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AgVetLink December 2003 - Special Issue for Registrants

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Questions and concerns about updating

What is the deadline?

All registered products must be updated to ACVM Act conditions by 1 July 2004.

What information is needed for an update application?

• a covering letter
• a Registration and Product Datasheet
• three copies of the revised draft label content.

There is more detail on the information required on page 3.

What does an application to update cost?

A simple update is done at no charge providing that it is received prior to 1 July 2004. Applications after that date will be charged on the basis of the time taken. Where the update shows a need for a variation of the registered product, normal costs will be incurred for the type of application.

What are the common concerns from registrants and how are they being addressed?

HSNO Act label requirements for the products have not been finalised yet. The update is for ACVM Act requirements only at this stage. Registrants need to put in an ACVM application prior to 1 July 2004, but there is no need to finalise labels for a period of up to two years. Products with old labels will be able to remain in the market place in most cases.

In the interim ERMA New Zealand has advised that proposed changes to the HSNO Act mean that it is unlikely that there will be tracking requirements for Class 9 substances, and that it is also unlikely that it will be a requirement to show EELs or TELs on the label.

Agcarm has developed a labelling guide for registrants to translate the HSNO and ACVM Act requirements into label statements for registrants. This guide is available free of charge on their website (www.agcarm.co.nz) or via a link from the labelling parts of the ACVM website.

We don’t know if the product will attract ‘approved handler’ status under the HSNO Act.
ERMA New Zealand has advised that they expect this to be clarified early in 2004.

It is expensive to get label proofs or final labels for the ACVM Group updates.
The ACVM Group does not require final labels. Updates will be approved on the basis of proposed label content or draft labels for ACVM Act purposes only.

Once HSNO requirements are finalised and final labels are confirmed, the ACVM Group will update the information held on the website free of charge. Charges for making label changes will be incurred only where there is also a change to the registration or registration conditions of the product.

What happens to stock-in-trade for products with old labels?
The ACVM Group works on the basic premise that in the vast majority of cases, the best way for ‘old label’ product to be disposed of is for it to be worked through the system and used as originally intended. For products in the control of the registrant, there will be a period of up to two years for product labels to be updated. ERMA New Zealand is considering adopting a similar policy (refer to the article on labels on page 3).

What will happen with products that are not updated on time?
The ACVM Group has an increased interest in compliance under the ACVM Act, and any products not updated by 1 July 2004 will be in breach of the conditions of registration. This means that it will be illegal to import, manufacture, sell or use the products until they are compliant. We have developed a compliance process for any non-compliant products that is outlined in detail on pages 4-5.

Update applications received prior to 1 July 2004 will be processed free of charge, whereas any received after 1 July 2004 will attract charges based on the time taken to process them. In addition, there will be prohibition notices and restrictions placed on non-compliant products to prevent importation manufacture, sale or use until they are registered.

How is the ACVM Group going to manage the flood of applications?
The ACVM Group has already taken on additional part-time staff to assist with update applications, and we have plans in place to take on more as the workload increases. As a general rule, products that come in early will be given the full three year registration. Products that come a little later will be given a shorter registration period from under one year to up to three years, depending on the time that they come into the system. This means that we will be able to process the applications quickly in the knowledge that they will be revisited within the three year timeframe.

Who is the ACVM Group talking to about the process?
In addition to providing this special edition AgVetLink for registrants, we plan to communicate with the key user groups (Federated Farmers, VegFed, veterinarians etc.) on the processes described in this issue of AgVetLink. This will mainly be through a range of articles in trade journals and the like.

Information on non-compliant products will be provided on the website so that users can easily ascertain if the products they are intending to use are legal.

We will also advise various parties of their responsibilities under the ACVM Act, and the ramifications for users in relation to non-compliant products.