I, David Poulton, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 1 April 2019
(signed electronically)
David Poulton
Assistant Director
Regulatory Education and Compliance Branch
Health Products Regulation Group
Department of Health
Contents
Schedule 1 - Specifications: Restricted representations and conditions
1 Name
This instrument is the Therapeutic Goods (Restricted Representations - Church & Dwight Australia Pty Ltd - Dencorub products) Permission 2019.
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 Provisions | Column 2 Commencement | Column 3 Date/Details |
|---|---|---|
| 1. The whole of this instrument | The day after this instrument is made. |
Note: This table relates only to the provisions of this instrument as originally made.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 subsections 42DK(1) and 42DK(4) 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:
- Therapeutic Goods Advertising Code
- Therapeutic goods
- Register
- Registration number
- Primary pack.
In this instrument:
Act means Therapeutic Goods Act 1989.
Label has the same meaning as in section 3 of the Act
name of the medicine has the same meaning as in section 6 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
restricted representation has the same meaning as in section 42DD of the Act.
serious form of a disease imeans a serious form of a disease within the meaning of subsection 28(1) of the Therapeutic Goods Advertising Code.
5 Permission
For subsections 42DK(1) and 42DK(4) of the Act, in relation to each item, the restricted representations specified in column 2 of the table in Schedule 1 to this instrument are permitted to be used in an advertisement specified in column 3 of the table about the therapeutic goods specified in column 4 of the table, subject to any conditions (if any) specified in column 5 of the table.
Schedule 1 - Specifications: Restricted representations and conditions
Note: See section 5.
| Permitted use of prohibited representation | ||||
|---|---|---|---|---|
| Column 1 Item | Column 2 Restricted representation | Column 3 Advertisement | Column 4 Therapeutic goods | Column 5 Condition |
| 1 | a representation that refers to one or more of the following serious forms of a disease:
|
| Dencorub Arthritis Cream (registration number 10148) Dencorub Extra Strength Heat Gel (registration number 10146) Dencorub Regular Strength Heat Cream (registration number 10133) | |
| 2 | a representation that refers to the following serious forms of a disease:
|
| Dencorub Arthritis Ice Therapy (registration number 10228) Dencorub Arthritis Cream (registration number 10148) | |
| 3 | a representation that refers to one or more of the following serious forms of a disease:
|
| Dencorub Dual Action Cream (registration number 148691) | |
| 4 | a representation that refers to the following serious form of a disease:
|
| Dencorub Pain Relieving Heat Patch (registration number 269435) | |
| 5 | a representation that refers to a serious form of the disease arthritis in the name of the medicine for a good specified in column 4 | An advertisement for goods specified in column 4 | Dencorub Arthritis Cream (registration number 10148) Dencorub Arthritis Ice Therapy (registration number 10228) | |