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/10826
You are here
Holders to notify the APVMA of new information
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 holder of the approval or a permit of an active constituent for a proposed or existing chemical product;
becomes aware of any relevant information in relation to the constituent or in relation to the product or of any of its constituents, 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
- shows that the constituent or product may not meet the safety criteria, trade criteria, or the efficacy 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 have may 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 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 by mail; please contact the APVMA on email@example.com for postal details.
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.