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I, Simon Singer, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 23 December 2020
Dr Simon Singer
Acting Assistant Secretary
Medical Devices Authorisation Branch
Health Products Regulation Group
Department of Health
Contents
5 Permission - prohibited representations
6 Permission - restricted representations
1 Name
This instrument is the Therapeutic Goods (Prohibited and Restricted Representations—Listed Disinfectants) Permission 2020.
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. | 24 December 2020 |
Note: This table relates only to the provisions of this instrument as originally made.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 section 3 of the Act, including the following:
(a) advertise;
(b) label;
(c) listed goods;
(d) Register;
(e) therapeutic goods; and
(f) Therapeutic Goods Advertising Code.
In this instrument:
Act means Therapeutic Goods Act 1989.
disinfectant has the same meaning as in the Regulations.
hospital grade disinfectant has the same meaning as in the Regulations.
household grade disinfectant has the same meaning as in the Regulations.
prohibited representation means a representation referred to in subsection 42DJ(1) of the Act.
Regulations means the Therapeutic Goods Regulations 1990.
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 section 28 of the Therapeutic Goods Advertising Code.
specified goods means disinfectants that are listed goods and are:
- hospital grade disinfectants; or
- household grade disinfectants.
5 Permission - prohibited representations
For subsection 42DK(2) of the Act, in relation to each item in the table in Schedule 1, the prohibited 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.
6 Permission - restricted representations
For subsection 42DK(1) of the Act, in relation to each item in the table in Schedule 2, 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.
Schedule 1 - Permission: prohibited representations
Note: See section 5.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Prohibited representations | Advertisements | Therapeutic goods | Conditions |
| 1 | a representation that contains a reference to an effect against one or more of the following viruses (the relevant viruses):
| an advertisement about the therapeutic goods including, but not limited to, an advertisement that is on:
| specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the efficacy of the goods against the relevant viruses | |
| 2 | a representation that contains a reference to an effect against Mycobacterium tuberculosis and related acid fast bacteria | an advertisement about the therapeutic goods including, but not limited to, an advertisement that is on:
| specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the efficacy of the goods against Mycobacterium tuberculosis and related acid fast bacteria | |
| 3 | a representation that contains a reference to the results of laboratory tests on one or more microorganisms (the relevant microorganisms) | an advertisement that is on a label (other than where the label is enclosed with the goods in their package) | specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the efficacy of the goods against the relevant microorganisms | |
| 4 | a representation regarding the prevention of one or more of the following diseases (the relevant diseases):
| an advertisement about the therapeutic goods including, but not limited to, an advertisement that is on:
| specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the efficacy of the goods against the microorganisms that cause the relevant diseases |
Schedule 2 - Permission: restricted representations
Note: See section 6.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Restricted representations | Advertisements | Therapeutic goods | Conditions |
| 1 | a representation that refers to a serious form of one or more of the following diseases, conditions, ailments or defects (the relevant diseases):
| an advertisement about the therapeutic goods including, but not limited to, an advertisement that is on:
| specified goods for which an indication has been accepted in relation to the inclusion of the goods in the Register that relates to the efficacy of the goods against the viruses that cause the relevant diseases |