Document ID: chunk:federal_register_of_legislation:F2022C00360:clause:2_11
Version: federal_register_of_legislation:F2022C00360
Segment Type: clause
Provision Reference: sch 2 cl 11
Character Range: 6628–8961

11  Microbiological attributes of a non-sterile medicine
 (1) A non-sterile medicine, other than a complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin, must comply with the relevant acceptance criteria for microbiological quality of one of the following:
 (a) the British Pharmacopoeia, Appendix XVI. D Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use;  when tested by the methods of:
 (i) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 2. Microbial Enumeration Tests; and
 (ii) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 1. Test for Specified Micro-organisms; or
 (b) the European Pharmacopoeia, Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use (5.1.4); when tested by the methods of:
 (i) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests (2.6.12); and
 (ii) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Test for Specified Micro-organisms (2.6.13); or
 (c) the United States Pharmacopeia – National Formulary, chapter <1111> , MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE, when tested by the methods of:
 (i) the United States Pharmacopeia – National Formulary, chapter <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS; and
 (ii) the United States Pharmacopeia – National Formulary, chapter <62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS.
 (2) A complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin must comply with the acceptance criteria for microbiological quality specified in Schedule 1 when tested by a method stated in subsection 11(1), other than a herbal medicine consisting solely of one or more herbal substances (whole, reduced or powdered) to which boiling water is added before use, which must comply with the acceptance criteria specified in Schedule 2 when tested with a method mentioned in subsection 11(1).