Therapeutic Goods (Permissible Ingredients - Application for Variation) Approval 2023

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

Dated 24 January 2023

Nicholas Henderson

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

1. Name

This instrument is the Therapeutic Goods (Permissible Ingredients - Application for Variation) Approval 2023.

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Note: This table relates only to the provisions of this instrument as originally made.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 subsection 26BD(3) of the Therapeutic Goods Act 1989.

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.

TGA Business Services means the TGA Business Services portal, accessed via the Therapeutic Goods Administration website.

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

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

5. Approved form

The approved form for making an application to the Secretary for a recommendation by the Secretary that the Minister vary a section 26BB determination is the online form titled Substance Evaluation, accessed via the electronic lodgement facility within TGA Business Services in the Applications menu under the heading Listed Medicine, as in force or existing on 1 February 2023.