Therapeutic Goods (Charges) Amendment Regulations 2003 (No. 1) (Cth)
Therapeutic Goods (Charges) Amendment Regulations 2003 (No. 1) 1
Statutory Rules 2003 No. 152 2
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
Parliamentary Secretary to the Minister for Health and Ageing
These Regulations are the
Therapeutic Goods (Charges) Amendment Regulations 2003 (No. 1) .
These Regulations commence on 1 July 2003.
3 Amendment of Therapeutic Goods (Charges) Regulations 1990 Schedule 1 amends the
Therapeutic Goods (Charges) Regulations 1990 .
(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.
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.
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.
omit drug
insert medicine
omit 6.7%
insert 6.8%
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 |
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
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