Therapeutic Goods (Charges) Amendment Regulations 2010 (No. )

Therapeutic Goods (Charges) Amendment Regulations 2011 (No. 1)1

Select Legislative Instrument 2011 No. 31

I, QUENTIN BRYCE, 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 10 March 2011

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

CATHERINE KING

Parliamentary Secretary for Health and Ageing

1 Name of Regulations

These Regulations are the Therapeutic Goods (Charges) Amendment Regulations 2011 (No. 1).

2 Commencement

These Regulations commence on the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010.

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), after definition of biological substance

insert

Class 1 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

Class 2 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

Class 3 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

Class 4 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

[2] After subregulation 3 (1A)

insert

(1AA) For subsection 4 (1AA) of the Act, the annual charges for inclusion of a biological in the Register under Part 3-2A of the Act are:

(a) for a class 1 biological whose inclusion in the Register is in force at any time during the financial year to which the charge relates — $550; and

(b) for a Class 2, Class 3 or Class 4 biological whose inclusion in the Register is in force at any time during the financial year to which the charge relates — $5 500.

[3] Regulation 4A

omit