Anthroposophic preparations and anthroposophic standards
3AB Anthroposophic preparations and anthroposophic standards
Anthroposophic preparation
For the purposes of this Act, an anthroposophic preparation is a preparation:
manufactured from a mother substance; and
manufactured in accordance with a manufacturing procedure described in an anthroposophic pharmacopoeia.
Anthroposophic standard
For the purposes of this Act, if:
there are therapeutic goods that are an anthroposophic preparation; and
the goods are the subject of one or more monographs (other than a monograph exempt under subsection (4)) in the anthroposophic pharmacopoeia describing the manufacturing procedure that the preparation was manufactured in accordance with;
then there is an anthroposophic standard, in relation to the goods, that is constituted by the statements (other than statements exempt under subsection (5)) in those monographs, as interpreted in accordance with any interpretation sections of that anthroposophic pharmacopoeia.
Specifying publications
The Minister may, by legislative instrument, specify either or both of the following for the purposes of the definition of anthroposophic pharmacopoeia in subsection 3(1):
publications;
parts of publications.
Exempting entire monographs
The Minister may, by legislative instrument, determine that specified monographs in a specified anthroposophic pharmacopoeia are exempt for the purposes of paragraph (2)(b).
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 a specified anthroposophic pharmacopoeia are exempt for the purposes of subsection (2).
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