Veterinary Manual of Requirements and Guidelines - Vet MORAG

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How to Use Volume 2

1.   WHAT IS VOLUME 2?

Volume 2 gives information to applicants to enable them to determine the category under which an application must be made.

On 1 July 2005, amendments to Schedules 6 and 7 of the Agvet Code Regulations revised the fees and structure of the application categories which had existed since 1993. The existing 50 application categories were revised into 25 categories.

Appendix A shows a comparison between the pre-July 2005 application categories and the current application categories.

The aim of Volume 2 is to enable applicants for approval of a new active constituent, or registration of a new agricultural or veterinary (agvet) chemical product, or approval of a label, or variations to a product, active constituent or label, to easily determine:

  • the correct application category
  • the fee and timeframe applicable to the application
  • data requirements for the application.

2.   HOW DOES AN APPLICANT USE VOLUME 2?

An applicant may apply to the APVMA for:

  • approval of a new active constituent
  • registration of an agricultural or veterinary product
  • approval of an agricultural or veterinary product label
  • variation of the particulars or conditions of product registration
  • variation of the particulars or conditions of label approval
  • variation of the particulars or conditions of approval of an approved active constituent
  • issue of a permit
  • any other assessment of a technical nature.

Applications must be made under one of the 25 application categories depending on the purpose of the application and the nature of the active constituent or product.

The application categories are derived from Schedule 6 to the Agvet Code Regulations (see Appendix B) and the categories correspond with the item numbers in column 1 of Schedule 6.

Schedule 6 also provides the application fee and timeframe for fixed categories.

Of the 25 application categories, 18 have a fixed application fee and assessment period and seven (categories 2, 10, 14, 21, 23 and 25) have a modular application fee and assessment period. The modular application categories are further explained the relevant application category chapters in this volume, and in ‘Module levels for modular categories’ in Volume 3.

A summary of the application categories is shown in Table 1.

Table 1: Summary of application categories

Category Type of application
1 Application for approval of a new active constituent and registration of a product and approval of the label (agricultural products only)
2 Application for approval of a new active constituent and registration of a product and approval of the label: modular
3–10 Application for registration of a product containing an approved active constituent and approval of the label (Categories 3 & 4 apply only to agricultural products)
11–14 Application to vary a product or label (Category 11 applies only to agricultural products)
15–17 Application for approval of an active constituent
18 Application for variation to approval of an active constituent
19–23 Application for a permit
24–25 Other applications

Data requirements for each application category are set out in the relevant category chapter in this volume and in ‘Module levels for modular categories’ in Volume 3.

The APVMA evaluates applications against criteria of safety and efficacy. These criteria are explained in ‘Legal background to the National Registration Scheme’ in Volume 1.

2.1.   Step-by-step use of Volume 2

  1. Determine the application category
  2. Determine data requirements, fee and timeframe
    • go to the specific application category chapter in Volume 2. This will provide general information on data requirements and will provide the fee and timeframe.
  3. Get further details on data requirements in Volume 3
    • go to Volume 3 for further details on data requirements:
      • if the application category is a modular category, ‘Module levels for modular categories’ will provide a list of data studies required for each type of application
      • if the application category is a fixed category, ‘Module levels for modular categories’ will also provide a list of data studies required for each type of application, because data requirements for fixed application categories are also linked to data modules.
    • Volume 3 also has specific guidance on each of the 10 data parts, which are:
    Part 1 Application Overview
    Part 2 Chemistry and Manufacture
    Part 3 Toxicology
    Part 4 Metabolism and Kinetics
    Part 5 Residues and Trade
    Part 6 Occupational Health and Safety
    Part 7 Environment
    Part 8 Efficacy and Host Animal Safety
    Part 9 Other Trade Aspects
    Part 10 Special Data Requirements

3.   HOW IS THE APPLICATION CATEGORY DETERMINED?

The category decision tree commencing at paragraph 4 show how the application category is determined.

The first step is to decide on the broad purpose of the application. From this, a range of possible categories can be determined.

Note that the category decision tree is relevant to the great majority of applications, but may not be relevant to a minority of specialised applications. For these specialised applications, further information and guidance is provided in specific category papers of this volume.

An applicant must nominate the relevant category on the application form, as described in Procedures for making an application in Volume 1.

