Instrument of arrangement: Use of computer program to make decisions, November 2017

THERAPEUTIC GOODS ACT 1989

Subsection 7C(1)

I, LARRY KELLY, a delegate of the Secretary of the Department of Health under s 7C(1) of the Therapeutic Goods Act 1989 (the Act), HEREBY ARRANGE for the use, under my control, of computer programs that facilitate the uploading of information into, and release from, the database known as the Adverse Event Management System for the purpose of releasing to the World Health Organisation (WHO) for the provision of information to regulatory authorities of member countries of WHO, under s 61(2)(a)(iii) of the Act, the content of reports to the Department concerning possible adverse effects of therapeutic goods.

Dated 2 November 2017

Dr Larry Kelly
First Assistant Secretary, Medicines Regulation Division
Therapeutic Goods Administration
Delegate of the Secretary of the Department of Health