Therapeutic Goods Act 1989
Permission under subsection 42DK(2)
I, Andrea Kunca, Head, Office of Devices Authorisation, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health for the purposes of section 42DK of the Therapeutic Goods Act 1989 (the Act), and being satisfied that the representations the subject of this notice are necessary for the appropriate use of the relevant therapeutic goods, permit, under subsection 42DK(2) of the Act, the use on the label of the relevant therapeutic goods or in information included in the package in which the goods are contained, prohibited representations of the following kinds:
- a representation containing a reference to the results of laboratory tests on micro-organisms;
- a representation containing a reference to an effect against viruses of any of the kinds described in Column A of Table 1 below or viruses generally;
- a representation containing a reference to an effect against Mycobacterium tuberculosis and related acid fast bacteria
- a representation that is a prohibited representation under Part 1 of Appendix 6 to the Therapeutic Goods Advertising Code by reason of a reference to prevention of any of the matters referred to in Column B of Table 1 below.
The relevant goods are therapeutic goods that are hospital grade disinfectant or household grade disinfectant1 that are on the Australian Register of Therapeutic Goods by reason of being registered under Part 3-2 of the Act.
Dated this 17 day of December 2014
Andrea Kunca
Delegate of the Secretary
Head, Office of Devices Authorisation
Note: It is an offence under subsection 22(5) of the Act for a person, by any means, to advertise registered therapeutic goods for indications that have not been accepted in relation to that registration and also a condition of registration.
| Column A | Column B |
|---|---|
| Prohibited representations (regulation 6B(1) and item 6(f) in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990) - hospital grade disinfectants and household grade disinfectants that contain a reference to an effect against viruses | Prohibited representations (regulation 6B(1) and item 1 in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990) - representation regarding the treatment, cure or prevention of certain diseases |
| Norovirus, Adenovirus, Rotavirus | |
| Influenza Type A (H1N1) Avian (Bird) influenza (virus) (H3N2) (H5N1) Influenza A all subtypes | |
| SARS associated Coronavirus | |
| Respiratory Syncytial Virus (RSV) | |
| Rhinovirus | |
| Human Immunodeficiency Virus (HIV) | HIV AIDS and/or HCV - Aids -Related Complex AIDS |
| Hepatitis C Virus (HCV) | HIV AIDS and/or HCV - Hepatitis C |
| Hepatitis B Virus (HBV) | HIV AIDS and/or HCV - Hepatitis B |
| Poliovirus Types 1 - 3 | |
| Cytomegalovirus | |
| Herpes simplex Types 1 and 2 | Sexually Transmitted Diseases (STD) |
| Ebola virus | |
| Marburg virus | |
| Lassa virus | |
| Vaccinia |
Footnote
- Definitions of hospital grade disinfectant and household grade disinfectant can be found in regulation 2 of the Therapeutic Goods Regulations 1990.