Timeframe and fees

The assessment period in which the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to determine an application varies depending on the complexity of the application. The legislation prescribes the assessment period for most application types; however, depending on the type of application, the assessment period may be extended in certain circumstances.

The assessment period for an application for approval, registration or variation commences on the day:

  • the notice advising you that your application has passed preliminary assessment is issued, provided you are not required to provide copies of your application or pay an outstanding amount of fees; or
  • you comply with the notice requesting the balance of fees or additional copies of your application.

As soon as practical after the commencement of the assessment period, the APVMA aims to determine:

  • if your application should be recategorised to ensure that the item and level of module assessment originally identified is appropriate;
  • if argument provided in your application in lieu of data is appropriate; or
  • if there are any obvious and critical information gaps in the dossier.

The assessment period may change if one of the circumstances listed below applies to the application.

  • If a notice requiring specified information under section 159 of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Agvet Code) is issued, the extended assessment period prescribed by the Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) (Agvet Code Regulations) will apply. This extension can only be applied once, regardless of how many notices are issued under section 159.
  • If a notice is issued changing the item or module level or type that is required to determine your application and this results in a change to the assessment period or fees, the assessment period may be lengthened or shortened. Where you are required to pay an additional fee the assessment period will be extended to allow for the period until the fee is paid. Fees must be paid within 28 days from the date of notice.
  • If a Notice of Proposal to refuse or to approve or register an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application is issued to you, the assessment period will be paused for the 28-day period within which you are invited to respond to the notice.

Assessment periods and fees

The application fee and the assessment period in which the APVMA is required to determine an application vary depending on the complexity of the application.

For more information on assessment periods, including extended assessment periods and maximum response periods, please refer to extended assessment period and maximum response period.

Revised fees and charges will take effect on 1 July 2020. The fees included in the tables below cover the period to 30 June 2020, as well as the revised fees to be implemented from 1 July 2020.

List of assessment periods and fees per application type

Table 1: Approvals and registrations made under section 10 of the Agvet Code

Please note: some item descriptions changed on 23 March 2019 due to changes to the Agvet Regulations.

Item

Description of application

Assessment period

Fee to?30?June 2020

Fee from

1?July 2020

Maximum pre?application assistance rebate

1

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 product.

18 months

$96?135

$116 501

$1?400

2

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 product.

Modular assessment period and fee

$1 400

3

Registration of a chemical product containing an approved active constituent, and approval of the product label, if there is no registered chemical product containing the active constituent and a full assessment of the product is required.

18 months

$64?620

$83 511

$1 050

4

Registration of a chemical product containing an approved active constituent, and approval of the product label, if there is a registered chemical product containing the active constituent and a full assessment of the product is required and there are no relevant maximum residue limits and poison schedule classification is required.

18 months

$36?675

$44 644

$1 050

5

a) Registration of a chemical product containing an approved active constituent and approval of the product label; or

b) Registration of a chemical product, approval of the active constituent in the chemical product and approval of the product label; or

c) Registration of a chemical product and approval of the product label

if:

d) the chemical product is similar to a registered chemical product; and

e) chemistry and manufacture data, efficacy data and target species safety data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product; and

f) for an application mentioned in paragraph (b) the active constituent complies with a monograph or compendial standard in the British Pharmacopoeia, British Pharmacopeia (Veterinary), European Pharmacopoeia or United States Pharmacopeia; and

g) for an application mentioned in paragraph (c) a separate application for the approval of the active constituent in the chemical product has been lodged.

8 months

$4?870

$7 566

$700

6

a) Registration of a chemical? product containing an approved active constituent and approval of the product label; or

b) Registration of a chemical product and approval of the active constituent in the chemical product and approval of the product label; or

c) Registration of a chemical product and approval of the product label

if:

d) the chemical product is closely similar to a registered chemical product; and

e) chemistry and manufacture data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product; and

f) for an application mentioned in paragraph (b) the active constituent complies with a monograph or compendial standard in the British Pharmacopoeia, British Pharmacopeia (Veterinary), European Pharmacopoeia or United States Pharmacopeia; and

g) for an application mentioned in paragraph (c) a separate application for the approval of the active constituent in the chemical product has been lodged.

