Varying relevant particulars and conditions

1. What is this guideline about?

  1. This guideline is made pursuant to section 6A of the Agricultural and Veterinary Chemicals Code, as set out in the Schedule 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 our functions and exercising our powers relating to varying relevant particulars and conditions under the Agvet Code.
  3. Variations to relevant particulars or conditions can take place in the following ways:
    1. Notified variations of relevant particulars, under Division 2AA of Part 2 of the Agvet Code;
    2. Prescribed variations of relevant particulars under Division 2A of Part 2 of the Agvet Code;
    3. Varying relevant particulars and conditions under Division 3 of Part 2 of the Agvet Code.
  4. See the Annexure for provisions of the Agvet Code and the Agvet Code Regulations referred to in this guideline.
  5. This revised guideline commences on 22 July 2020.

2. Notified variations of relevant particulars

2.1. What are ‘notifiable variations’?

  1. Division 2AA provides that certain relevant particulars of an approval or registration may be varied by way of notice given to APVMA by the holder of the approval. These variations are called ‘notifiable variations’
  2. Section 6 of the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2019 sets out the relevant particulars which can be varied by notice including, but not limited to:
    1. variations of the name of the manufacturer of an active constituent or chemical product, or the address at which a product is manufactured by a manufacturer;
    2. variations of the distinguishing name of a chemical product; and
    3. certain variations concerning the instructions for use of a chemical product, or the net contents of an agricultural product.

2.2. How are ‘notifiable variations’ made?

  1. To vary relevant particulars the holder of approvals or registrations may, in writing, lodge notice with the APVMA of one or more notifiable variations of the relevant particulars of an approval or registration. The notice must meet the notice requirements (section 26AB).
    Note: Section 26AD(1) of the Agvet Code defines the notice requirements.
  2. Once a compliant notice has been lodged with APVMA under section 26AB concerning the relevant particulars, APVMA will, under section 26AC of the Agvet Code:
    1. vary the relevant particulars as proposed in the notice, with effect from the day when the notice was lodged; and
    2. within 14 days after the notice is lodged, record the variation of the particulars in the relevant APVMA file, as well as in the Record and the Register.

2.3. Rules of general application

  1. You may lodge a notice containing more than one notifiable variation. The number of notifiable variations contained in it does not alter the application fee for your notice.
  2. If your notice contains multiple variations and at least one of the variations is not in fact a notifiable variation (for example, it is a ‘prescribed variation’), then the APVMA will determine that your notice does not meet the notice requirements (section 26AB). The APVMA will not be able to proceed with the remaining variations in the notice. The APVMA will write to you, explaining why your notice did not meet the requirements and you can then choose to re-submit your variations using the correct pathways.
  3. You may attach, or be required to attach, information to your notice, such as a draft label. In the event that your attached information contradicts the information contained in your notice, the APVMA will only act on the information contained in the notice.
  4. The APVMA will amend the Register so that a product is no longer noted to be a ‘listed chemical product’ if the relevant particulars of that listed chemical product are varied in such a way that the product, or any approved label for the product, does not comply with the ‘established standard’ for the product.

3. Prescribed variations of relevant particulars

3.1. What are ‘prescribed variations’ of relevant particulars?

  1. Division 2A provides for prescribed variations of relevant particulars of approvals and registrations. Prescribed variations of relevant particulars are certain variations of the name of a manufacturer of a chemical product, the address of each site in Australia where the product is manufactured, and certain variations of the constituents included in chemical products, as set out in section 5 of the Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019.
  2. The APVMA may also determine, by legislative instrument, that certain kinds of variations will be prescribed variations, under section 26B(6) of the Agvet Code.
  3. The APVMA must not determine a variation to be a prescribed variation unless it is satisfied that, with the particulars so varied:
    1. for an active constituent, it would meet the safety criteria; and
    2. for a chemical product, that the product would:
      1. meet the safety criteria, the trade criteria and the efficacy criteria; or
      2. comply with the established standard for the product; and
    3. for a label for a chemical product, that the label would:
      1. meet the labelling criteria; or
      2. comply with the established standard for the product.

