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AgVetLink August 2004: Page 8

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LABELLING

Harmonisation of veterinary medicine labels with Australia

Changes in the Australian Agricultural and Veterinary Chemical Code Act (Agvet Code), which was introduced last October, have resulted in the need for the APVMA to approve final marketed product labels (or printers’ proofs) rather than label content presented in text format as was the situation previously. The administrative flow-on effect has led to classifying minor label changes as Category 39 (fee attracting) whereas previously they were often classified as Category 38 (non-fee attracting).

APVMA approval may be required for harmonised labels that are being updated to comply with requirements of the ACVM Act in New Zealand. However, the APVMA has specified certain label changes that can be made to labels used in Australia without approval, subject to conformance with the stated conditions.

These changes are contained in Permit 6868, which is issued under section 114 of the Agvet Code, and may be viewed on the APVMA website ( http://permits.apvma.gov.au/PER6868.PDF ).

Part 3 of section A of Permit 6868 covers ‘Addition and/or deletion of clearly identified New Zealand classification or approval details and relevant New Zealand contact details’.

Advice received from APVMA is that, to comply with the intent of the words ‘clearly identified’ in this section, changes to the New Zealand required statements should be prefixed by or contain words such as ‘In New Zealand’. Alternatively, the use of a statement box identified as ‘New Zealand relevant information’ would ensure compliance.

The APVMA considers that the following changes are covered under Permit 6868:

• New Zealand registration statements, e.g. “Registered in New Zealand pursuant to the ACVM Act 1997, No. Axxxx” “See www.nzfsa.govt.nz/acvm for registration conditions”;

• New Zealand PAR statement, e.g. “Prescription Animal Remedy P.A.R. Class 1 For use only under the authority or prescription of a veterinarian”;

• New Zealand registrant/distributor contact details, e.g. name, street address, website, phone;

• New Zealand poisons information contact details, e.g. “New Zealand 0800 764 766 (0800 POISON)”.

The APVMA has advised that Australia does not regard the horse as a food animal.

For horse products that contain New Zealand restricted (EU or FDA banned) substances, harmonised labels are possible only if the New Zealand restraint statement is included in a text box identified as being relevant to New Zealand only. The inclusion of the statement in this manner would comply with the intent of Permit 6868.

The APVMA would need to examine situations that involve claims, instructions, recommendations, warnings or other statements that are different to those in Australia. Registrants are encouraged to contact the APVMA and the ACVM Group to seek further advice.

The ACVM labelling guides for plant compounds and veterinary medicines have been updated to reflect a change in policy – the physical address of the registrant is no longer required on the label.

 

Antibiotic Resistance Steering Group

The first meeting of the new Antibiotic Resistance Steering Group was held in Wellington on July to discuss terms of reference and composition of the expert panel for a further review of the New Zealand situation. The Steering Group consists of a representative of each of the organisations below, plus an additional consumer representative and a human health practitioner:

• NZFSA – ACVM Group (Convenor) 
• NZFSA – Animal Products Group 
• New Zealand Veterinary Association 
• Ministry of Health 
• Ministry of Research, Science and Technology 
• Consumers Institute 
• Poultry Industry Association 
• New Zealand Pork Industry Board 
• Federated Farmers 
• AGCARM (Agricultural Chemical and Animal Remedy Manufacturers Association) 
• Animal Remedies and Plant Protectants Association (ARPPA) 
• PipFruit New Zealand Incorporated 
• Dairy Insight

 

DAS reminder

When lodging an application, please remember to indicate in your covering letter if you wish the ACVM Group to undertake the data assessment or if you wish the application to go directly into review and evaluation.