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Therapeutic Goods (Prohibited Representations-Disinfectants) (COVID-19) Permission 2020

24 April 2020

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

Dated 24 April 2020

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

Contents

1 Name

This instrument is the Therapeutic Goods (Prohibited Representations-Disinfectants) (COVID-19) Permission 2020..

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. 25 April 2020

This table relates only to the provisions of this instrument as originally made.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

A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a)advertise;
(b) label;
(c) listed goods;
(d) medical device;
(e) Register;
(f) registered goods; and
(g) therapeutic goods.

In this instrument:

Act means Therapeutic Goods Act 1989.

prohibited representation has the same meaning as in subsection 42DJ(1) of the Act.

specified disinfectant means:
(a) in relation to a disinfectant that is a listed good-a disinfectant for which an indication has been accepted in relation to the inclusion of the disinfectant in the Register and that indication relates to the efficacy of the disinfectant against SARS-CoV-2 (COVID-19 virus);
(b) in relation to a disinfectant that is a registered good-a disinfectant for which an indication has been accepted in relation to the inclusion of the disinfectant in the Register and that indication relates to the efficacy of the disinfectant against SARS-CoV-2 (COVID-19 virus);
(c) in relation to a disinfectant included in the part of the Register for medical devices-a disinfectant that has an intended purpose certified under section 41FD of the Act that relates to the performance of the device against SARS-CoV-2 (COVID-19 virus).

SARS-CoV-2 (COVID-19 virus) means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Note: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the name given by the International Committee on Taxonomy of Viruses to the virus that causes COVID 19.

5 Permission - prohibited representation

For subsections 42DK(2) and (3) of the Act, in relation to each item mentioned in the table in Schedule 1, the prohibited representations specified in column 2 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.

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 Conditions
1

a representation to the effect that the therapeutic goods have a virucidal effect against SARS-CoV-2 (COVID-19 virus)

an advertisement about the therapeutic goods including, but not limited to, an advertisement that is:

  1. on the label of the therapeutic goods;
  2. on the package in which the therapeutic goods are contained;
  3. on any material included with the package in which the therapeutic goods are contained

specified disinfectants