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SR 2003 No. 152 Regulations as made
These Regulations amend the Therapeutic Goods (Charges) Regulations 1990.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR11-Aug-2003
Tabled Senate11-Aug-2003
Gazetted 26 Jun 2003
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods (Charges) Amendment Regulations 2003 (No. 1)1

Statutory Rules 2003 No. 1522

I, GUY STEPHEN MONTAGUE GREEN, Administrator of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods (Charges) Act 1989.

Dated 25 June 2003

G. S. M. GREEN

Administrator

By His Excellency’s Command

TRISH WORTH


1              Name of Regulations

                These Regulations are the Therapeutic Goods (Charges) Amendment Regulations 2003 (No. 1).

2              Commencement

                These Regulations commence on 1 July 2003.

3              Amendment of Therapeutic Goods (Charges) Regulations 1990

                Schedule 1 amends the Therapeutic Goods (Charges) Regulations 1990.


Schedule 1        Amendments

(regulation 3)

  

[1]           Subregulation 2 (1), before definition of Poisons Standard

insert

biologic, in relation to therapeutic goods, means goods in which the active ingredient is a biological substance.

biological substance means a substance of biological origin that:

                (a)    in many cases, is chemically complex and with a molecular weight of more than 1 000; and

               (b)    is not defined by a chemical name because its purity, strength and exact composition cannot be readily determined by chemical analysis.

Example

Hormones, enzymes and related substances are biological substances. Herbal substances and antibiotics are not biological substances.

[2]           Paragraphs 3 (1) (a) and (b)

substitute

                (a)    for goods of a kind whose registration is in force at any time during the financial year to which the charge relates and that is not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

                          (i)    if the goods are a medicine — $690; or

                         (ii)    if the goods are a device — $1 850; and

               (b)    for goods of a kind whose registration is in force at any time during the financial year to which the charge relates and that is mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

                          (i)    if the goods are a biologic — $2 300; or

                         (ii)    if the goods are not a biologic — $1 420; and

                (c)    for goods (other than goods produced for export) the listing of which is in force at any time during the financial year to which the charge relates:

                          (i)    if the goods are a medicine — $505; or

                         (ii)    if the goods are a device — $930.

[3]           Paragraphs 3 (1A) (a) and (b)

substitute

                (a)    for grouped goods whose registration is in force at any time during the financial year to which the charge relates and that are not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

                          (i)    if the grouped goods are medicines — $690; or

                         (ii)    if the grouped goods are devices — $1 850; and

               (b)    for grouped goods whose registration is in force at any time during the financial year to which the charge relates and that are included in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

                          (i)    if the grouped goods are biologics — $2 300; or

                         (ii)    if the grouped goods are not biologics — $1 420; and

                (c)    for grouped goods (other than goods all of which are produced for export) the listing of which is in force at any time during the financial year to which the charge relates:

                          (i)    if the goods are medicines — $505; or

                         (ii)    if the goods are devices — $930.

[4]           Paragraph 3 (2) (e)

omit

drug

insert

medicine

[5]           Paragraphs 4C (5) (a) and (b)

omit

6.7%

insert

6.8%

[6]           Further amendments — amounts of charges

 

Provision

omit

insert

Paragraph 3 (1B) (a)

$40

$45

Paragraph 3 (1B) (b)

$620

$645

Paragraph 3 (1B) (c)

$820

$850

Paragraphs 3 (2) (a) and (b)

$7 710

$7 965

Paragraphs 3 (2) (c), (d), (e), (f), (g) and (h)

$3 970

$4 100

Subparagraph 3 (2) (j) (i)

$70 000

$72 275

Subparagraph 3 (2) (j) (ii)

$2 210

$2 285

Subregulation 3 (3), note

$61 000

$62 985

Subregulation 4E (1)

$75

$80

Subregulation 4E (2)

$10 600

$10 945


Notes

1.       These Regulations amend Statutory Rules 1990 No. 395, as amended by 1991 No. 85; 1992 No. 88; 1993 No. 140; 1994 Nos. 149 and 223; 1995 No. 193; 1996 No. 132; 1997 No. 161; 1998 Nos. 246 and 260; 2000 Nos. 71, 125 and 266; 2001 No. 161; 2002 Nos. 144 and 235.

2.       Notified in the Commonwealth of Australia Gazette on 26 June 2003.