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AgVetLink: Number 51, August 2005

‘Breaking down’ registered products

Two of the considerations in the assessment and registration of an agricultural compound or veterinary medicine trade name product are the container or packaging in which the product will be offered for sale and the labelling of the product. Breaching the original container/packaging and removing a portion could result in significant changes in the product. It could also separate that portion from the information that must be provided with the product. Consequently, both the container/package and label are tools used to manage risks and are integral components of the ACVM approval for the product.

To avoid confusion about the possible terms such as decanting, separating, dispensing etc. that could be used to describe breaching a container and removing a portion, the ACVM Group will use the general term ‘breaking down’ regardless of the physical state or formulation type.

This policy relates to breaking down product into volumes or quantities that are different from those specified in the ACVM approval for the product and for which the container or packaging approved for general sale is breached. It does not refer to breaking down shipments or palettes of products when the integrity of packages approved for general sale is not breached.

While there may be circumstances in which breaking down of products may be appropriate, doing so may nullify the relevance of the registration approval.

The following are the rules of acceptable practice governing the breaking down of registered agricultural compound and veterinary medicine trade name products.

Operational policy

General

It is a breach of the ACVM Act (section 8) to offer for sale any product that is not registered or exempt from registration. Breaking down proprietary products alters characteristics of a registered product and, consequently, may nullify the relevance of the registration.

Acceptable practices after purchase

Once the purchaser of a registered trade name product takes possession of the product the purchaser is responsible for the appropriate care and use of that product, including any subsequent breaking down of the product. Breaking down the product by the owner of the product in any manner is not an offence under the ACVM Act as long as the result is not offered for sale.  If a product is purchased by a group of persons, each person in the group is considered by the ACVM Group to be an owner of the product and they can manage the care and use of that product as they see fit. (NOTE: The activities of the person or group may be subject to requirements under other legislation such as the HSNO Act.)

Agricultural contractors (including chemical application contractors or dipping/tailing/shearing contractors, farm management services, pest control contractors etc.) may break down registered trade name products in the course of providing their services. This should be done in a manner that is consistent with Standards New Zealand Standard P8409 Management of Agri-chemicals. Contractors must not sell broken down quantities of trade name products separately from their services (i.e. sell portions of the products they are using to any other person, including the person who contracted them). These rules apply in a contractor/sub-contractor arrangement as well as in the supply of pest control services.

Acceptable sales practices

Where breaking down of a product and subsequent sale was anticipated and provided for in the registration of a product, such activities must be carried out in accordance with the approved instructions for them. The registration will specify what the minimum requirements are for the product.

If breaking down was not provided for in the registration, then those activities must not be carried out and the results offered for sale. Traders in registered products should stock products in appropriate container/packaging sizes to meet their customers’ needs. Traders should recommend appropriate alternatives if certain products are not marketed in convenient sizes. Product must not be broken down and offered for sale if those activities were not provided for in the registration.

Approved traders in prescription animal remedy veterinary medicines must always follow the instructions of the prescribing veterinarian exactly. If some aspect is uncertain or might require variation from those instructions, this must be discussed with and endorsed by the prescribing veterinarian.

A veterinarian who determines that, for the welfare of the animals concerned, a specific quantity (less than the total quantity in an approved package size) of a registered veterinary medicine is required, that veterinarian may break down a registered trade name product and sell/supply the required amount.

If this is done, the veterinarian must take full responsibility for the appropriate repackaging and relabelling of the product dispensed to ensure that:

•         the quality or the product is not jeopardised;

•         the container packaging is safe and appropriate;

•         sufficient information is provided to allow the product to be used according to the veterinarian’s instructions; and

•         the veterinarian and/or veterinary practice and contact information are included.

Veterinarians must not offer altered product (including repackaged/relabelled product) for general sale.