This content is current only at the time of printing. This document was printed on 12 August 2020. A current copy is located at https://apvma.gov.au/node/232
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Cancellation or suspension of registration or permits
The APVMA may suspend or cancel a registration or permit for an agvet chemical product for reasons relating to non-compliance.
If the APVMA considers it necessary, a registration or permit may be cancelled to prevent imminent risk of death, serious injury or serious illness to people. We may exercise this authority regardless of whether:
- the chemical product that is the subject of the registration is being used in accordance with instructions for its use that the APVMA has approved
- the conditions of the permit have been, or are being, complied with.
A notice of suspension or cancellation must include the reasons or grounds for the decision.
When considering whether it is necessary to cancel or suspend a registration or permit in response to non-compliance with a condition, we take into account factors such as the following:
- a standard compliance assessment of the severity and risk of the noncompliance
- the nature of available evidence
- the type of condition that has been breached
- whether more than one condition has been breached
- the risk of harm to humans, animal health, the environment or trade that is intended to be mitigated by the condition
- the benefit the holder has obtained through non-compliance with the condition
- any mitigating circumstances (or reasonable excuse) that might apply
- submissions provided by the permit holder
- whether there is evidence of an imminent risk to people, animals.or the environment that relates to use of the registered or permitted use of the agricultural and veterinary (Agvet) chemical product
- whether the suspension or cancellation is strictly necessary to protect people
- whether the imminent risk is able to be addressed by cancelling or suspending the registration or permit
- whether the suspension or cancellation is necessary and the most appropriate action to address the imminent risk
- whether there are feasible and preferable alternative measures available to manage the imminent risk.
In considering whether it is necessary to cancel or suspend a permit in response to prior convictions of the permit holder, we consider factors such as the following:
- the nature of the prior conviction
- when the prior conviction occurred (within a 10-year timeframe)
- whether there are multiple prior convictions
- the impact on people to whom the permit applies if the permit were cancelled and whether a suitable new permit holder can be identified
- submissions provided by the permit holder.
The APVMA has discretion in determining whether a registration or permit should be cancelled. The APVMA ensures its use of Agvet Code provisions is reasonable and in accordance with procedural fairness.
Suspension of a permit
Provisions of the Agvet Code empower the APVMA to suspend a permit where it appears the permit holder has contravened a condition of their permit, or if it will prevent imminent risk to persons of death, serious injury or serious illness (Section 118).
Section 117A of the Agvet Code requires a range of procedural fairness actions on the part of the APVMA when suspension or cancellation is first proposed, including:
- providing written notice of the proposed suspension or cancellation to the permit holder
- providing reasons for proposed suspension or cancellation to the permit holder
- inviting submissions from the permit holder.
After a suspension notice is issued, the permit is not in force for the suspension period. This means that the relevant offence provisions under Agvet legislation apply.
State coordinators will be advised of the suspension-or any subsequent revocation of the suspension within 14 days, as required by the Agvet Code.
Period of suspension of a permit
The suspension commences when relevant notice is issued and the APVMA record is amended.
Where a permit is suspended, we must specify the period to which the suspension applies. We determine this on a case-by-case basis.
The APVMA may revoke a suspension by written notice to the permit holder. If this occurs, we must advise the holder within 14 days.
The APVMA can also revoke a cancellation, and must advise the jurisdictional coordinator within 14 days.
Cancellation of a permit
There a number of grounds on which the APVMA can cancel a permit these include:
- the holder has contravened a condition of the permit
- the holder has previously had a permit cancelled for providing false or misleading information
- the holder has been convicted of an offence or ordered to pay a pecuniary penalty under agvet legislation or other legislation relating to chemical products
- the holder has been ordered to pay a pecuniary penalty for the contravention of an Agvet penalty provision, another law relating to chemical products, or a law involving fraud or dishonesty
- the holder held a permit that was cancelled under the corresponding provision of the Code Act of another jurisdiction
- the holder has been convicted of fraud.
When a permit is cancelled, it ceases to have effect and the relevant offence provisions under Agvet legislation apply.
The APVMA issues a range of authorisations, including manufacturing licences and consents to import. We are empowered to suspend or cancel an authorisation in response to non-compliance with the authorisation.
In determining the need for action, we consider the public exposure to the active constituent or product and the likelihood of harm to people, animals, the environment or international trade. We also consider the legislated obligation of industry to provide information to us, comply with the conditions, and conform to assessed criteria as detailed in section 41 of the Code Act.
The Code Act provides that we may suspend a market authorisation in instances of:
- imminent risk to persons of death, serious injury or serious illness
- breaching a condition of approval or registration
- failing to give information, samples or results of trials or experiments when we ask for them
- providing false or misleading information to support, or in connection with, an approval or registration
- arbitration on compensation for use of protected information is unsuccessful
- chemical reconsideration decisions
- non-compliance with criteria for approval or registration.
Suspension and cancellation notices issued by the APVMA will be published.