Therapeutic Goods (Complementary Medicines-Registration) Approval of Application Forms 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 23B 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 Registration) Approval of Application Forms and Specification of Office to which Application Must be Delivered. .

2. Definitions

In this instrument:

complementary medicine means a medicine of the kind specified in paragraph 4( 1 )(b) of the Therapeutic Goods Act 1989.

RCM1 application has the meaning given by regulation 2 of the Regulations.

RCM2 application has the meaning given by regulation 2 of the Regulations.

RCM3 application has the meaning given by regulation 2 of the Regulations.

RCM4 application has the meaning given by regulation 2 of the Regulations.

RCM5 application has the meaning given by regulation 2 of the Regulations.

RCMC1 (section 23) application has the meaning given by regulation 2 of the Regulations.

RCMC2 (section 23) application has the meaning given by regulation 2 of the Regulations.

RCMC3 (section 23) application has the meaning given by regulation 2 of the Regulations.

RCMC4 (section 23) application has the meaning given by regulation 2 of the Regulations.

Regulations means the Therapeutic Goods Regulations 1990.

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 register a complementary medicine

4. Approval Form

The approved forms for an application to which this instrument applies are as follows:

1. for an RCM1 application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCM1 application;
2. for an RCM2 application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCM2 application;
3. for an RCM3 application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCM3 application;
4. for an RCM4 application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCM4 application;
5. for an RCM5 application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCM5 application;
6. for an RCMC1 (section 23) application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCMC1 section 23) application;
7. for an RCMC2 (section 23) application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCMC2 section 23) application;
8. for an RCMC3 (section 23) application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCMC3 section 23) application;
9. for an RCMC4 (section 23) application-the online form titled Non-Prescription Medicine application in the TGAs electronic lodgement facility, completed in accordance with the instructions for an RCMC4 section 23) application.

Note: The TGA's electronic lodgement facility is on the TGA Business Services website. (https://www.tga.gov.au/tga-business-services).

5. Office to which application must be delivered

An application must be delivered to the office of the TGA, using the TGA's electronic lodgement facility.