8 months

$4?290

$6 406

$700

7

Registration of a chemical product containing an approved active constituent, and approval of the product label, if the product is closely similar to a registered chemical product and efficacy and safety data are not required to demonstrate the similarity of the product to the registered chemical product and chemistry and manufacture data are not required.

3 months

$1?755

$2 632

$350

8

Registration of a chemical product containing an approved active constituent, and approval of the product label, if the chemical product is the same as a registered chemical product and the product is to be registered with a different name.

3 months

$1 655

$2 632

$350

9

Registration of a listed chemical product and approval of a product label where the product and label comply with an established standard that has been approved in accordance with section 8U of the code.

2 months

$1 595

$2 632

$350

10

For all situations other than those described in items 1–9:

a) Registration of a chemical product containing? an approved active constituent and approval of the product label; or

b) Registration of a chemical product and approval of the active constituent in the chemical product; or

c) Registration of a chemical product and approval of the product label (but only if a separate application for the approval of the active constituent in the chemical product has been lodged).

Modular assessment period and fee

$350

10A

Application for approval of a label for containers for a registered chemical product.

Modular assessment period and fee (relevant modules anticipated to be preliminary assessment and finalisation)

$350

15

Approval of an active constituent requiring a full assessment.

14 months

$30?550

$38 776

$1 400

16

Approval of an active constituent requiring less than a full assessment but requiring a toxicological assessment.

9 months

$18?805

$27 031

$700

17

Approval of an active constituent requiring less than a full assessment but not requiring a toxicological assessment?(unless item 5, 6 or 10 applies).

7 months

$3 155

$5 442

$700

24

Approval or registration under section 10 of the Code requiring assessment of a technical nature (other than of the kinds described in any of items 1 to 10, 15, 16 or 17).

Modular assessment period and fee

$350

27

Timeshift application (see definition of?timeshift application. PAA is required).

Modular assessment period and fee

$1 400

Table 2: Variation of approval or registration relevant particulars or conditions made under section 26B or 27 of the Agvet Code

Item

Description of application

Assessment period

Fee to 30 June 2020

Fee from 1 July 2020

Maximum pre?application assistance rebate

11

Vary particulars or conditions of registration or label approval where a full assessment of the chemical product is required.

10 months

$28?610

$36 205

$1 050

12

Vary particulars or conditions of registration or label approval if the variation is to allow a minor change and no data of a technical nature is required.

3 months

$1 170

$2 018

$350

13

Vary particulars or conditions of registration or label approval if the variation is to allow a minor change and no data of a technical nature is required and the variation is a change required by the APVMA.

3 months

Nil

Nil

Nil

13A

Vary a relevant particular of an approval or registration where the variation of the relevant particular is a prescribed variation under section 26B of the code.

1?month

$175

$175

Nil

14

Vary particulars or conditions of registration or label approval if the application is not of a kind described in any of items 11 to 13A.

Modular assessment period and fee

$350

18

Vary particulars or conditions of an approved active constituent.

7 months

$2 465

$4 252

$700

Table 3: Module levels, types, periods for completion and fees

Module level

Module type

Period for completion

Fee to 30 June 2020

Fee from 1 July 2020

1

Preliminary assessment

Not applicable

$710

$902

2.1

Chemistry

13 months

$9 220

$11 074

2.2

Chemistry

9 months

$3 075

$3 075

2.3

Chemistry

6 months

$1 580

$1 954

3.1

Toxicology

13 months

$27?920

$27 920

3.2

Toxicology

9 months

$15?795

$15 795

3.3

Toxicology

5 months

$4 050

$4 050

4.1

Toxicology requiring poison schedule classification

13 months

$2 435

$2 435

5.1

Residues

13 months

$18?170

$25 650

5.2

Residues

8 months

$10?525

$11 149

5.3

Residues (permit only)

8 months

$8 200

$16 400

5.4

Residues

4 months

$7?465

$7 465

5.5

Residues (permit only)

