This content is current only at the time of printing. This document was printed on 11 September 2020. A current copy is located at http://www.xlg888.com/node/10826
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Reporting relevant information
Holders of active constituent approvals, registration holders and permit holders must provide the APVMA with any information they become aware of, after approval or registration that shows the safety, trade or efficacy criteria may no longer be met, or that contradicts information held by the APVMA for the active constituent or product.
- new studies show different information to what was previously provided
- information obtained as a result of the manufacture, supply or use of the constituent or product—such as from an adverse experience report or as a result of residues monitoring.
Only relevant information is required
Section 161 of the Agvet Code states that holders of active constituent approvals, registration and permits must provide any relevant information to the APVMA that they become aware of as soon as they become aware of it.
Information is relevant if it:
- contradicts any information the APVMA has recorded in the record of approved active constituents, register of chemical products or record of permits; or
- shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria.
Section 160A of the Agvet Code imposes a similar obligation on applicants to provide relevant information that becomes available while an application for an approval, registration, permit or license is being evaluated by the APVMA.
How to report relevant information
Information that is relevant for the purposes of section 161 or 160A of the Agvet Code can be provided by:
- reporting it through the adverse experience reporting form on the APVMA’s website, or
- mail to our street address or post office box, or
- email to email@example.com.
When sending information to the APVMA, please identify why the information is relevant for the purposes of section 161 or 160A and why you believe the information shows the constituent or product may no longer meet the safety, trade criteria or efficacy criteria.
For information about products still being evaluated please ensure the application reference number is included, and clearly state why you believe the information is required by section 160A of the Agvet Code and why you believe the information is relevant.
What will happen next
The APVMA will acknowledge receipt of the reported information.
The APVMA will assess the information to determine what action if any is required.
If APVMA assesses the information is relevant we will contact you to advise:
- what changes, if any, can be made to bring the product in line with safety, trade or efficacy criteria, or
- that a chemical review of the product is required.
If the APVMA assesses the information as not relevant, we will:
- contact you to clarify your reasons for providing it and whether the information should be submitted as part of a variation application, or
- acknowledge the information has been received and that no further action is required.
Information provided about unfinalised product or active constituent applications will be assessed as part of the evaluation.
For details about sections 161 and 160A and the types of information defined as ‘relevant information’ see the Agricultural and Veterinary Chemicals Code Act 1994.