Therapeutic Goods (Restricted Representations - Government Health Campaigns) (COVID-19) Permission 2022

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

Dated 1 August 2022

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

Contents

1 Name

This instrument is the Therapeutic Goods (Restricted Representations - Government Health Campaigns) (COVID-19) Permission 2022.

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.	2 August 2022

Note: This table relates only to the provisions of this instrument as originally made.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

2. 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) current Poisons Standard;
(c) included in the Register;
(d) Register;
(e) State;
(f) therapeutic goods;
(g) Therapeutic Goods Advertising Code.

In this instrument:

Act means Therapeutic Goods Act 1989.

Commonwealth health campaign means a campaign about a public health matter that is conducted, approved, or funded by the Commonwealth.

restricted representation means a representation referred to in section 42DD of the Act.

serious, in relation to a form of a disease, condition, ailment or defect, has the same meaning as in the Therapeutic Goods Advertising Code.

specified goods means either of the following:

1. therapeutic goods, other than vaccines, that are included in the Register and that have an indication or intended purpose accepted in relation to the inclusion of the goods in the Register that relates to coronavirus disease 2019 (COVID-19);
2. therapeutic goods that are included in the Register and that are hand sanitisers, personal protective equipment or safety apparel.

Note: Personal protective equipment and safety apparel includes, without limitation, aprons, face masks, gloves, goggles, gowns and visors.

State health campaign means a campaign about a public health matter that is conducted, approved, or funded by a State.

Note: State is defined in subsection 3(1) of the Act as including the Australian Capital Territory and the Northern Territory.

5 Permission

1. For subsection 42DK(1) of the Act, in relation to each item mentioned in the table in Schedule 1, the restricted 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.
2. To avoid doubt, a reference in an advertisement that is made in accordance with this instrument, relating to therapeutic goods containing a substance included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, is by virtue of this instrument authorised for the purposes of subsections 42DL(10) and 42DLB(7) of the Act.

6 Repeals

Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

Schedule 1 - Permission: restricted representations

Note: See section 5.

Permitted use of restricted representations

Column 1	Column 2	Column 3	Column 4	Column 5
Item	Restricted representations	Advertisements	Therapeutic goods	Conditions
1	a representation that refers, expressly or by implication, to COVID-19	an advertisement about the therapeutic goods that is, or forms part of: a Commonwealth health campaign; a State health campaign	specified goods
2	a representation that refers, expressly or by implication, to a serious form of a disease, condition, ailment or defect, and that promotes the use or supply of the therapeutic goods	an advertisement about the therapeutic goods that is, or forms part of: a Commonwealth health campaign; a State health campaign	specified goods

Schedule 2 - Repeals

Note: See section 6.

Therapeutic Goods (Restricted Representations - Government Health Campaigns) (COVID-19 Tests) Permission 2022

1 The whole of the instrument

Repeal the instrument.

Therapeutic Goods (Restricted Representations - Government Health Campaigns) (COVID-19 Treatments) Permission 2022

2 The whole of the instrument

Repeal the instrument.