Therapeutic Goods - disinfectants & sterilants

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Preparations labelled or promoted for use as disinfectants and sterilants are subject to a Therapeutic Goods Order (TGO). Such goods are subject to testing and labelling requirements as outlined in the Standard for Composition Packaging Labelling and Performance of Disinfectants and Antiseptics (TGO 54/54A).

Where the primary use is industrial, agricultural or veterinary, the responsibility will be with NICNAS (section 0), National Registration Authority (see section 0) or the Australian Quarantine Investigation Service respectively though multiple applications may be required where there is overlap.

Scope

Products labelled as being a disinfectant are subject to registration or listing on the Australian Register of Therapeutic Goods. Specific testing and labelling requirements will be required for registrable products.
The TGO will apply to products which are primarily for use in human situations (eg. hospitals, the home etc.)

Exempt

Exempt products include household disinfectants without virucidal, tuberculocidal, fungicidal or sporocidal claims, sanitisers, detergents, laundry soaps etc., the primary purpose of which is household and commercial cleaning, deoderisers and cleaning wipes claiming an antibacterial action

Manufacturers

From January 1997, manufacturers of registrable or listable disinfectants have to be licensed. Manufacturers, including overseas manufacturers, will have to demonstrate compliance with Good Manufacturing Practice and assessed by TGO.
Testing varies with the application such as hospital grade disinfectants (as indicated on the label on the primary pack) is required to pass required sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal tests where specific activities are claimed.
Specific packaging and labelling requirements are defined including the quantity of disinfectant, batch number, expiry date, name and addresses, and use requirements.

Chemlink Pty Ltd ACN 007 034 022. Publications 1997. All contents Copyright © 1997. All rights reserved. Information in this document is subject to change without notice. Products and companies referred to are trademarks or registered trademarks of their respective companies or mark holders. URL: www.chemlink.com.au/

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