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The Agricultural Compounds and Veterinary Medicines (Transitional Provisions) 2002 came into force on 1 July 2002. This has altered the status of virtually all animal remedy and pesticide products that fit the definition of an agricultural compound. If you have any queries, the following should clarify the situation.

On 1 July 2002 virtually all animal remedy products were deemed not to be licensed under the Animal Remedies Act 1967. At the same time they were deemed to be registered under the Agricultural Compounds and Veterinary Medicines Act 1997 with an expiry date of 1 July 2004.

Therefore, animal remedy products are now registered under the ACVM Act but the registrations must be updated before 1 July 2004 or they will expire. In the meantime the products can be imported, manufactured, sold and used under the same conditions that applied to their animal remedy licence, using the existing approved label.

To update a registration, you apply for a variation in the registration of the product. With the application you must provide a currently correct product data sheet and the content of the label you intend to use on the product. The ACVM Group will process the application and provide you with a revised certificate of registration with an updated list of conditions, and a signed and stamped copy of the approved product data sheet and label content. The certificate, product data sheet and label content together constitute your updated registration. Once a registration is updated, the 1 July 2004 expiry date no longer applies.

You must update your registration before 1 July 2004. You can apply for a variation to update the registration at any time. However, the purpose of deeming the licences to be registrations under the same conditions was to avoid multiple changes in labels. The ACVM Group recommends that you delay any request to update a registration for at least 12 months so that you might be able to make one label change that meets both the HSNO and ACVM Act requirements.

If you have lodged a product data sheet with the ACVM Group you can refer to it and confirm that all the information in it is still current rather than submit a new product data sheet. In all cases there will be changes in the label content, even if it is only to change the reference from the Animal Remedies Act to the ACVM Act. It is anticipated that the new conditions will prompt label changes as well, so reference to the existing label will probably be inappropriate.

From now on the ACVM Group would prefer to handle any request for a variation as a request to update a registration. However, you may have a specific need to make some changes without prompting a registration update. Applications for variations of registration without updating the registration will be dealt with on a case by case basis after discussion with the applicant.

Provisional licences and research approvals are not affected by the Regulations, nor are the very few animal remedy licences that have a specified expiry date earlier than 1 July 2004. Those licences and approvals continue without change. The expiry date for provisional licences will not be extended beyond 1 July 2004. Any licences will have to be dealt with as provisional registrations under the ACVM Act.

There are relatively few products that have been issued an ACVM registration. These registrations are not affected by the Regulations and the 1 July 2004 expiry date does not apply. These registrations are considered to be updated already, so no action needs to be taken.

As from 1 July 2002, the ACVM Fees Regulations 2002 came into force. This means a change in fees and charges. See the article on page 4 for a detailed explanation.

The Regulations have no effect on the status of products in regard to

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