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Therapeutic Goods (Restricted Representations - Swisse Ultiboost High Strength Krill Oil) Permission 2023

I, Michael Shum, as delegate of the Secretary of the Department of Health and Aged Care, make the following permission.

Dated 17 August 2023

Michael Shum
Director
Regulatory Compliance Branch
Health Products Regulation Group
Department of Health and Aged Care

Contents

1 Name

2 Commencement

3 Authority

4 Definitions

5 Permission

Schedule 1 - Permission: restricted representations

1 Name

This instrument is the Therapeutic Goods (Restricted Representations—Swisse Ultiboost High Strength Krill Oil) Permission 2023.

2 Commencement

  1. 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.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument The day after this instrument is made. 18 August 2023

Note: This table relates only to the provisions of this instrument as originally made.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.

  1. 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; and
(g) Therapeutic Goods Advertising Code.

In this instrument:

Act means Therapeutic Goods Act 1989.

Regulations means the Therapeutic Goods Regulations 1990.

assessed listed medicine means a medicine that is listed in the Register under section 26AE of the Act.

restricted representation means a representation referred to in section 42DD of the Act.

Swisse Ultiboost High Strength Krill Oil means the assessed listed medicine, Swisse Ultiboost High Strength Krill Oil, listing number 417392.

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 representations

Note: See section 5.

Permitted use of restricted representations
Column 1 Column 2 Column 3 Column 4 Column 5
Item Restricted representations Advertisements Therapeutic goods Conditions

1

a representation that is to the effect of one or more of the following:

  1. the therapeutic goods decrease, reduce, or relieve knee pain and stiffness in moderate osteoarthritis;
  2. the therapeutic goods increase knee physical function in moderate osteoarthritis

an advertisement about the therapeutic goods, that is:

  1. on the label of the therapeutic goods;
  2. on the package in which the therapeutic goods are contained;
  3. on any material included with the package in which the therapeutic goods are contained

Swisse Ultiboost High Strength Krill Oil

the representation must be accompanied by advisory statements, which are to the effect of:

  1. may only provide a mild improvement in symptoms and take up to 6 months to see effects; and
  2. if symptoms persist, talk to your health professional

 
2

a representation that is to the effect of one or more of the following:

  1. the therapeutic goods decrease, reduce, or relieve knee pain and stiffness in moderate osteoarthritis;
  2. the therapeutic goods increase knee physical function in moderate osteoarthritis

an advertisement about the therapeutic goods other than an advertisement that is:

  1. on the label of the therapeutic goods; or
  2. on the package in which the therapeutic goods are contained; or
  3. on any material included with the package in which the therapeutic goods are contained
 Swisse Ultiboost High Strength Krill Oil

where:

  1. an advertisement facilitates directly the purchase or other supply of the therapeutic goods; and
  2. the goods are not able to be physically inspected by a consumer before the purchase or other supply;

then the representation must be accompanied by an advisory statement to the effect of:

  1. may only provide a mild improvement in symptoms and take up to 6 months to see effects

 

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