Labelling Codes – veterinary products

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 hormonal growth promotants must also carry the following information, as applicable.

3. Constituent statements

3.1. 'Active constituent' statement

The following statements must appear under the ‘Active constituents’ heading:

This product contains a palpable marker.
This product must only be supplied in accordance with Division 4.2 of the Agvet Code Regulations (Supply of Hormonal Growth Promotants).

6. Directions for use

The following statement must appear immediately under the ‘Directions for use’ heading:

To be used ONLY in accordance with the instructions on this label unless authorised under appropriate legislation.

6.1. Restraints

All products must carry the following statements under the ‘Restraints’ heading:

DO NOT USE in any animal other than [delete whichever does not apply: steers/heifers/steers and heifers] producing beef for human consumption.
DO NOT USE more than one implant of any type concurrently per [steer/heifer/steer or heifer].
DO NOT implant sooner than [x] days after the last implant.
DO NOT implant this product in any site other than beneath the skin in the middle third of the back of the ear.
DO NOT USE this product on HGP-free accredited cattle. It is a breach of Department of Agriculture accreditation conditions to use this product on HGP-free accredited cattle or to possess this product on any HGP-free accredited property (except for feedlots with flexible accreditation). Treated animals must be identified as having received a hormonal implant by use of an approved ear punch.

When use in heifers is approved, this additional statement is required:

DO NOT USE in heifers that are producing, or may in the future produce, milk that may be used or processed for human consumption.

6.3. Precautions

The following statements must appear under the ‘Precautions’ heading:

Implanting cattle under 6 weeks of age is NOT recommended.
Implanting cattle intended for breeding is NOT recommended as they may experience decreased fertility.

When the product contains trenbolone, the following alternative statement is required (3 months for grass-fed or 6 months for lot-fed beef):

Implanting cattle under [3 months for grass-fed/6 months for lot-fed] of age is NOT recommended.

6.4. Side effects

The following statements must appear under the ‘Side effects’ heading:

[Preputial/vaginal] and rectal prolapse, increased bulling activity, high tailheads, sunken loins, ventral oedema and udder development may occur as side effects of treatment. [Delete whichever does not apply]

6.5. Dosage and administration

The following statements must appear in the ‘Dosage and administration’ section:

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Approved implantation technique is fully described in the enclosed leaflet.
Cattle implanted with this product must be individually identified with an approved ear punch mark.
To help avoid abscess formation at the site of the implant, the surface of the ear should be thoroughly cleaned and disinfected before implantation.

6.6. General directions

The following statements must appear under the ‘General directions’ heading:

Growth responses may vary widely for nutritional or other reasons. Improved performance may be noted only when conditions are favourable for good growth.

13. Disposal statements

The following statements must appear under the ‘Disposal’ heading:

DO NOT dispose of unused implants in any way other than surrender to an approved retailer or wholesaler.
Dispose of empty cartridges by wrapping with paper and putting in garbage.
Discarded needles should immediately be placed in a designated ‘sharps’ container.