Therapeutic Goods Amendment Regulations 2006 (No. 2) (Cth)

Therapeutic Goods Amendment Regulations 2006 (No. 2)¹

Select Legislative Instrument 2006 No. 212

I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 10 August 2006

P. M. JEFFERY

Governor‑General

By His Excellency’s Command

CHRISTOPHER PYNE

Parliamentary Secretary to the Minister for Health and Ageing

Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2006 (No. 2).

Commencement

These Regulations commence on the day after they are registered.

Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1 Amendments

(regulation 3)

[1] Paragraph 45 (4A) (a)

omit

$7 360

insert

$7 620

[2] Paragraphs 45 (4A) (b), (c) and (ca)

omit

$6 140

insert

$6 350

[3] Paragraph 45 (4A) (d)

omit

$24 600

insert

$25 500

[4] Paragraphs 45 (4A) (e) and (f)

omit

$6 140

insert

$6 350

[5] Subregulation 45 (9)

omit each mention of

$3 690

insert

$3 820

[6] Subregulation 45 (11)

omit each mention of

$1 350

insert

$1 400

[7] Regulation 45A, heading

substitute

45ACharges reduced if annual turnover is not more than $68 300

[8] Subregulation 45A (1)

omit

$66 000

insert

$68 300

[9] Schedule 9, Part 2

substitute

Part 2 Table of fees

Column 1 Item	Column 2 Matter	Column 3 Fee $
1A	Application fee for processing an application for consent under section 14 of the Act	330
1	Evaluation fee for the purposes of subparagraph 19 (2) (b) (iii) of the Act: (a) if: (i) the goods are medicines for use solely for experimental purposes in humans; and (ii) the evaluation consists of the consideration of: (A) a summary of chemical, pharmaceutical and biological information about the goods; and	1 240
(B) descriptive information about the proposed clinical trial of the goods; and (C) information about adverse events associated with the use of the goods; and (D) information about the goods provided to the relevant ethics committee; — for each medicine
(b) if the goods are medicines for use solely for experimental purposes in humans (other than medicines to which paragraph (a) applies) — for each medicine	15 300
(c) if the goods are therapeutic devices referred to in item 3 of Part 1 of Schedule 3 for use solely for experimental purposes in humans where clinical studies are conducted to demonstrate safety and effectiveness	12 700
(d) if the goods are therapeutic devices for use solely for experimental purposes in humans and are goods to which paragraph (c) does not apply	1 910
2	Application fee for the purposes of paragraph 23 (2) (a) of the Act for registration of therapeutic goods (if regulation 43A does not apply and the application is not an application to which item 2AA or 3A applies):
(a) for an application relating to a medicine to which item 4 does not apply	950
(b) for an application relating to a therapeutic device of a kind mentioned in Part 2 of Schedule 3	1 010
(ba) for an application relating to a medicine to which item 4 applies, if: (i) the Secretary considers that the application cannot be determined because of insufficiency of information delivered (Act, paragraph 23 (2) (b)); or (ii) the application is withdrawn before notification of acceptance is sent under subregulation 16B (1)	6 620; or 20% of the relevant fee under item 4; whichever is the less
(c) subject to paragraph (d), for an application in any other case (d) subject to paragraph (f), if a person submits more than one application at the same time and: (i) the additional application is in relation to goods that contain the same therapeutically active ingredient or are therapeutic devices; and (ii) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made	3 050 1 520 — for each additional application, up to a maximum amount payable of $8 870 (including the fee payable under paragraph (c))
(f) if a person submits at the same time more than one application relating to item 5 and: (i) each of which relates to goods that contain the same therapeutically active ingredient; and (ii) the information in support of each of which is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made; for each additional application	420
(g) if: (i) a person submits at the same time more than 1 application relating to item 7; and (ii) the information in support of the applications is sufficiently common in respect of the therapeutic devices to which they relate to enable simultaneous evaluation of the devices; for each additional application	1 010
(h) if: (i) a person submits at the same time more than 1 application for a therapeutic device of a kind mentioned in Part 2 of Schedule 3; and (ii) the information in support of the application for each device is sufficiently common to enable simultaneous evaluation of each of the devices; for each additional application	520
