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/1081
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The Australian Pesticides and Veterinary Medicines Authority (APVMA) may issue recall or stop supply notices under the Agvet Code. This is a step that may be taken where:
- a product is unregistered or the registration is being re-considered under section 101 of the Agvet Code,
- the formulation does meet the safety, trade or efficacy criteria; the concentration, composition or purity differs more than the prescribed extent as outlined in section 102 of the Agvet Code,
- the label differs from the approved label, (including being unapproved) under section 103 of the Agvet Code,
- we consider there is a need for our intervention based on risk, noncompliance with Agvet legislation or an absence of responsible product stewardship.
The legislation requires that certain details of APVMA-initiated recalls are published in the Gazette. Penalties apply under section 105 of the Agvet Code for not complying with a recall or stop supply notice.
The APVMA also publishes manufacturer-initiated recall notices as a public service; the APVMA does not endorse either the product or the company. The APVMA may take further regulatory action when necessary.
Section 161 of the Agvet Code imposes reporting obligations on holders of approvals, registrations and permits. The APVMA considers that holders have met their obligations in notifying the APVMA on submission of accurate information, which for recalls is in the approved form to email@example.com.
To be notified of recalls via email, please complete a subscription form and select recall notices.
A manufacturer or supplier may initiate a recall for a variety of reasons. The recall may occur in response to a manufacturing quality issue or other concern related to specific batches of a chemical product.
It is important to notify the APVMA of any issue concerning product quality and compliance. Product registrants and manufacturers have responsibilities for product stewardship. However, not all recalls represent noncompliance with statutory requirements. When a recall notification is received, the APVMA will assess the risk and provide prompt advice about the holder’s responsibilities.
The APVMA encourages the reporting of potential recalls as soon as a problem is identified, and considers that prompt reporting demonstrates sound product stewardship.