Module Descriptors

What is this Guideline about?

  1. This Guideline is made pursuant to section 6A of the Agvet Code.
  2. The purpose of this Guideline is to set out descriptors for working out the appropriate modular assessment level for certain applications and reconsiderations as set out in Schedule 7 to the Agvet Code Regulations. In determining the appropriate modular assessment level, the modular assessment fee and modular assessment period that applies is also determined.
  3. This Guideline is designed to help inform the APVMA and applicants as to the modules that will apply for different types of applications. The Guideline is not the law. The APVMA will have regard to it, but from time to time may depart from it when working out what modules are necessary for a particular application to undergo.
  4. Modular assessment fees are determined in accordance with subregulation 70A(4) of the Agvet Code Regulations. They are based on the modules, levels and types of assessment that the APVMA considers necessary for the application to undergo, in addition to the preliminary assessment module (item 1 of Schedule 7) and the relevant finalisation assessment module (items 11.1 to 11.3 of Schedule 7).
  5. Modular assessment periods are determined in accordance with subregulation 77(2) or regulation 78B of the Agvet Code Regulations. A modular assessment period also depends on the modules or levels of assessment that the APVMA considers necessary for the application.
  6. The Guideline commences on 1 July 2014 and may be updated from time to time.
  7. The Guideline contains 3 Schedules:
    1. Schedule 1 explains the modules that usually apply to different kinds of applications.
    2. Schedule 2 is a dictionary that defines certain terms used in Schedule 1.
    3. Schedule 3 provides links to relevant data for modules.

Schedule 1: Descriptions for working out the module level

Timeshift applications

If an application is an item 27 timeshift application, the modules that the APVMA considers necessary for the application to undergo are the following modules, to the extent that undergoing the modules is consistent with the project plan for the application:

  1. module 1;
  2. module 2.4;
  3. module 3.4;
  4. module 4.2;
  5. module 5.6;
  6. module 6.4;
  7. module 7.4;
  8. module 8.4;
  9. module 9
  10. module 10.4;
  11. module 11.1 or 11.2;
  12. module 12.

Note: A timeshift application can include an application under international work share or global joint review.

Module 1—Preliminary assessment

This module applies to all modular application items.

Module 2—Chemistry

Module 2.1—Level 1 Comprehensive Chemistry Assessment

  1. This module applies to applications for approval of a new active constituent or registration of a new chemical product containing a new active constituent where the new active constituent is:
    1. an active constituent manufactured by chemical synthesis;
    2. a highly purified and well characterised active constituent derived from plants or animals;
    3. a semi synthetic active constituent manufactured by the chemical modification of a highly purified and well characterised intermediate derived from plants or animals;
    4. a semi synthetic active constituent manufactured by the chemical modification of an intermediate produced by conventional fermentation;
    5. an active constituent produced by conventional fermentation or using recombinant DNA technology (excluding biological veterinary chemical products described in module 2.2 paragraph (a) below);
    6. an active constituent produced by transgenic technology (excluding biological veterinary chemical products described in module 2.2 paragraph (a) below);
    7. an active constituent that is a growth regulator, antibiotic or polypeptide; or
    8. some animal tissue extracts and some plant extracts or oils.
  2. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a comprehensive chemistry assessment.
  3. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) above.

Module 2.2—Level 2 Reduced Chemistry Assessment

  1. This module applies to applications for approval of a new active constituent or registration of a new chemical product, of the following type:
    1. new biological chemical products containing a new active constituent except those included in module 2.1 above;
    2. new agricultural chemical products containing a new active constituent which is used in domestic or industrial chemicals;
    3. new agricultural chemical products containing a new manufacturing source of approved active constituent;
    4. new ectoparasiticide veterinary chemical products containing a new manufacturing source of approved active constituent (for which there is no acceptable compendial standard);
    5. new immunobiological veterinary chemical products containing a new active constituent;
    6. immunobiological veterinary chemical products with a major change to seed strains (including substitution of source or the addition of antigen) such that it is considered a new veterinary chemical product;
    7. new direct fed microbial veterinary chemical products containing a new active constituent;
    8. new enzyme veterinary chemical products containing a new active constituent;
    9. new herbal veterinary chemical products containing a new active constituent;
    10. new chemical products where the active constituent in the chemical product has been previously assessed in an application for a permit in relation to that chemical product; or
    11. any other chemical products with a new active constituent which require a chemistry assessment.
  2. For the purposes of module 2.2 paragraph (a) (3), an active constituent may be a solvent, surfactant and oil used to dilute or spread other agricultural chemical products, or a disinfectant or biocide which is a commonly used domestic or industrial chemical. If these active constituents are well known, in common use, and have a history of safety in the context of use, they or the chemical products that contain them may qualify for reduced chemistry assessment.
  3. This module also applies to applications for a permit in relation to chemical products containing a new active constituent.
  4. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a reduced chemistry assessment.
  5. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (c) above.

