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Determinations/Health as made
This determination, made under subsections 23B(9) and (10) of the Therapeutic Goods Act 1989, sets out the kind of information which must accompany an application for the registration of a complementary medicine, and the form in which the application must be submitted. The Determination replaces the previous Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018, registered on 21 May 2018, to reflect the update to the TGA guidance document General Dossier Requirements in July 2018.
Administered by: Health
Registered 23 Aug 2018
Tabling HistoryDate
Tabled HR10-Sep-2018
Tabled Senate10-Sep-2018

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination August 2018

I, Jane Cook, Acting 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, revoke the Therapeutic Goods (Complementary Medicines – Information that Must Accompany Application for Registration) Determination 2018, registered on 21 May 2018, and make the following Determination under subsections 23B(9) and (10) of that Act.

Dated 20th August 2018

(Signed by)


JANE COOK

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 August 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 (www.tga.gov.au).

6  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 1.4, published by the TGA in July 2018.

Note:          The document mentioned in paragraph 6(b) is available on the TGA website (www.tga.gov.au).