The application fee and 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 is appropriate
- the argument provided in your application in lieu of data is appropriate
- 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.
For more information on assessment periods, including extended assessment periods and maximum response periods, please refer to the extended assessment period and maximum response period.
List of assessment periods and fees
- Approvals and registrations
- Variation of approval or registration
- Module levels, types, periods for completion and fees
- Notifications
- Applications under Agvet Code Regulations
- Other fees
- Registration renewals
- Permit applications
Table 1: Approvals and registrations
Approval and registration applications made under section 10 of the Agvet Code:
| Item | Application description | Assessment period | Fee from 1/7/20 to 31/1/23 | Fee from 2/1/23 | Maximum PAA 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 | $116 501 | $11 6501 | $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 | $83 511 | $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 | $44 644 | $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 | $7 566 | $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 | $6 406 | $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 | $2 632 | $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 | $2 632 | $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 | $2 632 | $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 | $38 776 | $38 776 | $1 400 |
| 16 | Approval of an active constituent requiring less than a full assessment but requiring a toxicological assessment. | 9 months | $27 031 | $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 | $5 442 | $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 18). | 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
Applications to vary the relevant particulars or conditions under section 26B or section 27 of the Agvet Code:
| Item | Application description | Assessment period | Fee from 1/7/20 to 31/1/23 | Fee from 1/2/23 | Maximum PAA rebate |
|---|---|---|---|---|---|
| 11 | Vary particulars or conditions of registration or label approval where a full assessment of the chemical product is required. | 10 months | $36 205 | $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 | $2 018 | $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 | $4 252 | $4 252 | $700 |
| 24 | Variation of approval or registration under section 27 of the Code requiring assessment of a technical nature (other than of the kinds described in any of items 1 to 18). From 1 February 2023 only. | 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 3: Module levels, types, periods for completion and fees
Note: the module structure for technical assessment has changed effective from 1 February 2023. Toxicology and Occupational Health and Safety modules have been replaced by new Health modules. Timeframes and fees have been reduced for 2 of the Residues modules, and there are new Chemistry and Environment modules.
The discontinued Toxicology, Occupational Health and Safety and Residues modules (which apply to applications received prior to 1 February 2023) are retained at the end of this table for reference. For modular applications, the module descriptors explain which modules are required for different application types.
| Module level or type | Period for completion | Fee to 31/1/23 | Fee from 1/2/23 | |
|---|---|---|---|---|
| Discontinued modules (from 1 February 2023). These modules continue to apply for applications received prior to 1 February 2023. | ||||
| 1 | Preliminary assessment | Not applicable | $902 | $902 |
| 2.1 | Chemistry 1 | 13 months | $11 074 | $11 074 |
| 2.2 | Chemistry 2 | 9 months | $3 075 | $3 075 |
| 2.3 | Chemistry 3 | 6 months | $1 954 | $1 954 |
| 2.4 | Chemistry 4 (new module) | 3 months | N/A | $970 |
| 2.5 | Chemistry 5 (new module) | 2 months | N/A | $480 |
| 3.1 | Health 1 (new module replaces Toxicology 1 and Occupational Health and Safety 1 combined) | 13 months | N/A | $36 740 |
| 3.2 | Health 2 (new module replaces Toxicology 1) | 11 months | N/A | $27 920 |
| 3.3 | Health 3 (new module replaces Toxicology 2 and Occupational Health and Safety 2 combined) | 9 months | N/A | $18 980 |
| 3.4 | Health 4 (new module replaces Toxicology 3 and Occupational Health and Safety 3 combined) | 5 months | N/A | $7 963 |
