The Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Code Regulations 1995 (Agvet Code Regulations) requires that all agricultural and veterinary chemical (agvet) products supplied to the marketplace must have a label attached to the container. In addition, the Australian Pesticides and Veterinary Medicines Authority (APVMA) cannot register an agvet product without also approving a label for containers for the product.
Among other things, a label must comply with the requirements of the Labelling Standard or, if there is no Labelling Standard, the Agricultural or Veterinary Labelling Codes made by the APVMA, as in force from time to time.
Label submission and approval
While all label information must comply with the relevant Labelling Standard or Code, the APVMA will only assess and formally approve the subset of label-related information identified in the E-label template (that is, the information to which the APVMA must have regard to satisfy itself that a label meets the labelling criteria and approve the label (sections 5D and 14 of the Agvet Code)). The final E-label version is defined as the ‘approved (product) label’.
Labels and label variations must be submitted electronically using the E-label template.
Please refer to the introduction to preparing a label and the label approval process for more information.
Veterinary Labelling Code
The Veterinary Labelling Code (VLC) draws together the requirements of the Agvet Code and the Agvet Code Regulations (including in relation to the relevant particulars of labels and label conditions). It also includes additional guidance developed by the APVMA to ensure labels for containers for veterinary chemical products reflect current best practice.
The VLC aims to accurately reflect legislative requirements. Labels for containers for veterinary chemical products must comply with the VLC. If the VLC is found to be inconsistent with the Agvet Code or the Agvet Code Regulations, the Agvet Code and the Agvet Code Regulations take precedence. The VLC may be revised from time to time.
Terminology
Where the term 'must' is used in the VLC, it is a legal requirement that labels comply with this provision or as determined by the APVMA.
Where the term ‘should’ is used in the VLC, the APVMA expects to see the statement(s) based on best practice and risk assessment or industry agreement.
Where the terms ‘may’ or ‘could’ are used in the VLC, it is strongly advised that this information is placed on labels, but is not compulsory.
Any variation from these words must be justified by supporting information or argument.
Any specific wording required to be included on a particular product label will be determined by the APVMA during evaluation of the application for approval of the label or variation of the approved label.
Labelling requirements and guidance
The VLC is presented below as a series of labelling requirements that cover the label content, presentation and layout of the approved and marketed labels.
Label content – veterinary products explains the general labelling information that needs to be placed on labels for veterinary chemical products and provides examples of acceptable wording for certain statements where specific statements are not mandated by the legislation. Some variations to the general labelling requirements apply to certain product classes. The specific requirements relate only to the particular product types or certain aspects of labelling identified. The content of a specific labelling requirement may extend content, or replace part of the content, contained in the general labelling requirements. All labels should otherwise comply with the general labelling requirements.
Label presentation and layout – veterinary products explains the requirements and additional guidance on how approved and marketed labels are to be structured and presented.
Additional guidance on veterinary products and/or labelling that do not form part of the VLC are presented in the left-hand navigation menu for informational purposes only.
How to use the VLC
Specific labelling requirements for individual veterinary chemical product classes can be viewed by using the dropdown menu below. Alternatively, you can view both the general and specific labelling requirements for individual product classes on the label content section of the VLC.
Headings, mandatory statements or examples of specific wording are presented in grey boxes throughout the specific labelling requirements. These statements are displayed in the font and/or formatting required for the marketed label presentation (e.g. regular or bold typeface and lower or upper case). If font and/or formatting requirements are not stated, it is encouraged the statements follow the VLC example formatting.
Label presentation boxes
Additional information about the presentation of the marketed label and layout of specific sections can be accessed by clicking the ‘Click to view label presentation’ options throughout each part of the general and specific labelling requirements. This information will be displayed in a grey box and can be collapsed by clicking the ‘Click to view label presentation’ heading.
Please refer to the label presentation and layout of veterinary chemical products for more information on the format and presentation of marketed labels.
General labelling requirements
Specific labelling requirements
In addition to the standard labelling requirements, labels on antibiotics must also carry the following information, as applicable.
4. Statement of claims for use
In light of the threat to public and animal health from the development of antimicrobial resistance (AMR), applicants must add 'resistance statement(s)' on product labels. The precise statement(s) will be considered on a case-by-case basis by the APVMA during product evaluation.
The Australian Government maintains a current list of Importance Ratings and Summary of Antibacterial Uses in Human and Animal Health in Australia with expert input from the Australian Strategic and Technical Advisory Group on Antimicrobial Resistance (ASTAG). The term ‘antibacterial’ is used, as the more common term ‘antimicrobial’ technically includes agents with other antimicrobial properties (e.g. antifungals).
A number of factors should be considered when developing resistance statement(s) including the importance rating. More information about antibiotic resistance risk assessments is available on our website.
The following statement has been provided as an example and should appear under the 'Claims' heading:
Indiscriminate use of [name of product] could (or ‘may’) contribute to the development of antibiotic resistance
Click to view label presentation
Resistance statements should be provided in full on the approved label (i.e. E-label template). These can be summarised on the main panel on the marketed label and provided in full on the ancillary panel or leaflet. If space is limited, these statements can be placed on the ancillary panel or leaflet.
6.1. Restraints
6.1.1. Gentamicin products
All gentamicin products must include the following ‘Restraints’ statement. This should be placed immediately below the ‘Restraints' heading.
DO NOT USE [in/on] animals that may be used for human consumption
6.5. Dosage and administration
6.5.1. Long-acting oxytetracycline products
The following must appear under the 'Dosage and administration' heading:
Injections should be given in the neck region.
Injection site volumes should not exceed 10 mL per site.