- PDF Version (138K) - Print Friendly - Help

AgVetLink: Number 52, October 2005

New application type

Under the ACVM Act and Regulations only products that are registered or exempt from the requirement for registration may be imported for general sale and use. A registered trade name product (TNP) may be imported or sold only if its conditions of registration are met. One of those conditions is that it must be sold with the label text as included in the current approval.

It is recognised, however, that in certain situations (see 3 below) it will not be possible for a registered TNP to be sold in New Zealand with the approved label text. In consequence, it has been necessary to implement a system that will allow the importation and sale of incorrectly labelled product if certain specific criteria can be met. Approval will be issued via this mechanism only if the following criteria are fulfilled.

1. The registrant of the registered TNP must make the request and be in a position to maintain control of product from the time of importation until the time of sale to the prescribing veterinarian or end user (i.e. product must not be made available to third party wholesalers or intended for retail shelves).

2. Product requested for importation must be identical to a product currently registered in New Zealand in all respects other than the label.

3. One of the following two circumstances resulting in correctly labelled product being unavailable to the New Zealand market must apply. Either:

a. it is the result of unforeseen circumstances (e.g. demand outstripping ability to supply) and where there will be significant issues for animals or users if the product is not supplied; or

b. it is the result of limited product sales where it is not viable to maintain New Zealand labelled stock on-hand and where otherwise the registered TNP would be withdrawn from the market This is considered to be predictable product unavailability.

4. Where 3b applies, approval will be granted only for supply to specified individuals where imminent need for product can be satisfactorily established.

Approvals that are issued under this system will be referred to as ‘Temporary Approvals’ and will be for a specified quantity of product and time period.

The conditions as specified in the product’s current approval continue to apply to product imported under the temporary approval with the exception of the requirement that it must be labelled as per the label content specified in the current approval.

All temporary approvals will be subject to conditions that will vary according to the proposed risk management systems. A common condition will be that product imported under this system will not be able to be specifically offered for sale and can be supplied only upon request as a substitute.

The application form (which includes further information regarding the information that must be supplied) is located on the Import Approvals section of the website. A fee of $123.75 per application applies.