of the proposed policy. The ACVM Group and the NZFSA Policy team are working on how to address concerns and will contact a range of the stakeholders to work through adjustments to the policy.

Ongoing obligations of registrants

A new registration condition has been implemented to give effect to the ongoing obligations of the registrant of a trade name product. Registrants must advise the ACVM Group of any new studies on their product and of any data that contradict previous information supplied to the ACVM Group or that indicate unintended harmful effects from using their product (adverse events).

A summary of adverse events for the past year should be provided at the same time the annual fees are paid. Adverse events or any additional studies or data that have serious implications for the continued use of the product must be notified immediately. These obligations are described in more detail in the ACVM Registration Information Requirements for Plant Compounds and ACVM Registration Information Requirements for Veterinary Medicines.

Withdrawal of the low risk registration option

The low risk registration standard was introduced under the Animal Remedies and Pesticides Acts to provide a simple registration process for products where it was recognised that limited information was required. It primarily provided for products that were being considered for exemption from registration under the ACVM Act.

Since the implementation of the ACVM Act, the low risk registrations have consisted mainly of oral nutritional compounds that have not met the requirements for exemption because of the inclusion of feed additives not listed in the GRAS list in the regulations.

The ACVM Group plans to remove the option of low risk registration and replace it with guidelines for registration of product types where limited data is required. This is intended to provide an easy to follow process for putting together an application while preserving the advantages of the low risk system.

Until guidelines are available for the types of products currently being submitted as low risk, the registration requirements will remain on the website for guidance in submitting applications.

In the interim, the disclaimer that was previously required on labels is no longer being applied.