Module 2.3—Level 3 Limited Chemistry Assessment

  1. This module applies to an application for an approval of new source of approved active constituent.
  2. This module applies to applications for registration of a new chemical product containing an approved active constituent, or for permits in relation to such products, which require an assessment of chemistry and manufacture data for the product only.
  3. This module applies to applications for variation of the particulars or conditions of a registered chemical product which require a chemistry assessment such as:
    1. minor formulation changes requiring technical assessment;
    2. extension of shelf life;
    3. extension of in use shelf life; or
    4. changes to storage temperature or conditions
  4. This module applies to applications for a permit in relation to use of a registered chemical product beyond the registered particulars or conditions of the chemical product where chemistry assessment is required (for example, an extension of the shelf life of a batch of product);
  5. This module also applies to any other application for:
    1. registration of a new chemical product;
    2. variation of the particulars or conditions of a registered chemical product or
    3. variation of the particulars or conditions of approval of a label for containers for a registered chemical product
    which requires a chemistry assessment that is not in module 2.1, or 2.2 or 2.3 (a) to (c) above.
  6. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a limited chemistry assessment.
  7. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (d) above.

Module 3—Toxicology

General information

For the purpose of determining the appropriate module under module 3.1, 3.2 and 3.3, the following veterinary chemical products do not normally require toxicological assessment:

  1. mineral, vitamin or nutritional supplements for a single animal or a small number of animals that are administered directly to the animal or are administered daily in food or water;
  2. animal bacterial and viral vaccines;
  3. direct fed microbial products where all the microbial active constituents are approved and have been previously considered appropriate by the NDPSC;
  4. enzyme products where all of the active constituents in the products are approved and have been previously considered appropriate by the NDPSC; or
  5. applications for variation of the particulars or conditions of a registered veterinary chemical product for a variation of use to non-food producing species.

Module 3.1—Level 1 Comprehensive Toxicology Assessment

  1. This module applies to applications for approval of a new active constituent or registration of a new chemical product containing a new active constituent and which are generally for food producing species, other than applications referred to in module 3.2 or 3.3 below.
  2. This module applies to applications for approval of a permit in relation to a chemical product containing a new active constituent and which are generally for food producing species, other than applications referred to in module 3.2 or 3.3 below.
  3. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a comprehensive toxicology assessment.
  4. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) or (b) above.

Module 3.2—Level 2 Reduced Toxicology Assessment

  1. This module applies to applications for approval of a new active constituent or registration of a new chemical product containing a new active constituent and products which are generally for non-food producing species.
  2. This module applies for applications for a variation of the particulars or conditions of a registered chemical product containing an approved active constituent and which involve an additional use from non-food producing species to food producing species for the first time for any chemical product containing the approved active constituent which the chemical products contain (so that an ADI, with or without an ARfD, is required.
  3. This module applies to applications for approval of a permit in relation to a chemical product containing a new active constituent and products which are generally for non-food producing species.
  4. This module applies to applications for approval of a permit in relation to a chemical product containing an approved active constituent and which involve an additional use from non-food producing species to food producing species for the first time for any chemical product containing the approved active constituent which the chemical products contain (so that an ADI, with or without an ARfD, is required.
  5. This module applies to applications for approval of a research permit in relation to a chemical product which contains a new active constituent and the related product is for a food producing use with restrictions of single season, single use, or specified research personnel.
  6. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a reduced toxicology assessment.
  7. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (e) above.

Module 3.3—Level 3 Limited Toxicology Assessment

  1. This module applies to applications for registration of a new agricultural chemical product containing an approved active constituent and which involve a new formulation or a major formulation change.
  2. This module applies to applications for registration of a new biological chemical product containing a new active constituent, adjuvant or excipient.
  3. This module applies to applications for variation of the particulars or conditions of a registered agricultural chemical product containing an approved active constituent and which involve a variation of use pattern of the product from commercial use to a domestic use in the home or home garden.
  4. This module applies to applications for variation of the particulars or conditions of the approval of a label for containers for a registered chemical product involving changes to one or more of the following:
    1. label safety directions (hazard statements);
    2. label first aid statements; or
    3. poison scheduling;
  5. This module applies to applications for approval of a research permit in relation to a chemical product containing a new active constituent and which the related product is for non-food producing species with restrictions including single season, single use, or specified research personnel.
  6. This module applies to applications for approval of a permit in relation to biological chemical products containing a new active constituent, adjuvant or excipient.
  7. This module applies to applications for approval of a permit in relation to chemical products containing an approved active constituent and which involve a new formulation or a major formulation change.
  8. This module applies to any other application for:
    1. registration of a new chemical product;
    2. variation of the particulars or conditions of a registered chemical product or
    3. variation of the particulars or conditions of approval of a label for containers for a registered chemical product
    which require a toxicology assessment associated with any potential risks to human health that is not referred to in module 3.1, or 3.2 or 3.3 (a) to (f) above.
  9. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a limited toxicology assessment.
  10. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (g) above.

Other modules that may apply

If a poison schedule classification is required a module 4 will also apply.

Module 4—Toxicology (poison schedule classification)

Module 4.1—Toxicology – poison schedule classification

  1. This module applies to applications that are referred to the Secretary of the Department of Health for poisons scheduling, in addition to a module 3 level.
  2. This module may apply to a chemical reconsideration, where poison schedule classification is required.

Module 5—Residues

General information

Residues assessment includes the establishment of residues definition, maximum residue limits (MRLs), and withholding periods (WHPs), and the assessment of the trade implications of an application including the establishment of any export intervals (EIs).

