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 (Cth) (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 relating to approvals and registrations under Division 2 of Part 2 of the Agvet Code.
3. It covers preliminary assessments, determining applications (including the information the APVMA takes into account), restrictions on the APVMA’s power to approve or register, conditions on approvals and registrations, and notices of proposed decisions.
4. The provisions of the Agvet Code and the Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) (Agvet Code Regulations) covered by this guideline are outlined in the annexure to this guideline.
5. This guideline commences on 20 July 2020.

2. Preliminary assessment – where can I get more information? 

1. The APVMA expects applicants to lodge an application for approval or registration that contains or is accompanied by all relevant information such that the application ‘meets the application requirements’.
2. Note: Section 8A of the Agvet Code defines ‘meets the application requirements’.
3. The APVMA will undertake a preliminary assessment of applications for approval or registration in accordance with Section 6A guideline – preliminary assessment.
4. For the purposes of section 11(4) of the Agvet Code, the APVMA may alter an application, after it has passed preliminary assessment, with the written consent of the applicant, in accordance with Section 6A guideline – altering applications.
5. e. Following preliminary assessment of an application, and prior to determination of that application, the APVMA may recategorise the application in accordance with Section 6A guideline – recategorising applications.

3. How will the APVMA determine applications for approval or registration?

1. The APVMA must be satisfied of the relevant matters in section 14 of the Agvet Code before it can approve an active constituent or label, or register a chemical product.   This includes being satisfied that the active constituent meets the safety criteria; or chemical product meets the safety, efficacy and trade criteria and that a label meets the labelling criteria.

3.1. When will the safety criteria be met?

1. To approve an active constituent or register a chemical product, the APVMA must be satisfied that, among other things, the constituent or product meets the safety criteria in accordance with section 5A of the Agvet Code.
2. In satisfying itself that an active constituent meets the safety criteria, the APVMA must have regard to the matters set out in section 5A(2)(a), and the APVMA may have regard to such other matters as it thinks relevant (section 5A(2)(b)). In satisfying itself that a chemical product meets the safety criteria, the APVMA must have regard to the matters set out in section 5A(3)(a), and it may have regard to the matters set out in section 5A(3)(b), including such other matters as the APVMA thinks relevant (section 5A(3)(b)(vi)).

3.2. When will the efficacy criteria be met?

1. To register a chemical product, the APVMA must be satisfied that, among other things, the product meets the efficacy criteria in accordance with section 5B of the Agvet Code.
2. The APVMA must do this by having regard to the matters set out in sections 5B(1) and 5B(2) of the Agvet Code, but only to the extent that the APVMA thinks those matters are relevant (see section 5B(3)).
3. For certain chemical products or classes of chemical products, the APVMA may think that it is not relevant to have regard to the matters in sections 5B(1) and 5B(2) for the purposes of the operation of the Agvet Code in relation to those products or classes of products.

3.3. When will the trade criteria be met?

1. To register a chemical product, the APVMA must be satisfied that, among other things, the product meets the trade criteria in accordance with section 5C of the Agvet Code.
2. The APVMA must do this by having regard to the matters set out in sections 5C(1) and 5C(2) of the Agvet Code for chemical products where it can reasonably be expected that the product will be used in relation to a:
   1. crop or animal, a product of which might be provided to a place outside Australia, or
   2. crop that will be fed to an animal, a product of which might be provided to a place outside Australia (see section 5C(3) and regulation 8AD).
3. For any other chemical product, the APVMA must only have regard to the matters set out in sections 5C(1) and 5C(2) to the extent that the APVMA thinks those matters are relevant (see section 5C(3) and regulation 8AD).
4. For certain chemical products or classes of chemical products, the APVMA may think that it is not relevant to have regard to the matters in sections 5C(1) and 5C(2) for the purposes of the operation of the Agvet Code in relation to those products or classes of products.

