Module Descriptors

What is this guideline about?

This guideline is:

  1. made pursuant to section 6A of the Agvet Code.
  2. designed to inform the APVMA and applicants the modules to apply for different types of applications. Assessment fees and assessment periods are based on the modules and module levels recommended by this guideline. Within the guideline a link is provided to the information required for each module level.
  3. 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. Where an applicant does not consider a particular recommended module, or level, is relevant to their application, they may apply for Pre-application assistance or the applicant may proceed to lodge their application acknowledging it may be delayed through re-categorisation or rejection.
  4. designed to be read top down. Once your application meets a module level descriptor your application should be submitted with that module and level. If no module level has been described for the application type by the end of the descriptors for a Module it is likely that module is not necessary.
  5. is updated from time to time.

Definition of terms

Relevant data for modules

Veterinary

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for approval of an active constituent only
  • Apply for a permit

Data that may be relevant to particular assessment modules can be found here.

Module 1—Preliminary assessment

Module 1.0

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for approval of an active constituent only
  • Apply for a permit

Applies to all modular application items.

Module 2—Chemistry

Module 2.1—Level 1

  • Apply to register a new product that contains a new active constituent

a. A new product with a new active constituent including:

  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. active constituent produced by conventional fermentation or using recombinant DNA technology (excluding products described in Module 2.2 paragraph (a) below);
  6. an active constituent produced by transgenic technology (excluding 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.
  • Apply for approval of an active constituent only

b. A new active constituent including:

  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. active constituent produced by conventional fermentation or using recombinant DNA technology (excluding biological veterinary products described in module 2.2 paragraph (a) below);
  6. an active constituent produced by transgenic technology (excluding biological veterinary 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.

Module 2.2—Level 2

  • Apply to register a new product that contains a new active constituent

a. A product not included in Module 2.1 including:

  1. new biological products:
  2. new immunobiological;
  3. immunobiological products with a major change to seed strains (including substitution of source or the addition of antigen) such that it is considered a new product;
  4. new direct fed microbial products;
  5. new enzyme products; or
  6. new herbal products.
  • Apply for approval of an active constituent only

b. A new active constituent not included in module 2.1 including:

  1. new biological products:
  2. new immunobiological;
  3. immunobiological products with a major change to seed strains (including substitution of source or the addition of antigen) such that it is considered a new product;
  4. new direct fed microbial products;
  5. new enzyme products; or
  6. new herbal products.
  • Apply for a permit

c. A product containing a new active constituent.

Module 2.3—Level 3

  • Apply to register a new product that contains an approved active constituent

a. All products

  • Apply to vary a product registration, label approval and/or active constituent approval

b. A variation to:

(i) extension of shelf life;
(ii) extension of in use shelf life; 
(iii) changes to storage temperature or conditions; or
(iv) a formulation change.

  • Apply for approval of an active constituent only

c. A new source of approved active constituent only.

  • Apply for a permit

d. A product containing an approved active constituent which requires a chemistry assessment.

  • Apply for a permit

e. A registered product involving changes to the registered particulars or conditions of the product (e.g. extension of shelf life).

Module 3—Toxicology

Module 3.0

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for approval of an active constituent only
  • Apply for a permit

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

a  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; and
b. animal bacterial and viral vaccines.

Module 3.1—Level 1

  • Apply to register a new product that contains a new active constituent
  • Apply for a permit

a. A product containing a new active constituent for food species (other than applications referred to in Module 3.2 or 3.3 below).

  • Apply for approval of an active constituent only

b. A new active constituent for food species (other than applications referred to in module 3.2 or 3.3 below).

Module 3.2—Level 2

  • Apply to register a new product that contains a new active constituent
  • Apply for a permit

a. A product containing a new active constituent for a non-food species.

  • Apply to register a new product that contains a new active constituent

b. A product containing a new biological active constituent for a food species.

  • Apply for a permit

c. A product containing an approved active constituent for use in a food species for the first time (to establish an ADI, and/or an ARfD).

  • Apply to vary a product registration, label approval and/or active constituent approval

d. A variation which involves use in a food species for the first time (to establish an ADI, and/or an ARfD).

  • Apply for approval of an active constituent only

e. A new active constituent for a non-food species.