Module 5.1—Level 1 Comprehensive Residue Assessment

  1. This module – comprising the establishment of residues definition, MRLs and WHPs, and the assessment of the trade implications of an application including the establishment of any EIs – applies to applications for:
    1. registration of a new agricultural chemical product containing a new active constituent and for which the product is for use on a food crop;
    2. registration of a new agricultural chemical product containing an approved active constituent and for which the product involves a variation of use from a non-food crop to a food crop for the first time for any chemical product containing the approved active constituent which the chemical products contain;
    3. a variation of the particulars or conditions of a registered agricultural chemical product containing an approved active constituent and for which the product involves a variation of use from a non-food crop to a food crop; or
    4. a permit in relation to agricultural chemical products containing a new active constituent and for which the product is for use on a food crop.
  2. This module applies to applications for:
    1. registration of a new veterinary chemical product containing a new active constituent and for which the product is for use in or on food producing species;
    2. registration of a new veterinary chemical product, containing an approved active constituent and for which the product involves a variation of use from non-food producing species to food producing species for the first time for any chemical product containing the active constituent which the veterinary chemical products contain;
    3. variation of the particulars or conditions of a registered veterinary chemical product containing an approved active constituent and for which the product involves a variation of use from non-food producing species to food producing species for the first time for any chemical product containing the active constituent which the veterinary chemical products contain;
    4. a permit in relation to veterinary chemical products containing a new active constituent and for which the product is for use in or on food producing species.
  3. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a comprehensive residues assessment.
  4. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) or (b) above.

Module 5.2—Level 2 Reduced Residue Assessment—Product Registration only

  1. This module – comprising the establishment or variation of MRLs and WHPs, and the assessment of the trade implications of an application including the establishment of any EIs – applies to applications for:
    1. registration of a new veterinary chemical product containing an approved active constituent and for which the product has a new route of administration in food producing species;
    2. variation of the particulars or conditions of a registered agricultural chemical product containing an approved active constituent and for which the product involves a variation of use to, or use in, a crop producing major export food commodity group;
    3. variation of the particulars or conditions of a registered agricultural chemical product containing an approved active constituent and for which the product involves a variation of use to, or new use in, 6 or more food crops or crops producing feed for food-producing species;
    4. variation of the particulars or conditions of a registered agricultural chemical product involving a major formulation change;
    5. variation of the particulars or conditions of a registered veterinary chemical product containing an approved active constituent and for which the product involves a variation of use in or on, a new food producing species;
    6. variation of the particulars or conditions of a registered veterinary chemical product containing an approved active constituent and for which that product has a change in dose rate or frequency of application to food producing species and where a change to established MRLs are required.
  2. This module applies to applications for variation of the particulars or conditions of the approval of a label for containers for a registered chemical product for which the product has potential risks of residues and where a change to established MRLs is required.
  3. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a reduced residues assessment.
  4. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) or (b) above.

Module 5.3—Level 3 Reduced Residue Assessment—Permit only

  1. This module – comprising the establishment of MRLs and WHPs and the assessment of trade implication– applies to applications for:
    1. a permit in relation to agricultural chemical products containing an approved active constituent for use in or on a crop producing a major export food commodity group;
    2. a permit in relation to agricultural chemical product containing an approved active constituent for use in or on, 6 or more food crops or crops producing feed for food-producing species;
    3. a permit in relation to veterinary chemical products containing an approved active constituent for use in or on new food producing species.
  2. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) above.

Module 5.4—Level 4 Limited Residue Assessment—Product Registration only

  1. This module – comprising the establishment or variation of WHPs and, where necessary, the establishment of MRLs and the assessment of trade implications of an application– applies to applications for:
    1. variation of the particulars or conditions of a registered agricultural chemical products containing an approved active constituent and for which the product involves a variation of use to, or use in, a crop that does not produce a major export food commodity group;
    2. variation of the particulars or conditions of a registered agricultural chemical product containing an approved active constituent and for which the product involves a variation of use to, or use in, less than 6 food crops or crops producing feed for food-producing species;
    3. variation of the approval of a label for containers for a registered agricultural chemical product which have potential risks of residues.
  2. This module – comprising the establishment of WHPs and, the assessment of trade implications of an application including the establishment of any EIs where appropriate – applies to applications for:
    1. registration of a new veterinary chemical product containing an approved active constituent and for which the product involves an existing use patterns;
    2. registration of a new veterinary chemical product containing an approved active constituent for which the products are similar to a reference product except for a change in WHP where no change to the established MRL is required;
    3. variations of the particulars or conditions of a registered veterinary chemical product involving a change in formulation;
    4. variation of the particulars or conditions of approval of a label for containers for a registered veterinary chemical product which have potential risks of residues and where no change to the established MRLs is required.
  3. This module also applies to any other application for:
    1. registration of a new chemical product;
    2. variation of the particulars or conditions of a registered chemical product or
    3. variation of the particulars or conditions of approval of a label for containers for a registered chemical product
    which require a residues assessment that is not referred to in module 5.1, or 5.2 or 5.4 (a) or (b) above.
  4. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a limited residue assessment.
  5. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) or (b) above.

