Every report of non-compliance is assessed by the APVMA.?

The APVMA may commence an investigation based on reports about:

• the advertising and supply of unregistered agvet chemicals
• inappropriate or incorrect veterinary chemical product manufacture
• agvet chemicals that fail to meet APVMA conditions or standards
• the importation of unregistered agvet chemical products.

An investigation establishes if non-compliance is (or is not) occurring. Based on this, responses may include:?

• not pursuing a matter further
• supporting and encouraging voluntary compliance (by providing advice, raising awareness and engaging stakeholder groups)
• taking administrative action to control risk
• implementing a compliance response, such as a formal warning
• pursuing a sanction such as an infringement notice, civil penalty order or prosecution.

All reports of non-compliance, including complainant details, are treated confidentially. However, the APVMA may need to disclose details of an investigation if a matter proceeds to court.?

Levels of non-compliance risk?

The level of non-compliance is categorised based on risk and seriousness. Incidents that require only minor corrective action may be considered low level or low regulatory risk. Where non-compliance requires significant corrective action or has resulted in harm, this may be considered as mid to high-level regulatory risk.?

Low level regulatory risk?

Examples of low level non-compliance include:

• a self-reported minor incident
• a one-off incident that is. easily rectified and where direct benefit is negligible
• an isolated incident in a high-volume business
• an incident involving a reasonable misinterpretation of a definition, condition or requirement.

Medium to high level regulatory risk?

Examples of mid to high level non-compliance include:

• repeated contraventions or failure to respond to APVMA compliance interventions
• incidents that have a significant impact on matters protected by agvet legislation
• incidents that provide significant potential for direct benefit to the offender or loss to others
• frequent incidents in a high-volume business
• deliberate, reckless or criminal non-adherence to definitions, conditions or requirements
• the submission of false and misleading information
• levy evasion.

Resolution?

Guidance and support is available for those who may be involved in non-compliance, which typically involves an exchange of correspondence and advice or a visit to a premises by APVMA inspectors. A matter of alleged non-compliance is likely to be closed in good faith, provided there is agreement that action will be taken to return to compliance.?

High-level responses to non-compliance may involve investigation, the issue of enforceable directions, fines, suspensions or cancellations of authorisations, or prosecution.?

All APVMA responses to non-compliance, including decisions to take no further action, are recorded.?

Should the APVMA become aware that compliance has not been achieved after a reasonable period, escalated compliance and enforcement action is considered.?