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AgVetLink June 2004: Page 8

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Compliance

Two major non compliance matters are with the NZFSA Compliance and Investigation Group (CIG) at present. One in the veterinary medicines area is going through to prosecution, and is likely to become public shortly.

Information for a plant compound investigation in regards to unregistered product being sprayed on produce is still being collected. However, we can confirm that there were no residue concerns.

On a day to day basis, we are still receiving advertising complaints in regards to competitive products. In some cases a company is making reference to its competitor’s products in a manner that claims one to be superior to the other. The ACVM Group has referred the complainants to the Commerce Commission.

There are companies in the equine industry who just don’t seem to get the ‘message’ on arthritis and muscle products in regards to claims and registration. We have recently intercepted a muscle powder product that was advertised in a local newspaper as being manufactured ready for sale. We contacted the proprietor, and have been told that we should be receiving an application in the very near future.

We have compiled an active compliance list of companies in regards to continual non compliance. These companies may be included in our ongoing audit programme.

The ACVM Group is expecting an increase in compliance activity as we implement the PAR trader process.

In addition, compliance activity may increase if companies have not updated their products to the ACVM Act by 1 July 2004.

 

Registrants: If you do not get your products ‘stamped received’ into the system on or before 1 July 2004, your products will be illegal, and non compliance action will be taken.

General applications received into the system take precedence over update applications, with requests for review and evaluation actioned first to ensure that the regulatory timeframes are met.

 

Class Determination Expiry Date

The ACVM Group has reviewed the current two year expiry on class determinations and has changed this date to three years to bring it into line with the three year expiry on registered trade name products.

We remind class determination requesters that it is your responsibility, before the expiry date on the outcome letter is due, to apply to have the determination reconsidered and rolled over for a further three years. When you apply for reconsideration the following must be supplied:

• letter declaring that the trade name product has not changed since the first determination was made;

• one copy of the label;

• full formulation information;

• fee of $60.75.

 

VICH Pharmacovigilance

First steps in breaking the deadlock in achieving international agreement on the management of pharmacovigilance under VICH were taken at a special meeting of regulators held in Canada in March. Australia and New Zealand were represented by Dr Peter Dagg from the Australian Pesticides and Veterinary Medicines Authority (APVMA).

A number of proposals were developed and submitted to the VICH Steering Committee in May (see page 7) for wider discussion with regulatory and industry groups of the VICH participating members.

These related to:

• the formal international birth date of a product and the synchronising of adverse event (caused by the product) reporting;

• the reporting of adverse events to third countries and the timing of such reports;

• the standard terms to be used in adverse event reports and the format appropriate for electronic transfer of reports;

• a common dictionary; and

• information sharing between VICH regulatory authorities.