This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/127
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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.
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.?