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 sheep, goats and cattle must also carry the following information, as applicable.

4. Statement of claims for use

All approved label (E-label template) claims must contain, as a minimum, the following statements:

[Name of product] contains [name of active ingredient], a member of the [name of the anthelmintic group] family of chemicals.
It is effective against sensitive strains of the following internal parasites: [list of scientific and common names used in Australia].
Resistance may develop to any chemical.
  • Labels may also show claims that a product is effective against resistant parasites, providing you present us with convincing data to satisfy registration requirements.
  • Both the common and scientific name of parasites must appear in the ‘Claims for use’ statement on the label.
  • Resistance statements can be modified to align with the claims, which will be assessed during product evaluation.
Click to view label presentation

Claims, resistance warning statements and parasite names must 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. Please note that abbreviated claims must be included on the E-label template and will be assessed during product evaluation.

The scientific name must either be written in italics or underlined.

For example:

Aids in control of Barber’s Pole Worm (Hemonchus contortus), Tapeworm (Moniezia expansa).

Labels on products for sheep and goats must also contain the following statements:

Ask your local veterinarian or animal health adviser for recommended parasite management practices for your area to reduce development of resistance.

It is advisable that a resistance test be conducted before any parasite treatment is used.

6.2. Contraindications

For all anthelmintic products to be used in sheep, goat and/or cattle, the following contraindication statement should be included:

This product should not be used in dogs, horses or any other pets

For anthelmintic products to be used in sheep and/ or cattle the following contraindication statement should be included, unless data are provided to support the use in goats:

This product is not recommended for use in goats as safety and efficacy have not been evaluated

6.2.1. Abamectin based products

Products containing abamectin for sheep, goats and/or cattle should include the following ‘Contraindications’ statements, unless data are assessed to support an alternative:

6.2.1.1. Sheep and goats

This product is contraindicated for use in lambs/kids under 6 weeks of age or less than 10 kg body weight

6.2.1.2. Cattle

This product is contraindicated for use in calves under 16 weeks of age or less than 50 kg body weight

6.3. Precautions

6.3.1. Oral products containing levamisole

Oral products containing levamisole must include the following ‘Precautions’ statements:

Exercise care in handling weak, pregnant and young animals to avoid unnecessary stress.
Avoid yarding animals off-feed overnight and ensure animals have access to water when yarded prior to drenching.
Recommended dose should not be exceeded.

6.5. Dosage and administration

The directions for use should be simple, clear and concise and provide adequate information on how to use the product appropriately. Where appropriate, the ‘Dosage and administration’ instructions may appear in tabular form.

The dose rate of anthelmintic for sheep, goats and cattle is to be expressed as:

[x] mL/ [y] kg body weight

6.5.1. Sheep and goats

Dose volume tables are to be shown for sheep and goats up to 75 kg. Tables for sheep and goat products should include dose or volume increments of no greater than 10 kg of body weight for animals up to 75 kg body weight.

The following statement should appear after the dose or volume tables for sheep and goat products:

Animals heavier than 75 kg to be dosed at [x] mL per [y] kg. A representative sample of animals should be weighed before treatment. Dose the mob to the heaviest animal by live weight in each group (ewes, wethers, rams, lambs); (bucks, does, kids). Where there is a large variation in size within the group, dose rate should be based on the label directions for each weight range. Do not underdose. Drafting into 2 or more lines may be appropriate, to avoid excessive overdosing.

6.5.2. Cattle

Dose volume tables are to be shown for cattle up to 650 kilograms (kg).Tables for cattle products should include dose or volume tables with increments of no greater than 50 kg of body weight up to 650 kg body weight.

The following statement should appear after the dose or volume table for cattle products:

Cattle heavier than 650 kg should be dosed at [x] mL per [y] kg. A representative sample of animals should be weighed before treatment either with scales or a weighband. Dose rate to be based on heaviest cattle in each group (bulls, cows, steers, calves, etc.). Do not underdose. Where there is a large variation in size within the group, draft into 2 or more lines based on body weight, to avoid excessive overdosing.