1. What is this guideline about?

  1. This guideline is made pursuant to section 6A of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code).
  2. The purpose of this guideline is to set out our principles and processes in relation to performing the Australian Pesticides and Veterinary Medicines Authority's (APVMA) functions and exercising its  powers under Division 4A of Part 2 of the Agvet Code.
  3. This guideline does not cover:
    1. the provisions limiting the APVMA’s capacity to use certain information, in section 14B of the Agvet Code and Part 7B of the Admin Act
    2. the compensation provisions in Part 3 of the Agvet Code
    3. the disclosure of confidential commercial information, provided for in section 162 of the Agvet Code.
  4. This guideline commences on 21 July 2020.

2. Overview

  1. The APVMA can use information the APVMA obtains from any source for the purpose of performing any functions or exercising any powers under the Agvet Code and the Agvet Code Regulations, subject to certain limitations contained in the Agvet Code and the Agvet Code Regulations (section 6C).
    1. These limitations include those contained in what are commonly referred to as the ‘limits on use of information’ provisions (see Division 4A of Part 2 of the Agvet Code). Subject to specific exceptions, these provisions limit the use the APVMA can make of information given to the APVMA: in connection with an application for approval or registration under section 10 of the Agvet Code
    2. in connection with an application for variation of the relevant particulars or conditions of approval under section 27 of the Agvet Code
    3. under section 161 (which imposes a standing requirement on certain persons to provide us with certain information).

3. General rules concerning limits on use of information

3.1. What information is covered by the limits on use of information provisions?

  1. Section 34G of the Agvet Code contains general rules preventing the APVMA from ‘using’, for the purposes of assessing or making a decision on an application under sections 10, 27, 26C, 29A or a reconsideration decision under Division 4 of Part 2, ‘information’ given to the APVMA ‘in connection with’ other applications under sections 10 or 27 or given under section 161. The APVMA must not use the ‘information’ for these purposes unless an exception applies (see below).
  2. The general rules in section 34G do not apply to information given to the APVMA before the section commenced in 2014 (see section 34G(2)).

3.2. What is meant by 'information'?

  1. ‘Information’ is not defined in the Agvet Code and is therefore given its ordinary meaning. It includes any knowledge communicated to the APVMA to enable the APVMA to assess relevant criteria for an active constituent, a chemical product or a label in undertaking the assessment of an application, a variation or a reconsideration (such as the safety criteria, the efficacy criteria or the trade criteria). It includes such things as reports, studies, reviews, descriptions of methods of analysis, scientific argument prepared to address relevant criteria, or other scientific work intended to inform the APVMA assessment of relevant criteria.

3.3. What is meant by 'in connection with' an application?

  1. Information is given ‘in connection with’ an application if the information is given to to the APVMA by an applicant for the purposes of assessing the applicant’s application, or to otherwise inform the APVMA assessment of the applicant’s application.

3.4. ​What is meant by 'use of information'?

  1. For the purposes of the ‘limits on use of information’ provisions, the Agvet Code defines the ‘use of information’ to include:
    1. applying  a decision made, or a conclusion reached, based on the information;
    2. the use of knowledge or understanding gained from the information.
    3. Example: If a registered chemical product is referenced in an application for registration of a new chemical product, the referencing of that product is regarded as use of the information underpinning the registered product’s registration (that is, the information which informed the APVMA assessment and registration of that product). This is because the purpose of referencing a registered chemical product is to enable the APVMA to rely on the APVMA’s satisfaction of particular criteria for the registered product as establishing the APVMA’s satisfaction of those criteria for the new product.

4. What are the exceptions to the limits on use of information?

  1. Sections 34J to 34M of the Agvet Code provide for exceptions to the general rule limiting the use the APVMA can make of the information referred to in section 34G of the Agvet Code. This guideline covers these exceptions.

4.1. Where the limitation period has expired

The APVMA may use information subject to the ’limits on use of information’ provisions if a limitation period applies to that information and the limitation period has ended or, in respect of a reconsideration, if the decision on the reconsideration is made after the limitation period has ended (sections 34L and 34M of the Agvet Code).

