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 non-prescription injectable products must also carry the following information, as applicable.

2. Product name

2.1. Calcium, magnesium, glucose and phosphorus solutions for the treatment of metabolic diseases in sheep and cattle

Use of the phrase ‘four in one’ or ‘4 in 1’ in the product name for products containing calcium, magnesium, glucose and phosphorus may be used, provided that only the:

  • calcium, phosphorus and magnesium content are declared as active constituents, as per the example below:
    • Active constituents – per 500 mL
    • Calcium (as the gluconate) – 12.50 g
    • Phosphorus (as the hypophosphite) – 6.00 g
    • Magnesium (as the hypophosphite) – 2.35 g
    • Also contains:
    • Glucose (as dextrose monohydrate) – [x] g
  • treatment of hypocalcaemia (parturient paresis or milk fever) and related metabolic diseases (transit paresis, transit tetany) in sheep and cattle are claimed in the indications for use. The claim may also include the treatment of hypomagnesaemia (grass tetany or lactation tetany), provided that directions are given for initial treatment with a magnesium salt solution, as well as with the product making the claim. The claim should not include any indication for hypoglycaemia (pregnancy toxaemia or ketosis or acetonaemia).

4. Statement of claims for use

4.1. Intravenous injections (non-prescription)

For all non-prescription products (excluding remedies for metabolic diseases – see below) that are intended for intravenous administration, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

For intravenous (IV) use by or under the direction of a veterinarian.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

4.2. Calcium, magnesium, glucose and phosphorus solutions for the treatment of metabolic diseases in sheep and cattle

For injectable solutions of calcium, magnesium, glucose and/or phosphorus for the treatment of metabolic diseases in sheep and cattle, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

Use of this product intravenously may be hazardous to the animal and advice from a veterinarian should be sought.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

6.5. Dosage and administration

6.5.1. Intravenous injections (non-prescription)

For all non-prescription products (excluding remedies for metabolic diseases – see below) that are intended for intravenous administration, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

For intravenous (IV) use by or under the direction of a veterinarian.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

6.5.2. Calcium, magnesium, glucose and phosphorus solutions for the treatment of metabolic diseases in sheep and cattle

For injectable solutions of calcium, magnesium, glucose and/or phosphorus for the treatment of metabolic diseases in sheep and cattle, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

Use of this product intravenously may be hazardous to the animal and advice from a veterinarian should be sought.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

6.6. General directions

6.6.1. Subcutaneous injections (non-prescription)

For non-prescription products intended for subcutaneous administration to food-producing animals, the following directions should appear with the ‘Caution’ statement under the subheading ‘General directions’.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling (or equivalent) before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use shortest needle possible, certainly not exceeding 15 mm.
5. As far as possible, avoid injection of animals during wet weather or under dusty conditions.
6. This product should be injected only under the skin.
7. If possible, inject high on the neck behind the ear.
Click to view label presentation

The ‘Caution’ statement should appear in bold-face, sans-serif letters in sentence case. For print size and style requirements, refer to the Printing and legibility requirements.

Note:

  • Items 4, 5 and 7 may not be appropriate for calcium borogluconate and other metabolic disease remedies, or for other injections of relatively large volume.
  • Item 7 may not be appropriate for products administered to poultry.

6.6.2. Intramuscular injections (non-prescription)

For non-prescription products intended for intramuscular administration to food-producing animals, the following directions should appear with the ‘Caution’ statement under the subheading ‘General directions’.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use needles of appropriate gauge and length.
5. As far as possible, avoid injection of animals during wet weather or under dusty conditions.
6. This product should be injected only into muscle tissue.
7. If possible, inject into muscle tissue on side of neck.
Click to view label presentation

The ‘Caution’ statement should be in bold-face sanserif letters in sentence case. For print size and style requirements, refer to the Printing and legibility requirements.

Note:

  • We suggest you replace Item 7 for injectable iron compounds for preventing piglet anaemia – because of insufficient bulk of cervical muscle in newborn piglets – with:
Injections may be made into the muscles of the hind leg. This product is not to be administered to piglets after the first 4 weeks of life.
  • Item 7 may not be appropriate for products administered to poultry.

6.6.3. Combined intramuscular or subcutaneous injections (non-prescription)

For non-prescription products intended to be administered either intramuscularly or subcutaneously to food-producing animals, the following directions should appear with the ‘Caution’ statement under the subheading ‘General directions’.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use needles of appropriate gauge and length. For subcutaneous administration, use shortest needle possible, certainly not exceeding 15 mm.
5. As far as possible, avoid injection of animals in wet weather or under dusty conditions.
6. Intramuscular injections should be made into muscle tissue on the side of the neck. Subcutaneous injections should be made under the skin, high on the neck behind the ear.
Click to view label presentation

The ‘Caution’ statement should be in bold-face, sans-serif letters in sentence case. For print size and style requirements, refer to the Printing and legibility requirements.

Note:

  • Item 6 may need to be modified to delete the reference to injection on the neck for products administered to poultry.