Holders are required to notify the Australian Pesticides and Veterinary Medicines Authority (APVMA) of new information under section 161 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code).
A notification under section 161 is required if the holder of:
- registration or a permit in relation to a chemical product; or
- the approval or a permit of an active constituent for a proposed or existing chemical product; or
- the approval of a label for containers for a chemical product;
becomes aware of any relevant information in relation to the constituent in relation to the product or of any of its constituents, or in relation to the label, the holder must, as soon as the holder becomes aware of the information, give that information to the APVMA.
A corporation is taken to be aware of any information if a related corporation is aware of that information.
Information is relevant information if it:
- contradicts information entered in the Record, Register or Record of Permits for the constituent or product or in the relevant APVMA file for the label; or
- shows that the constituent or product may not meet the safety criteria, trade criteria, efficacy criteria, or that the label may not meet the labelling criteria.
- new studies showing different information to what was previously provided
- reports of crop damage suspected to be caused by use of the product
- out-of-specification results for batches of a veterinary product or active constituent
- product defects which may have implications for safety or efficacy
- information obtained as a result of the manufacture, supply or use of the constituent or product – such as from product complaints, an adverse experience report or as a result of residues monitoring.
When to report
Relevant information should be reported to the APVMA as soon as the holder becomes aware of the information. The APVMA should be notified prior to investigating further, although information provided can include an outline of how the holder proposes to investigate.
It is an offence not to comply with the obligations imposed by section 161 of the Agvet Code.
How to report relevant information
Any information that is given to the APVMA under section 161 of the Agvet Code must be provided in writing signed by the holder.
Information given by email must include an electronic signature of the holder. These may be sent to firstname.lastname@example.org with the subject ‘Section 161: notification of relevant information’.
Alternatively, information can be provided to the APVMA by mail to the postal address on our website.
Information provided to the APVMA through other means, for example as a report of an adverse experience or in preparation for a manufacturing audit, does not discharge obligations under section 161.
What will happen next
The APVMA will record the date a notification is made under section 161 and assess the information provided. The further action required, if any, will be communicated to holders.