Schedule 1 Amendments

(regulation 3)

[1] Subregulations 3 (1) and (1A)

substitute

(1) For the purposes of subsection 4 (1) of the Act, the annual charges for the registration or listing of therapeutic goods are:

(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 — $720; and

(ii) if the goods are a medical device — $1 910; and

(iii) in any other case — $1 090; 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 — $3 050; and

(ii) if the goods are not a biologic — $1 820; 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 — $530; and

(ii) if the goods are a medical device — $960; and

(iii) in any other case — $550.

(1A) For the purposes of subsection 4 (1A) of the Act, the annual charge for the registration or listing of grouped therapeutic goods is:

(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 goods are medicines — $720; and

(ii) if the goods are medical devices — $1 910; and

(iii) in any other case — $1 090; 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 mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

(i) if the goods are biologics — $3 050; and

(ii) if the goods are not biologics — $1 820; 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 — $530; and

(ii) if the goods are medical devices — $960; and

(iii) in any other case — $550.

[2] Subregulation 3 (1B)

after

medical devices

insert

(other than medical devices produced for export)

[3] Subregulation 3 (2)

substitute

(2) For the purposes of subsection 4 (2) of the Act, the annual charge for a licence that is in force at any time during a financial year is as follows:

(a) for a licence for the manufacture of sterile or non-sterile therapeutic goods — $8 210;

(b) for a licence for the manufacture of containers in which therapeutic goods are to be packed — $8 210;

(c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods — $4 230;

(d) for a licence for a single step in the manufacture of therapeutic goods — $4 230;

(e) for a licence for the manufacture of a sterile or non-sterile single medicine — $4 230;

(f) for a licence for the manufacture of a sterile or non-sterile single type of therapeutic device — $4 230;

(g) for a licence for the manufacture of sterile or non-sterile diagnostic goods for in vitro use — $4 230;

(h) for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the Poisons Standard (other than Schedule 5 or 6) — $4 230;

(j) for a licence for the manufacture of human blood and blood components at manufacturing premises covered by the licence:

(i) for a primary site — $98 300; and

(ii) for each additional fixed (non-mobile) manufacturing site associated with the primary site — $3 770;

(k) for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence — $4 230;

(l) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence — $8 210.

[4] After subregulation 3 (3), including the note

insert

(4) For paragraph (2) (j):

primary site means the principal premises in the capital city of each State and Territory where human blood and blood components are manufactured.

[5] Further amendments — amounts of charge

Provision	omit	insert
Paragraph 3 (1B) (a)	$45	$50
Paragraph 3 (1B) (b)	$645	$670
Paragraph 3 (1B) (c)	$850	$880
Subregulation 3 (3), note	$62 985	$65 000
Subregulation 4E (1)	$80	$90
Subregulation 4E (2)	$10 945	$11 300

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; 2003 No. 152.

2. Notified in the Commonwealth of Australia Gazette on 25 June 2004.