Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3)1

Statutory Rules 2000 No. 2662

I, WILLIAM PATRICK DEANE, Governor-General 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 27 September 2000

WILLIAM DEANE

Governor-General

By His Excellency’s Command

GRANT TAMBLING

1 Name of Regulations

  These Regulations are the Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 3).

2 Commencement

  These Regulations commence on gazettal.

3 Amendment of Therapeutic Goods (Charges) Regulations 1990

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

Schedule 1 Amendments

(regulation 3)

[1] Paragraph 3 (2) (h)

omit

$3,500.

insert

$3 500;

[2] After paragraph 3 (2) (h)

insert

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

 (i) in relation to a metropolitan site — $8 000; and

 (ii) in relation to each additional fixed (non‑mobile) manufacturing site associated with the metropolitan site — $1 950.

[3] Regulation 3, note

substitute

Note   Under subregulation 45A (1) of the Therapeutic Goods Regulations 1990, the annual charge for a licence under Part 4 of the Therapeutic Goods Act 1989 that is payable by a person whose wholesale turnover of therapeutic goods in a financial year is not more than $56 000 is half of the relevant amount specified in subregulation 3 (2). Under subregulation 45A (2) of those Regulations, the reduction in the annual charge does not apply in respect of a licence for the manufacture of human blood and blood components.

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 and 125.

2. Notified in the Commonwealth of Australia Gazette on 28 September 2000.