I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 2 July 2021
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 - Caruso's Prostate Eze Max) Permission 2021.
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. | 3 July 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Note: This table relates only to the provisions of this instrument as originally made.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.
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) label;
(c) listing number; (d) medicine;
(e) Register;
(f) therapeutic goods; (g) Therapeutic Advertising Code.
In this instrument:
Act means Therapeutic Goods Act 1989.
assessed listed medicine means a medicine that is listed in the Register under section 26AE of the Act.
Caruso's Prostate Eze Max means the assessed listed medicine, Caruso’s Prostate Eze Max, listing number 367190.
prominently displayed or communicated has the same meaning as in the Therapeutic Goods Advertising Code.
restricted representation means a representation referred to in section 42DD of the Act.
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.
Schedule 1 - Permission: restricted representation
Note: See section 5.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|
| Item | Representation | Advertisement | Therapeutic goods | Condition |
| 1 | a representation that is to the effect that the therapeutic goods relieve night-time urinary frequency (nocturia) associated with medically diagnosed benign prostatic hypertrophy | an advertisement about the therapeutic goods that is:
| Caruso's Prostate Eze Max | the representation must be accompanied by an advisory statement, which is to the effect of the following:
|
| 2 | a representation that is to the effect that the therapeutic goods relieve night-time urinary frequency (nocturia) associated with medically diagnosed benign prostatic hypertrophy | an advertisement about the therapeutic goods that is not:
| Caruso's Prostate Eze Max | the representation must be accompanied by an advisory statement, which is prominently displayed or communicated and to the effect of the following:
|