Therapeutic Goods (Authorised Prescriber Scheme - Application Form) Approval (No. 2) 2024

I, Nicholas Henderson, as delegate of the Secretary of the Department of Health and Aged Care, make the following approval.

Dated 16 December 2024

Nicholas Henderson
First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health and Aged Care

1 Name

This instrument is the Therapeutic Goods (Authorised Prescriber Scheme - Application Form) Approval (No. 2) 2024.

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Note: This table relates only to the provisions of this instrument as originally made.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 the following provisions of the Therapeutic Goods Act 1989:

1. subsection 19(5AA);
2. subsection 32CM(1A);
3. subsection 41HC(1A).

4 Definitions

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

1. Secretary.

In this instrument:

Act means the Therapeutic Goods Act 1989.

SAS and AP Online System means the TGA Special Access Scheme and Authorised Prescriber Scheme Online System, accessed via the Therapeutic Goods Administration website.

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

Therapeutic Goods Administration, or TGA, means the part of the Department known as the Therapeutic Goods Administration.

5 Approved form

For the purposes of:

1. subsection 19(5) of the Act; and
2. subsection 32CM(1) of the Act; and
3. subsection 41HC(1) of the Act;

the following forms are approved for an application for an authority mentioned in those provisions:

4. the online form titled New AP submission, accessed via the AP Dashboard in the SAS and AP Online System, as in force or existing at the commencement of this instrument;
5. the form titled Authorised Prescriber Scheme - application form, available upon request from the TGA, as in force or existing at the commencement of this instrument.