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Therapeutic Goods (Prohibited and Restricted Representations - Registered Disinfectants) Permission 2020

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

1 Name

2 Commencement

3 Authority

4 Definitions

5 Permission - prohibited representations

6 Permission - restricted representations

7 Repeals

Schedule 1 - Permission: prohibited representations

Schedule 2 - Permission: restricted representations

Schedule 3 - Repeals

1 Name

This instrument is the Therapeutic Goods (Prohibited and Restricted Representations—Registered Disinfectants) Permission 2020.

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Note: This table relates only to the provisions of this instrument as originally made.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

  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 section 3 of the Act, including the following:
(a) advertise;
(b) label;
(c) Register;
(d) registered goods;
(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:

  1. hospital grade disinfectants; or
  2. 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.

7 Repeals

Each instrument that is specified in the table in Schedule 3 is repealed.

Schedule 1 - Permission: prohibited representations

Note: See section 5.

Permitted use of prohibited representations
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):

  1. adenovirus;
  2. calicivirus;
  3. cytomegalovirus;
  4. ebola virus;
  5. hepatitis B virus (HBV);
  6. hepatitis C virus (HCV);
  7. herpes simplex virus type 1;
  8. herpes simplex virus type 2;
  9. human immunodeficiency virus (HIV);
  10. influenza type A viruses (all subtypes, including H1N1, H3N2, H5N1 and H7N9);
  11. lassa virus;
  12. Marburg virus;
  13. norovirus;
  14. parvovirus;
  15. poliovirus type 1;
  16. poliovirus type 2;
  17. poliovirus type 3;
  18. respiratory syncytial virus (RSV);
  19. rhinovirus;
  20. rotavirus;
  21. severe acute respiratory syndrome (SARS) associated coronavirus;
  22. vaccinia virus

an advertisement about the therapeutic goods including, but not limited to, an advertisement that is on:

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

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:

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

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):

  1. hepatitis C virus (HCV);
  2. human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS);
  3. sexually transmitted diseases

an advertisement about the therapeutic goods including, but not limited to, an advertisement that is on:

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

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.

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 refers to a serious form of one or more of the following diseases, conditions, ailments or defects (the relevant diseases):

  1. cholera;
  2. cytomegalovirus infection;
  3. herpes simplex type 1 infection;
  4. herpes simplex type 2 infection;
  5. influenza;
  6. polio;
  7. respiratory disease caused by respiratory syncytial virus (RSV);
  8. severe acute respiratory syndrome (SARS);
  9. vaccinia virus infection;
  10. viral gastroenteritis;
  11. viral haemorrhagic fevers, including Ebola virus disease, Marburg virus disease and Lassa fever

an advertisement about the therapeutic goods including, but not limited to, an advertisement that is on:

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

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

Schedule 3 - Repeals

Note: See section 7.

Permitted use of restricted representations
Column 1 Column 2 Column 3
Item Name of instrument and delegate Date of making
1

Permission under subsection 42DK(1) of the Therapeutic Goods Act 1989 made by Andrea Kunca

17 December 2014
2

Permission under subsection 42DK(2) of the Therapeutic Goods Act 1989 made by Andrea Kunca

17 December 2014

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