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AgVetLink: Number 52, October 2005

Notification of changes not yet on label

The majority of products licensed under the Animal Remedies and Pesticides Acts have now been updated to comply with the requirements of the ACVM Act. In some cases, the update review process has resulted in changes to important user information and conditions of registration such as applicable withholding periods, use patterns and prescription animal remedy (PAR) status.

The ACVM Group has endeavoured to be as flexible as possible during the transition phase with respect to the timing of label changes in order to accommodate large ‘old’ label reserves and the ERMA process, and many registrants have been granted grace periods before the currently approved label needs to be used.

Users not informed

It has come to our attention, however, that in some cases where important changes have been made to the registration of products, registrants with old labels in the marketplace have not informed users of these changes. This leads to user confusion between what is currently approved by the ACVM Group and what is perceived to be approved as a result of label content. Even where current labels are being used, intelligence from the marketplace suggests that unless changes are specifically brought to the attention of the user there remains a reasonable risk that the changes will remain unnoticed for some time. Although the ACVM register is updated at regular intervals, it is useful only where users actively seek the information.

In consequence, where changes have been made to the conditions of registration or label statements that impact on product users and where old labels will remain in the marketplace, registrants should notify all product purchasers or users of the relevant changes either via product representatives or at the point of sale. It would be advantageous to all parties involved if this activity were undertaken for all products where changes have occurred even if new labels are in use.