Repealed: Therapeutic Goods (Restricted Representations - COVID-19 Rapid Antigen Tests) Permission 2021
I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 18 August 2021
Acting First Assistant Secretary
Regulatory Practice and Support Division
Health Products Regulation Group
Department of Health
This instrument is the Therapeutic Goods (Restricted Representations - COVID-19 Rapid Antigen Tests) Permission 2021.
- 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|
|1. The whole of this instrument||The day after this instrument is made.||19 August 2021|
Note: This table relates only to the provisions of this instrument as originally made.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.
This instrument is made under section 42DK of the Therapeutic Goods Act 1989.
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(b) health practitioner;
(c) included in the Register;
(d) label; (e) Register;
(f) therapeutic goods; (g) Therapeutic Goods Advertising Code.
In this instrument:
Act means Therapeutic Goods Act 1989.
infection with COVID-19 means infection with the virus SARS-CoV-2 that causes coronavirus disease (COVID-19).
IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
prominently displayed or communicated has the same meaning as in section 4 of the Therapeutic Goods Advertising Code.
relevant practitioner means:
- a health practitioner; or
- a person registered under a law of a state or territory to practice paramedicine.
Note: The term health practitioner is defined in subsection 3(1) of the Act to mean a person who is registered or licenced under a law of a state or territory to practice in certain health professions specified in the definition, including medicine.
restricted representation means a representation referred to in section 42DD of the Act.
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|
a representation to the effect that the therapeutic goods may be used as a screening tool to detect possible infection with COVID-19
an advertisement about the therapeutic goods, other than an advertisement that is:
all of the following:
Note: The advertisements mentioned in the table must comply with the Act and the Therapeutic Goods Advertising Code, including requirements relating to the accuracy of the advertisements.