This content is current only at the time of printing. This document was printed on 19 May 2022. A current copy is located at https://apvma.gov.au/node/97396
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Voluntary suspensions at the request of the holder
Holders can request to suspend their active constituent approval, product registration or label approval by making a written application to the Australian Pesticides and Veterinary Medicines Authority (APVMA) in accordance with section 42 of the Agvet Code. To request suspension of your active constituent approval, product registration or label approval, please complete the Suspension of approval or registration at the request of holder form and return it to firstname.lastname@example.org.
Once a completed form is received, the APVMA will consider the suspension request pursuant to section 42 of the Agvet Code and will give written notice of its decision on this request to you under section 42(2) of the Agvet Code. Please note, the APVMA must give written notice of all proposed suspensions to State Coordinators at least 10 days before a suspension, except in exceptional circumstances. Please take this timeframe into account when submitting a request to suspend an approval or registration.
If the APVMA suspends the approval or registration, details of the suspension will be published in the Gazette, including instructions that set out how a person can deal with the suspended active constituent, suspended product or product bearing a suspended label. It is generally considered that a suspended active constituent (including products containing the active constituent), suspended product or product bearing a suspended label cannot be supplied during the suspension period unless the APVMA grants permission to do otherwise.
To be notified of voluntary suspensions via email, please complete a subscription form and select 'voluntary suspensions at the request of the holder'.
Amending a suspended approval or registration
Holders may make an application to vary the relevant particulars or conditions for a suspended active constituent, product registration or label approval, provided the application relates to the reason for the suspension (in accordance with section 43(5) of the Agvet Code). The APVMA must be able to determine that the variation application is to address the reason for suspension or the application may be refused.
Please use the APVMA Online Services Portal to commence an application. If you experience difficulties applying to vary your suspended active constituent, product registration or label approval please contact email@example.com.
Holders may also make prescribed or notifiable variations to suspended active constituents, products or labels provided the variation relates to the reason for the suspension. For further information on how to make a prescribed or notifiable variation, please refer to the minor variations section of our website.
Revoking a suspension
If the reason for a suspension was to address an issue related to compliance with legislated criteria in the Agvet Code (for example, an active constituent or product registration was suspended as the product may not meet the safety, efficacy or trade criteria), the APVMA will not revoke the suspension until such issue has been addressed through an application.
Once the APVMA completes assessment of the variation application and determines that relevant issues have been addressed and all legislated criteria have been met, the suspended active constituent, product or label will be re-instated. A Gazette notice will be published advising of the updated registration or approval once the application has been finalised.
The APVMA will consider a request to revoke a suspension in accordance with section 46 of the Agvet Code if the reason for the suspension was not due to compliance with legislated criteria (for example, suspension was requested for business reasons). If the APVMA agrees to revoke the suspension, the holder will be advised in writing and a notice of revocation will be published in the Gazette.
Holders may request to revoke a suspension by contacting the APVMA at firstname.lastname@example.org. Requests must be in writing and signed by an authorised person.