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Information requirement for transfer

The transfer of licences or registra-tions of specific trade name products (TNPs) will commence on receipt of a transfer request. The information required to process a transfer consists of a product data sheet and either:

• the content of the label, including the script and any graphic material that expresses or implies a use, claim or instruction for use (or the actual label);
• a material safety data sheet for the formulated product, if available; and
• a signed declaration that the product being transferred is the same as the product that is licensed or registered.

Labels

Note that label means any written, pictorial, or other descriptive matter under which the compound is sold or to be sold that purports to give some information about theTNP.

As stated on a number of occasions, the ACVM Group will not be approv-ing labels per se. However, it will examine label content or labels to confirm that the product is being marketed in accordance with the approved product specifications and the conditions of registration. The ACVM Group will accept reference to the label content provided for any product data sheet information that is detailed on the label.

Product data sheet

The product data sheet must contain:

• trade name
• existing registration number
• details of the registrant (and New Zealand agent if applicable)
• details of approved manufacture(s)
• formulation type
• uses and instructions
• warnings or contraindications
• withholding period
• ingredients and concentrations
• shelf life
• packaging specifications
• labelling specifications.

All ingredients and their proportion, and instructions for use must be included, so that the ACVM Group can confirm that:

• the product is the same product as the one that is licensed/registered; and
• the licence/registration can be updated without reviewing any data.

Hazardous substances

The ACVM Group is working with ERMA NZ to ensure that, wherever possible, the product data sheet required by the ACVM Group con-tains the same information that could be used to determine if the product is hazardous or not. The information required by ERMA NZ to determine the actual hazard classification will be a matter that must be discussed between the licensee/registrant and ERMA NZ. The ACVM group is interested only in whether the trade name product does or does not require an approval from ERMA.

Confidentiality

The full product data sheet will be confidential, but a version will be extracted from what is provided and made public as part of the public register entry for the product. The ACVM Group considers that the only commercially sensitive information that it requires on the product data sheet is the list of ingredients and their proportions. It considers that the public register should list the ingredients with biological activity, but the other ingredients can and will remain confidential.

Material discrepancies

The ACVM Group is anticipating circumstances in which, for one reason or another, the product being trans-ferred is not exactly the same as the one licensed/registered. The informa-tion provided should specify what the product is at the time it is being transferred. Any material discrepan-cies between the product specifica-tions in the existing licence/registra-tion and the information provided will be discussed with the licensee/ registrant. The ACVM Group may decide that the discrepancies are insignificant and will issue the updated registration. However, it reserves the right to require re-licensing or re-registration before the transfer if the discrepancies suggest that the transfer cannot be carried out safely.

The information should be provided in hard copy with an electronic version of any text. The ACVM Group has developed specifications for how the electronic information should be provided. These will be provided to all licensee/registrants, but can be found on the ACVM Group website ( www.maf.govt.nz/acvm/ ).

FREQUENTLY ASKED QUESTIONS

The ACVM Group has prepared answers to frequently asked questions such as:

• When will animal remedy and pesticide products get transferred to the ACVM registrations?
• What will happen with products under a provisional registration or an experimental use permit?
• What happens with annual fees under the Animal Remedies and Pesticides Act when licences and registrations are transferred?

These can be found on the Group’s website ( www.maf.govt.nz/acvm/ ).
The Group will add questions and answers over the next few months, so you may want to check the site regularly for updates.