Module 5.5—Level 5 Limited Residue Assessment—Permit or Trial Protocol only

  1. This module—comprising the establishment of WHPs and establishment or variation of MRLs and the assessment of trade implications of an application where appropriate—applies to applications for:
    1. a permit in relation to agricultural chemical products containing an approved active constituent for use on a crop that does not produce a major export food commodity group;
    2. a permit in relation to agricultural chemical product containing an approved active constituent for use on crops from less than 6 food crops or crops producing feed for food-producing species
    3. permit in relation to veterinary chemical products containing an approved active constituent for use in or on food-producing species.
  2. This module—comprising the establishment of WHPs and, establishment or variation MRLs and the assessment of trade implications of an application (where appropriate)—is required for applications for a technical assessment of a trial protocol for an agricultural chemical product for use on a food crop.
  3. This module—comprising the establishment of WHPs and the assessment of trade implications of an application (where appropriate) for applications involving a technical assessment of a trial protocol for a veterinary chemical product for use in or on food producing species.
  4. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (c) above.

Module 6—Work Health and Safety (WH&S)

General information

Several types of applications for registration of a new chemical product do not require WH&S assessment as the product is not normally associated with any potential risks to human health. Where, however, there is any such risk, an appropriate WH&S assessment is required. The types of application for chemical products which do not normally require WH&S assessment are as follows:

  1. applications for a permit for a veterinary chemical product, registration of a new veterinary chemical product or variation of the particulars or conditions of a registered veterinary chemical product that are:
    1. animal therapeutics and mineral and nutritional supplements in tablet, capsule, slow release bolus or skin implant form;
    2. animal therapeutics which have Therapeutic Goods Administration approval for direct administration to humans and the use pattern indicates low worker exposure potential (that is, not mob or flock treatments with a drench or a pour on, or as a feed additive, or other equivalent use pattern, as these have high worker exposure potential);
    3. mineral, vitamin and nutritional supplements for a single animal or a small number of animals and are administered directly to the animal or into daily food or water;
    4. vitamins; digestive enzyme supplements; electrolytes; iron and haematopoietic agents; tonics and stimulants; or preservatives;
    5. micro organism and enzyme products for use in non-food producing species;
    6. stockfood additives and nutrition or metabolism products (other than those listed in this paragraph) with established safety directions, which are directly applicable to the concentration of the additive and the form in which it is to be used;
    7. animal bacterial and viral vaccines;
    8. extension of use applications to non-food producing species; or
    9. approval of a research permit in relation to veterinary chemical products or active constituent.
  2. applications for a permit for an agricultural chemical product, registration of a new agricultural chemical product or variation of the particulars or conditions of a registered agricultural chemical product that are:
    1. products to be used domestically in the home and home garden; or
    2. approval of a research permit in relation to agricultural chemical products or active constituents, excluding new application method or new use situation (approved active constituents) for use by persons generally.
  3. applications a permit for an chemical product, registration of a new chemical product or variation of the particulars or conditions of a registered chemical product that are microbial products where all the microbial active constituents are approved active constituents.

Module 6.1—Level 1 Comprehensive WH&S Assessment

  1. This module applies to applications for registration of a new agricultural chemical product containing new active constituent.
  2. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a comprehensive WH&S Assessment.
  3. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) above.

Module 6.2—Level 2 Reduced WH&S Assessment

  1. This module applies to applications for registration of a new veterinary chemical product containing a new active constituent and for which the product, including biological chemical products, is for use in or on food producing species.
  2. This module applies to applications for registration of a new veterinary chemical product containing a new active constituent and for which the product, excluding biological chemical products, is for use in or on non-food producing species.
  3. This module applies to applications for variations to the particulars or conditions of a registered agricultural chemical product containing an approved active constituent which involves a major formulation change.
  4. This module applies to applications for variations to the particulars or conditions of a registered agricultural chemical product containing an approved active constituent and for which the product involves a new crop group or new situation and/or a new application method.
  5. This module applies to applications for approval of a research permit in relation to agricultural chemical products containing a new active constituent and where the permit applies to persons generally.
  6. This module applies to applications for approval of a permit in relation to veterinary chemical products containing a new active constituent and for which the product, including biological chemical products, are for use in or on food producing species.
  7. This module applies to applications for approval of a permit in relation to veterinary chemical products containing a new active constituent and for which the product, excluding biological chemical products, are for use in or on non-food producing species.
  8. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a reduced WH&S assessment.
  9. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (g) above.

Module 6.3—Level 3 Limited WH&S Assessment

  1. This module applies to applications for variation of the particulars or conditions of a registered veterinary chemical product containing an approved active constituent and for which the product involves a major formulation change and/or a change of use pattern.
  2. This module applies to applications for a variation of the particulars or conditions of approval of a label for containers for a registered chemical product which involve a change or reassessment of user safety directions and/or re-entry or re handling statements.
  3. This module applies to applications for approval of a permit in relation to agricultural chemical products containing an approved active constituent and for which the product which involves a new application method or a new use situation and where the permit applies to persons generally.
  4. This module applies to applications for approval of a permit in relation to veterinary chemical products containing an approved active constituent and for which the product involves a major formulation change and/or a change of use pattern.
  5. This module also applies to any other application for:
    1. registration of a new chemical product;
    2. variation of the particulars or conditions of a registered chemical product or
    3. variation of the particulars or conditions of approval of a label for containers for a registered chemical product
    which require an WH&S assessment that is not referred to in module 6.1, or 6.2 or 6.3 (a) or (b) above.
  6. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a limited WH&S assessment.
  7. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (d) above.

