Document ID: chunk:federal_register_of_legislation:F2020C01070:clause:3_8
Version: federal_register_of_legislation:F2020C01070
Segment Type: clause
Provision Reference: sch 3 cl 8
Character Range: 11775–12951

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.

Division 2Requirements for tablets and capsules for which there is an applicable monograph