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Repealed - Therapeutic Goods (Prohibited Representations - HIV Self-Test Fact Sheet) Permission 2019

I, Gillian Mitchell, as delegate of the Secretary of the Department of Health, make the following permission.

Dated 15 February 2019

Gillian Mitchell
First Assistant Secretary
Regulatory Practice and Support Division
Health Products Regulation Group
Department of Health

Contents

  1. Name
  2. Commencement
  3. Authority
  4. Definitions
  5. Permission

Schedule 1 - HIV Self-Test Fact Sheet

Schedule 2 - Permission

1 Name

This instrument is the Therapeutic Goods (Prohibited Representations - HIV Self-Test Fact Sheet) Permission 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.

Note: This table relates only to the provisions of this instrument as originally made.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 subsection 42DK(3) 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. medical device; and
  4. Register.

In this instrument:

Act means Therapeutic Goods Act 1989.

AFAO means the Australian Federation of Aids Organisations (ABN 9 I 708 3 10 631).

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.

Class 4 IVD medical device has the same meaning as in the Regulations.

HIV Self-Test Fact Sheet means the document in Schedule 1 to this instrument.

prohibited representation has the same meaning as in subsection 42DJ(l) of the Act.

Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

5 Permission

For subsection 42DK(3) of the Act, in relation to each item, the prohibited 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.

Schedule 1 - HIV Self-Test Fact Sheet

Note: See section 4, definition of HIV Self Test Fact Sheet.

picture of HIV Self-Test Fact Sheet

Schedule 2 - Permission

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)
 HIV Self-Test Fact Sheet Atomo HIV Self Test

Print version

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