Module 7—Environment

General information

Where there is any potential risk to the environment, an appropriate environmental assessment is required. However, some types of applications for registration of a new veterinary chemical product containing an approved active constituent, or variation to the particulars or conditions of a registered veterinary chemical product, do not require environmental assessment as they are not normally associated with any potential risks to the environment. The types of veterinary products which do not normally require environmental assessment are:

  1. animal therapeutics and mineral and nutritional supplements in single, capsule, slow release bolus or skin implant form other than parasiticides;
  2. animal immunobiological products (except those containing GMOs);
  3. animal therapeutics given by injection for use under prescription in individual animals; or
  4. applications for extension of use of a registered product in/on non-food animals.

Module 7.1—Level 1 Comprehensive Environment Assessment

  1. This module applies to applications for registration of a new chemical product containing a new active constituent unless included in module 7.3 below.
  2. This module applies to applications for registration of a new agricultural chemical product containing an approved active constituent where the approved active constituent has only been approved for use in veterinary chemicals products.
  3. This module applies to applications for registration of a new veterinary chemical product containing an approved active constituent or variation of the particulars or conditions of a registered veterinary chemical product, where a VICH Phase II assessment is required and the reference product (including the approved active constituent of the reference product) has only been subject to a VICH Phase I assessment.
  4. This module may apply to a chemical reconsideration, where the scope of the environmental aspects of the reconsideration includes extensive consideration of fate, effects or environment monitoring data or extensive exposure modelling.
  5. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (c) above.

Module 7.2—Level 2 Reduced Environment Assessment

  1. This module applies to application for registration of a new chemical product containing approved active constituents where the proposed product involves:
    1. a new combination of approved active constituents;
    2. a reference product that is not the same, closely similar or similar;
    3. use in any crop, situation or herd animal unless there is a reference product with the same use with the same active(s) at an equivalent or higher dose, rate and frequency.
  2. This module applies to applications for a variation of the particulars or conditions of a registered chemical product where the variation involves a major formulation change.
  3. This module applies to applications for a variation of the approval of a label for containers for a registered chemical product where the variation involves:
    1. variation to use pattern to include a new crop, a new situation or a new herd animal;
    2. variation to use pattern to include for an existing crop, a situation or herd animal to increase the dose rate, application rate or frequency
    3. to change environmental instructions or warnings
    unless there is a nominated reference product that is the same, closely similar, similar or with the same use with the same active(s) at an equivalent or reduced rate.
  4. This module applies to applications for a permit in relation to chemical products containing a new active constituent or containing an approved active constituent where extensive consideration of fate, effects or environmental monitoring data or extensive exposure modelling are required.
  5. This module may apply to a chemical reconsideration, where the scope of the environmental aspects of the reconsideration requires some consideration of fate, effects or environmental monitoring data or extensive exposure modelling.
  6. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (d) above.

Module 7.3—Level 3 Limited Environment Assessment

  1. This module applies to applications for registration of a new agricultural chemical product (other than a vertebrate poison) containing new or approved active constituents and where the product is for use:
    1. domestically in the home or home garden;
    2. domestically in a swimming pool or spa;
    3. in buildings not used in animal production (for example, warehouses, offices, or glasshouses).
  2. This module applies to applications involving a VICH Phase I environmental impact assessment. VICH Phase I environmental impact assessment may apply to applications for registration of a new veterinary chemical product or variation of the particulars or conditions of a registered veterinary chemical product other than biological chemical products.
  3. This module applies to applications for a permit in relation to chemical products containing an approved active constituent where some consideration of fate, effects or environmental monitoring data or exposure modelling are required.
  4. This module applies to any other application for:
    1. registration of a new chemical product;
    2. variation of the particulars or conditions of a registered chemical product; or
    3. variation of the particulars or conditions of approval of a label for containers for a registered chemical product
    where the regulatory proposal may result in increased environmental risks, or for proposed use patterns where there is no suitable reference product, and which requires an environment assessment that is not referred to module 7.1 or 7.2 above.
  5. This module may apply to a chemical reconsideration, where the scope of the environmental aspects of the reconsideration does not involve the assessment of data and requires only limited exposure modelling.
  6. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (c) above.

Module 8—Efficacy and Safety

General information

Assessment of efficacy and safety refers to assessment of efficacy and host crop or animal safety and includes (as relevant to either agricultural or veterinary chemical products as the case may be):

  1. assessment of the results of experimental trials for efficacy and safety;
  2. effect on following crops or non-target crops;
  3. organoleptic tests;
  4. effects of residues on subsequent processing of crops;
  5. safety to non-target crops;
  6. safety to target animals; or
  7. pharmacologic studies.

New chemical products for use in/on food or fibre producing species—other than cattle, sheep, pigs and chickens—qualify for a reduced (module 8.2) efficacy and safety assessment (for example: goats, llamas, alpacas, and emus).

