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Therapeutic Goods Order No. 98 – Microbiological Standards for Medicines 2018
No longer in force
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Administered by
Department of Health and Aged Care
This item is authorised by the following title:
Therapeutic Goods Act 1989
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F2018L01287
14 September 2018
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07 December 2018
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1 Name
2 Commencement
3 Authority
4 Interpretation
5 Application
6 General exemptions
7 Sterility and Bacterial Endotoxin testing
8 Efficacy of antimicrobial preservation of a multidose medicine
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9 Microbiological attributes of a non-sterile medicine
Schedule 1— Microbial attributes for a complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin
Schedule 2— Microbial attributes for a complementary medicine oral dosage form containing raw material of natural (vegetal) origin that is a herbal medicinal product consisting solely of one or more herbal substances (whole, reduced or powdered) to which boiling water is added before use