3.2. How are ‘prescribed variations’ made?

  1. The holder may apply to the APVMA for one or more prescribed variations of the relevant particulars of an approval or registration. The application must meet the application requirements (section 26B). Note: ‘meets the application requirements’ is defined under section 8A of the Agvet Code.
  2. Under section 26C(1)(a) if the APVMA is satisfied that the application meets the application requirements, it must vary the relevant particulars as proposed in the application. If it is not so satisfied, the APVMA must refuse the application (section 26C(1)(b)).
  3. Section 26D provides that the variation of particulars will take effect when the APVMA records the variation (including the relevant particulars as varied and the date of the variation) in the Record, the Register or the relevant APVMA file.
  4. If relevant particulars of a listed chemical product are varied, and those variations cause the product or an approved label from the product not to comply with the established standard for the product, the APVMA must amend the register so that the product is no longer noted as a listed chemical product.

4. Applying for variation

4.1. Preliminary assessment—where can I get more information?

  1. If a variation being sought by an applicant is not a notifiable or prescribed variation, the applicant will need to apply for variation under Division 3 of Part 2 of the Agvet Code.
  2. Applicants must, when lodging an application to vary relevant particulars or conditions of an approval or registration, ensure that the application contains or is accompanied by all relevant information such that the application ‘meets the application requirements’.
    Note: Section 8A of the Agvet Code defines ‘meets the application requirements’.
  3. We will undertake a preliminary assessment of applications for variation in accordance with Section 6A guideline—preliminary assessment.
  4. For the purposes of section 28(4) of the Agvet Code, we may alter an application, after it has passed preliminary assessment, and with the written consent of the applicant, in accordance with Section 6A guideline—altering applications.

4.2. How will the APVMA determine applications for variation?

  1. The APVMA must be satisfied of the relevant matters in section 29 of the Agvet Code before we can vary the relevant particulars or conditions of an approval or registration. All applications for variations must meet the application requirements. Depending on whether the application is with respect to an active constituent, chemical product or label for a chemical product, we will also need to be satisfied:
    1. For an active constituent, that if the particulars were varied as requested that the constituent would meet the safety criteria;
    2. For a chemical product, that if the particulars were varied as requested the product would meet the safety criteria, the trade criteria and the efficacy criteria, or comply with the established standard for the product; and
    3. For a label for a chemical product, that if the particulars were varied as requested the label would meet the labelling criteria, or comply with the established standard for the product.
  2. We will take into account Section 6A guideline—approvals and registrations in performing this function.

5. Varying on our own initiative

  1. Under section 29A of the Agvet Code, we may, on our own initiative, and with the written consent of the holder, vary the relevant particulars or conditions of an approval or registration.
  1. Division 2AA of Part 2 of the Agvet Code provides for the variation of certain relevant particulars by notice to the APVMA. Section 26AA provides an overview of Division 2AA. Section 26AB of the Agvet Code deals with notices of notifiable variations (see also Section 6 of the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2019). Section 26AC requires the APVMA to vary the relevant particulars in accordance with notices. Section 26AD sets out the notice requirements for notices of notifiable variations.
  2. Division 2A of Part 2 of the Agvet Code provides for the variation of certain relevant particulars by application to the APVMA. Section 26A provides an overview of Division 2A. Section 26B deals with applications for prescribed variations (see also section 5 of the Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019). Section 26C requires the APVMA to make a decision concerning prescribed variations on application. Section 26D deals with how the prescribed variation will take place.
  3. Division 3 of Part 2 of the Agvet Code provides for the variation of relevant particulars or conditions of an approval or registration. Section 27 of the Agvet Code deals with applications to vary a relevant particular or condition. Section 28 deals with preliminary assessment of the application (see also regulation 19AD of the Agvet Code Regulations). Section 29 deals with assessment of an application for a variation. Section 29A gives us the power to vary a relevant particular or condition on its own initiative, with the consent of the holder. Section 29B sets out how a variation takes place.

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