Module 8.1—Level 1 Comprehensive Efficacy and Safety Assessment

  1. This module applies to applications for registration of a new agricultural chemical product or a new veterinary chemical product for use on food producing species or companion animal containing:
    1. a new active constituent;
    2. a new combination of approved active constituents; or
    3. a significant new formulation (such that it is considered a new chemical product) not included in module 8.2 below.
  2. This module applies to applications for registration of a new agricultural chemical product containing an approved active constituent and for which the product is for use in a new crop group or new situation and/or for the control of new pests.
  3. This module applies to applications for registration of a new veterinary chemical product containing an approved active constituent and for which the product involves use in or on a new food producing species or companion animal.
  4.  This module applies to applications for variation of the particulars or conditions of a registered agricultural chemical product containing an approved active constituent and for which the product is for use in a new crop group or new situation and/or for the control of new pests.
  5. This module applies to applications for variation of the particulars or conditions of a registered veterinary chemical product containing an approved active constituent and for which the product involves use in or on new food producing species or companion animal.
  6. This module applies to applications for variation of the particulars or conditions of a registered chemical product that involves a major change in formulation, unless valid scientific argument is provided regarding submission of relevant efficacy/safety data to justify a different level of assessment.
  7. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a comprehensive efficacy and safety assessment.
  8. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (f) above.

Module 8.2—Level 2 Reduced Efficacy and Safety Assessment

  1. This module applies to application for registration of a new agricultural chemical product containing approved active constituents where the proposed product involves:
    1. new domestic or home garden use such that it is considered a new chemical product;
    2. a variation of use involving a new minor use for new pests where the use is closely similar to an existing use pattern such that it is considered a new chemical product; or
    3. a significant new formulation requiring reduced assessment of both efficacy and safety such that it is considered a new chemical product.
  2. This module applies to applications for registration of a new veterinary chemical product where the proposed product:
    1. involves a variation of use to a new pest or disease or for a new purpose in/on the same food producing species or companion animal such that it is considered a new chemical product;
    2. involves a change to the dosage or administration instructions—including treatment number, frequency, duration, dose, and route of administration—in/on the same food producing species or companion animal such that it is considered a new chemical product;
    3. involves use in or on a food producing species or companion animal with a new formulation which is not the same, nor closely similar, nor similar to a reference product such that it is considered a new chemical product.
  3. This module applies to applications for variation of the particulars or conditions of a registered agricultural chemical product which involves a variation of use to a new host or a new pest within the same crop group or situation and with the same general use pattern.
  4. This module applies to applications for variation of the particulars or conditions of a registered agricultural chemical products for which the product involves:
    1. new domestic or home garden use;
    2. a variation of use involving a new minor use for new pests where the use and the pests are closely similar to an existing use pattern; or
    3. a significant new formulation requiring reduced assessment of both efficacy and safety.
  5. This module applies to applications for variation of the particulars or conditions of a registered veterinary chemical product for which the product involves:
    1. a variation of use to a new pest or disease or for a new purpose in/on the same food producing species or companion animal;
    2. a change to the dosage or administration instructions—including treatment number, frequency, duration, dose, and route of administration—in/on the same food producing species or companion animal; or
    3. use in/on a food producing species or companion animal with a new formulation which is not the same, nor closely similar, nor similar to a reference product.
  6. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a reduced efficacy and safety assessment.
  7. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (e) above.

Module 8.3—Level 3 Limited Efficacy and Safety Assessment

  1. This module applies to applications for registration of a new agricultural chemical product where efficacy and safety data are required to demonstrate bioequivalence to a registered product, where a bioequivalence study is the only data provided.
  2. This module applies to applications for registration of a new veterinary chemical product where only a blood/plasma bioequivalence study is required to demonstrate equivalence to a registered veterinary chemical product.
  3. This module applies to applications for registration of a new veterinary chemical product which involve demonstration of pharmaceutical equivalence with a registered product.
  4. This module applies to applications for registration of a new veterinary chemical product for use in or on a non-food producing species other than a dog, cat or horse.
  5. This module applies to applications for variation of the particulars or conditions of a registered chemical product involving a formulation change for which the product is expected to have a minor impact on efficacy or crop or host animal safety.
  6. This module applies to applications for variation of the particulars or conditions of an approval of a label for containers for a registered chemical product involving a formulation change for which the product is expected to have a minor impact on efficacy or crop or host animal safety.
  7. This module applies to applications for variation of the particulars or conditions of a registered agricultural chemical product which involve a variation of use to a minor use within the same crop group or situation and which involve an existing pest and application rate.
  8. This module applies to applications for variation of the particulars or conditions of a registered veterinary chemical product which involve a variation of use to a new non-food producing species other than a dog, cat or horse.
  9. This module applies to applications for variation of the particulars or conditions of a registered veterinary chemical product where only a blood/plasma bioequivalence study is required to demonstrate equivalence.
  10. This module applies to applications for variation of the particulars or conditions of a registered veterinary chemical product which involves demonstration of pharmaceutical equivalence with a registered product.
  11. This module applies to applications for approval for a permit in relation to an agricultural chemical product which involves a minor use on a new crop or situation.
  12. This module applies to applications for a permit in relation to veterinary chemical products which involve a minor use in or on a new animal species.
  13. This module applies to any other application for:
    1. registration of a new chemical product;
    2. variation of the particulars or conditions of a registered chemical product or
    3. variation of the particulars or conditions of approval of a label for containers for a registered chemical product
    4. which requires an efficacy and/or safety assessment of a type that is not included in modules 8.1 or 8.2 or 8.3 (a) to (l), above.
  14. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a limited efficacy and safety assessment.
  15. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) to (l) above.

