Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 3C

Exempting monographs in pharmacopoeias

Exempting entire monographs

  (1)   The Minister may, by legislative instrument, determine that specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia - National Formulary are exempt in relation to specified therapeutic goods for the purposes of paragraph   (b), (c) or (d) of the definition of standard in subsection   3(1). The determination applies to those monographs as in force from time to time.

Note:   For specification by class, see subsection   13(3) of the Legislation Act 2003 .

Exempting parts of monographs

  (2)   The Minister may, by legislative instrument, determine that specified statements in specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia - National Formulary are exempt in relation to specified therapeutic goods for the purposes of paragraph   (b), (c) or (d) of the definition of standard in subsection   3(1). The determination applies to those statements and monographs as in force from time to time.

Incorporation of other instruments

  (3)   Despite subsection   14(2) of the Legislation Act 2003 , a determination under subsection   (1) or (2) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.


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