Reporting New Information
The APVMA has prepared information to assist applicants, approval and permit holders and registrants to comply with the requirements of s161 and s160A of the Agvet Code.
Please read the Guidance on Submission of Relevant Information to the APVMA (under s160A and s161 of the Agvet Code) (external site).
This document is a guidance and should not be considered a substitute for competent legal advice. The reader is encouraged to refer to the relevant legislation and seek legal opinion as necessary.
Overview
By law, interested persons and permit holders must provide information to the APVMA if information becomes available that alters or might alter the conclusions that the APVMA would have made about the product had the information been available at the time of registration or issue of permit.
Such information can become available as a result of:
- new studies being conducted that show different information to that previously available
- experiences obtained as a result of manufacture, supply or use of the product
(eg. adverse experience reports, residues monitoring, epidemiological studies).
Without this information, the APVMA would be unable to assess the impact the information would have on its previous considerations about the product.
For full details, please read Section 161 of the Agricultural and Veterinary Chemicals Code Act 1994 (the AgVet Code).
Similar requirements are imposed by section 160A of the AgVet Code on provision of relevant information that might become available whilst a product or active constituent is undergoing APVMA consideration for registration or approval.
Notification of relevant information under s161 and s160A is mandatory and failure to notify is subject to penalties.