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AgVetLink December 2003 - Special Issue for Registrants

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Compliance process:
For registered products NOT updated to the ACVM Act by 1 July 2004

All registrants of animal remedies and pesticide products must update their products to the Agricultural Compounds and Veterinary Medicines Act 1997 by 1 July 2004 or the registrations will lapse.

This means that under the ACVM Act, PRODUCTS WILL NOT BE ABLE TO BE IMPORTED, MANU-FACTURED, SOLD OR USED.

They must be updated in order to remain legally existing. Because the timeframe is set by Regulation, there is no opportunity for extension to the date of 1 July 2004 – registrants must have an application in the system.

Compliance process

This process covers the implications should a registrant not update their product(s) by the date of 1 July 2004.

The ACVM Group will undertake the following procedure:

• Registrants will be advised in the near future of the products that they have registered that have yet to be updated. The ACVM Group will keep a running check on the progress of updates received into the system.
• An initial report will be run of all products to identify those that have not been updated by 1 July 2004, i.e. applications will be date stamped and must be accepted into the ACVM system by the end of business on 1 July 2004.
• Fees will be charged for any requests for updates received after 1 July 2004 on the ‘time and materials’ basis allowed for in the ACVM Fees Regulations.
• It is expected that prohibition notices (under section 65 of the ACVM Act) will be issued to importers and manufacturers for any products without an application for an update. These will remain in force until the product is approved as registered under the ACVM Act.
• The ACVM Group will maintain a list of products that have not been updated on the website.
• Where applications for updating have not been received by 1 August 2004, the prohibition notices will be extended to cover any stocks of product that have been sold to third parties that can be identified by searches of registrant records. The notice will prevent sale, but will allow return of stocks to the registrant. In this instance the ACVM Group will also contact the main user groups of affected products to advise that the products concerned are not able to be legally used until they are registered.
• Reports of products not updated will also be held by MAF Quarantine Service (MQS) at the border because the importation of unregistered products is illegal under the ACVM Act. Clearance will not be given to any products that have not been updated until the product is approved under the ACVM Act. Products will either be held at the cost of the importer or reshipped.

Prohibition notices

It is expected that there will be a considerable influx of applications for update of products close to 1 July 2004 and that there will be a backlog of applications. Products where there have been prohibition notices issued will not get any preferential treatment and applications will be considered in the order that they are received, with the notice remaining in force until the registration is approved.

Prohibition notices are issued in line with sections 6 and 8 of the ACVM Act. Notices issued under section 65 to registrants who have not ‘updated’ products will prohibit any party from manufacturing, selling and using agricultural compounds in contravention of the Act. This process will cover all registrants and the New Zealand manufacturers of trade name products (where they may not be the registrant). Prohibition notices will be lifted only once registrants have completed the update process including payment of the appropriate fee. Notices may be varied:

• where there may be several products under the prohibition notice and one is approved, or
• where no application is received and further compliance action is to be taken.

Appeals

Any person who is affected by a prohibition notice may appeal within 14 days to the District Court on the grounds that it is unreasonable. The Court can then vary, rescind or confirm the notice but an appeal does not operate as a stay of the notice or as a variation to the notice.

Active compliance

It is also expected that non-compliant registrants will be placed on an active compliance list and may be visited unannounced by an inspector to ensure future compliance with the ACVM Act.