Therapeutic Goods (Six Monthly Report Form - Authorised Prescriber) Approval 2021

I, Petra Bismire, as delegate of the Secretary of the Department of Health, make the following approval.

Dated 4 November 2021

Petra Bismire
Director, Experimental Products Section
International Regulatory Branch
Health Products Regulation Group
Department of Health

Contents

1 Name

This instrument is the Therapeutic Goods (Authorised Prescriber - Form for Six Monthly Report) Approval 2021.

2 Commencement

1. Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

2. Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under regulation 47B of the Therapeutic Goods Regulations 1990.

4 Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

1. biological;
2. medical device;
3. medicine;
4. secretary;
5. therapeutic goods.

In this instrument:

Act means the Therapeutic Goods Act 1989.

authorised prescriber means a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device.

Regulations means the Therapeutic Goods Regulations 1990.

Therapeutic Goods Administration means the part of the Department known as the Therapeutic Goods Administration.

5 Approved form

The approved form for providing a report to the Secretary by an authorised prescriber under paragraph 47B(1)(b) of the Regulations is the form titled Six monthly report – supply of unapproved therapeutic goods by an authorised prescriber (November 2021) published on the Therapeutic Goods Administration website.

Note: The Therapeutic Goods Administration's website can be accessed at https://www.tga.gov.au.

6 Repeals

Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.

Schedule 1 - Repeals

Therapeutic Goods (Authorised Prescriber - Form for Six Monthly Report) Approval 2019

1 The whole of the instrument

Repeal the instrument.