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AgVetLink April 2005 

Modification of conditions of registration

In most cases conditions of registration are modified in response to an application to vary an existing registration. However, there are times when the need to change conditions of registration (usually for a group of products) is initiated by the ACVM Group because of some new information that requires a reassessment.

The ACVM Act provides for reassessments under section 29 if:

• significant new information on a matter related to the use of a registered trade name product has become available; or

• there has been a significant change in the use of any or all of the registered trade name products.

New information includes, but is not limited to, information not previously considered during an assessment of the registered trade name product and the information indicates that the conditions placed on the registration do not adequately manage the risks associated with the product. For example, it has become apparent during the review of prudent use of antibiotics that advertising prescription antibiotics directly to end-users diminishes the effectiveness of the prescription condition. Consequently, the ACVM Group has reassessed the registrations of all such products and intends to impose a prohibition on advertising them directly to end-users. 

From time to time the ACVM Group will carry out reassessments and, consequently, change conditions of registration. The Group’s policy Modification of Conditions of Registration, 174 ACVM 02/05 governs the way this is done and puts it into the context of a reassessment under sections 29-33 of the ACVM Act.