This content is current only at the time of printing. This document was printed on 28 March 2017. A current copy is located at http://apvma.gov.au/node/61
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Vet Labelling Code
The Agvet Code requires that all agvet products supplied to the market place must have a label attached to the container. This label must state the relevant particulars, must not contain information that is contrary to the relevant particulars, and must comply with all conditions of label approval.
Veterinary labelling code
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) collectively prescribe the approval process and content requirements for labels for containers for veterinary chemical products. 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.
This Veterinary Labelling Code 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 that labels for containers for veterinary chemical products reflect current best practice.
The Veterinary Labelling Code aims to accurately reflect legislative requirements. Labels for containers for veterinary chemical products must comply with the Veterinary Labelling Code. In the event that the Veterinary Labelling Code 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 Veterinary Labelling Code may be revised from time to time.
Where the term 'must' is used, it is a legal requirement that labels comply with this provision. The Veterinary Labelling Code also provides advice on how the requirement might be met, under the sub-heading ‘Guidance notes’. This advice is for guidance only, and is not mandatory. It contains words that have previously been considered by the APVMA and that are likely to be able to be accepted as suitable without an in-depth assessment. Any variation from these words should be justified by supporting information or argument.
The APVMA cannot register a veterinary chemical product without also approving a label for containers for the product. Similarly the APVMA cannot approve a label for containers for a veterinary chemical product without also registering the product. (The Agvet Code also provides that a registered chemical product may have more than one approved label.)
Assessing and approving labels is a key part of the product registration process. While all label information must comply with the Veterinary Labelling 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)),
All of the key information required to be set out on labels for containers for veterinary chemical products is outlined in the Veterinary Labelling Code (including the requirements of the Agvet Code and the Agvet Code Regulations). The Veterinary Labelling Code also provides additional guidance and examples of suitable wording for common situations. The examples are not exhaustive and may not be required or be appropriate for all circumstances. The specific information required on the label for each product will be determined by the APVMA during the evaluation of the application for approval of the label or for variation of the approved label.
The Veterinary Labelling Code is presented as a series of general labelling requirements and guidance. 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 and guidance. All labels should otherwise comply with the general labelling requirements.
General labelling requirements of the Veterinary Labelling Code
- An introduction to preparing a label and the label approval process
- Label presentation and layout
- Label content
Specific labelling requirements of the Veterinary Labelling Code
- Non-prescription injectable products
- Anthelmintics for dogs and cats
- Ectoparasiticides for dogs and cats
- Anthelmintics for sheep, goats and cattle
- Ectoparasiticides for sheep and goats
- Hormonal growth promotants
- Therapeutic pet food products
- Complementary animal health products
- Veterinary vaccines and antisera
- Teat dips and sprays
- Intraruminal products
- Products for application to wounds
- Products containing minerals
- Individual/multi/variable dose forms
- Professional packs of oral non-prescription products
Labels and label variations must be submitted electronically using the e-label template.