Agricultural and Veterinary Chemicals Code Regulations 1995

Applications 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

18 months

25 months

$1,400

$116,501

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

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

$1,400

The modular assessment fee

Applications 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:

(a) there is no registered chemical product containing the active constituent; and

(b) a full assessment of the chemical product is required

18 months

25 months

$1,050

$83,511

4

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

(a) there is a registered chemical product containing the active constituent; and

(b) a full assessment of the chemical product is required; and

(c) there are no relevant maximum residue limits; and

(d) poison schedule classification is required

18 months

25 months

$1,050

$44,644

5

Application for:

(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 Pharmacopoeia (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

12 months

$700

$7,566

6

Application for:

(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 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 Pharmacopoeia (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

12 months

$700

$6,406

7

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

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

(b) efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and

(c) chemistry and manufacture data are not required

3 months

5 months

$350

$2,632

8

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

(a) the chemical product is the same as a registered chemical product; and

(b) the chemical product is to be registered with a different name

3 months

5 months

$350

$2,632

9

Application for 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

4 months

$350

$2,632

10

Application for:

(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);

for all situations other than those described in items 1 to 9

The modular assessment period

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

$350

The modular assessment fee

10A

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

The modular assessment period

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

$350

The modular assessment fee

Applications for approval or registration for prescribed active constituents, chemical products or labels

10B

Application under subsection 14C(1), 14D(1) or 14E(1) of the Code

A period specified in, or worked out in accordance with, a legislative instrument made by the APVMA

A period specified in, or worked out in accordance with, a legislative instrument made by the APVMA

An amount (if any) specified in, or worked out in accordance with, a legislative instrument made by the APVMA

An amount specified in, or worked out in accordance with, a legislative instrument made by the APVMA

Applications to vary a registration or approval

11

Application to vary relevant particulars or conditions of registration or label approval where a full assessment of the chemical product is required

10 months

15 months

$1,050

$36,205

12

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

(a) the variation is to allow a minor change; and

(b) no data of a technical nature is required

3 months

5 months

$350

$2,018

13

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

(a) the variation is to allow a minor change; and

(b) no data of a technical nature is required; and

(c) the variation is a change required by the APVMA

3 months

5 months

Nil

Nil

13A

Application to 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

Not applicable

Nil

$175

14

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

The modular assessment period

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

$350

The modular assessment fee

Applications for approval of an active constituent

15

Application for approval of an active constituent requiring a full assessment

14 months

20 months

$1,400

$38,776

16

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

9 months

13 months

$700

$27,031

17

Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment (unless item 5, 6 or 10 applies)

7 months

11 months

$700

$5,442

Applications for variation to an approved active constituent

18

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

7 months

11 months

$700

$4,252

Applications for permits

19

Application for 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

5 months

$350

$350

20

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

3 months

5 months

$350

$350

21

Application for a permit, or extension of a permit, where the proposed use is a minor use

The modular assessment period

The modular assessment period, plus 6 months (unless the APVMA and the applicant agree to a shorter period)

$350

$350

22

Application for 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

Not applicable—(see subregulation 76(4))

Not applicable

Nil (see paragraph 70(8)(b))

Nil (see paragraph 70(8)(b))

23

Application for 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 22

The modular assessment period

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

$350

The modular assessment fee

Other applications

24

Application made under:

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

(b) section 27 of the Code requiring assessment of a technical nature (other than those of the kinds described in any of items 11 to 14 or 18).

The modular assessment period

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

$350

The modular assessment fee

25

Application made under regulation 8AS for a technical assessment

The modular assessment period

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

Nil

The modular assessment fee, plus GST

27

Timeshift application (see regulation 3BA)

The modular assessment period

Not applicable

$1,400

The modular assessment fee

28

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

The modular assessment period

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

Nil

The modular assessment fee

29

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

The modular assessment period

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

Nil

The modular assessment fee