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AgVetLink August 2004: Page 6

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COMPLIANCE

Transition to ACVM registrations

The ACVM (Transitional Provisions) Regulations 2002 provided that all products covered by the registration provision of the ACVM Act needed to be updated by 1 July 2004. On this date, the ACVM Group still had not received applications to update products for 70 registrants (92 veterinary medicines and 49 plant compounds). These registrants were sent a letter on 19 July advising them that their product registrations were cancelled. Their products are now illegal and prohibited from further import or manufacture. Product already in the distribution chain could be depleted, but no further product could leave storage or warehouse premises under the registrant’s control.

A list of unregistered products and their registrants has been given to MAF Quarantine Services for detainment at the border. The list has also been placed on the ACVM website.

Exempt products/GRAS applications

However, some of these products may be exempt from registration under the ACVM Regulations. A Class Determination is needed to confirm exemption status, and registrants were told in the letter that they had seven working days to request a Class Determination for their product(s). An official Class Determination would be required for any imported product to facilitate border clearance.

If a registrant has had a product cancelled (through non-update) but it is likely to be exempt once an application for inclusion on the GRAS list is approved, the ACVM Group is unlikely to take compliance action provided the application for GRAS inclusion has been made.

New application

To reinstate cancelled products, an application for registration that includes relevant data packages must be made. If necessary, a HSNO approval may be required. It is possible to cross reference information held on file for recently cancelled products.

 

Fieldays

ACVM Group staff members attended the Hamilton Fieldays in June and visited many exhibitors to:

• assess the marketplace in veterinary medicines and plant compounds;

• confirm compliance of approved products with the conditions of their approval;

• provide education to people marketing agricultural compounds who were unfamiliar with their obligations under the Agricultural Compounds and Veterinary Medicines Act 1997.

As in previous years, some non-compliant products were identified at the Fieldays and the Group will take action as needed to rectify the situation.

 

Vet Quick Search Area on ACVM website

In response to feedback received during the recent ACVM workshops for veterinarians, a new section specific to veterinarians has been added to the ACVM website homepage. The new section gathers together all documents likely to be of interest to veterinarians, including residue and withholding period information, presentations, publications, and current issues.

The ACVM Group also intends to include information pertaining to changes in registered product current approvals (e.g. new claims, altered WHPs) and new products in this section. The format is yet to be decided.

 

Update

Compliance activity during the past few weeks has involved relatively minor issues split evenly between veterinary medicines and plant compounds. Most of the dozen or so concerns involve label claims.

At present, the ACVM Group is planning compliance programmes for the upcoming year. The Group anticipates a large commitment to compliance activity will be required when the new PAR trader system is operational.

Decisions are also being made on the ‘slice of life’ programme for the next 12 months.