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AgVetLink June 2003

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Prohibition notices

The ACVM Group advises that we have recently issued prohibition notices in regards to the suspected illegal importation of product.

Under section 65 of the ACVM Act 1997, inspectors or authorised persons may give written prohibition notices for non-compliance with the requirements of the Act and Regulations. These notices advise the recipient of the actions required to rectify concerns to the satisfaction of the inspector or authorised person. Such notices may include a requirement for the recipient to recall all product from the market, and to cease all manufacturing and sale. The powers granted to inspectors under the Act include being able to obtain information about who distributors are, who sales have been made to, the batch numbers of products etc.

Prohibition notices are usually served by NZFSA Compliance and Investigation Group staff, but ACVM Group staff are also warranted to exercise the powers set out in sections 64 to 67 of the ACVM Act 1997. As previously advised in AgVetLink, ACVM technical assessors and advisors have been appointed as inspectors under the ACVM Act.

Compliance under the ACVM Act

This article is intended to be a brief review of our current compliance programmes and notice of developments as the programmes evolve. In all cases the programmes will continue to be developed around the risks to be managed and tailored to the complexity of the operations being performed.

Inspections or verification activities are carried out to provide assurance that participants, processes and facilities are complying with standards that have been set or legislative requirements that have been implemented to manage certain risks.

The frequency of visits varies and is related to the level of risk to be managed. For example, continuous checking of passengers and their luggage by questionnaires and electronic screening is in place at the borders. This is to manage risks from importation of unregistered agricultural compounds and veterinary medicines, and risks to the country’s biosecurity.

On the other hand, manufacturers of veterinary medicines undergo regular inspections of their sites and operations every two years.

Manufacturers of registered veterinary medicines

Inspections of manufacturers of registered veterinary medicines are carried out to confirm that the registered veterinary medicines are being manufactured in accordance with the information and processes that were notified at the time of registration and in appropriate facilities. The basis of the inspection is the assessment of a manufacturer’s level of compliance with the ACVM Standard for Good Manufacturing Practice and, where appropriate, the ACVM Guideline for Good Manufacturing Practice for manufacture of specific categories of products.

Products under this category vary in complexity from high risk veterinary pharmaceuticals to low risk dietary products. The scope and intensity of the inspections are matched to the risk levels of the products being manufactured.
These inspections are carried out by trained inspectors in a third party agency, AgriQuality New Zealand, under contract to the ACVM Group. The costs of the inspection are recovered from the manufacturers by the ACVM Group.

Manufacturers of other products

Vertebrate pest control products were controlled under the Pesticides Act, and manufacturers were not subject to inspection for Good Manufacturing Practice (GMP) compliance. These products have now been brought under the ACVM and HSNO Acts. Because the products are used for the management of animals, the manufacturers have been included in the regular GMP inspection programme for manufacturers of veterinary medicines.

Manufacturers of veterinary medicines exempt from registration

Agricultural compounds and veterinary medicines that are exempt from registration with conditions are set out in Regulations dated 28 May 2001, under the ACVM Act 1997. 
Manufacturers of products that are exempt from registration with conditions are expected to comply with the ACVM Standard for Good Manufacturing Practice, but they are not subject to regular inspection.

However, all aspects of the ACVM Act are covered by responsive compliance. 
This means that any allegation or suspicion of non-compliance with the conditions of exemption from registration will be investigated and may

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