I, Nicole McLay, as delegate of the Secretary of the Department of Health and Aged Care, make the following permission.
Dated 4 August 2022
Nicole McLay
Assistant Secretary
Regulatory Compliance Branch
Health Products Regulation Group
Department of Health and Aged Care
Contents
Schedule 1 - Permission: restricted representations
Therapeutic Goods (Restricted Representations - COVID-19 Oral Treatments) Permission (No. 2) 2022
1 Name
This instrument is the Therapeutic Goods (Restricted Representations - COVID-19 Oral Treatments) Permission (No. 3) 2022..
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 | Column 2 | Column 3 |
|---|---|---|
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | The day after this instrument is made. | 5 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Note: This table relates only to the provisions of this instrument as originally made.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.
- 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) medicine;
(d) Register;
(e) registered goods; (f) therapeutic goods;
(g) Therapeutic Goods Advertising Code.
In this instrument:
Act means Therapeutic Goods Act 1989.
Regulations means the Therapeutic Goods Regulations 1990.
relevant COVID-19 oral treatment means registered goods that are medicine, and that:
- contain a substance included in Schedule 4 to the current Poisons Standard; and
- have an indication accepted in relation to the inclusion of the goods in the Register that relates to the treatment of coronavirus disease 2019 (COVID-19); and
- are for oral administration.
restricted representation means a representation referred to in section 42DD of the Act.
trade name has the same meaning as in the Regulations.
5 Permission
- 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.
- 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 4 to 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 Application
This instrument does not apply to an advertisement made in accordance with the Therapeutic Goods (Restricted Representations - Government Health Campaigns) (COVID-19) Permission 2022.
Note: The Therapeutic Goods (Restricted Representations - Government Health Campaigns) (COVID-19) Permission 2022 deals with Commonwealth and State and Territory health campaigns related to COVID-19, and may be accessed at www.tga.gov.au.
7 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.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Restricted representations | Advertisements | Therapeutic goods | Conditions |
|
1 |
a representation to the effect that the therapeutic goods are available for supply on prescription from a particular pharmacy or other dispenser, for the treatment of COVID-19 |
an advertisement about the therapeutic goods, other than an advertisement that is:
|
a relevant COVID-19 oral treatment |
the advertisement must specify either or both of the following:
of the therapeutic goods available at the particular pharmacy or other dispenser |
Note: Advertisements mentioned in this table must comply with the Act and the Therapeutic Goods Advertising Code.
Schedule 2 - Repeals
Note: See section 7.
Therapeutic Goods (Restricted Representations - COVID-19 Oral Treatments) Permission (No. 2) 2022
1 The whole of the instrument
Repeal the instrument.