3.4. When will the labelling criteria be met?

1. To approve a label for containers for a chemical product, the APVMA must be satisfied that the label meets the labelling criteria in accordance with section 5D of the Agvet Code.
2. The APVMA must be satisfied that the label contains adequate instructions relating to such of the matters set out in section 5D(1) as are appropriate. The APVMA must do this by having regard to the matters set out in section 5D(2) of the Agvet Code.

4. What information does the APVMA take into account in determining an application?

1. Section 8C of the Agvet Code sets out the information that the APVMA must take into account, may take into account and must not take into account in determining an application.
2. Despite section 8C, there is certain information that the APVMA cannot take into account in determining an application. This includes information subject to the limits on use of information provisions in Division 4A of Part 2 of the Agvet Code, and other similar provisions (see section 14B and Part 3 of the Agvet Code and Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth) (Agvet Admin Act). The details of the kind of information subject to the limits on use of information provisions in Division 4A of Part 2 of the Agvet Code, and the extent of the limits, are set out in Section 6A guideline – limits on use of information.
3. Section 8C of the Agvet Code requires the APVMA, in determining an application, to have regard to any submission made in response to an invitation given by the APVMA in relation to the application. The APVMA will only invite a person to make a submission in relation to an application where the APVMA is required by the Agvet Code or the Agvet Code Regulations to invite submissions (see, for example, sections 8S, 12 and 13 of the Agvet Code).

5. How will the APVMA manage related applications for registration and approval?

1. Under section 15 of the Agvet Code, we must not:
   1. register a chemical product unless it also approves each active constituent for the product, and approves a label for the containers for the product
   2. approve a label for containers for a chemical product unless we also register the product.
   3. approve a label for containers for a chemical product unless the APVMA also registers the product.
2. Where the APVMA is required to assess related applications – that is, applications for an active constituent and label approval and chemical product registration, where the applications relate to the same active constituent or chemical product – the APVMA will not take steps to grant any one application unless it is satisfied that all of the applications can be granted.
3. If the APVMA is satisfied that any one of the applications cannot be granted, it will issue a notice proposing to refuse each of the applications under section 8S of the Agvet Code (see below).

6. What kinds of conditions will the APVMA impose on approvals and registration?

1. Section 23(1) of the Agvet Code provides that approvals and registrations are subject to the conditions prescribed in the Agvet Code Regulations and any other conditions imposed that the APVMA thinks appropriate.
2. The APVMA may think it will be appropriate to impose conditions on the:
   1. approval of an active constituent so that the APVMA can be satisfied that the constituent meets the safety criteria (and can, as a result, be approved)
   2. registration of a chemical product so that the APVMA can be satisfied that the product meets the safety criteria, the trade criteria and the efficacy criteria (and can, as a result, be registered)
   3. approval of a label for containers for a chemical product so that the APVMA can be satisfied that the label meets the labelling criteria (and can, as a result, be approved).
3. Any conditions that the APVMA imposes on an approval or registration will be:
   1. consistent with the Agvet Code and the Agvet Code Regulations, and otherwise lawful
   2. consistent with the APVMA’s regulatory approach as set out in the guidelines; and
   3. capable of being monitored and measured.

7. Notice of a proposed decision (section 8S)

7.1. How much time is there to respond to the notice?

1. Once the APVMA has assessed an application, and except where the APVMA decides to grant the application in accordance with the terms of the application, the APVMA will give the applicant a notice of its proposed decision and invite the applicant to make written submissions within 28 days or within a further period specified in the notice (see section 8S of the Agvet Code).
2. In deciding whether to specify a ‘further period', the APVMA will take the following matters into account:
   1. the statutory timeframe for assessing the application, and
   2. the APVMA’s reasons for proposing to take the action set out in the section 8S notice.

