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AgVetLink: Number 55, April 2006

Updating Labels for HSNO Requirements

The ACVM Group requires electronic copies and hard copies of a company’s marketed label(s), inclusive of all the HSNO controls.

When a company has updated its label for HSNO requirements but has made no changes to the ACVM risk areas of the label, we have been accepting and returning a stamped, signed copy of the label at no charge. It is important to note that the ACVM Group is not approving the label in this instance. Therefore, registrants may use the HSNO updated label without first submitting it to the ACVM Group for acceptance.

However, if a registrant makes any label changes relating to our risk areas, he/she must submit the appropriate application to us and gain approval before placing a product into the marketplace.

We are reminding registrants of the above because we understand they are required to have HSNO-compliant labels for new stock (not stock in trade) entering the marketplace by 1 July 2006. It is also our understanding that stock in trade that is not HSNO-compliant at 1 July 2006 will be allowed to be used until 1 July 2007. If you are unsure of your obligations in this area, it is recommended you contact ERMA New Zealand.

The ACVM Group anticipates that it will receive a significant number of HSNO- compliant labels in the lead up (particularly in June 2006) to the 1 July 2006 deadline. This will have an impact on resources within the Group. Therefore, there are likely to be delays in returning stamped, signed copies of the label to registrants. This should have no impact on labelling new stock with HSNO controls, although if the ACVM Group identifies labels of stock in trade with unapproved changes to our risk areas, then compliance action may ensue.