Non-compliance risk

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. 

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