Exempting monographs in pharmacopoeias
3C Exempting monographs in pharmacopoeias
Exempting entire monographs
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.
For specification by class, see subsection 13(3) of the Legislation Act 2003.
Exempting parts of monographs
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
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.
This Act’s bill:Second reading speech
The statute text is free to read above. View subscription options to unlock the case-law research tools for each provision.