  • Apply for approval of an active constituent only

f. A a new biological active constituent for a food species.

  • Apply for a permit

g. A product containing a new active constituent for a food species where a full assessment is not required.

Module 3.3—Level 3

  • Apply to register a new product that contains a new active constituent

a. A product containing a new biological active constituent for a non-food species.

  • Apply to register a new product that contains an approved active constituent

b. A product containing an approved active constituent which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing first aid and hazard statements..
  • Apply to vary a product registration, label approval and/or active constituent approval

c. A variation which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing first aid and hazard statements..
  • Apply for approval of an active constituent only

d. A new biological active constituent for a non-food species.

  • Apply for approval of an active constituent only

e. Any other application to vary the particulars or conditions of approval where a toxicology assessment is required.

  • Apply for a permit

f. A product containing a new active constituent for a non-food species where a full assessment is not required.

  • Apply for a permit

g. A product containing an approved active constituent in a new formulation where toxicological consideration is required.

Module 4—Toxicology (poison schedule classification)

Module 4.1

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for approval of an active constituent only
  • Apply for a permit

Applications where poison scheduling is required. This will include all new active ingredients or where changes are required to an established schedule for an existing active constituent (excluding vaccines).

Module 5—Residues

Module 5.1—Level 1

  • Apply to register a new product that contains a new active constituent

a. A product containing a new active constituent to be used in a food species.

  • Apply to register a new product that contains an approved active constituent

b. A product containing an approved active constituent to be used on a food species for the first time.

  • Apply to vary a product registration, label approval and/or active constituent approval

c. A variation which involves use on a food species for the first time.

  • Apply for a permit

d. A product containing a new active constituent for use in food species.

Module 5.0—General information

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for a permit

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 5.2—Level 2

  • Apply to register a new product that contains an approved active constituent

a. A product containing an approved active constituent for use in a new food species where establishment or variation of MRLs and WHPs and/or trade implications are required. Such circumstances may include the establishment or variation of any ESIs and consideration of a new route of administration.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. Variation of use in a new food species.

  • Apply to vary a product registration, label approval and/or active constituent approval

c. Variation to change the dose rate or frequency of application to food species and where a change to established MRLs are required.

Module 5.3—Level 3

  • Apply for a permit

a. A product containing an approved active constituent for use in a new food species where consideration of MRLs and WHPs and/or trade implications are required.

Module 5.4—Level 4

  • Apply to register a new product that contains an approved active constituent

a. A product for use in a food species where use of the active constituent is currently approved for a similar formulation type and route of administration with consideration of variation of MRLs and WHPs and/or ESIs.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. A variation which involves review of WHPs and trade implications including:

  1. a minor formulation change;
  2. changes to a label which have potential risk of residues where no change to the established MRLs is required; or
  3. residues assessment that is not referred to in Module 5 above including establishing or amending Table 5 entries.
  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for approval of an active constituent only

c. where residues do not occur in foods or animal feeds; or where the residues are identical to or indistinguishable from natural food components; or otherwise are of no toxicological significance and an MRL is not necessary (Table 5 entry in the MRL Standard is appropriate).

Module 5.5—Level 5

  • Apply for a permit

a. A product for use in a food species where use of the active is currently approved and consideration of MRLs and WHPs and/or trade implications are required.

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

Module 6.0—General Information

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for a permit

Several types of applications for registration of a new 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 products which do not normally require WH&S assessment are as follows:

a   applications for a permit for a product, registration of a new product or variation of the particulars or conditions of a registered 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 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; and
  7. animal bacterial and viral vaccines.

Module 6.2—Level 2

  • Apply to register a new product that contains a new active constituent

A product containing a new active constituent for use in food species

  • Apply to register a new product that contains a new active constituent

a. A product containing a new active constituent for use in food species.

  • Apply to register a new product that contains an approved active constituent

b. A product containing an approved active constituent which requires or involves:

1. changes to the Poisons Standard; and/or
2. establishing safety directions.

  • Apply to vary a product registration, label approval and/or active constituent approval

c. A variation which involves:

  1. a change in use pattern to include a new species or situation; or
  2. a new application method.
  • Apply for a permit

d. A product containing a new active constituent for use in a food species.

