APVMA to prepare standards
8U APVMA to prepare standards
This section applies in respect of each listed chemical product, whether or not the product is the subject of a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary) or in a similar publication.
The APVMA must, by legislative instrument, make a standard for each listed chemical product. A particular standard may relate to a specified chemical product or specified chemical products or to each chemical product in a specified class of chemical products.
The standard for a listed chemical product must require that the product be labelled in a manner, or kept in containers that comply with requirements, specified in the standard.
The APVMA may, in a standard, direct that the particulars required by the standard be set out, in a manner specified in the standard, on:
chemical products, or a class of chemical products, identified in the standard; or
a container containing chemical products, or a class of chemical products, identified in the standard; or
a label for containers for chemical products, or a class of chemical products, identified in the standard.
A standard for a listed chemical product:
may be specified by reference to any one or more of the following:
the composition and form of the constituents of the product;
the physical and chemical properties of the chemical product;
the quantity of the chemical product when contained in specified containers;
procedures to be carried out in the manufacture of the chemical product;
a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary);
a monograph in another publication approved by the APVMA for the purposes of this subparagraph;
a monograph referred to in subparagraph (v) or (vi) as modified in a manner specified in the standard;
a standard published by Standards Australia;
such other matters as the APVMA thinks fit; and
may require that a matter relating to the standard be determined in accordance with a particular test.
Subsections (4) and (5) do not limit subsection (3).
The standard made by the APVMA in relation to a listed chemical product is the established standard for the product.
The APVMA may revoke or amend a standard. See subsection 33(3) of the Acts Interpretation Act 1901.
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