3.1.   Modular application categories

Seven of the application categories (2, 10, 14, 21, 23, 24, 25) are modular categories. This means that data requirements for an application will be made up of a number of modules, of the data parts for chemistry, toxicology, residues and trade, occupational health and safety, environmental safety, efficacy and crop/animal safety, and finalisation of the application.

After working through the category decision tree an applicant may realise that the application fits one of the modular categories. If so, the applicant should refer to Module levels for modular categories’ in Volume 3, to find further information on the data requirements for each module.

4.   CATEGORY DECISION TREE

Beginning with Diagram 1, applicants should work through the category decision tree until they reach the category that suits their application, referring to the instructions on the previous pages if necessary.

Diagram 1. First step of category decision tree

Diagram 1. First step of category decision tree Link to Diagram 2 Link to Diagram 5 Link to Diagram 5 Link to Diagram 3 Link to Diagram 4

Diagram 2. Registration of a new product (Categories 1–10)

Diagram 2. Registration of a new product (Categories 1–10) Link to

Diagram 3. Variation of a registered product or label (Categories 11–14)

 

Diagram 3. Variation of a registered product or label (Categories 11–14) Click here

Diagram 4. Approval of an active constituent or variation to an approved active constituent (Categories 15–18)

Diagram 4. Approval of an active constituent or variation to an approved active constituent (Categories 15–18) Click here

Diagram 5. Permit (Categories 19–23) Other applications (Categories 24–25)

Diagram 5. Permit (Categories 19–23) Other applications (Categories 24–25) Click here Click here

5.   REQUIREMENTS AND GUIDELINES

Requirements may vary for a particular application category. Applicants should carefully read the relevant category chapter to discover the specific requirements and guidelines for that category.

Each application category also has specific data requirements. To determine the exact data requirements, refer to the specific category chapter and also Volume 3: Data requirements and guidelines.

5.1.   Application and data

Applicants must provide with their application:

1. One copy of the combined Application Form and Overview

The details which must be provided in the combined Application Form and Overview are slightly different for each application category. Applicants should refer to the specific category chapter in this volume for further information.

More information on the combined Application Form and Overview can be found in ‘Part 1 – Application Overview’ in Volume 3.

2. One copy of each of the relevant data Parts

Data requirements for each application category are provided in the specific category chapters in this volume and in Volume 3: Data requirements and guidelines.

5.2.   Labels

Applicants must provide a label with the Application Form and Overview. The APVMA recommends that the label be in draft form so that it can be amended if necessary, however applicants may choose to submit the marketed product label (MPL).

Applicants may provide the draft label as either:

  • two copies of the text label (TXL) printed on paper; or
  • an e-label on CD. The CD must be attached to the Application Form and Overview and not submitted separately or by email.

The draft label must include all label components ie primary pack, immediate container and leaflet, as relevant.

All parts of the draft label must be in accordance with the latest editions of the:

After the APVMA has assessed the draft label and is satisfied that the label is acceptable, the APVMA will ask the applicant to provide an e-label of the MPL for approval. If the MPL is acceptable and all other matters relevant to the application are acceptable, the APVMA will approve the label and grant the application.

Refer to Label Approval Process in Volume 5 for further information.

5.3.   Fees and assessment timeframes

The fee and assessment timeframe for each category are shown in Appendix B.

5.4.   Screening the application

Details of the screening process are in ‘Procedures for making an application’ in Volume 1.

Once the application passes screening the APVMA will usually request additional copies of data for distribution to relevant agencies or reviewers for technical evaluation.

6.   DATA PROTECTION

The APVMA is limited from using protected data from one application for the purpose of granting another application without the consent of the appropriate authorising party. See the APVMA website data protection for further details on data protection. A summary of data protection is provided in Volume 1: ‘Legal Background to the National Registration Scheme’.

If applicants cannot provide consent for use of protected data, applicants must provide their own data to meet the relevant APVMA requirements.