2AA	Application fee for the purposes of paragraph 23 (2) (a) of the Act for the registration of therapeutic goods if the previous registration was cancelled solely because of failure to pay the annual registration charge and the application is made within 30 days of the cancellation	700
2A	Fee for varying an entry in the Register (not including evaluation of data) under subsection 9D (1), (2) or (3) of the Act, if the variation is for:
(a) a registered medicine that is mentioned in Part 1 of Schedule 10 — for each submission	1 250
(b) a registered medicine that is mentioned in Part 2 or Part 3 of Schedule 10	950
(c) a listed medicine	260
(d) a registered therapeutic device that is mentioned in Part 2 of Schedule 3	520
(e) a registered therapeutic device, other than a device mentioned in paragraph (d)	1 010
(f) a listed therapeutic device	310
(g) a medical device	310
2B	Fee for an application to which regulation 16F or 16G applies, for evaluation of the chemistry, quality control or manufacturing process of the medicine — for each submission	4 230
2C	Fee for an application under subsection 9D (1), (2) or (3) of the Act (other than an application to which item 4 applies), for evaluation of clinical, pre‑clinical or bioequivalence data, or the chemistry, quality control or manufacturing process, of the goods	4 230
3	Application fee for paragraph 23 (2) (a) of the Act for the listing of therapeutic goods (other than for an application to which regulation 43A, or item 3AA applies) if the goods are:
(a) a device	310
(b) a medicine	520
3AA	Application fee for the purposes of paragraph 23 (2) (a) of the Act for the listing of therapeutic goods if the previous listing was cancelled solely because of failure to pay the annual listing charge and the application is made within 30 days of the cancellation	360
3A	Application fee for paragraph 23 (2) (a) of the Act for registration of a therapeutic device to which item 5 of Part 1 of Schedule 3 applies (if the application is not an application to which item 2AA applies)	The fee applicable under paragraph 2 (c) or (d) for an application of that nature
3B	Evaluation fee for subsection 24 (1) of the Act for a therapeutic device to which item 5 of Part 1 of Schedule 3 applies, if the evaluation is for:
(a) the device	The fee applicable under item 6 for an evaluation of that nature
(b) a document setting out animal toxicological information about the medicinal component of the device	The fee applicable under item 4 for an evaluation of that nature
(c) a document setting out the chemistry, quality control and manufacturing information of the medicinal component of the device	The fee applicable under item 4 for an evaluation of that nature
4	Evaluation fee, for subsection 24 (1) of the Act, under a submission (if paragraph (ba) of item 2 does not apply) for evaluation relating to:
(a) a new chemical entity (other than an entity to which paragraph (aa) applies)	178 000
(aa) a new chemical entity incorporated as an ancillary medicinal component of a medical device or a therapeutic device if the evaluation of the new chemical entity involves an evaluation of:
(i) documentation setting out the chemistry, quality control and manufacturing of the new chemical entity; or	one‑third of the fee specified in paragraph (a)
(ii) documentation relating to pre‑clinical studies; or	one‑third of the fee specified in paragraph (a)
(iii) documentation mentioned in subparagraphs (i) and (ii)	two‑thirds of the fee specified in paragraph (a)
(b) an extension of indications (other than an extension of indications to which paragraph (bb) applies)	105 800
(bb) an extension of indications or a major variation in respect of a medicine incorporated as an ancillary medicinal component of a medical device or a therapeutic device if the evaluation of the medicine involves an evaluation of:
(i) documentation setting out the chemistry, quality control and manufacturing of the medicine; or	one‑third of the fee specified in paragraph (b) or (g) for an evaluation of that nature
(ii) documentation relating to pre‑clinical studies; or	one‑third of the fee specified in paragraph (b) or (g) for an evaluation of that nature
(iii) documentation mentioned in subparagraphs (i) and (ii)	two‑thirds of the fee specified in paragraph (b) or (g) for an evaluation of that nature
(c) a new generic product	65 000
(d) an additional trade name	11 200
(e) a change to product information	4 060
(f) a change to consumer patient information	1 250
(g) a major variation (that is not a variation mentioned in any of paragraphs (a) to (f))	69 000
(h) a minor variation (that is not a variation mentioned in any of paragraphs (a) to (f))	4 230
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	6 320
(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	6 320
(ii) over 50 pages, but not over 250 pages	8 100
(iii) over 250 pages, but not over 500 pages	11 100
(iv) over 500 pages, but not over 1 000 pages	14 800
