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 ectoparasiticides for dogs and cats must also carry the following information, as applicable.

2. Product name

Where a product does not require further dilution before usage, the following words may be included in the product name:

READY TO USE

3. Constituent statements

3.1. 'Active constituent' statement

The active isomer (and, where relevant, the isomeric ratio) must be specified under the ‘Active constituent’ heading. For example:

S-methoprene and permethrin 60:40

4. Statement of claims for use

Where control of ticks is claimed, the species name of ticks must be stated. Where tick control is claimed and paralysis tick is not controlled, the following statement must appear:

Does not control paralysis tick (Ixodes holocyclus)

Products that claim to control Ixodes holocyclus should have the following label statement:

Ixodes holocyclus ticks do not occur in Western Australia

If a claim is made in relation to I. holocyclus ticks, the following grooming statement must appear:

In tick season, daily searching for, and removal of, any ticks found is recommended
Click to view label presentation

Both the common and scientific names of parasites must appear in the 'Claims' statement on the label. The scientific name must be written in italics or underlined. The scientific names are optional in the summary claim appearing on the main panel if they appear in the complete claim on the ancillary panel.

Products that have the claim ‘aids in the control of fleas’ (efficacy 75% to 95%) must show the following statement:

Aids in the control of fleas and may not completely eliminate fleas from treated animals. Total eradication of fleas requires appropriate treatment of both the animal and its environment. A veterinarian should be consulted when flea infestation continues to be a problem.

A repellent claim is not permitted in relation to ticks and fleas without supporting data.

6.2. Contraindications

Either of the following 'Contraindications' statements must appear on all products, except those containing pyrethrins or permethrin (unless data to the contrary is supplied):

Not recommended for use on kittens and puppies under 3 months of age
Must not be used on kittens and puppies under 3 months of age

6.4. Side effects

Sprays containing pyrethrin or permethrin and intended for use on cats must carry the following statement under the ‘Side effects’ heading:

May cause drooling and unsteady gait in cats. If these occur, wipe off excess product and contact a veterinarian.

Products containing actives belonging to the isoxazoline family must contain the following statement:

[Active(s)] is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lethargy, inappetence, itching and very rarely, seizures. Most adverse reactions are self-limiting and of short duration. If you have any concerns, please speak to your veterinarian.

6.6. General directions

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

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.
Click to view label presentation

The general limitation statement must be printed in bold-face and sans-serif capital letters. For print size and style requirements, refer to the Printing and legibility requirements.

Advice on the control of fleas in the animal’s environment may be required (for example, treat bedding, carpet, etc.) as determined by the APVMA during product evaluation.

6.6.1. Dog spot-ons that contain permethrin

In addition to the standard labelling requirements and those described above, dog spot-ons that contain permethrin must also carry the following information.

The label must contain the following warning statements:

Keep cats separated from recently treated dogs.
There are reports of toxic effects in cats which groom or contact dogs treated 48 hours earlier.
Toxic effects include behaviour changes, drooling, tremors and death.
Seek veterinary advice immediately if you suspect toxicity in a cat.

Each warning statement is to begin on a separate line.

For the purpose of the E-label template these statements should be placed under the ‘General directions’ heading.

Click to view label presentation

The warning image and the warning statements are displayed on the label in accordance with the following requirements:

Label approval requirement 1 (warning image)

The label must contain either the white keyline image or the white box image set out below at greater than or equal to the dimensions specified for each image.

Label presentation - label approval requirement 1 (warning image)

Label approval requirement 2

The warning image and the warning text must be displayed on the label in accordance with the following requirements:

Front of package

  • The warning image must be placed on the front of each package in the dimensions stated in requirement 1 or a larger dimension.
  • The PMS colours must be green PMS 355C and red PMS 485C.
  • The warning image must be placed beneath the active constituents and as close to the active constituents as possible in accordance with the APVMA Labelling Code.

Back of package

  • The same version of the warning image used on the front of the package must appear on the back of the package, beneath the ‘Directions for use’ heading.
  • The warning image must be in the dimensions stated above in requirement 1 or a larger dimension.
  • The warning text must accompany the warning image and be either directly below or beside the warning image.
  • The warning text must be in at least the same size text as the rest of the text on the back of the package.

Internal packaging

  • For internal foil packs, the warning image must be in the dimensions stated in requirement 1 or a larger dimension, but may be printed in a single colour.
  • For pipettes, a version of the warning image is to appear if space permits. If space does not permit, the words ‘toxic to cats’ must appear in text at least 1.5 mm high.
  • For leaflets, the warning image must be in the dimensions stated above in requirement 1 or a larger dimension and may be printed in a single colour. The warning text must appear as it appears on the back of package.