When proposing an application category, applicants must be aware that with respect to data protection, the APVMA will only evaluate an application under an application category which has data requirements appropriate for the assessments required. This is shown in the following flowchart:

Flowchart - Data Protection

Appendix A: Comparison of pre-1 July 2005 application categories and current application categories


Pre-1 July 2005 Application Category
Fee
Timeframe (months)
Current Application Category
Fee
Timeframe (months)

NEW PRODUCTS

1 $20,620 15 1 $72,100 15
2 $2,060 15 2 Modular
3 $6,185 15
4 $1,030 15
5 Modular
6 $620 as primary
7 $4,125 8
8 $4,125 8
9 $2,060 5
10 $1,030 5
11 $620 5
12 $12,370 8 10 Modular
13 $1,030 8
Vet 14 $12,370 8
Ag 14 $12,370 8 4 $27,505 15
Ag 15 $12,370 13 3 $48,465 15
Vet 15 $12,370 13 10 Modular
16 $1,030 8
17 $620 8
18 Modular
19 $620 5
20 $3,095 8
21 $1,650 5
22 $6,185 8
23 $1,030 8
23A $310 3 8 $1,250 3
or 10 Modular
24 $3,095 5 5 $3,655 5
25 $3,095 Modular 10 Modular
26 $1,030 3 6 $3,220 5
or 7 $1,315 3
27 $620 3 8 $1,250 3
28 $12,370 8 10 Modular
29 $5,155 8
30 $1,030 3
  9 (listed reg) $1,195 3
NEW ACTIVE CONSTITUENT
31 $6,000 12 15 $25,775 12
or 16 $14,105 8
or 17 $2,365 5
VARIATION TO PRODUCT/LABEL
32 $10,310 8 11 $21,460 8
33 $2,060 5 14 Modular
34 $10,310 8
35 $12,370 13
36 $3,095 5
37 $1,030 3
38 $0 3 13 $0 3
39 $620 3 12 $875 3
40 $2,060 8 14 Modular
VARIATION TO ACTIVE CONSTITUENT
41 $2,500 8 17 $2,365 5
41A Modular 18 $1,850 5
PERMITS
42 $620 3 20 $350 3
43 $0 N/A 22 $0 N/A
44 Modular 21 $350
Modular
45 $2,060 12
Modular
46 $1,030 6
47 $620 3
48 $0 N/A 19 $350 3
49 $620 3 21 $350 Modular
OTHER APPLICATIONS
50 $1,030 3 25 Modular
  24 Modular

Appendix B: Schedule 6 of the Agvet Code Regulations – Table of fees and assessment periods (Regulations 70, 76 & 78)

Item Description of application Period Fee

Application for approval of active constituent contained in a chemical product, registration of the chemical product and approval of the product label

1. Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring a full assessment of the active constituent and chemical product. 15 months

$72,100

2.

Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring less than full assessment of the active constituent and chemical product.

The modular assessment period

The modular assessment fee

Application for registration of a chemical product containing an approved active constituent and approval of the product label

3.

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

  1. there is no registered chemical product containing the active constituent; and
  2. a full assessment of the chemical product is required.

15 months

$48,465

4.

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

  1. there is a registered chemical product containing the active constituent; and
  2. the chemical product is to be used on a major food crop; and
  3. there are no relevant maximum residue limits; and
  4. poison schedule classification is required.

15 months

$27,505

5.

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

  1. the chemical product is similar to a registered chemical product; and
  2. chemistry and manufacture, efficacy and target species safety data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product.

5 months

$3,655

6.

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

  1. the chemical product is closely similar to a registered chemical product; and
  2. efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and
  3. chemistry and manufacture data are required.

5 months

$3,220

7.

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

  1. the chemical product is closely similar to a registered chemical product; and
  2. efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and
  3. chemistry and manufacture data are not required.

3 months

$1,315

8.

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

  1. the chemical product is the same as a registered chemical product; and
  2. the chemical product is to be registered with a different name.

3 months

$1,250

9.

Application for a listed registration of a chemical product containing an approved active constituent and approval of a product label for which an established standard has been approved in accordance with section 56D of the Code.

3 months

$1,195

10.

Application for registration of a chemical product containing an approved active constituent (or an active for which the APVMA has received an application for approval) and approval of the product label for all situations other than as described in items 3 to 9.

The modular assessment period

The modular assessment fee

Application to vary a registration or label approval

11.

Application to vary particulars or conditions of registration or label approval where the variation is to extend the use of the chemical product to a new major food crop.

8 months

$21,460

12.

Application to vary particulars or conditions of registration or label approval if:

  1. the variation is to allow a minor change; and
  2. no data of a technical nature is required.

3 months

$875

13.