(v) over 1 000 pages, but not over 2 000 pages	22 100
(vi) over 2 000 pages, but not over 3 000 pages	29 500
(vii) over 3 000 pages	44 200
(c) under subsection 9D (1), (2) or (3) of the Act ¾ 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	2 280
(d) under subsection 9D (1), (2) or (3) 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	2 280
(ii) over 50 pages, but not over 250 pages	8 100
(iii) over 250 pages, but not over 500 pages	11 100
(iv) over 500 pages, but not over 1 000 pages	14 800
(v) over 1 000 pages, but not over 2 000 pages	22 100
(vi) over 2 000 pages, but not over 3 000 pages	29 500
(vii) over 3 000 pages	44 200
5A	Evaluation fee for subsection 24 (1) of the Act for a therapeutic device to which any of items 2 to 5 of Part 2 of Schedule 3 applies, and that involves the evaluation of:
(a) design or materials information or testing	3 820
(b) manufacture, quality control or sterile manufacture, or testing information	3 820
(c) biocompatability or pre‑clinical information	3 820
(d) software	3 820
(e) human clinical information	3 820
(f) control material for use with diagnostic goods for in vitro use	3 820
5B	Evaluation fee for subsection 24 (1) of the Act in respect of disinfectants or diagnostic goods for in vitro use	12 700
6	Evaluation fee for the purposes of subsection 24 (1) of the Act in respect of a therapeutic device to which any of items 1 to 4 of Part 1 of Schedule 3 applies involving the evaluation of:
(a) design or materials information or testing	22 400
(b) manufacture, quality control or sterile manufacture or testing information;	15 200
(c) biocompatability or pre‑clinical information;	15 200
(ca) software;	15 200
(d) human clinical information	25 500
6AA		Fee for evaluation of data in relation to goods, a step in the manufacture of which was carried out outside Australia (in addition to any other fee prescribed in this Schedule in relation to the application) to determine whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable: (a) for the purposes of subsection 9D (1), (2) or (3) of the Act; or (b) for the purposes of paragraph 25 (1) (g), 26 (1) (g), 31 (1) (e) or 31 (2) (d) of the Act	270
6AB		Fee for Department obtaining evidence from overseas regulatory authority of the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in item 6AA)	480
6AC		Fee for reinstatement of acceptance status of data relating to the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in item 6AA)	820
6AD		Fee for evaluation, under section 25 of the Act, in relation to a therapeutic device:
(a) establishing from overseas reports or data that the manufacture of the device is of an acceptable standard	15 200
(b) if a person makes simultaneous applications in relation to more than 1 device and the overseas reports or data in support of the application for each device have sufficient commonality that a simultaneous evaluation of the manufacture of each device may conveniently be made — performing the function mentioned in paragraph (a) in relation to each such additional device	3 820
6A		Fee for evaluation of data, under subsection 9D (1), (2) or (3) of the Act, about an entry in the Register relating to a therapeutic device to which any of items 2 to 5 of Part 2 of Schedule 3 applies	1 010
6B		Fee for evaluation of data, under subsection 9D (1), (2) or (3) of the Act, about an entry in the Register relating to disinfectants and diagnostic goods for in vitro use	2 550
6C		Fee for evaluating documents and other information, relating to the safety of a medicine, obtained under paragraph 31 (2) (f) of the Act (other than an evaluation to which item 6D applies)	5 070
6D		Fee for evaluating documents and other information, relating to the safety, quality and efficacy of a medicine, obtained under paragraphs 31 (2) (f) and (h) of the Act, if the total number of pages of the evaluation documentation is:
(a) not over 50 pages	6 320
(b) over 50 pages, but not over 250 pages	8 100
(c) over 250 pages, but not over 500 pages	11 100
(d) over 500 pages, but not over 1 000 pages	14 800
(e) over 1 000 pages, but not over 2 000 pages	22 100
(f) over 2 000 pages, but not over 3 000 pages	29 500
(g) over 3 000 pages	44 200
7	Evaluation fee for data submitted in support of a change to a therapeutic device to which any of items 1 to 4 of Part 1 of Schedule 3 applies, if the evaluation involves review of:
(a) design or materials information or testing	7 620
(b) manufacturing, quality control and sterile manufacture or testing information;	6 350
(c) biocompatability or pre‑clinical information;	6 350
(ca) software;	6 350
(d) human clinical information	25 500
(e) confirmatory review of clinical information	6 350
(f) confirmatory evaluation of overseas reports or data	6 350