Major formulation change

Applications for variation of the particulars or conditions of a registered chemical product that involves a major change in formulation are generally assessed under Module 8.1. However, applicants may provide valid scientific argument regarding submission of relevant efficacy/safety data to justify a different level of assessment.

For example:

  1. if the change in formulation is likely to affect only safety, then assessment under Module 8.3 may be appropriate; or
  2. data to demonstrate comparable efficacy with the previous formulation may be assessed under Module 8.3; or
  3. data to demonstrate comparable bioequivalence with the previous formulation may be assessed under Module 8.3.

Module 9—Non-food trade

  1. This module applies to applications for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product involving trade risks not related to food residues, including:
    1. residues in wool and fibre;
    2. the presence of disease or seropositive testing to exotic or notifiable agents;
    3. hormonal growth promotants and other endocrine substances; or
    4. genetically modified produce.
  2. This module may apply to a chemical reconsideration, where the scope of the reconsideration is consistent with the description in (1) above.
  3. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (1) above.

Module 10—Special Data

General information

This module applies to all applications for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product, which contain active constituents that are new antibiotic substances or which contain genetically modified organisms (GMOs) require a module 10 assessment.

Module 10.1—Level 1 Comprehensive Special Data Assessment

  1. This module applies to applications for new registration of a new veterinary chemical product containing a new antibiotic active constituent.
  2. This module applies to applications for a permit in relation to veterinary chemical products containing a new antibiotic active constituent (other than for small scale research).
  3. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a comprehensive special data assessment.
  4. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) or (b) above.

Module 10.2—Level 2 Reduced Special Data Assessment

  1. This module applies to applications for registration of new veterinary chemical products applications for variation of the particulars or conditions of a registered chemical product containing an approved antibiotic active constituent and which is expected to result in significantly increased volume of use of the approved antibiotic active constituent or an increased risk to public health including:
    1. a variation of use to a new food producing species, or a dog or a cat;
    2. a variation of use to another major group within the same food producing species (for example: broiler chickens to layers; beef cattle to dairy cattle); or
    3. a change in dosage form or use pattern (for example: from use in individual animals to mass medication).
  2. This module applies to applications for a permit in relation to veterinary chemical products containing an approved antibiotic active constituent and which are for use in or on a new animal species.
  3. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a reduced special data assessment.
  4. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) or (b) above.

Module 10.3—Level 3 Limited Special Data Assessment

  1. This module applies to any other application for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product including an assessment of chemical products containing GMOs, requiring a module 10 assessment that is not included in modules 10.1 or 10.2.
  2. This module may apply to a chemical reconsideration, where the scope of the reconsideration warrants a limited special data assessment.
  3. This module may apply to an item 25 technical assessment, where the scope of the assessment requested is consistent with the description in (a) above.

Module 11—Finalisation

General information

This module encompasses administrative steps relating to the finalisation of the application which can include public consultation, entering the required information into the relevant record or register and the completion of the technical evaluation and risk assessment report outlining the evaluation of the application.

Module 11.1—Finalisation Type 1

  1. This module applies to applications for:
    1. the approval of an active constituent;
    2. the registration of a new chemical product;
    3. a variation of the particulars or conditions of a registered chemical product; or
    4. a permit in relation to chemical products;
    where three or more modules ranging between modules 2.1 to 10.3 apply.
  2. This module may apply to a chemical reconsideration.
  3. This module may apply to a label approval.

Module 11.2—Finalisation Type 2

  1. This module applies to applications for:
    1. the approval of an active constituent;
    2. the registration of a new chemical product; or
    3. a variation of the particulars or conditions of a registered chemical product;
    where fewer than three modules ranging between modules 2.1 to 10.3 apply.
  2. This module may apply to a chemical reconsideration.
  3. This module may apply to a label approval.

Module 11.3—Finalisation Type 3

  1. This module applies to minor applications requiring no or minimal assessment
  2. This module applies to applications for a permit in relation to chemical products where fewer than three modules ranging between modules 2.1 to 10.3 apply.
  3. This module may apply to a chemical reconsideration.
  4. This module may apply to a label approval.
  5. This module applies for item 25 technical assessment.

Module 12—Limits on use of information

This module applies to any application which attracts limits on use of information under Division 4A of Part 2; or Part 3 of the Agvet Code.

Note: This module is not applicable for item 25 technical assessment.

Schedule 2: Dictionary

  1. Unless the contrary intention appears, an expression used in the Agvet Code or the Agvet Code Regulations and in this Guideline has the same meaning in this Guideline as in the Agvet Code or the Agvet Code Regulations.
  2. In this Guideline, unless the contrary intention appears:

Acceptable Daily Intake (ADI) means the daily intake of a chemical which, during an entire lifetime, appears to be without appreciable risk to the health of the consumer on the basis of all the known facts at the time. The ADI is expressed in milligrams of the chemical per kilogram of body weight per day (mg/kg/day).

