This content is current only at the time of printing. This document was printed on 8 December 2022. A current copy is located at https://apvma.gov.au/label-content-vet-products
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Label content – veterinary products
The Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, stipulates that, for a label for a container for a chemical product to meet the labelling criteria and be approved, the label must contain adequate instructions relating to specified matters (as are appropriate), including any matters prescribed by the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations).
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 Australian Pesticides and Veterinary Medicines Authority (APVMA), as in force from time to time.
The Veterinary Labelling Code (VLC) is presented as a series of labelling requirements that cover the label content, presentation and layout of the approved and marketed labels. This ‘Label content’ page explains the information that must be placed on labels for veterinary chemical products and provides examples of acceptable wording for certain statements where specific words are not mandated by the legislation.
Please refer to the label presentation and layout of veterinary products for labelling requirements on how approved and marketed labels are to be structured and presented.
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 it 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 veterinary chemical product label will be determined by the APVMA during evaluation of the application for approval of the label or variation of the approved label.
General and specific labelling requirements
The general content labelling requirements are summarised in 19 parts and reflect the required information as prescribed by section 5D of the Agvet Code, the relevant particulars and other information prescribed by the Agvet Code Regulations (regulations 8AE and 17), and any information required by APVMA under the label approval process (Agvet Code section 21).
Parts 1 to 14 are included in the E-label template and are assessed by the APVMA. If the proposed wording submitted complies with the relevant particulars and conditions of label approval, the APVMA will approve this wording. The final E-label version is defined as the 'approved (product) label'. Parts 15 to 18 are not included in the approved E-label but must be included on the marketed label. Section 19 is relevant to any other label information not regulated by the APVMA.
Some variations to the general content labelling requirements apply to certain classes of products. Specific requirements over and above the minimum requirements for placement and legibility of the particulars are also provided under these sections, as relevant.
How to use the VLC
The following drop-down menu shows the labelling requirements for veterinary chemical products. You can select to view the general labelling requirements from the drop-down menu or view the specific labelling requirements for individual product classes.
The labelling requirements are separated into 19 parts, and you can click the heading of each part to expand or collapse the section. Any specific labelling requirements for individual product classes will appear towards the end of the part underneath the product class heading.
Please note: the general requirements that appear when an individual product class is selected may not always be relevant. Alternatively, you can view the specific labelling requirements (which exclude the general requirements) for individual product classes.
Headings, mandatory statements or examples of specific wording are presented in grey boxes throughout each part of the 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 labelling requirements. This information will be displayed in a grey box and can be collapsed by clicking the ‘Click to view label presentation’ heading.