THERAPEUTIC GOODS AMENDMENT REGULATIONS 2000 (NO. 1) 2000 NO. 29 - SCHEDULE 1 Amendments commencing on gazettal

Commonwealth Numbered Regulations

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2000 (NO. 1) 2000 NO. 29 - SCHEDULE 1

Amendments commencing on gazettal

(subregulation 3 (1))

[1] Regulation 2, after definition of pharmaceutical benefit

insert

"Poisons" Standard has the same meaning as current Poisons Standard .

[2] Part 3A, heading

substitute

Part 3A Applications for evaluation

[3] Part 3A, before regulation 16A

insert

Division 1 Goods mentioned in Part 1 of Schedule 10

[4] After regulation 16G

insert

Division 2 Applications for evaluation of substances
16GA Evaluation other than evaluation under subsection 24 (1) or
32 (3), (4) or (5) of Act

(1): At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:

(a): a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;
(b): a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.

(2): An evaluation under this regulation may be made, although an application under section 23 or subsection 32 (3), (4) or (5) of the Act is not current.

Exemption from fee

(3): No fee is payable for an evaluation under paragraph (1) (b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.

[5] Schedule 9, paragraph 2 (a)

substitute

	(a) for an application relating to a medicine to which item 4 of Schedule 9 does not apply	650
	(b) for an application relating to a therapeutic device of a kind mentioned in Part 2 of Schedule 3	540
	(ba) for an application relating to a medicine to which item 4 applies	the lesser of 5,000 and the amount that is 10% of the relevant fee under item 4

[6] Schedule 9, paragraph 2 (d)

omit

paragraphs (e) and

insert

paragraph

[7] Schedule 9, paragraph 2A (b)

omit

540

insert

650

[8] Schedule 9, item 4

after

for therapeutic goods

insert

in respect of therapeutic goods of a kind mentioned in Part 1 of Schedule 10 that are

[9] Schedule 9, item 4

Provision	omit	insert
Subparagraph (a) (i)	5,200	5,400
Subparagraph (a) (ii)	16,000	16,500
Subparagraph (a) (iii)	38,000	39,500
Subparagraph (a) (iv)	70,000	72,500
Subparagraph (a) (v)	80,000	83,000
Subparagraph (a) (vi)	85,000	88,500
Subparagraph (a) (vii)	90,000	93,500
Subparagraph (b) (i)	3,000	3,125
Subparagraph (b) (ii)	10,250	10,650
Subparagraph (b) (iii)	37,000	38,500
Subparagraph (b) (iv)	55,000	57,000
Subparagraph (b) (v)	60,000	62,500
Subparagraph (b) (vi)	65,000	67,500
Subparagraph (c) (i)	700	725
Subparagraph (c) (ii)	6,000	6,200
Subparagraph (c) (iii)	13,250	13,750
Subparagraph (c) (iv)	18,000	18,500
Subparagraph (c) (v)	28,000	29,000
Subparagraph (c) (vi)	37,000	38,500
Subparagraph (c) (vii)	45,000	47,000

[10] Schedule 9, item 4A

omit

[11] Schedule 9, item 5

substitute

5	evaluation fee: (a) under subsection 24 (1) of the Act — in respect of a medicine to which item 4 does not apply, if the evaluation documentation does not contain clinical or toxicological information	4,300
	(b) under subsection 24 (1) of the Act — in respect of a medicine to which item 4 does not apply, if the evaluation documentation contains clinical or toxicological information, and the total number of pages is: (i) not over 50 pages (ii) over 50 pages, but not over 250 pages (iii) over 250 pages, but not over 500 pages (iv) over 500 pages, but not over 1,000 pages (v) over 1,000 pages, but not over 2,000 pages	4,300 5,500 7,500 10,000 15,000
	(vi) over 2,000 pages, but not over 3,000 pages (vii) over 3,000 pages	20,000 30,000
	(c) under subsection 32 (3), (4) or (5) of the Act - in relation to an entry in the Register relating to a medicine (other than an entry for goods in relation to which a fee specified in item 4 applies), if the evaluation documentation does not contain clinical or toxicological information	1,550
	(d) under subsection 32 (3), (4) or (5) of the Act — in relation to an entry in the Register relating to a medicine (other than an entry for goods in relation to which a fee specified in item 4 applies), if the evaluation documentation contains clinical or toxicological information, and the total number of pages is: (i) not over 50 pages (ii) over 50 pages, but not over 250 pages (iii) over 250 pages, but not over 500 pages (iv) over 500 pages, but not over 1,000 pages (v) over 1,000 pages, but not over 2,000 pages (vi) over 2,000 pages, but not over 3,000 pages (vii) over 3,000 pages	1,550 5,500 7,500 10,000 15,000 20,000 30,000

[12] Schedule 9, after item 7

insert

7A	fee for evaluation under paragraph 16GA (1) (a): (a) if the evaluation documentation does not contain clinical or toxicological information (b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is: (i) not over 50 pages (ii) over 50 pages, but not over 250 pages (iii) over 250 pages, but not over 500 pages (iv) over 500 pages, but not over 1,000 pages (v) over 1,000 pages, but not over 2,000 pages (vi) over 2,000 pages, but not over 3,000 pages (vii) over 3,000 pages	4,300 4,300 5,500 7,500 10,000 15,000 20,000 30,000
7B	fee for evaluation, under paragraph 16GA (1) (b), in relation to 1 or more new excipients for use in particular therapeutic goods: (a) if the evaluation documentation does not contain clinical or toxicological information (b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is: (i) not over 50 pages (ii) over 50 pages, but not over 250 pages (iii) over 250 pages, but not over 500 pages (iv) over 500 pages, but not over 1,000 pages (v) over 1,000 pages, but not over 2,000 pages (vi) over 2,000 pages, but not over 3,000 pages (vii) over 3,000 pages	4,300 4,300 5,500 7,500 10,000 15,000 20,000 30,000

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