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42DK(1) Permitted representation: Hospital grade disinfectant or household grade disinfectant
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
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.
|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|
- Definitions of hospital grade disinfectant and household grade disinfectant can be found in regulation 2 of the Therapeutic Goods Regulations 1990.