7AA	Fee for evaluation of data submitted in support of a change to a therapeutic device to which item 5 of Part 1 of Schedule 3 applies, if the evaluation involves review of:
(a) the device (not including the medicinal component of the device)	The fee applicable under item 7 for an evaluation of that nature
(b) the medicinal component of the device	The fee applicable under item 4 and paragraph (d) of item 7 for an evaluation of that nature
(c) the device (including the medicinal component of the device)	The fee applicable under items 4 and 7 for an evaluation of that nature
7A	Fee for evaluation under paragraph 16GA (1) (a):
(a) if the evaluation documentation does not contain clinical or toxicological information	6 320
(b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is:
(i) not over 50 pages	6 320
(ii) over 50 pages, but not over 250 pages	8 100
(iii) over 250 pages, but not over 500 pages	11 100
(iv) over 500 pages, but not over 1 000 pages	14 800
(v) over 1 000 pages, but not over 2 000 pages	22 100
(vi) over 2 000 pages, but not over 3 000 pages	29 500
(vii) over 3 000 pages	44 200
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:	6 320
(i) not over 50 pages	6 320
(ii) over 50 pages, but not over 250 pages	8 100
(iii) over 250 pages, but not over 500 pages	11 100
(iv) over 500 pages, but not over 1 000 pages	14 800
(v) over 1 000 pages, but not over 2 000 pages	22 100
(vi) over 2 000 pages, but not over 3 000 pages	29 500
(vii) over 3 000 pages	44 200
8	Application fee for the purposes of paragraph 37 (1) (g) of the Act	700
9	(a) Fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection within Australia (except for therapeutic goods mentioned in items 9AA, 9AB, 9AC and 9ACA), per hour, per inspector, for:	460
(i) the manufacture of therapeutic goods; or
(ii) a step in the manufacture of therapeutic goods; or
(iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or
(iv) the manufacture of herbal or homoeopathic preparations; or
(v) the manufacture of diagnostic goods for in vitro use
(b) Fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection outside Australia, per hour, per inspector, for inspection of a kind mentioned in paragraph (a)	940
9AA	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of haematopoietic progenitor cells under licence, for each inspector engaged per hour, or part of an hour	460
9AB	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at the primary site covered by the licence, for each inspector engaged per hour, or part of an hour	630
9AC	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at a site covered by the licence other than the primary site, for each inspector engaged per hour, or part of an hour	460
9ACA	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of human tissues under licence, for each inspector engaged per hour, or part of an hour	460
9AD	Fee for paragraph 25 (1) (g) or (h), or 26 (1) (g) or (h) of the Act (and, in relation to associated inspections, for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act), in respect of the evaluation of the manufacture of human blood and blood components prepared under licence by reference to data contained in files known as technical master files or plasma master files, where the total number of pages of each file referred to is:
(a) not over 10 pages	920
(b) over 10 pages, but not over 50 pages	7 880
(c) over 50 pages, but not over 100 pages	17 500
(d) over 100 pages, but not over 1 000 pages	23 600
(e) over 1 000 pages, but not over 3 000 pages	36 800
(f) over 3 000 pages, but not over 4 000 pages	48 900
(g) over 4 000 pages	59 600
9B	Evaluation fee for assessing, for paragraph 26 (1) (d) of the Act, whether a therapeutic device is safe for the purposes for which it is to be used	12 700
9C	Fee for evaluating documents and other information, relating to the safety of a listed therapeutic device, obtained under paragraph 31 (2) (f) of the Act	12 700
9D	Fee for evaluation, under subsection 9D (1), (2) or (3), subsection 24 (1) or paragraph 26 (1) (d) of the Act, of data relating to the device component of a medicine (in addition to the fee prescribed in item 4 or 5 for evaluating the medicine):
(a) for a device component to which Chapter 3 of the Act applies	The fee applicable under item 5A, 6, 7 or 9B for an evaluation of that nature
(b) for a device component to which Chapter 4 of the Act applies	The fee applicable, under item 1.9, 1.10, 1.12 or 1.16 (and, if applicable, clause 2.2) of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002, to the kind of work to be undertaken
10	Fee for an application for certification under paragraph 58 (3) (a) of the Act	110 multiplied by the number of certifications sought in the application
11	Fee for the inspection of manufacturing operations other than for the purposes of Part 3‑3 of the Act	The fee applicable under item 9 for that step of manufacture
