Instrument of arrangement: Use of computer programs to make decisions, Jul 2017

Instrument under the Therapeutic Goods Act 1989

Arrangement under section 7C of the Therapeutic Goods Act 1989 for use of computer programs to make decisions

I, Lyndall Soper, Assistant Secretary, Complementary and OTC Medicines Branch, Medicines Regulation Division, a delegate of the Secretary of the Department of Health for the purposes of section 7C of the Therapeutic Goods Act 1989 (the Act):

ARRANGE under subsection 7C(1) of the Act for the use of the computer program known as TGA Business Services to make decisions for the Secretary as specified below:

1. decisions under subsection 9D(2C) of the Act to vary an entry in the Register,
   1. in accordance with a request to the Secretary from the person in relation to whom the therapeutic goods which are the subject of the entry are registered or listed;
   2. where the variation is of a kind specified in the regulations for the purposes of paragraph 9D(2C)(b) of the Act; and
   3. the conditions specified in the regulations for the purposes of paragraph 9D(2C)(c) of the Act are satisfied;
2. decisions under paragraph 9D(1)(b) of the Act to vary an entry in the Register in relation to goods, to correct the name of an ingredient of the goods to reflect the updated Australian Approved Name for the ingredient, in accordance with the TGA's International Harmonisation of Ingredient Names (IHIN) project.

This approval has effect from 1 July 2017.

Lyndall Soper
Delegate of the Secretary

30 June 2017