Reconsidering approvals and registrations

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 APVMA’s functions and exercising its powers relating to reconsidering approvals and registrations under Division 4 of Part 2 of the Agvet Code.
  3. It covers initiating reconsiderations, giving notice and obtaining information for the purposes of the reconsideration, and the process of reconsideration (including deciding on the scope of the reconsideration and what the APVMA takes into account in carrying out the reconsideration).
  4. The provisions of the Agvet Code and the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations) covered by this guideline are outlined in the annexure to this guideline.
  5. This guideline commences on 22 July 2020.

1.1. Overview

Division 4 of Part 2 of the Agvet Code provides for the reconsideration of:

  1. the approval of an active constituent for a proposed or existing chemical product
  2. the registration of a chemical product, and
  3. the approval of a label for containers for a chemical product.

The APVMA may invite the public to propose reconsiderations of active constituents, chemical products or labels. The APVMA can also commence a reconsideration of its own initiative.

Before commencing a reconsideration the APVMA must prepare a work plan in accordance with regulation 20(1) of the Agvet Code Regulations. A work plan must be regularly updated in accordance with regulation 20(2). Note that the work plan requires calculation of the proposed time frame for the reconsideration in accordance with regulation 78B.

The Division sets out the notice and other requirements associated with the reconsideration process. Following reconsideration, the APVMA must:

  1. affirm the approval or registration
  2. vary the relevant particulars or conditions of the approval or registration in such a way as to allow the approval or registration to be affirmed, or
  3. suspend or cancel the approval or registration.

1.2. How are reconsiderations initiated?

The APVMA may reconsider an approval or registration under section 31 of the Agvet Code if, based on information, the APVMA has reason to believe:

  1. for an active constituent—that the constituent may not meet the safety criteria or may not comply with a requirement prescribed by the Agvet Code Regulations
  2. for a chemical product—that the product may not meet the safety criteria, the trade criteria or the efficacy criteria or may not comply with a requirement prescribed by the Agvet Code Regulations
  3. for a label—that the label may not meet the labelling criteria or may not comply with a requirement prescribed by the Agvet Code Regulations.
  4. The information may include the following:
    1. information we have generated or obtained through the performance of our functions (including our surveillance functions)
    2. information given to us by the holder of an approval or registration
    3. information given to us by third parties (including adverse experience reports from product users, and reports or other information from government bodies, research bodies and advocacy groups including equivalent overseas regulators)..

1.3. Notice of reconsideration to the holder—what will it require and by when?

Under section 32(1) of the Agvet Code, we must give written notice of a reconsideration of an approval or registration to the holder. The notice will, among other things, require the holder to provide specified information, and invite the holder to make written submissions within a specified period in relation to the matters the APVMA proposes to deal with in the reconsideration and the reasons for so proposing.

  1. In determining the ‘period’ within which the holder must respond to the notice, the APVMA will take into account the requirements of the notice, such as the kind of information required to be provided, whether the information is readily available, and the steps the recipient would need to take to provide the information.  The period cannot be less than 28 days after the day the notice is given.  The APVMA may extend the period by written notice to the holder.

  2. The APVMA will require the holder to give it either or both of the following:
    1. any information of a kind specifically stated in the notice of which the holder is aware (being information the APVMA regards as relevant to the reconsideration), and/or
    2. any other information of which the holder is aware that is relevant to the reconsideration.
  3. Failure by the holder to provide the information within the stipulated period is a criminal offence and may give rise to a civil penalty.
  4. When the APVMA asks for information of which the holder is aware, it means information that is known or in existence. The APVMA would not require the holder to provide it with specific information if it would require the holder to undertake substantial work to generate information to comply with the notice (rather, the APVMA would issue a notice under section 33 of the Agvet Code for that purpose).

1.4. Informing others and inviting submissions—how and by when?

Under section 32(2) of the Agvet Code, the APVMA may, if it thinks it desirable to do so, inform any person, in any matter it thinks appropriate, that it proposes to reconsider or is reconsidering an approval or registration—in which case the APVMA may, among other things, invite them to make written submissions within a specified period in relation to the matters the APVMA proposes to reconsider or is reconsidering.

  1. The APVMA will generally publish a notice in the Gazette and on its website to inform all relevant stakeholders and the public at large of a reconsideration (or proposed reconsideration), and to invite submissions. This is to ensure that the APVMA informs as many people as possible who may have an interest in a reconsideration (or proposed reconsideration).
  2. In determining the ‘period’ within which written submissions must be made, the APVMA will take into account the nature of the reconsideration (or proposed reconsideration). Generally, the APVMA will request that written submissions be made within 28 days (it cannot be for a shorter period) however longer periods may be appropriate depending on the number and nature of matters to be taken into account as part of the reconsideration or proposed reconsideration.

1.5. When will the APVMA require further information, reports, results or samples from the holder?

Under section 33 of the Agvet Code, the APVMA may issue a notice to a holder requiring, within a ‘reasonable period’, that the holder:

  1. give the APVMA specified information
  2. carry out a search of published literature and provide the APVMA with a report on the result of that search
  3. conduct or cause to be conducted trials or laboratory experiments and provide the APVMA with the results of the trials or experiments, or
  4. provide the APVMA (or another specified body) with a sample of an active constituent, or chemical product or any of its constituents, for analysis.
  5. the APVMA may issue a notice where the information sought or the thing required to be done:
    1. is necessary for the APVMA to undertake the reconsideration, and
    2. the information is not information that the APVMA has or is likely to receive in response to the notice issued to the holder under section 32(1) of the Agvet Code.
  6. if the APVMA decides to issue a notice, it will do so:
    1. as early in the reconsideration process as is appropriate, and
    2. by issuing a single consolidated notice to the holder in relation to the reconsideration (rather than issuing multiple notices in respect of the same reconsideration), where appropriate.
  7. the APVMA will not issue a notice if to do so would likely compromise its ability to undertake the reconsideration within the applicable statutory timeframe.