Application to vary particulars or conditions of registration or listed registration or label approval if:

  1. the variation is to allow a minor change; and
  2. no data of a technical nature is required; and
  3. the variation is a change required by the APVMA.

3 months

Nil fee

14.

Application to vary particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in item 11 to 13.

The modular assessment period

The modular assessment fee

Application for approval of an active constituent

15.

Application for approval of an active constituent requiring a full assessment.

12 months

$25,775

16.

Application for approval of an active constituent requiring less than full assessment but requiring a toxicological assessment.

8 months

$14,105

17.

Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment.

5 months

$2,365

Application for variation to an approved active constituent

18.

Application to vary particulars or conditions of an approved active constituent.

5 months

$1,850

Application for a permit

19.

Application for a permit to possess or supply, other than for use in Australia, an active constituent that is not an approved active constituent or a chemical product that is not a registered chemical product.

3 months

$350

20.

Application for a permit where a previous assessment remains valid and no data of a technical nature is required.

3 months

$350

21.

Application for a permit where the proposed use is a minor use.

The modular assessment period

$350

22.

Application for a permit in respect of a chemical product or an active constituent if the proposed use of the chemical product or active constituent is determined by the APVMA to be an emergency use.

Not applicable

Nil fee

23.

Application for a permit in respect of a chemical product or an active constituent if the application is not of a kind described in items 19 to 21.

The modular assessment period

The modular assessment fee

Other applications

24.

Application made under section 10 of the Code (other than those of the kinds in items 1, 2, 3, 4, 5, 6, 7, 8, 10, 15, 16 or 17) requiring assessment of a technical nature.

The modular assessment period

The modular assessment fee

25.

Any other application:

  1. that is not made under section 10 of the Code; and
  2. that is not of a kind listed in an item of this Schedule requiring assessment of a technical nature.

The modular assessment period

The modular assessment fee

Appendix C: Module fees and timeframes

– amended from Schedule 7 to the Regulations to the Agvet Code


Module
Fee1
Timeframe2
1        Screening
$535
 
2.1     Chemistry
$6,915
12 months
2.2     Chemistry
$2,305
8 months
2.3     Chemistry
$1,185
5 months
2.4     Chemistry
$570
3 months
3.1     Toxicology
$20,940
12 months
3.2     Toxicology
$14,620
8 months
3.3     Toxicology
$3,035
4 months
4        Scheduling
$2,435
12 months
5.1     Residues
$13,630
12 months
5.2     Residues
$7,895
6 months
5.3     Residues
$6,150
6 months
5.4     Residues
$5,600
3 months
5.5     Residues
$1,500
3 months
6.1     OH&S
$4,310
12 months
6.2     OH&S
$2,900
6 months
6.3     OH&S
$2,985
4 months
7.1     Environment
$19,795
12 months
7.2     Environment
$5,485
6 months
7.3     Environment
$1,290
4 months
8.1     Efficacy & host animal safety
$1,865
5 months
8.2     Efficacy & host animal safety
$750
4 months
8.3     Efficacy & host animal safety
$500
3 months
9        Non-food trade
$1,175
5 months
10.1   Antibiotic resistance
Nil fee
12 months
10.2   Antibiotic resistance
Nil fee
6 months
10.3   GM Organism / other special data
Nil fee
6 months
11.1   Finalisation
$3,040
3 months
11.2   Finalisation
$1,175
2 months
11.3   Finalisation
$645
2 months
11.4   Finalisation
$570
2 months
12      Data protection
$345
 

FOOTNOTES

  1. To calculate the fee for the application, total the modular fees for all items.
  2. To calculate the assessment period for the application, add the longest assessment period for modules 2–10 to the relevant module 11 assessment period.

REVISION HISTORY

Revision Date Description of Revision
1 July 2005

First edition

1 October 2005

Second edition

  • old and new category comparison table (Annexe A): old category 30 corrected to correspond to new Category 10 (modular)
  • old and new category comparison table (Annexe A): old category 50 corrected to correspond to new Category 25 (modular) only
  • hyperlinks inserted to SUSDP and FAISD handbook.

1 April 2006

Third edition

  • old and new category comparison table (Annexe A): old category 44 corrected to correspond to new Category 21 (modular).
1 July 2007

Fourth edition

  • minor text edits.