Repealed - Therapeutic Goods (Prohibited and Restricted Representations - Atomo HIV Self Test) Permission 2019
I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 2 April 2019
Nicole McLay
Assistant Secretary
Regulatory Education and Compliance Branch
Health Products Regulation Group
Department of Health
Contents
- Name
- Commencement
- Authority
- Definitions
- Permission - prohibited representation
- Permission - restricted representation
- Repeals
Schedule 1 - Permission: prohibited representation
Schedule 2 - Permission: restricted representation
Schedule 4 - Instructions for use
1 Name
This instrument is the Therapeutic Goods (Prohibited and Restricted Representations - Atomo HIV Self Test) Permission 2019.
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 Provisions | Column 2 Commencement | Column 3 Date/Details |
|---|---|---|
| 1. The whole of this instrument | The day after this instrument is made. | 3 April 2019 |
Note: This table relates only to the provisions of this instrument as originally made.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
A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
- device number;
- included in the Register;
- label;
- medical device;
- Register; and
- Therapeutic Goods Advertising Code.
In this instrument:
Act means Therapeutic Goods Act 1989.
Atomo HIV Self Test means the Class 4 IVD medical device, Atomo HIV self test – HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid (device number 311989), included in the Register with the commencement date 28 November 2018.
care card, in relation to the Atomo HIV Self Test, means the document in Schedule 6 to this instrument.
Class 4 IVD medical device has the same meaning as in the Regulations.
fact sheet, in relation to the Atomo HIV Self Test, means the document in Schedule 3 to this instrument.
instructions for use, in relation to the Atomo HIV Self Test, means the document in Schedule 4 to this instrument.
instructional video, in relation to the Atomo HIV Self Test, means the on-line instructional video referenced in the specific conditions in the entry on the Register for the Atomo HIV Self Test.
label, in relation to the Atomo HIV Self Test, means the document, of part of the document, in Schedule 5 to this instrument.
prohibited representation has the same meaning as in subsection 42DJ(1) of the Act.
restricted representation has the same meaning as in section 42DD of the Act.
Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
serious form, in relation to a disease, condition, ailment or defect, has the same meaning as in subsection 28(1) of the Therapeutic Goods Advertising Code.
website means the website at www.atomohivtest.com.
5 Permission - prohibited representation
For subsections 42DK(2) and (3) of the Act, in relation to each item, the prohibited representations specified in column 2 of the table in Schedule 1 to this instrument are permitted to be used:
- on the label; or
- on the package; or
- on other material included with the package; or
- in the advertisement;
specified in column 3 of the table, in relation to the therapeutic goods specified in column 4 of the table, subject to the conditions (if any) specified in column 5 of the table in that Schedule.
6 Permission - restricted representation
For subsection 42DK(1) of the Act, in relation to each item, the restricted representations specified in column 2 of the table in Schedule 2 to this instrument are permitted to be used in an advertisement specified in column 3 of the table, about the therapeutic goods specified in column 4 of the table, subject to the conditions (if any) specified in column 5 of the table of that Schedule.
6 Repeals
Each instrument that is specified in Schedule 7 to this instrument is repealed as set out in the applicable items in that Schedule.
Schedule 1 - Permission
Note: See section 5.
| Column 1 Item | Column 2 Prohibited representation | Column 3 Advertisement | Column 4 Therapeutic goods | Column 5 Condition |
|---|---|---|---|---|
| 1 | a representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to:
| fact sheet | Atomo HIV Self Test | |
| 2 | a representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to:
| each of the following:
| Atomo HIV Self Test | the advertisements specified in column 3 must only be:
|
| 3 | a representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to:
| each of the following:
| Atomo HIV Self Test | the advertisement specified in column 3 must only be published or disseminated by means of the website |
Schedule 2 - Permission: restricted representation
Note: See section 6.
| Column 1 Item | Column 2 Restricted representation | Column 3 Advertisement | Column 4 Therapeutic goods | Column 5 Condition |
|---|---|---|---|---|
| 1 | a representation that refers to one or more serious forms of bleeding disorders, including haemophilia | instructions for use | Atomo HIV Self Test | the advertisement specified in column 3 must only be:
|
Schedule 3 - Fact sheet
Note: See section 4, definition of fact sheet.
Schedule 4 - Instructions for use
Note: See section 4, definition of instructions for use.
Schedule 5 - Label
Schedule 6 - Care card
Note: See section 4, definition of care card.
Schedule 7 - Repeals
Note: See section 7.
Therapeutic Goods (Prohibited Representations - HIV Self-Test Fact Sheet) Permission 2019
1 The whole of the instrument
Repeal the instrument.