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I, Elizabeth Butt, as delegate of the Secretary of the Department of Health, make the following instrument.
Dated 10 November 2021
Elizabeth Butt
Director, Regulatory Compliance Branch
Regulatory Practice and Support Division
Health Products Regulation Group
Department of Health
Contents
1 Name
This instrument is the Therapeutic Goods (Application for Use of Restricted Representation) Approval 2021.
2 Commencement
- 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.
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | The day after this instrument is made. | 10 November 2021 |
Note: This table relates only to the provisions of this instrument as originally made.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.
- 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 Authority
This instrument is made under section 42DE 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:
(a) Secretary.
In this instrument:
Act means Therapeutic Goods Act 1989.
Regulations means the Therapeutic Goods Regulations 1990.
restricted representation has the same meaning as in section 42DD of the Act.
Therapeutic Goods Administration has the same meaning as in the Regulations.
5 Approved form
The approved form for making an application to the Secretary for approval of the use of a restricted representation is the online application form titled Application for approval to use a restricted representation accessed via the Lodge an application link on the Application for approval to use a restricted representation in advertising page on the Therapeutic Goods Administration website.
Note: The Therapeutic Goods Administration website can be accessed at https://www.tga.gov.au.
6 Repeals
Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.
Schedule 1 - Repeals
Note: See section 6.
Therapeutic Goods (Restricted Representations - Approval of Application Form) Instrument 2019
1 The whole of the instrument
Repeal the instrument.