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AgVetLink October 2003

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ACVM Group compliance activities

In recent months a number of complaints have been investigated in relation to non-compliant products or activities.

FIELDAYS

The ACVM Group’s attendance at the Hamilton Fieldays in June 2003, with representatives from the Compliance and Investigation Group (CIG) of NZFSA, was a success from a compliance and education of exhibitors perspective.

This year the ACVM Group took a different approach in that we visited organisations with stands rather than spending the majority of the time on the NZFSA stand. Actions taken by the ACVM Group were placed into four categories:

• compliance issues – educational
• compliance issues – repeat offenders
• miscellaneous incidents – non-compliance
• prohibition notices served.

Educational

In this category, some of the companies were unknown to the ACVM Group, and were generally spoken to in regards to therapeutic claims made on their veterinary medicine products. Product types consisted of either oral nutritional or oral herbal compounds.

Non-compliant information on products was either noted on labels or in leaflets provided on their exhibition stands.

Companies were advised of their responsibilities under the ACVM Act.

Repeat offenders

Three companies were approached in regard to continuing to advertise and sell products that the ACVM Group had informed them already were non-compliant.

Each of the companies was making claims on products that categorised them as veterinary medicines requiring registration. As a result of these activities a prohibition notice was served on one of the companies.

Miscellaneous incidents/non-compliance (vendors not spoken to at the time)

Over the four day period of the Fieldays, the ACVM Group picked up various product pamphlets that were then reviewed and classified by way of a class determination once we had returned to the office.

Most of the non-compliances in this area were for non-approved claims, not on the labels as such but in pamphlets and / or advertising material. Companies have been contacted regarding their responsibilities under the ACVM Act.

Prohibition notices

Three further companies were issued prohibition notices with a requirement for product to be removed from the shelves at the Fieldays. This action was taken only where there had been a prior dialogue with the ACVM Group and the company concerned.

As a result of collecting a pamphlet obtained at the Fieldays, and a follow up investigation, a further prohibition notice was placed on one company for advertising a product where claims were not approved.

These prohibition notices prohibit the manufacturing, selling, or using any agricultural compound in contravention of any provision of the ACVM Act and Regulations.

‘SLICE OF LIFE’ AUDITS

As per our August AgvetLink article, the ACVM Group has agreed a programme outline with the CIG for the current year for ‘slice of life’ audits. These audits are additional to any investigative work carried out by CIG.

In mid-June the first part of an audit of Border activities was carried out at MAF Quarantine Service in Auckland, covering Air Cargo, the International Mail Centre and the Airport Terminal. It covered the importation of both veterinary medicines and plant compound products. In mid-July the audit covered the airport in Christchurch. ACVM staff were present at both Borders and have given technical advice where needed on clearance of ACVM products. We are currently waiting for a legal opinion on Biosecurity/ACVM Act interface issues before recommendations are finalised and the report is drafted. In the interim, we can advise that the outcomes of both visits were, in general, favourable.

A further ‘slice of life’ audit will commence soon in regards to the use of human medicines by veterinarians. The terms of reference have been drafted and agreed for this review.

Harmonisation with Australia

During a recent visit to Australia the ACVM Group again raised the issue of the opportunity to harmonise with Australia on assessments of products for companion animals (cats, dogs, aviary birds, aquaria fish, reptiles, etc. but excluding horses) and possibly even to harmonise labels. One of the key industry associations in Australia is very interested and will progress matters with the Australian APVMA. New Zealand organisations that we have spoken to so far are also supportive of the initiative. This activity fits within the mandate of the ANZ registration liaison committee that is already in place to facilitate harmonisation initiatives.