Module 6.3—Level 3

  • Apply to register a new product that contains an approved active constituent

a. A product that is not referred to in Module 6.2 above including an assessment of human exposure to establish re-handling statements and/or vary safety directions.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. A variation that is not referred to in Module 6.2 above, that requires a WH&S assessment due to a varied exposure scenario (for example, to consider re-handling statements and/or safety directions).

  • Apply for a permit

c. A product containing an approved active constituent that requires a WH&S assessment due to a change of use pattern.

  • Apply for a permit

d. A product containing an a new active constituent for use in a non-food of species.

Module 7—Environment

Module 7.0—General information

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for a permit

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 product containing an approved active constituent do not require environmental assessment as they are not normally associated with any potential risks to the environment. The types of products which do not normally require environmental assessment are:

a. animal therapeutics and mineral and nutritional supplements in single, capsule, slow release bolus or skin implant form other than parasiticides;
b. animal immunobiological products (except those containing GMOs); and
c. animal therapeutics given by injection for use under prescription in individual animals.

Module 7.1—Level 1

  • Apply to register a new product that contains a new active constituent

a. A product containing a new active constituent (unless included in a VICH phase 1).

The VICH website has guidance on both phase I and phase II assessments.

  • Apply to register a new product that contains an approved active constituent

b. Applies 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.

The VICH website has guidance on both phase I and phase II assessments.

  • Apply to vary a product registration, label approval and/or active constituent approval

c. A 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.

The VICH website has guidance on both phase I and phase II assessments.

Module 7.2—Level 2

  • Apply to register a new product that contains an approved active constituent

a. A product which involves:

  1. a new combination of approved active constituents; or
  2. use in any situation or herd animal unless the active is currently approved in the species for a similar formulation type and use pattern.
  • Apply to vary a product registration, label approval and/or active constituent approval

b. Variations of an approval which involves:

  1. a new herd animal or new situation;
  2. changes to application method; or
  3. increase in application rate, dose or frequency for an existing use pattern.
  • Apply for a permit

c. A product containing a new active constituent (unless included in a VICH Phase 1).

The VICH website has guidance on both Phase I and Phase II assessments.

Module 7.3—Level 3

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent

a. Applications involving a VICH phase I environmental impact assessment. A VICH phase I environmental impact assessment may apply to applications to register a product.

The VICH website has guidance on both phase I and phase II assessments.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. Applications involving a VICH phase I environmental impact assessment.

The VICH website has guidance on both phase I and phase II assessments.

  • Apply for a permit

c. A product containing an approved active constituent that requires an environmental assessment due to a varied exposure scenario (unless included in a VICH Phase 1).

The VICH website has guidance on both Phase I and Phase II assessments.

Module 8—Efficacy and Safety

Module 8.0—General information

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply for a permit

Assessment of efficacy and safety refers to assessment of efficacy and animal safety and includes (as relevant):

a. assessment of the results of experimental trials for efficacy and safety;
b. organoleptic tests;
c. safety to target animals, and
d. pharmacologic studies.

New products for use in/on food or fibre 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).

  • Apply to vary a product registration, label approval and/or active constituent approval

Formulation changes

Applications for variation that involve a major formulation change will be considered under the module level that would apply if they were a new product registration.

  • Apply to vary a product registration, label approval and/or active constituent approval

a. If the change in formulation is likely to affect only safety, then assessment under Module 8.3 may be appropriate.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. Data to demonstrate comparable efficacy with the previous formulation may be assessed under Module 8.3.

  • Apply to vary a product registration, label approval and/or active constituent approval

c. Data to demonstrate comparable bioequivalence with the previous formulation may be assessed under Module 8.3.

Module 8.1—Level 1

  • Apply to register a new product that contains a new active constituent

a. A product containing a new active constituent for use in food species or companion animals.

  • Apply to register a new product that contains an approved active constituent

b. Registration of a product which involves:

  1. Use in/on a food species or dog, cat or horse for the first time; or
  2. a new formulation type; or
  3. a new combination of approved active constituents.
  • Apply to vary a product registration, label approval and/or active constituent approval

8.1.e  A variation which involves use in a new food species or dog, cat or horse.

Module 8.2—Level 2

  • Apply to register a new product that contains a new active constituent

a. A product containing a new active constituent for use in food or fibre species other than cattle, sheep, pigs and chickens.

