Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018 (Cth)
Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018
I, Larry Kelly, First Assistant Secretary, Medicines Regulation Division, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23B of the Therapeutic Goods Act 1989, make the following Determination under subsections 23B(9) and (10) of that Act.
Dated 17th May 2018
(Signed by)
LARRY KELLY
Delegate of the Secretary of the Department of Health
1 Name
This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018.
2 Commencement
This instrument commences on the day after it is registered.
3 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.
4 Applications to which this instrument applies
This instrument applies to an application to register a complementary medicine.
5 Kind of information
For the purposes of subsection 23B(9) of the Act, the application must be accompanied by:
(a) the information required by the document titled CTD Module 1: registered complementary medicines, version 8.0, published by the TGA in April 2018; and
(b) the information required by the document titled Mandatory requirements for an effective registered complementary medicines application, version 1, published by the TGA in March 2018.
Note: The documents mentioned in section 5 are available on the TGA website ( Form of information
For the purposes of subsection 23B(10) of the Act, the information must be :
(a) contained in an application dossier; and
(b) in a form consistent with the document titled General dossier requirements, version 1.3, published by the TGA in March 2018.
Note: The document mentioned in paragraph 6(b) is available on the TGA website (
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