1.6. What does a ‘reasonable period’ mean?

The length of ‘reasonable period’ will depend on the particular circumstances of the reconsideration and will vary in each case.

  1. In determining what a ‘reasonable period’ is, the APVMA will take the following into account:
    1. the maximum period prescribed by regulation 21 of the Agvet Code Regulations, and
    2. the requirements of the proposed notice, such as the kind of information required to be provided, whether the information is readily available, and the steps the recipient would need to take to provide the information.

1.7. When will the APVMA allow a holder further time to respond to a notice?

The APVMA may allow the holder a further period to respond to a notice if an extraordinary event or circumstance beyond the holder’s control prevents the holder from fulfilling the obligations in the notice (section 33(1B) and regulation 21(3)).

  1. an extraordinary event or circumstance may include such things as natural disasters and similar events beyond the holder’s control (for example, the destruction of premises or documents by flood or fire).
  2. the APVMA will not allow further time to respond to a notice merely to allow the holder more time in which to generate new information, or to accommodate the impending end of a limitation or restriction on the use of particular information.

In order to satisfy the notice requirements, the information needs to be provided to the APVMA in a specified manner described in section 33(1D).  Failure of a holder to comply with a notice under section 33 is a criminal offence and may also give rise to a civil penalty.

1.8. How will the APVMA decide what will be covered by the reconsideration?

Section 34(1) of the Agvet Code sets out matters about which the APVMA must be satisfied of to affirm an approval or registration following reconsideration. However, the APVMA needs only be satisfied of those matters to the extent that the APVMA decides that those matters are to be covered by the reconsideration (section 34(2)). For example, the APVMA may decide to reconsider the registration of a chemical product only on the basis that it may not meet the safety criteria, in which case the APVMA will decide that the reconsideration will only cover whether or not the product meets the safety criteria.

  1. The matters to be covered by the reconsideration will depend on whether, based on information, the APVMA has reason to believe:
    1. for an active constituent—that the constituent may not meet the safety criteria or may not comply with a requirement prescribed by the Agvet Code Regulations
    2. for a chemical product—that the product may not meet the safety criteria, the trade criteria or the efficacy criteria or may not comply with a requirement prescribed by the Agvet Code Regulations
    3. for a label—that the label may not meet the labelling criteria or may not comply with a requirement prescribed by the Agvet Code Regulations.
  2. The information may include the following:
    1. any information given or submissions made in response to a notice issued under section 30 of the Agvet Code in relation to the reconsideration
    2. any information given or submissions made in response to a notice issued under section 32(1) of the Agvet Code in relation to the reconsideration
    3. any submissions made in response to an invitation issued under sections 32(2A)(b) or 34AB(2)(f) of the Agvet Code in relation to the reconsiderationany submissions made in response to an invitation issued under sections 32(2A)(b) or 34AB(2)(f) of the Agvet Code in relation to the reconsideration
    4. any information, reports, results or samples provided in response to a notice issued under section 33(1) of the Agvet Code in relation to the reconsideration
    5. any information given to the APVMA as required by section 161 of the Agvet Code in relation to the subject of the reconsideration
    6. any other information the APVMA has generated or obtained through the performance of its functions that is relevant to the reconsideration, including information the APVMA has obtained from the holder or from third parties (including adverse experience reports from product users, and reports or other information from government bodies, research bodies and advocacy groups including equivalent overseas regulators).
  3. The matters to be covered by the reconsideration may change during the course of the reconsideration.

1.9. What does the APVMA take into account in carrying out a reconsideration?

In undertaking a reconsideration the APVMA must first determine whether it can affirm the approval or registration. In doing this the APVMA must have regard to the information specified in section 34(3) of the Agvet Code, including any other information the APVMA considers necessary to enable it to make a decision on the reconsideration.

  1. This information includes all of the information referred to above to the extent the APVMA considers it necessary to enable it to make a decision whether to affirm the approval or registration.

Section 30 of the Agvet Code authorises the APVMA to invite the public to propose reconsiderations. Section 31 authorises the APVMA to reconsider approvals and registrations (see also regulations 20 and 78B of the Agvet Code Regulations). Section 32 deals with notice requirements prior to reconsideration (see also regulation 21 of the Agvet Code Regulations). Section 33 allows APVMA to require the holder to provide information, reports, results or samples. Sections 34, 34A and 34AA deal with the reconsideration process and possible outcomes. Section 34AB deals with notice requirements in respect of the proposed decision on the reconsideration. Sections 34AC deals with notice requirements if the APVMA affirms the approval or registration following reconsideration (see also regulation 22 of the Agvet Code Regulations). Section 34F deals with reconsideration of approval of a label without notice (see also regulation 22AA of the Agvet Code Regulations).

Failure to comply, without reasonable excuse, with a requirement in a notice under sections 32(1) or 33 of the Agvet Code may lead to suspension and cancellation of an approval or registration by the APVMA under section 38.

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