  • Apply to register a new product that contains an approved active constituent

b. Registration of a product which involves:

  1. a new pest or disease or for a new purpose in/on a food species or dog, cat or horse; or
  2. new dosage or administration instructions in/on the species. This includes having consideration of dose, frequency, duration, and route of administration; or
  3. a product is not the same, nor closely similar, nor similar to an existing registered reference product.
  • Apply to vary a product registration, label approval and/or active constituent approval

c. A variation which involves:

  1. use on a new pest or disease or for a new purpose in the same food species or companion animal; or
  2. a change to the dosage or administration instructions—including treatment number, frequency, duration, dose, and route of administration—in the same food species or companion animal.

Module 8.3—Level 3

  • Apply to register a new product that contains a new active constituent

a. A product containing a new active constituent for use in non-food species other than companion animals (i.e. dog, cat or horse).

  • Apply to register a new product that contains an approved active constituent

b. A product which involves:

  1. use in or on a non-food species (other than a dog, cat or horse); or
  2. a product which is similar to a registered reference product.
  • Apply for a permit

c. A permit for minor or emergency use of a product.

  • Apply to vary a product registration, label approval and/or active constituent approval

e. A variation involving a formulation change.

  • Apply to vary a product registration, label approval and/or active constituent approval

h. A variation which involves:

  1. use in a non-food species (other than a dog, cat or horse): or
  2. where only bioequivalence or pharmaceutical equivalence is required to demonstrate the efficacy and safety.

Module 9—Non-food trade

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval

a. A product involving trade risks not related to food residues, including:

  1. residues in wool and fibre;
  2. genetically modified produce;
  3. the presence of disease or seropositive testing to exotic or notifiable agents;
  4. hormonal growth promotants and other endocrine substances; or

Module 10—Special Data

Module 10.0—General information

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for approval of an active constituent only
  • Apply for a permit

This module applies to all applications for registration of a new product or variation of the particulars or conditions of a registered 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

  • Apply to register a new product that contains a new active constituent
  • Apply for a permit

a. A product containing a new antibiotic active constituent.

  • Apply for approval of an active constituent only

b. Assessment of an active constituent containing a genetically-modified organism (GMO).

Module 10.2—Level 2

  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval

a. A 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 species, or a dog or a cat;
  2. a variation of use to another major group within the same food 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).
  • Apply for a permit

b. A product containing an approved antibiotic active constituent and which are for use in a new species.

Module 10.3—Level 3

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent

a. A product containing GMOs.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. A product containing GMOs requiring a module 10 assessment that is not included in module 10 above.

Module 11—Finalisation

Module 11.0—General information

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply to vary a product registration, label approval and/or active constituent approval
  • Apply for approval of an active constituent only
  • Apply for a permit

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

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent

a. A product where three or more modules from 2.1 to 10.3 apply.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. A variation where three or more modules between 2.1 to 10.3 apply.

  • Apply for approval of an active constituent only

c. An application where three or more modules from 2.1 to 10.3 apply.

  • Apply for a permit

d. A permit where three or more modules from 2.1 to 10.3 apply.

Module 11.2—Finalisation Type 2

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent

a. A product where less than three modules from 2.1 to 10.3 apply.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. A variation where fewer than three modules between 2.1 to 10.3 apply.

  • Apply for approval of an active constituent only

c. An application where less than three modules from 2.1 to 10.3 apply.

  • Apply for a permit

d. A permit where less than three modules between 2.1 to 10.3 apply.

Module 11.3—Finalisation Type 3

  • Apply to register a new product that contains an approved active constituent

a. Minor applications requiring no or minimal assessment.

  • Apply to vary a product registration, label approval and/or active constituent approval

b. Variations requiring no or minimal assessment.

  • Apply for a permit

c. A permit where less than three modules between 2.1 to 10.3 apply.

Module 12—Limits on use of information

Module 12.0—General information

  • Apply to register a new product that contains a new active constituent
  • Apply to register a new product that contains an approved active constituent
  • Apply for approval of an active constituent only
  • Apply for a permit

Module 12 relates to the protection, handling and use of information provided to the APVMA.  In general, the APVMA must not use information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances.  These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement.  This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.