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AgVetLink June 2003

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result in implementation of regular inspection of the manufacturer.

It should be noted that the ACVM Group considers that there may be risks associated with the manufacture of animal feeds that contain dietary supplements or antibiotics. 
Consideration is being given to whether additional regulatory controls need to be applied to this category of manufacturer and, if so, at what frequency.

Traders of veterinary medicines

Proposed changes to the conditions of registration of prescription animal remedies (PARs) will require increased controls on the distribution chain for these products. Traders of PARs will be required to be registered and to operate in compliance with a standard for traders of PARs. Existing veterinary wholesalers and veterinary practices of registered veterinarians will be placed on the register automatically, and new traders of PARs will be inspected for compliance with the standard before being registered. The programme will be reviewed during the next 2 to 3 years to determine whether regular cost recovered compliance inspections need to be implemented to secure the distribution and sale of PARs.

Manufacturers of plant compound products

The ACVM Group has not implemented regular inspection of manufacturers of plant compound products to date. All of the complex chemical actives are manufactured overseas and the specifications of the actives used in products formulated in New Zealand are assessed during the registration process for purity and freedom from residues.

The animal welfare risk area in the Act does not usually apply to these products and, over many years, any adverse events recorded have related to misuse rather than inappropriate manufacture. Therefore, the imposition of regular inspections as an overarching requirement is not considered to be justifiable at this time.

A general condition of registration is placed on the registration of all plant compound products. The product must be manufactured in accordance with the ACVM Standard for Good Manufacturing Practice. Some manufacturers of plant compound products have requested to be inspected and approved as manufacturers, and this activity has been provided as a discretionary service.

Manufacturers of biological products could be considered to be in a separate category from manufacturers that only formulate, fill and pack. Consideration is being given to whether regular monitoring should be implemented in the future for manufacturers of those biological plant compound products. It is likely that the decision on this will be subject to the outcome of future ‘slice of life’ audits in this area.

Traders of plant compound products

As for the manufacturers of plant compound products, it does not appear to be appropriate to introduce registration of traders of plant compound products as a general requirement at this time.

Suspected illegal importation

The ACVM Group, in conjunction with the NZFSA Compliance and Investigation Group, is investigating the suspected illegal importation into New Zealand of unregistered veterinary medicines. Information was received in the form of a complaint to the ACVM Group.

If the investigation shows illegal importation has occurred, this is a serious breach of the ACVM Act and it could also result in breaches under other legislation. The importation of unapproved veterinary medicines products has the ability to undermine the ACVM risk management process.

Where the ACVM Group has reasonable grounds to believe that any person manufacturing, selling, or using any agricultural compound is acting in contravention of any provision of the Act, or conditions on the registration of a trade name product, the Group will use the powers of the ACVM Act to issue a prohibition notice (see box at left) in the first instance. Subsequent investigation will provide the evidence to make the decision on progressing to a prosecution under the ACVM Act or any related legislation. A prohibition notice requires the recipient to cease all manufacturing, sale, or use of that product or the agricultural compound until such time as the contravention of the Act is rectified.

Offences under the ACVM Act can attract penalties of up to $30,000 for a person or $150,000 for a corporation.