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42DK(1) Permitted representation: Hospital grade disinfectant or household grade disinfectant

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17 December 2014

Therapeutic Goods Act 1989

Permission under subsection 42DK(1)

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), under subsection 42DK(1) 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, representations that are a restricted representation under Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code by reason of a reference to any of the matters referred to in the table 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.

Table 1
Column A
Restricted representations (section 42DD of the Act and regulation 6 of the Therapeutic Goods Regulations 1990) - a representation that refers, expressly or by implication, to a serious form of a disease, condition, ailment or defect listed in Table 1, Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code 2007
Gastrointestinal Disease - Viral Gastroenteritis
Respiratory Disease - Influenza Virus
Respiratory Disease - SARS
Respiratory Disease - Respiratory Syncytial Virus (RSV)
Infectious Disease - Polio
Infectious Disease - Cytomegalovirus
Infectious Disease - Herpes simplex Types 1 and 2
Infectious Disease - Viral haemorrhagic fever including Ebola, Marburg and Lassa
Infectious Disease - Vaccinia infection

Footnote

  1. Definitions of hospital grade disinfectant and household grade disinfectant can be found in regulation 2 of the Therapeutic Goods Regulations 1990.