4 months

$2 000

$4 000

6.1

Occupational health and safety

13 months

$4?410

$8 820

6.2

Occupational health and safety

7 months

$3 185

$3 185

6.3

Occupational health and safety

4 months

$2 910

$3 913

7.1

Environment

13 months

$26?390

$26 390

7.2

Environment

7 months

$7 315

$7 659

7.3

Environment

4 months

$1 720

$2 979

8.1

Efficacy and safety

6 months

$2 370

$4 740

8.2

Efficacy and safety

4 months

$975

$1 950

8.3

Efficacy and safety

3 months

$580

$1 160

9

Non-food trade

6 months

$1 175

$1 175

10.1

Special data

13 months

Nil

Nil

10.2

Special data

7 months

Nil

Nil

10.3

Special data

7 months

Nil

Nil

11.1

Finalisation

3 months

$4 055

$8 110

11.2

Finalisation

2 months

$1 545

$3 090

11.3

Finalisation

2 months

$865

$1 730

12

Data protection

Not applicable

$460

$460

Table 4: Notifications

Description?

Period for completion

Fee to

30 June 2020

Fee from

1 July 2020

Notices of notifiable variations

Not applicable

$50

$50

Table 5: Applications under Agvet Code Regulations

Item

Description of application

Assessment period

Extended assessment period

Fee to

30 June 2020

Fee from

1 July 2020

Maximum pre-application assistance rebate

?

25

Application for a technical assessment made under regulation 8AS.

Modular assessment period

One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month.

Modular assessment fee

Nil

28

Applications made under subclause 10(1) of Schedule 3AA to make or vary an ingredient determination.

Modular assessment period

One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month.

Modular assessment fee

Nil

29

Application made under regulation 19AEB to make an interchangeable constituent determination.

Modular assessment period

One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month.

Modular assessment fee

Nil

Table 6: Other fees

Item

Description of application

Assessment period

Fee to

30 June 2020

Fee from

1 July 2020

Maximum pre-application assistance rebate

HGP

Application/renewal fee

N/A

$305

$429

N/A

Certificate of Export

Requires technical assessment

N/A

$230

$230

N/A

Certificate of Export

No technical assessment

N/A

$125

$125

N/A

GMP Audit

Assessment fee—Item 1 and Multi-Item 2–4

N/A

$7 500

$7 500

N/A

GMP Audit

Assessment fee—Single Item 2–4

N/A

$5 000

$5 000

N/A

GMP Audit

Assessment fee—Item 6

N/A

$1 800

$1 800

N/A

GMP Overseas Compliance Audit

(fee applicable to product registration)

Assessment fee

N/A

$1 000

$1 000

N/A

GMP New Licence

Application fee

N/A

$900

$900

N/A

GMP licence variation audit (fee covers assessment of the application and audit)

Review fee

N/A

$1 800

$1 800

N/A

Low income manufacturer—single-category

?

N/A

$2 500

$2 500

N/A

Low income manufacturer—category 1 and multi-category

?

N/A

$3 750

$3 750

N/A

Low income manufacturer—category 6

?

N/A

$900

$900

N/A

Table 7: Registration renewals

Description of application

Assessment period

Fee from 1 July 2020 to 30 June 2021

Fee from 1 July 2021 to 30 June 2022

Maximum pre?application assistance rebate

Renewal of registration (1 year)

The APVMA must renew the registration before the registration end date.

$550

$600

N/A

Renewal of registration (5 years)

The APVMA must renew the registration before the registration end date.

$3 350

$3 650

N/A

Renewal of registration late fee

Within 1 month after the late application is made.

$50

$50

N/A

Table 8: Permit applications

Item

Description of application

Assessment period

Fee to 30 June 2020

Fee from 1 July 2020

Maximum pre?application assistance rebate

19

A permit, or extension of 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, where no data of a technical nature is required.

3 months

$350

$350

$350

20

A permit, or extension of a permit, where a previous assessment remains valid and no data of a technical nature is required.

3 months

$350

$350

$350

21

A permit, or extension of a permit, where the proposed use is a minor use.

Modular assessment period

$350

$350

$350

22

A permit, or extension of 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.

Nil

?

23

A permit, or extension of a permit, in respect of a chemical product or an active constituent if the application is not of a kind described in any of Items 19 to 21.

Modular assessment period and fee

$350

See Table 3 for module levels, types, periods for completion and fees.

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