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AgVetLink July 2003 - Special Issue for Registrants

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‘Slice of life’ audits and positive compliance checking

The NZFSA Compliance and Investigation Group (CIG) is undertaking a series of ‘slice of life’ audits to check the effectiveness of the ACVM regulatory process.

These are undertaken at no direct cost to the people and organisations being audited – costs are recovered from the compliance component of the product registration fee, or from the compliance part of the annual fee.

Information from the audits will be used to estimate the required frequency of future verification checks, as well as to adjust the level of regulatory intervention. In some cases we may be able to reduce controls; in others we may have to increase them or look for more effective mechanisms.

If there is evidence of non-compliance discovered during an audit, in most cases the ACVM Group will work to educate the parties involved on responsibilities under the ACVM Act. However, serious non-compliances will always trigger investigation activity. One component of the education process will require the parties concerned to participate in a positive compliance programme.

The ACVM Group is developing the programme covering proactive audits where non-compliances have been identified in the ‘slice of life’ audits, investigations or via other means. It is envisaged that there will be a programme of three or four audits within a two year period to ensure that the organisation is in compliance with the ACVM Act (via the appropriate standards or codes of practice), with a longer time period where there are identified failures.

Positive compliance audits are cost recovered from the organisations being audited. The ACVM hourly rate of $121.50 per hour (inclusive of GST) plus any disbursements such as travel will apply.

 

Prohibition notices

The Compliance and Investigation Group (CIG) and the ACVM Group have issued a number of prohibition notices recently for contravention of the ACVM Act and Regulations.

A prohibition notice, which is a written notice issued by an inspector, means that the affected product may not be manufactured, sold or used until the identified contravention of the ACVM Act is rectified to the satisfaction of the inspector. A prohibition notice may be issued to any person manufacturing, selling or using a product – not just the registrant.

Other powers of inspectors under the ACVM Act provide for information gathering and sampling of products for the purpose of determining compliance with the Act and Regulations. In many cases, this will mean that the affected product is recalled and returned to the supplier at their cost. It is an offence to contravene a prohibition notice or to permit a contravention of a notice.

Prohibition notices are not issued for importation because every product must be cleared for entry by an inspector and any products of concern are notified to the MAF Quarantine Services staff at the border where they are held or returned to the supplier.

Notices can be varied or withdrawn, and there is an opportunity to appeal a notice within 14 days of issue to the District Court on the grounds that it is unreasonable.

 

Labels on the ACVM website

All products that are updated to ACVM Act registrations now have the approved label (or the approved label content) posted on the ACVM website in the list of registered products.

Registrants are reminded that where there is a valid reason, such as an imminent product launch, they can negotiate with the ACVM Group to delay the posting of the label information.

It is also important that you check the information and advise us as soon as possible if there are any problems.