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These guidelines describe the information to be supplied for the registration or listing of disinfectants and sterilants in the Australian Register of Therapeutic Goods (ARTG). They may also serve as a guide to the sponsors of other products that have to meet Therapeutic Goods Order No 54- Standard for Disinfectants and Sterilants (TGO 54), but which are exempt from the requirement for registration or listing. Applications for registration will be subject to evaluation by the Conformity Assessment Branch (CAB) and the Therapeutic Goods Laboratories Branch (TGAL) of the Therapeutic Goods Administration (TGA), in accordance with Section 25 of the Therapeutic Goods Act 1989 (the Act). Applications for listing will be reviewed by CAB in accordance with section 26 of the Act. Substantial deficiencies in the completeness or rigour of material provided for evaluation will result in the application being rejected or refused and new fees will be payable. Sponsors must, as for all submissions, keep the needs of evaluators in mind and ensure that the material which is submitted is indexed. In the case of listing applications, sponsors should ensure that complete information is provided. Omissions may lead to non acceptance of the application. 1. BASIC REQUIREMENT

Year: 2011
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