This content is current only at the time of printing. This document was printed on 8 December 2022. A current copy is located at https://apvma.gov.au/immunobiological-products-specific
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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.
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 immunobiological products (veterinary vaccines, antisera, biologicals) must also carry the following information, as applicable.
1. Signal heading
The Schedule 4 signal heading: PRESCRIPTION ANIMAL REMEDY is required for:
- all live-virus veterinary vaccines (unless listed as exempt from Schedule 4 for live veterinary vaccines in the Poisons Standard)
- canine tick antiserum
- monoclonal antibodies
- Plasmid DNA vaccines for animal use except when separately specified in the Poisons Standard.
2. Product name
The name must identify whether the product is live or inactivated where applicable.
The name of the product may also include the word ‘vaccine’ or ‘antisera’ or other suffix to indicate its class of action.
3. Constituent statements
3.1. Active constituent(s) and scheduled non-active constituents
Labels for vaccines and antisera should include the qualitative and quantitative details of the active ingredient(s). This will normally be expressed as the end of shelf life titre of the product or as the antigen.
Vaccine types (for example, ‘whole cells’, ‘cell fractions’, ‘subunits’, ‘toxoid’, etc.) must be described in the ‘Active constituent’ statement unless already in the product name. If a vaccine contains both live and inactivated components, then this should be clearly stated in the ‘Active constituents’ statement.
The qualitative and quantitative composition of the adjuvant(s) must be stated. For 'tradenames' and confidential formulas the APVMA can address them on a case-by-case basis.
The qualitative and quantitative details of any preservative must be listed on the label.
Scheduled excipients, adjuvants and preservatives must be referred to by their recommended Pharmacopoeia or CAS name.
Labels for monoclonal antibody products must include minimum and maximum dose.
The actives should appear first, followed by adjuvants and preservatives and scheduled excipients.
The concentration and name of any adjuvant(s) or preservative must be proceeded by the following subheading:
And have immediately following or beside the ingredient statement the word:
4. Statement of claims for use
The label efficacy claims for veterinary vaccines should follow APVMA guidance.
6.5. Dosage and administration
For multiple-dose containers and for freeze-dried products that must be reconstituted before use, the in-use shelf-life stability statement must be placed under the ‘Dosage and administration’ sub heading. In the absence of data the statement 'use immediately on broaching or reconstitution' must be included on the label.
Use immediately on broaching/reconstitution.
6.6. General directions
Instructions to sterilise reusable syringes and needles should appear on labels for vaccines for livestock and must include specific advice on the number of washings required when devices have been chemically sterilised or the period required for cooling down when heat sterilised.
7. Withholding period statements
A withholding period of zero (0) days must be included on labels for food producing animals unless the data indicates an alternative specified withholding period.
8. Trade advice
Export slaughter interval – If determined to be zero (0) days, the default statement as described in the general labelling requirements content is not required for immunobiological products. Statement to include:
11. Additional user safety information
Additional user safety instructions may apply to vaccines. These should be placed under the heading ‘Additional user safety information’.
For all injectable vaccines a standard warning statement must be included:
The following statements relate to adjuvants, and the relevant statement based on the type of adjuvant used in the vaccine must be applied. Statements for other adjuvants not included in the list below will be treated on a case-by-case basis during assessment.
11.2. Emulsion, vegetable oil, mineral oil or Freund’s
This product contains [adjuvant type] and is an irritant. In the event of self-administration, it can cause significant pain and swelling at the injection site, perhaps also involving the draining lymph nodes. Medical or surgical intervention may be required. Contact a doctor immediately, even if only a very small amount is injected, and take this package leaflet/carton with you. Allow the wound to bleed freely and DO NOT squeeze or interfere with the injection site.
Ancillary advice to the medical practitioner
This product contains [adjuvant type]. Even small amounts of self-administered [adjuvant type] can cause intense swelling and a persistent granulomatous inflammatory reaction. If injected into a finger joint or tendon sheath, the product may track along the tendon, perhaps also involving the draining lymph nodes. The swelling and inflammation may compromise blood supply and result in necrosis that, in rare cases, may lead to the loss of a digit.
Following appropriate immediate local cleansing, corticosteroids may be considered to decrease the severity of any local reaction. Ascertain the patient’s tetanus immunisation status, and provide booster or primary series, as appropriate.
In some cases of self-injection, PROMPT surgical attention may be required. The wound should be incised and irrigated to remove the vaccine, especially where there is involvement of finger pulp or tendon. Complete curettage or total excision of the lesion may be required for chronic granulomatous reactions. Meticulous technique is required to stop inadvertent spread of the product.