This content is current only at the time of printing. This document was printed on 20 February 2017. A current copy is located at http://apvma.gov.au/node/190
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- 1. What is in a substantiation notice?
- 2. Overview of the legislative provisions
- 3. What can the substantiation notice require?
- 4. What timeframes apply?
- 5. Can the notice be withdrawn?
- 6. What happens if the notice is complied with?
- 7. What happens if the notice is not complied with?
- 8. What if a person responds to a substantiation notice and provides false or misleading information?
The APVMA has powers under the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Admin Act) and the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) to require a person to produce information or documents to substantiate claims or representations made about agricultural and veterinary (Agvet) chemical products and active constituents. The substantiation powers relate to information about the import, export, supply, manufacture, efficacy and safety of the product.
The authority to issue substantiation notices is intended as a preliminary investigative tool to be used if we suspect that a representation might not be able to be substantiated and is subsequently in breach of the Admin Act, Agvet Code or the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.
We can issue a notice when the basis for claims or representations made in the promotion of the supply of the product or active constituent is not clear.
We issue substantiation notices via registered post or through the engagement of a process server.
This page explains the types of information that you might be required to supply, when it is required, what it must include, how to comply with a substantiation notice, and how we might respond to noncompliance.
1. What is in a substantiation notice?
The notice specifies the claims that we are seeking information about and indicates the types of information or documents that must be provided. It can apply to one or more claims.
2. Overview of the legislative provisions
A substantiation notice under section 69EN of the Admin 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 must name the person to whom it is given, specify the claim or representation to which it relates and 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.
Section 69ENA of the Admin Act and section 145GA of the Agvet Code require you to comply with a substantiation notice within the period specified in the notice. We can allow an extension of time, determined by us, if you apply to us within 21 days of receiving the notice.
Failure to comply with the substantiation notice within the required period will result in a contravention of s 69ENB of the Admin Act or s 145GB of the Code respectively. However, you will not contravene ss 69ENB or 145GB if you refuse to produce particular information or documents that might tend to incriminate you or expose you to a penalty.
Failure to comply with a substantiation notice is an offence, and a civil penalty provision for which we may seek an order for a pecuniary penalty.
3. What can the substantiation notice require?
The substantiation notice can require the provision of information or documents. To comply with the substantiation notice, you must mail or deliver the 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.
4. What timeframes apply?
You must deliver the documents or information required by the substantiation notice within the period specified in the notice.
We can grant an extension of time for your response if you request one in writing. It is up to us whether we grant or refuse an extension. If one is granted, you must comply with the new timeframe.
5. Can the notice be withdrawn?
We can withdraw a substantiation notice at our discretion. We may decide to do so if we receive additional information that resolves our concerns or if you show us that there was a reasonable excuse leading to the claim and withdraw the claim.
6. What happens if the notice is complied with?
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 compliance and enforcement action is needed.
7. What happens if the notice is not complied with?
If you fail to respond to a substantiation notice within the specified time, we may issue an infringement notice, issue a formal warning or commence court proceedings to seek a civil penalty order if we consider it to be in the public interest to do so.
If you, as an individual, reasonably believe that the information or documents we ask for would incriminate you or expose you to a penalty, you may refuse or fail 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.
8. What if a person responds to a substantiation notice and provides false or misleading information?
It is an offence to provide false or misleading information in response to a substantiation notice.