In addition to the standard labelling requirements, labels on antibiotics must also carry the following information, as applicable.

4. Statement of claims for use

In light of the threat to public and animal health from the development of antimicrobial resistance (AMR), applicants must add 'resistance statement(s)' on product labels. The precise statement(s) will be considered on a case-by-case basis by the APVMA during product evaluation. 

The Australian Government maintains a current list of Importance Ratings and Summary of Antibacterial Uses in Human and Animal Health in Australia with expert input from the Australian Strategic and Technical Advisory Group on Antimicrobial Resistance (ASTAG). The term ‘antibacterial’ is used, as the more common term ‘antimicrobial’ technically includes agents with other antimicrobial properties (e.g. antifungals).

A number of factors should be considered when developing resistance statement(s) including the importance rating. More information about antibiotic resistance risk assessments is available on our website.

The following statement has been provided as an example and should appear under the 'Claims' heading:

Indiscriminate use of [name of product] could (or ‘may’) contribute to the development of antibiotic resistance

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Resistance statements should 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. If space is limited, these statements can be placed on the ancillary panel or leaflet.

 

6.1. Restraints

6.1.1. Gentamicin products

All gentamicin products must include the following ‘Restraints’ statement. This should be placed immediately below the ‘Restraints' heading.

DO NOT USE [in/on] animals that may be used for human consumption

6.5. Dosage and administration

6.5.1. Long-acting oxytetracycline products

The following must appear under the 'Dosage and administration' heading:

Injections should be given in the neck region.
Injection site volumes should not exceed 10 mL per site.