1. Information required on labels

The label must also comply with any of the particulars prescribed by the Agvet Code Regulations (17) that are appropriate to be contained on the label. The following particulars are prescribed:

• The appropriate signal words required by the current Poisons Standard
• The name of the chemical product
• The name of each active constituent in the product
• The proportion of each active constituent in the product
• The name of each constituent for the product that is:
  • not an active constituent, and
  • classified as a poison in the current Poisons Standard.
• The proportion of each constituent that is:
  • not an active constituent, and
  • classified as a poison in the current Poisons Standard.
• The net contents of the product
• Other particulars determined by the APVMA CEO

The ‘relevant particulars’ in relation to the approval of a label, as defined in the Agvet Code, include the adequate instructions and prescribed particulars specified above. In addition, if approval of a label takes place, the APVMA will give it a distinguishing number as per section 21(b) of the Agvet Code.

The label must also comply with any conditions of the approval imposed by the APVMA. 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.

The VLC also includes requirements relating to certain additional information on the label, its layout, presentation, printing and legibility. These requirements must be met for the label to comply with the conditions of approval of the label.

Please refer to the introduction to preparing a label and the label approval process for more information.

Labels may also include:

• information needed to meet the requirements of other regulators; for example, reference to safety data sheet and transport emergency information
• other company chosen statements, such as warranty statements, disclaimers regarding liability, logos such as drumMUSTER, barcodes and QR codes.
• other information that is not contrary to the label’s relevant particulars or the requirements of the Agvet Code and the Agvet Code Regulations.

This additional information must be placed in such a way as to enable compliance with the layout requirements of this Labelling Code. It will not be assessed as part of the APVMA’s label approval process and does not need to be supplied to the APVMA for the purposes of label approval.

According to the Agvet Code, a label must not include any statement or expression that expressly or impliedly claims – irrespective of how the claim is stated – that the:

• APVMA recommends the use of the product
• APVMA guarantees, warrants or assures the safety or efficacy of a product
• product is natural, organic, safe, harmless, non-toxic, non-poisonous, non-injurious or environmentally friendly without qualification, or with a qualification that is not acceptable to the APVMA.

In addition, advertising statements are not permitted on labels. This includes cross-references to other products. An exception to cross-references to other products may be for compatibility purposes or pest or disease management where specific approval has been obtained from the APVMA.

The information on a label should avoid using certain terms and making claims that cannot be substantiated (see Tables 1.1 and 1.2).

Logos must not interfere with the required label information. Labels must not include logos that:

• contain letters or words that are superlatives or comparatives
• make a claim regarding product safety or efficacy
• make a promotional or marketing inference or statement.

Logos and pictures should be pertinent to the product, and not confuse, mislead, be deceptive, or reduce the readability of the label. If a label features a non-target species used as either a background graphic or logo, it should show enough information or instructions on the label to clearly indicate the species for which the product is intended.

All words, symbols and numbers that appear between 'FOR ANIMAL TREATMENT ONLY' and the ‘Active constituent’ statement are considered to be the name of the product.

Company logos containing representations of animals that are not included in the claim for the product or other pictures should be located next to the registration holder or distributor name and address – in other words, well separated from the claim and product name. The size and prominence of such a logo should not diminish the prominence of the product name or claims for use.

If a logo containing a registered trade name is used as part of the label name of a product, the inclusion of this trade name is acceptable, provided all other labelling requirements stated in this publication are met.

An Australian-made logo or graphic (for example, Australian flag, kangaroo, koala) that implies a product is Australian may appear on a label in a position that does not interfere with the label’s function. This does not represent approval for the use or the accuracy of such claims. Relevant consumer affairs and trade practices authorities should be contacted for information about the valid use of these claims.

A single product may be registered with several pack sizes, provided it is the same product (that is, it has the same formulation, specifications). In general, the product will have the same immediate container packaging material and shelf life, but we will consider these on a case-by-case basis. The product will have the same relevant particulars, except that the different pack sizes will have different net contents of the containers and possibly different ‘Disposal’ statements relevant to the pack size.

However, related veterinary chemical products that have different dosage masses or different concentrations cannot be registered as different pack sizes and must be registered as separate products. This is because they have different pharmaceutical properties that may result in different stability, different efficacy and safety profiles, and different label instructions to ensure the safe and effective use of the product. The packs containing different dosage masses or different concentrations should be easily recognised and differentiated, to avoid inadvertent over-dosing or under-dosing.

Please refer to the guidance on professional packs of oral non-prescription veterinary products for more details.