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

2. Product name

2.1. Use of specific terminology: ‘Broad-spectrum’ or ‘all wormer’

The term ‘broad-spectrum’ or ‘all wormer’, with reference to cat and dog anthelmintics, should only be used for worm treatments that control all major types of gastrointestinal worms (that is, roundworms, tapeworms, hookworms and whipworms in dogs; and roundworms, tapeworms and hookworms in cats).

4. Statements of claims for use

Label claims must only state the specific parasites and stages of the life cycle against which the compound has been tested and proved effective.

Click to view label presentation

Both the common and scientific name of parasites must appear in the medicinal claims on the labels of anthelmintics for dogs and cats; for example, roundworms (Toxocara canis). However, where space is limited and the scientific names are included in the complete claim that appears on an ancillary panel or leaflet, they do not have to appear in the summary claim on the main label panel.

  • Generic claims for hookworm in dogs are only permitted when the product demonstrates control for both Uncinaria and Ancylostoma species.
  • Where ‘broad-spectrum’ or ‘all wormer’ is claimed for anthelmintics for dogs, the following statement must be included in the claim on the front panel unless data to the contrary is provided:
Does not control heartworm in dogs

A generic claim for tapeworm control is permitted only when a product used at the recommended label rate removes greater than 99% of hydatid tapeworm. Where no hydatid control claim is made, the label must have the following statement in the claim on the front panel:

Does not control hydatid tapeworms (Echinococcus granulosus)

All labels for dog and cat anthelmintics for gastrointestinal parasites must carry the statement:

If worm problems persist, consult a veterinarian
Click to view label presentation

This statement can appear on the ancillary panel or leaflet and does not have to appear in the summary claim on the main label panel.

6.5. Dosage and administration

The following tables serve as examples of appropriate dosing instructions for dogs and cats. These statements will be determined by the APVMA on a case-by-case basis during product evaluation.

Table 1: Dosage for cats

Parasite/situation

Treatment

Tapeworm

Treat every 3 months

Roundworm or hookworm

Treat at 6, 8, and 12 weeks of age – thereafter every 3 months

Pregnant cats

Treat at mating, before birth of kittens and then every 3 months

Table 2: Dosage for dogs

Parasite/situation

Treatment

Hydatid tapeworm

Dogs should not be fed, or allowed to feed on offal from any species. Dogs in hydatid areas should be treated every 6 weeks

Other tapeworms

Treat every 3 months. A statement regarding flea control should appear on the labels in relation to Dipylidium species (not relevant to Taenia species)

Roundworm and hookworm

Treat at 2, 4, 8 and 12 weeks – thereafter every 3 months

Whipworm

Treat every 6 to 8 weeks after 3 months of age

Pregnant bitches

Treat at mating, before whelping and then every 3 months

All heartworm products should carry the following instruction:

Treatment for heartworm should occur regularly at [x] intervals