Acute Reference Dose (ARfD) means the estimate of the amount of a substance in food or drinking water, that can be ingested in one meal or during one day, without appreciable health risk to the consumer, on the basis of all known facts at the time. The ARfD is expressed in milligrams of the chemical per kilogram of body weight (mg/kg).

Agvet Code means the Agricultural and Veterinary Chemicals Code, scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.

Agvet Code Regulations means the Agricultural and Veterinary Chemicals Code Regulations 1995.

biological chemical product means a chemical product where the active constituent comprises or is derived from a living organism (for example, a plant organism, animal organism or micro organism), with or without modification.

biotechnology chemical product means a chemical product that is developed by means of one of the following biotechnological processes

  1. recombinant DNA technology;
  2. controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; or
  3. hybridoma and monoclonal antibody methods.

companion animal means a non-food producing species and for the purposes of efficacy modules a companion animal means a dog, cat or horse

environmental instructions or warnings includes environmental protection statements and restraints from the agricultural and veterinary labelling codes

food-producing species has the same meaning as defined in section 3 of the Agvet Code. In this guideline the term food-producing species also includes fibre producing species, which is any species of animal used to produce fibre (including wool and mohair) for human use.

food crop for the purposes of this guideline, means any crop that is intended for, or capable of being used for, human consumption or as a feed for food-producing species. It does not include tobacco or crops used in human or veterinary drug or medicine production unless by-products of those crops are foods, or feeds for food-producing species.

formulation change has the same meaning as defined in section 3 of the Agvet Code Regulations.

genetically modified organisms (GMOs) are biotechnology chemical products.

immunobiological chemical product means a product which, when administered to the host, provides, induces or changes an immune response to a target chemical or biological entity. Immunobiological chemical products include vaccines, antisera, antibodies and cytokines.

major export food commodity group has the same definition as that in the Agricultural—Overseas trade (Part 5B) Regulatory Guideline;

major formulation change, for the purposes of a toxicology, environment or WHS modules means a change to the formulation of a chemical product, including new combinations of approved active constituents, such that safety to humans, the environment and/or target species may need separate assessment. For example, where:

  1. there has been a significant increase in the concentration of the active constituent which could affect the hazard potential, poison scheduling, safety directions or residues;
  2. a major change in non-active constituent which significantly affects the performance, stability or other attributes of the product; or
  3. the formulation has been changed significantly to accommodate a new application method or use pattern (for example, changing from a wettable powder to an emulsifiable concentrate or changing from an oral drench to a topical pour on dosage form).

major formulation change, for the purposes of an efficacy/safety module, means a change to the formulation of a chemical product, including new combinations of approved active constituents, such that efficacy and/or safety to the host crop/animal requires assessment. For example, where:

  1. there has been a significant change in the concentration of active constituent and where the application/dose rate to the crop/animal is changed;
  2. a major change in non-active constituent significantly affects the performance, stability or other attributes of the product;
  3. there has been a significant change in product specifications;
  4. the formulation has been changed significantly to accommodate a new application method or use pattern (for example, changing from a wettable powder to an emulsifiable concentrate or changing from an oral drench to a topical pour on dosage form); or
  5. the new formulation is not identical, nor closely similar, nor similar to a registered reference product (as defined in section 3B of the Agvet Code Regulations).

module means the module of assessment, including its level or type of assessment, as set out as items in the table in Schedule 7 to the Agvet Code Regulations (for example, module 2.1 is the chemistry module—level 1).

minor use means minor use as defined in section 3 of the Agvet Code Regulations.

NDPSC means the poison scheduling process as administered under section 6-3 of the Therapeutic Goods Act 1989.

new active constituent means an active constituent that, at the time an application in respect of that active constituent is lodged with the APVMA, has not been approved in Australia.

new chemical product means a chemical product that, at the time an application in respect of that chemical product is lodged with the APVMA, has not been registered in Australia.

new source of existing active constituent means:

  1. a new manufacturing source of an approved active constituent for an agricultural chemical product where, at the time an application in respect of that active constituent is lodged with the APVMA, that source has not been approved by the APVMA; or
  2. a new manufacturing source of an approved active constituent for a veterinary chemical product that is an ectoparasiticide and for which there is no compendial standard, and where, at the time an application in respect of that active constituent is lodged with the APVMA, that source has not been approved by the APVMA.

poison scheduling in relation to a chemical product, means the classification of the product or any of its constituents in the Poisons Standard.

reference product means reference chemical product as defined in section 3B of the Agvet Code Regulations.

technical assessment has the same meaning as in regulation 8AS of the Agvet Code Regulations.

Timeshift application has the same meaning as defined in section 3 of the Agvet Code Regulations.

use pattern means the combination of all factors involved in the use of a formulated agricultural or veterinary chemical product. These include:

  • the host crop or animal species to which the product will be applied
  • the concentration of any active constituent in the preparation being applied
  • the rate of application
  • the method of application
  • the time, frequency and duration of treatments
  • adjuvants recommended to be added
  • other directions that may appear on the label attached to the container for the chemical product that determine the total quantity applied, timing of treatment and the withholding period(s).

VICH means the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. Information on VICH Phase I and Phase II environment impact assessments can be found in the VICH website and in the Veterinary—Environment Regulatory Guideline.

Schedule 3: Relevant data for modules

Relevant data for modules – Agricultural

Relevant data for modules – Veterinary

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