Therapeutic Goods (TGA Assessed Claim) Authorisation 2020

I, John Skerritt, Deputy Secretary, make the following authorisation.

Dated 20 August 2020

Adjunct Professor John Skerritt
Deputy Secretary
Health Products Regulation Group
Department of Health

1 Name

This instrument is the Therapeutic Goods (TGA Assessed Claim) Authorisation 2020.

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Note: This table relates only to the provisions of this instrument as originally made.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 Purpose

This instrument is made for the purposes of paragraphs 42DL(9)(b) and 42DLB(6)(b) of the Therapeutic Goods Act 1989.

4 Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

1. advertise;
2. label;
3. medicine;
4. Register; and
5. Secretary.

In this instrument:

Act means the Therapeutic Goods Act 1989.

complementary medicine has the same meaning as in the Regulations.

Guidelines means the Guidelines for using the TGA assessed claim on medicine labels (Version 1.1, August 2020) published by the Therapeutic Goods Administration, as in force or existing immediately before the commencement of this instrument.

Note: The Guidelines are published at www.tga.gov.au.

Regulations means the Therapeutic Goods Regulations 1990.

TGA assessed claim means the TGA assessed statement with or without the TGA assessed symbol.

TGA assessed statement means the statement set out in Part 2 of Schedule 1.

TGA assessed symbol means the symbol set out in Part 1 of Schedule 1.

Therapeutic Goods Administration has the same meaning as in the Regulations.

5 Authorisation

1. Subject to subsection (2), the TGA assessed claim is authorised for use in an advertisement in relation to a medicine where:
   1. the medicine is:
      1. listed in the Register under section 26AE of the Act; or
      2. a complementary medicine registered under section 25 of the Act; and
   2. the label of the medicine displaying the TGA assessed claim was considered and agreed to by the Secretary in the course of:
      1. evaluating the medicine under section 25 or 26AE of the Act; or
      2. deciding a request for a variation of the entry in the Register in relation to the medicine under section 9D of the Act.
2. The use of the TGA assessed claim must be in accordance with the requirements set out in the Guidelines.

6 Repeals

Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

Schedule 1 - TGA assessed claim

Note: See section 4, definitions of TGA assessed symbol and TGA assessed statement.

Part 1 - TGA assessed symbol

Part 2 - TGA assessed statement

Evidence for the approved indications has been assessed by the TGA.

Schedule 2 - Repeals

Note: See section 6.

Therapeutic Goods (TGA Assessed Claim) Authorisation 2019

1. The whole of the instrument

Repeal the instrument.