I, Nicole McLay, as delegate of the Secretary of the Department of Health, make the following permission.
Dated 31 January 2020
Nicole McLay
Assistant Secretary
Regulatory Education and Compliance Branch
Health Products Regulation Group
Department of Health
Contents
1 Name
This instrument is the Therapeutic Goods (Restricted Representations -Modified-Release Paracetamol) 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. | 1 February 2020 |
This table relates only to the provisions of this instrument as originally made.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) indication;
(c) label;
(d) Register; and
(e) therapeutic goods.
In this instrument:
Act means Therapeutic Goods Act 1989.
active ingredient, for a medicine, has the same meaning as in the Therapeutic Goods Regulations 1990.
modified-release has the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
Note: The Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 may be accessed on the internet at www.legislation.gov.au.
registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.
restricted representation has the same meaning as in section 42DD of the Act.
stated content has the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
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 | Restricted representation | Advertisement | Therapeutic goods | Condition |
| 1 | a representation that is to the effect that the therapeutic goods can provide temporary relief of persistent pain associated with osteoarthritis | an advertisement about the therapeutic goods including, but not limited to, an advertisement that is:
| a registered medicine, other than a prescription medicine, that:
|