| 3.5 | Health 5 (new module replaces either Toxicology 3 or Occupational Health and Safety 3) | 4 months | N/A | $4 000 |
| 3.6 | Health 6 (new module) | 2 months | N/A | $2 000 |
| 4.1 | Poisons scheduling | 13 months | $2 435 | $2 435 |
| 5.1 | Residues 1 | 13 months | $25 650 | $25 650 |
| 5.2 | Residues 2 | 8 months | $11 149 | $11 149 |
| 5.3 | Residues 3 (new module) | 6 months | N/A | $9 000 |
| 5.4 | Residues 4 | 4 months | $7 465 | $7 465 |
| 5.5 | Residues 5 (new module) | 3 months | N/A | $2 000 |
| 7.1 | Environment 1 | 13 months | $26 390 | $26 390 |
| 7.2 | Environment 2 | 7 months | $7 659 | $7 659 |
| 7.3 | Environment 3 | 4 months | $2 979 | $2 979 |
| 7.4 | Environment 4 (new module) | 3 months | N/A | $1 490 |
| 8.1 | Efficacy and safety 1 | 6 months | $4 740 | $4 740 |
| 8.2 | Efficacy and safety 2 | 4 months | $1 950 | $1 950 |
| 8.3 | Efficacy and safety 3 | 3 months | $1 160 | $1 160 |
| 9 | Non-food trade | 6 months | $1 175 | $1 175 |
| 10.1 | Special data 1 | 13 months | Nil | Nil |
| 10.2 | Special data 2 | 7 months | Nil | Nil |
| 10.3 | Special data 3 | 7 months | Nil | Nil |
| 11.1 | Finalisation 1 | 3 months | $8 110 | $8 110 |
| 11.2 | Finalisation 2 | 2 months | $3 090 | $3 090 |
| 11.3 | Finalisation 3 | 2 months | $1 730 | $1 730 |
| 12 | Limits on use of information | Not applicable | $460 | $460 |
| 3.1 (old module) | Toxicology – level 1 (replaced by Health modules) | 13 months | $27 920 | N/A |
| 3.2 (old module) | Toxicology – level 2 (replaced by Health modules) | 9 months | $15 795 | N/A |
| 3.3 (old module) | Toxicology – level 2 (replaced by Health modules) | 5 months | $4 050 | N/A |
| 5.3 (old module) | Residues – level 3 | 8 months | $16,400 | N/A |
| 5.5 (old module) | Residues – level 5 | 4 months | $4,000 | N/A |
| 6.1 (old module) | Occupational health and safety – level 1 (replaced by Health modules) | 13 months | $8 820 | N/A |
| 6.2 (old module) | Occupational health and safety – level 2 (replaced by Health modules) | 7 months | $3 185 | N/A |
| 6.3 (old module) | Occupational health and safety – level 2 (replaced by Health modules) | 4 months | $3 913 | N/A |
Table 4: Notifications
| Description | Period for completion | Fee to 31/1/23 | Fee from 1/2/23 |
|---|---|---|---|
| Notices of notifiable variations | N/A | $50 | $50 |
Table 5: Applications under Agvet Code Regulations
| Item | Application description | Assessment period | Extended assessment period | Fee to 31/1/23 | Fee from 1/2/23 | Maximum PAA 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 | |
Table 6: Other fees
Note: there is no assessment period or pre-application assistance rebate for any of these item types.
| Item | Application description | Fee to 31/1/23 | Fee from 1/2/23 |
|---|---|---|---|
| HGP | Application/renewal fee | $429 | $429 |
| Certificate of Export | Requires technical assessment | $230 | $230 |
| Certificate of Export | No technical assessment | $125 | $125 |
| GMP Audit | Assessment fee – Item 1 and Multi-Item 2 to 4 | $7 500 | $7 500 |
| GMP Audit | Assessment fee – Single Item 2 to 4 | $5 000 | $5 000 |
| GMP Audit | Assessment fee – Item 6 | $1 800 | $1 800 |
GMP Overseas Compliance Audit (fee applicable to product registration) | Assessment fee | $1 000 | $1 000 |
| GMP New Licence | Application fee | $900 | $900 |
| GMP licence variation audit (fee covers assessment of the application and audit) | Review fee | $1 800 | $1 800 |
| Low income manufacturer – single-category | $2 500 | $2 500 | |
| Low income manufacturer – category 1 and multi-category | $3 750 | $3 750 | |
| Low income manufacturer – category 6 | $900 | $900 |
Table 7: Registration renewals
| Application description | Assessment period | Fee from 1/7/20 to 31/1/23 | Fee from 1/2/23 |
|---|---|---|---|
| Renewal of registration (1 year) | The APVMA must renew the registration before the registration end date. | $600 | $600 |
| Renewal of registration (5 years) | The APVMA must renew the registration before the registration end date. | $3 350 | $3 650 |
| Renewal of registration late fee | Within 1 month after the late application is made. | $50 | $50 |
Table 8: Permit applications
| Item | Application description | Assessment period | Fee to 31/1/23 | Fee from 1/2/23 | Maximum PAA 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.