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AgVetLink June 2003

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Recent events

• The final report from the United Kingdom Competition Commission on Veterinary Medicines was released on 11 April 2003. The full report and the summary are available on their website (http://www.competition-commission.org.uk/inquiries/archive.htm).
• The draft review report from the Australian Pesticide and Veterinary Medicines Authority (APVMA) on Virginiamycin was released in March 2003. See their website (http://www.apvma.gov.au/) for details.
• A full summary of submissions received during consultation on the draft Policy for the Regulatory Control of Prescription Animal Remedies is available on the ACVM website (http://www.nzfsa.govt.nz/acvm/archive/draft/policies/index.htm).

Recent events Fibrosarcomas at injection sites of cats

The European Medicines Evaluation Agency (EMEA) Committee for Veterinary Medicinal Products has issued an advisory notice on the development of fibrosarcomas in cats following subcutaneous injection.

This states it is not possible to make firm conclusions on the risk associated with any product or type of product that causes inflam-mation after subcutaneous injection in cats. However, it advises that there may be an increased risk of fibrosarcoma at that site and that, if more specific information becomes available, this has the potential to impact on regulatory information require-ments and risk assessments.

A copy of this report may be viewed on the EMEA website (www.emea.eu.int/pdfs/vet/press/pos/020503en.pdf).

Who is responsible for the ACVM Act?

The ACVM Act and all other NZFSA administered legislation, including the Food Act, the Meat Act, the Animal Products Act, the Dairy Industry Act and the Winemakers Act, are now the responsibility of the Minister for Food Safety, Hon Annette King.

In some parts of the ACVM Act, such as section 21 (Decision on Application) and section 28 (Codes of Practice), there is reference to the powers of the Director-General (of MAF) to make decisions or approve. In each of these instances the powers and functions of the Director-General have been delegated to the ACVM Group Director and, in some cases, to members of the ACVM Group.

Attention all PAR product registrants!

During the investigation of a possible residue violation, the ACVM Group has found that the IVS, published by Havas MediMedia (NZ) Ltd, is not providing the most up to date information regarding the use conditions for a product. This means that registrants may be ‘advertising’ incorrect information to prescribing veterinarians in possible breach of the ACVM Act. This is of particular concern because prescribing veterinarians need to be aware of many recent changes to registration conditions, especially of antibiotic products.

We ask that all registrants immediately check the information published in IVS in relation to their products, and correct any errors both with IVS and with prescribing veterinarians. If similar information is provided by registrants to other publications or if the information is shown on websites, then information should be checked and updated as needed.

The ACVM Group reminds all registrants and prescribing veterinarians that under the ACVM Act a product may be used only according to the conditions of registration. There is no provision for a veterinarian or anyone else to prescribe or use a product other than in the manner approved.

In many instances there is still an allowance for products to be used on species other than those shown on the label. In this case there will be a registration condition to the effect that the product may be used on other species for other conditions providing the ACVM Act concerns over residues and animal welfare are managed. For PAR products, the prescribing veterinarian is responsible for these risks and for advice to the owner of the animals concerned.

Where there is a registration condition restricting the use of a product to specific species (for example, a number of antibiotic products are limited to use in pigs and poultry), or there is a statement such as ‘not for use in food animals’, it is a breach of the ACVM Act for a veterinarian to prescribe products in conflict with their conditions. It is also a breach of appendix 1 of the Code of Professional Conduct, which is approved under section 28 of the ACVM Act.