I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 31 January 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 Tests) 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. | 1 February 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Note: This table relates only to the provisions of this instrument as originally made.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) included in the Register;
(c) State;
(d) therapeutic goods.
In this instrument:
Act means Therapeutic Goods Act 1989.
Class 1 IVD medical device has the same meaning as in the Medical Devices Regulations.
Class 3 IVD medical device has the same meaning as in the Medical Devices Regulations.
Commonwealth health campaign means a campaign about a public health matter that is conducted, approved, or funded by the Commonwealth.
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
restricted representation means a representation referred to in section 42DD of the Act.
SARS-CoV-2 (COVID-19) means the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes the disease COVID-19.
specified goods means:
- a COVID-19 Polymerase Chain Reaction (PCR) test that is
- (i) included in the Register;
- (ii) classified as a Class 3 IVD medical device;
- a COVID-19 rapid antigen test kit that is:
- (i) included in the Register; and
- (ii) classified as a Class 3 IVD medical device; and
- may (or may not) be supplied for use in conjunction with an instrument or analyser that is a Class 1 IVD medical device.
State health campaign means a campaign about a public health matter that is conducted, approved, or funded by a State.
5 Permission
For subsection 42DK(1) of the Act, in relation to each item mentioned in the table in Schedule 1, the 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: restricted representation
Note: See section 5.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Restricted representation | Advertisement | Therapeutic goods | Conditions |
| 1 | a representation to the effect, expressly or by implication, that the therapeutic goods may be used to detect possible infection with SARS-CoV-2 (COVID-19), including a representation that is contained within the name of the goods | an advertisement about the therapeutic goods that is, or forms part of, a:
| specified goods |