  1. The APVMA will generally consider whether this exception is available before considering whether any other exceptions may be available.
  2. If a limitation period does not apply to the information (or if it does and the relevant period has not ended), the information remains subject to the ‘limits on use of information’ and confidential commercial information provisions (unless an exception applies).
  3. The limitation periods are set out in section 34M and only apply in relation to information given to the APVMA under sections 10 or 27 if that information was relied on by the APVMA in making particular decisions. If it was not relied upon it is protected indefinitely. Information given under section 161 does not have this restriction.

4.2. Consent to use

The APVMA may use information subject to the ’limits on use of information’ provisions if the ‘authorising party’ gives written consent to the use of the information (section 34J(2) of the Agvet Code).

  1. It is the responsibility of the applicant or holder to obtain the written consent of the ‘authorising party’ and give it to the APVMA. The APVMA will not obtain the written consent on behalf of the applicant or holder. The written consent must be signed by the authorising party.
  2. The information otherwise remains subject to the ‘limits on use of information’ and confidential commercial information provisions (unless an exception applies).

4.3. Use in the public interest

The APVMA may use information subject to the ‘limits on use of information’ provisions if the APVMA is satisfied that the use is in the ‘public interest’ (section 34J(3) of the Agvet Code).

  1. The information otherwise remains subject to the ‘limits on use of information’ and confidential commercial information provisions (unless an exception applies).
  2. The APVMA will not rely on the public interest exception if another exception applies.
  3. The APVMA must give notice to the original provider of the information before using the information under this exception (section 34K).

4.4. Information does not favour the applicant or holder

The APVMA may use information subject to the ‘limits on use of information’ provisions if the information relates to a proposed or existing approval of an active constituent for a proposed or existing chemical product, or to a proposed or existing registration of a proposed or existing chemical product, and the information shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria (section 34J(4) of the Agvet Code).

  1. The APVMA may rely on this exception if the APVMA considers that the information may result in the APVMA either refusing the application or not affirming the approval or registration (as the case may be) on the basis that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria.
  2. The information otherwise remains subject to the ‘limits on use of information’ and confidential commercial information provisions (unless an exception applies).

4.5. Information given again

The APVMA  may use information subject to the ‘limits on use of information’ provisions to assess or make a decision on an application or to reconsider an approval or registration if the information is also given to the APVMA  in connection with the application or the reconsideration (as the case may be) (section 34J(5) of the Agvet Code).

  1. The information otherwise remains subject to the ‘limits on use of information’ and confidential commercial information provisions (unless an exception applies).

4.6. Information is publicly available

The APVMA may use information subject to the ‘limits on use of information’ provisions if the information is publicly available (section 34J(5B) of the Agvet Code).

  1. Information that is publicly available includes such things as published reports or articles or other documents (including where they are published on the internet), and information that is otherwise accessible to the public (for example, information on a publicly-accessible register).
  2. Information that is or becomes publicly available is not subject to the ‘limits on use of information’ provisions and confidential commercial information provisions may not apply by virtue of this exception.

4.7. Information given to the APVMA in connection with certain applications

The APVMA may use information subject to the ‘limits on use of information’ provisions if the information was given to to the APVMA in connection with certain applications (section 34J(6) of the Agvet Code).

  1. The APVMA may use information given to the APVMA in connection with an application for approval, as an active constituent for a chemical product, of a substance that was an endorsed active constituent on 1 January 2005.
  2. The APVMA may use information given to the APVMA  in connection with an application for the variation of the relevant particulars or conditions of the approval of an active constituent for a chemical product.
  3. This information is not subject to the ‘limits on use of information’ provisions by virtue of this exception, however would be subject to confidential commercial information provisions.

Section 6C of the Agvet Code deals with the APVMA’s right to use information. Division 4A of Part 2 deals with limits on use of information.

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