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Purpose
This OTC Medicine Monograph outlines the requirements for Australian market authorisation of preparations containing bromhexine hydrochloride as a single active ingredient when applied for as an OTC new medicine N2 application.
Proposed medicines must comply with all aspects of the monograph relevant to their strength and dosage form to qualify for evaluation as an N2 application.
This monograph should be read in conjunction with the document Requirements for OTC new medicine N2 applications.
Explains legislation
Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines (22/09/2008)
Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008)