Sub menu

 
 

Repealed: Therapeutic Goods (Prohibited and Restricted Representations - Atomo HIV Self Test) Permission (No. 2) 2019

I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.

Dated 10 April 2019

Nicole McLay
Assistant Secretary
Regulatory Education and Compliance Branch
Health Products Regulation Group
Department of Health

Contents

  1. Name
  2. Commencement
  3. Authority
  4. Definitions
  5. Permission - prohibited representation
  6. Permission - restricted representation
  7. Repeals

Schedule 1 - Permission: prohibited representation

Schedule 2 - Permission: restricted representation

Schedule 3 - Fact sheet

Schedule 4 - Instructions for use

Schedule 5 - Label

Schedule 6 - Care card

Schedule 7 - Repeals

1 Name

This instrument is the Therapeutic Goods (Prohibited and Restricted RepresentationsAtomo HIV Self Test) Permission (No. 2) 2019.

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.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement 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Note: This table relates only to the provisions of this instrument as originally made.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.

  1. 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 section 3 of the Act, including the following:

  1. device number;
  2. included in the Register;
  3. label;
  4. medical device;
  5. Register; and
  6. 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:

  1. on the label; or
  2. on the package; or
  3. on other material included with the package; or
  4. 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.

7 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: prohibited representation

Note: See section 5.

Permitted use of prohibited representation
Column 1 Column 2 Column 3 Column 4 Column 5
Item Prohibited representation Advertisement Therapeutic goods Condition
1

a representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to:

  1. sexually transmitted diseases; and
  2. human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS)
 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:

  1. sexually transmitted diseases; and
  2. human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS)

each of the following:

  1. instructions for use;
  2. label;
  3. care card
 Atomo HIV Self Test

the advertisements specified in column 3 must only be:

  1. published or disseminated by means of the website; or
  2. distributed with the goods specified in column 4
3

a representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to:

  1. sexually transmitted diseases; and
  2. human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS)

each of the following:

  1. instructional video;
  2. other online content
 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.

Permitted use of restricted representation
Column 1 Column 2 Column 3 Column 4 Column 5
Item Restricted representation Advertisement Therapeutic goods 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:

  1. published or disseminated by means of the website; or
  2. distributed with the goods specified in column 4

Schedule 3 - Fact sheet

Note: See section 4, definition of fact sheet.

HIV Self-Test Fact Sheet

Schedule 4 - Instructions for use

Note: See section 4, definition of instructions for use.

Instructions for Use

Instructions for Use

Schedule 5 - Label

Note: See section 4, definition of label.

HIV Self Test Label

Schedule 6 - Care card

Note: See section 4, definition of care card.

Care Card

HIV Support Services

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.

Print version

Help us improve the Therapeutic Goods Administration site