Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
8General requirements
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8 General requirements
(1) The requirements in relation to a tablet or capsule for which there is an applicable monograph are: (a) those requirements specified in that monograph, subject to the matters specified in Division 2; or (b) those requirements specified in Division 3 (the Australian specific requirements) together with the requirements relevant to the tablet or capsule that are specified in one of the following: (i) the general monographs in the European Pharmacopoeia; (ii) the general monographs in the British Pharmacopoeia; (iii) the general chapters of the United States Pharmacopeia-National Formulary. (2) The requirements in relation to a tablet or capsule for which there is no applicable monograph are: (a) the Australian specific requirements; and (b) the requirements relevant to the tablet or capsule that are specified in one of the following: (i) the general monographs in the European Pharmacopoeia; (ii) the general monographs in the British Pharmacopoeia; (iii) the general chapters of the United States Pharmacopeia-National Formulary.