12	Fee for evaluation of data in relation to therapeutic goods specified in Schedule 10 for the purposes of subsection 9D (1), (2) or (3) of the Act	The fee applicable under item 1, 4, 5, 6 or 7 for an evaluation of that nature
13	Fee for an evaluation under subsection 66 (4) of the Act	The fee applicable under item 1, 4, 5, 6 or 7 for an evaluation of that nature
14	Fee for notification of intention to sponsor a clinical trial using a specified medicine	240
14A	Fee for notification of intention to sponsor a clinical trial using a specified therapeutic device, if the sponsor of the device notifies the Secretary, in accordance with item 3 of Schedule 5A, of 1 or more bodies or organisations conducting the trial for the sponsor, including the sponsor, if the sponsor is conducting the trial (whether or not the sponsor has previously notified the Secretary of 1 or more bodies or organisations conducting the trial)	240
16	Fee, including deposit, for an application under subsection 61 (6) of the Act	The amount, including a deposit, that would be payable under the Freedom of Information Act 1982 and the Freedom of Information (Fees and Charges) Regulations for a request if the application were a request under section 15 of that Act
17	Fee for an application, under regulation 5F, for approval of an advertisement intended to be published in specified media (other than broadcast media):
(a) if the time needed to process the application is an hour or less — for an advertisement:
(i) of not more than 100 words	160
(ii) of more than 100 words	200
(iii) of more than 300 words (including an advertorial)	330
(iv) that is intended for publication in the classified advertisement columns of a newspaper or other publication	90
(b) if the time needed to process the application is more than an hour	The fee applicable under paragraph (a) plus $140 for each additional hour or part of an hour
(c) if the application is for approval of a minor change to an approved advertisement (other than a change to information of the kind mentioned in paragraph 5C (2) (b), (e) or (f) of these Regulations) and the application is made more than 3 months after the advertisement was approved	90
(d) if the application is for approval of an advertisement that is identical to an approved advertisement the approval number of which has expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
(e) if the application is for approval of a variation of an approved advertisement the approval number of which has not expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
17A	Fee for an application, under regulation 5F, for approval of an advertisement intended to be broadcast in broadcast media:
(a) if the time needed to process the application is an hour or less — for an advertisement that is:
(i) a television or cinema advertisement of not more than 150 seconds, including up to 3 variations of the advertising concept for the same product	840
(ii) a television advertisement for a retail outlet that is intended to be broadcast on 1 regional station only in that station’s regional area	430
(iii) a television advertorial of more than 150 seconds:
(A) for the first minute of each script	630
(B) for each additional minute or part of a minute of each script	170
(iv) a radio advertisement, including up to 6 variations of the advertising concept for the same product	310
(v) a radio advertisement that is intended to be broadcast in a regional area only, including up to 6 variations of the advertising concept for the same product	210
(vi) a still cinema media advertisement (including outdoor media):
(A) of not more than 100 words	160
(B) of not more than 300 words	200
(C) of more than 300 words	330
(b) if the time needed to process the application is more than an hour	The fee applicable under paragraph (a) plus $140 for each additional hour or part of an hour
(c) if the application is for approval of a minor change to an approved advertisement (other than a change to information of the kind mentioned in paragraph 5C (2) (b), (e) or (f) of these Regulations) and the application is made more than 3 months after the advertisement was approved	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
(d) if the application is for approval of an advertisement that is identical to an approved advertisement the approval number of which has expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
(e) if the application is for approval of a variation of an approved advertisement the approval number of which has not expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
18	Fee for testing a sample of, and providing advice in relation to, a prescription medicine on request by the Pharmaceutical Benefits Program of the Department before listing the medicine in the Pharmaceutical Benefits Listing Program of the Department	1 500

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See