This content is current only at the time of printing. This document was printed on 4 October 2022. A current copy is located at https://apvma.gov.au/node/190
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A substantiation notice can require a person to produce information or documents to verify claims made about agricultural and veterinary (agvet) chemical products and active constituents.
A substantiation notice under section 69EN of the Administration Act requires you to provide information in relation to imports, possible imports or exports of the product or constituent.
A substantiation notice under section 145G of the Agvet Code requires you to provide information in relation to the supply, manufacture, safety or efficacy of the product or constituent.
The substantiation notice will:
- name the receiving person
- specify the claim or representation to which it relates
- explain the effects of sections 69ENA; 145GA (Compliance with substantiation notices) and 69ENB; 145GB (Failure to comply with substantiation notice) of the Admin Act or Agvet Code respectively.
How to comply with a substantiation notice
If you have received a substantiation notice, you must comply with the listed conditions within the specified time period. We can allow an extension of time, determined by us, if you apply to us within 21 days of receiving the notice.
You must mail or deliver the requested information to the address specified in the substantiation notice within the specified timeframe. Alternatively, we may advise you of a place and contact for you to deliver the information or documents in person. Failure to comply is an offence and penalties may apply.
If you comply with the substantiation notice and submit the required information, we will acknowledge receipt of the information and advise you whether the issue is resolved, or whether further action is needed.
The APVMA can decide to withdraw a substantiation notice if we receive additional information that resolves our concerns.
Non-compliance with a substantiation notice
If you fail to respond to a substantiation notice within the specified time, we may issue an infringement notice, a formal warning or commence court proceedings to seek a civil penalty order.
It is an offence to provide false or misleading information in response to a substantiation notice
Failure to comply with the notice means you are breaching section 69ENB of the Administration Act or section 145GB of the Agvet Code. However, you will not contravene sections 69ENB or 145GB if you refuse to produce particular information or documents that may incriminate you or expose you to a penalty.
If you reasonably believe that the information or documents we ask for would incriminate you, or expose you to a penalty, you may refuse to provide the material on those grounds. In those circumstances, you must still respond to the notice advising that you do not intend to provide the material on that basis.