I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 29 June 2022
Nicole McLay
Assistant Secretary
Regulatory Compliance Branch
Health Products Regulation Group
Department of Health
Contents
1 Name
This instrument is the Therapeutic Goods (Restricted Representations - Government Health Campaigns) (COVID-19 Treatments) Permission 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. | 30 June 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Note: This table relates only to the provisions of this instrument as originally made.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) Register;
(d) registered goods;
(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.
Regulations means the Therapeutic Goods Regulations 1990.
relevant COVID-19 treatment means registered goods that 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).
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
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
- 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 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.
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 that refers, expressly or by implication, to COVID-19 | an advertisement about the therapeutic goods that is, or forms part of:
| a relevant COVID-19 treatment | |
| 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 relevant COVID-19 treatment |