7.2. To what extent does the APVMA take into account a response to the notice? 

1. In determining an application, the APVMA must take into account anything given in response to its invitation to make written submissions in the section 8S notice (see section 8C(1)(a)(iii)). However, the APVMA is not required to take account of anything given in response to the invitation that is not related to information:
   1. already given to the APVMA by or on behalf of the applicant, or
   2. on which the APVMA’s reasons for the proposed course of action are based, as set out in the notice (including information not given to the APVMA by the applicant) (see section 8S(3)).
2. b. The following are examples of the kinds of things that are likely to be ‘not related’ to this information:
   1. Reports, data sets or other information that would change fundamentally the nature of the application
   2. Reports, data sets or other information that would require the APVMA to consider the application anew, based on the new information rather than on the information already provided
   3. Reports, data sets or other information that would require the APVMA to ignore the information already provided

8. Annexure – relevant legal provisions

8.1. Applying for approval or registration

1. The Agvet Code provides that a person may apply to the APVMA:
   1. for approval of an active constituent for a proposed or existing chemical product
   2. for registration of a chemical product, or
   3. for approval of a label for containers for chemical product.
2. The application:
   1. must meet the application requirements, and 
   2. for an active constituent or chemical product – must include proposed instructions for the use of the constituent or product.
3. Within 10 working days of receiving the application, the APVMA will notify the applicant that the application has been received.

   Note: Section 10 of the Agvet Code deals with the making of applications. Section 8A defines ‘meets the application requirements’. Regulation 75 of the Agvet Code Regulations deals with the notice requirements.

8.2. Preliminary assessment

1. The Agvet Code provides that the APVMA must complete a preliminary assessment of the application within one month after it is lodged.
2. If it appears from the preliminary assessment that the application meets the application requirements, the APVMA must, within 14 days:
   1. give the required form of written notice to the applicant, and
   2. publish a summary of the application that includes any details prescribed in the Agvet Code Regulations.
3. If it does not appear from the preliminary assessment that the application meets the application requirements, the APVMA must refuse the application.
4. d. The Agvet Code provides that the APVMA may alter an application, after it passes preliminary assessment, with the written consent of the applicant.

   Note: Section 11 of the Agvet Code deals with preliminary assessments (see also regulations 8B, 8D and 8E of the Agvet Code Regulations in relation to summary publication and notice requirements). Section 8A defines ‘meets the application requirements’.

8.3. Determining the application

1. The Agvet Code requires the APVMA to approve the active constituent or label, or register the chemical product if the APVMA is satisfied:
   1. that the application meets the application requirements, and 
   2. for an active constituent – that the constituent meets the safety criteria, and
   3. for a chemical product – that the product:
      1. meets the safety criteria, the trade criteria and the efficacy criteria, or
      2. complies with the established standard for the product, and
      3. for a label for a chemical product—that the label:
         A. meets the labelling criteria, or
         B. complies with the established standard for the product
2. If the APVMA is not satisfied of the relevant matters in respect of a particular application, the APVMA must refuse the application.
3. The Agvet Code sets out information that the APVMA must, may and must not take into account in determining an application.
4. At any time after an application is made and before it is determined, the applicant may withdraw it by giving the APVMA notice of the withdrawal signed by the applicant.

   Note: Section 14 of the Agvet Code deals with determining an application. Section 8A defines ‘meets the application requirements’ (see also section 8B). Section 5A defines ‘meets the safety criteria’ (see also regulation 8AB of the Agvet Code Regulations). Section 5B defines ‘meets the efficacy criteria’. Section 5C defines ‘meets the trade criteria’ (see also regulation 8AD of the Agvet Code Regulations). Section 5D defines ‘meets the labelling criteria’ (see also regulation 8AE of the Agvet Code Regulations). Section 8U deals with the ‘established standard’ for the product. Section 8C deals with the information to be taken into account in determining an application (see also sections 14A and 14B). Section 15 deals with restrictions on our power to register products and approve labels. Section 16 deals with multiple approvals or registrations. Section 23 deals with conditions of approval or registration. Section 8D deals with the withdrawal of applications.

8.4. Notice of proposed decision

1. Before determining an application, the APVMA must, in specified circumstances, give the applicant written notice of what the APVMA proposes to do.

   Note: Section 8S of the Agvet Code deals with these notices.