Therapeutic Goods (Complementary Medicines-Section 26AE Listing) Approval of Application Form and Specification of Office to which Application Must be Delivered

I, Larry Kelly, Acting Deputy Secretary, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23 B of the Therapeutic Goods Act 1989, make the following instrument under subparagraph 23B(2)(a)(i), and paragraph 23B(2)(c), of that Act.

Dated: 29 March 2018

Larry Kelly
Delegate of the Secretary of the Department of Health

1. Name

This instrument is the Therapeutic Goods (Complementary Medicines-Section 26AE Listing) Approval of Application Form and Specification of Office to which Application Must be Delivered.

2. Definitions

In this instrument:

Act means the Therapeutic Goods Act 1989.

complementary medicine means a medicine of the kind specified in paragraph 4(1)(b) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.

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

3. Applications to which this instrument applies

This instrument applies to an application to list a complementary medicine under section 26AE of the Act.

4. Approved form

For the purposes of subparagraph 23B(2)(a)(i) of the Act, the form titled Application form to list or vary the listing of an assessed listed medicine, published by the TGA in March 2018, is approved for an application to which this instrument applies.

Note: The form mentioned in section 4 is available on the TGA website (www.tga.gov.au)

5. Office to which application must be delivered

An application must be delivered to the office of the TGA.

Note: The address of the office of the Therapeutic Goods Administration is:

Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
AUSTRALIA

or

Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
AUSTRALIA

or

nonprescriptionmedicines@health.gov.au.