Timeframe and fees

The assessment period in which the 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 or 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, we aim 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
  • 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 Agvet Code is issued, the extended assessment period prescribed by the 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.

Table 1: Approvals and registrations made under section 10 of the Agvet Code
Item Description of application Assessment period Fee
1 July 2014
Fee
1 Jan 2015
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 $84 115 $96 135 $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 $56 545 $64 620 $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 $32 090 $36 675 $1 050
5 Registration of a chemical product containing an approved active constituent, and approval of the product label, if the product is similar to a registered chemical product and chemistry and manufacture, efficacy or target species safety data is the only data required to demonstrate the similarity of the product to the registered chemical product 8 months $4 260 $4 870 $700
6 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 required 8 months $3 755 $4 290 $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 $1 535 $1 755 $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 $1 455 $1 655 $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 $1 395 $1 595 $350
10 Registration of a chemical product containing an approved active constituent (or an active constituent for which the APVMA has received an application for approval) and approval of the product label for all situations other than those described in items 3 to 9 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 $26 730 $30 550 $1 400
16 Approval of an active constituent requiring less than a full assessment but requiring a toxicological assessment 9 months $16 455 $18 805 $700
17 Approval of an active constituent requiring less than a full assessment but not requiring a toxicological assessment 7 months $2 760 $3 155 $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 for approval of an active constituent that is not a previously endorsed active constituent or registration of a chemical product containing an active constituent that is not an active constituent contained in any other registered chemical product 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
1 July 2014
Fee
1 Jan 2015
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

$25 035 $28 610 $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

$1 020 $1 170 $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 months

$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

$2 155 $2 465 $700
Table 3: Module levels, types, periods for completion and fees
Module level Module type Period for completion Fee
1 July 2014
Fee
1 Jan 2015
1 Preliminary assessment Not applicable $620 $710
2.1 Chemistry 13 months $8 065 $9 220
2.2 Chemistry 9 months $2 690 $3 075
2.3 Chemistry 6 months $1 380 $1 580
2.5 Chemistry—timeshift only As set out in project plan $8 065 $9 220
3.1 Toxicology 13 months $24 430 $27 920
3.2 Toxicology 9 months $14 620 $15 795
3.3 Toxicology 5 months $3 540 $4 050
3.4 Toxicology—timeshift only As set out in project plan $24 430 $27 920
4.1 Toxicology requiring poison schedule classification 13 months $2 435 $2 435
4.2 Toxicology requiring poison schedule classification—timeshift only As set out in project plan $2 435 $2 435
5.1 Residues 13 months $15 900 $18 170
5.2 Residues 8 months $9 210 $10 525
5.3 Residues (permit only) 8 months $7 175 $8 200
5.4 Residues 4 months $6 535 $7 465
5.5 Residues (permit only) 4 months $1 750 $2 000
5.6 Residues—timeshift only As set out in project plan $15 900 $18 170
6.1 Occupational health and safety 13 months $4 310 $4 410
6.2 Occupational health and safety 7 months $2 900 $3 185
6.3 Occupational health and safety 4 months $3 480 $2 9101
6.4 Occupational health and safety—timeshift only As set out in project plan $4 310 $4 410
7.1 Environment 13 months $23 095 $26 390
7.2 Environment 7 months $6 400 $7 315
7.3 Environment 4 months $1 505 $1 720
7.4 Environment—timeshift only As set out in project plan $23 095 $26 390
8.1 Efficacy and safety 6 months $2 075 $2 370
8.2 Efficacy and safety 4 months $855 $975
8.3 Efficacy and safety 3 months $505 $580
8.4 Efficacy and safety—timeshift only As set out in project plan $2 075 $2 370
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
10.4 Special data—timeshift only As set out in project plan nil nil
11.1 Finalisation 3 months $3 545 $4 055
11.2 Finalisation 2 months $1 350 $1 545
11.3 Finalisation 2 months $755 $865
12 Data protection Not applicable $400 $460

1Per the Agvet Regulations Schedule 7, the fee for module 6.3 is $3 980. However the APVMA has waived a portion of this fee to bring it in proportion to the fees charged for modules 6.1 and 6.2. $1 070 of the $3 980 fee has been waived to bring the fee down to $2 910.

Table 4: Notifications
Description  Period for completion

Fee

1 Jan 2015

Notices of notifiable variations Not applicable $50
Table 5: Applications under Agvet Code Regulations
Item Description of application Assessment period Extended assessment period Fee from 1 July 2016 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, plus GST 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

Information on permit timeframes and fees can be found here.

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