I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 14 October 2021
Nicole McLay
Assistant Secretary
Regulatory Compliance Branch
Health Products Regulation Group
Department of Health
Contents
1 Name
This instrument is the Therapeutic Goods (Prohibited and Restricted Representations - HIV Self Tests) Permission 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. | 15 October 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Note: This table relates only to the provisions of this instrument as originally made.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 42DK of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) advertise;
(b) included in the Register;
(c) label;
(d) medical device;
(e) Register;
(f) Therapeutic Goods Advertising Code.
In this instrument:
Act means Therapeutic Goods Act 1989.
Class 4 IVD medical device has the same meaning as in the Medical Devices Regulations.
instructions for use has the same meaning as in the Medical Devices Regulations.
IVD medical device has the same meaning as in the Medical Devices Regulations.
IVD medical device for self-testing has the same meaning as in the Medical Devices Regulations.
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
prohibited representation means a representation referred to in subsection 42DJ(1) of the Act.
prominently displayed or communicated has the same meaning as in the Therapeutic Goods Advertising Code.
restricted representation means a representation referred to in section 42DD of the Act.
serious form, in relation to a disease, condition, ailment or defect, has the same meaning as in the Therapeutic Goods Advertising Code.
specified goods means an IVD medical device for self-testing that:
- is included in the Register; and
- is classified as a Class 4 IVD medical device; and
- has an intended purpose certified under section 41FD of the Act, and accepted in relation to the inclusion of the goods in the Register, that relates to the detection of the human immunodeficiency virus (HIV).
5 Permission
- For subsection 42DK(1) of the Act, in relation to each item mentioned in the table in Schedule 1, the representations specified in column 2 (to the extent that those representations are restricted representations) are permitted to be used in the advertisements specified in column 3, about the therapeutic goods specified in column 4, subject to the conditions (if any) specified in column 5.
- For subsection 42DK(3) of the Act, in relation to each item mentioned in the table in Schedule 1, the representations specified in column 2 (to the extent that those representations are prohibited representations) are permitted to be used in the advertisements specified in column 3, about the therapeutic goods specified in column 4, subject to the conditions (if any) specified in column 5.
6 Repeals
Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.
Schedule 1 - Permission
Note: See section 5.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Restricted representation | Advertisement | Therapeutic goods | Conditions |
| 1 | a representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring of, or susceptibility to:
| an advertisement about the therapeutic goods in any form or media, including but not limited to, an advertisement that is:
| specified goods | all of the following:
|
| 2 | one or both of the following:
| an advertisement made in accordance with item 1 that includes information about the proper use of the therapeutic goods (including, but not limited to, instructional videos, fact sheets, diagrammatic reference guides or instructions for use documents) | specified goods |
Note: The advertisements mentioned in the table must comply with the Act and the Therapeutic Goods Advertising Code, including requirements relating to the accuracy of the advertisements.
Schedule 2 - Repeals
Note: See section 6.
Therapeutic Goods (Prohibited and Restricted Representations - Atomo HIV Self Test) Permission (No. 2) 2019
1 The whole of the instrument
Repeal the instrument.