Commonwealth Numbered Acts

Health Acts Amendment Act 1981 No. 118 of 1981 - SECT 88

88. The Principal Act is amended by inserting after section 16 the following
section: Mode of specifying standards, &c.

''16A. (1) The Minister may specify a standard in relation to goods for
therapeutic use in pursuance of section 11, 13, 14 or 15-

   (a)  by setting out in the order specifying the standard the statements
        that are to constitute the standard;

   (b)  by reference to a monograph in-

        (i)    a prescribed publication;

        (ii)   the European Pharmacopoeia;

        (iii)  a publication of the organization known as the Standards
               Association of Australia; or

        (iv)   any other publication that the Minister is satisfied is a
               proper source for the standard; or

   (c)  by reference to a monograph in the British Pharmacopoeia or in a
        publication referred to in paragraph (b), being that monograph as
        modified in such manner as is specified in the order specifying the
        standard.

''(2) Where a standard is specified in the manner referred to in paragraph (1)
(b), the standard shall be constituted by the statements in the monograph.

''(3) Where a standard is specified in the manner referred to in paragraph (1)
(c), the standard shall be constituted by the statements in the monograph as
modified in the manner specified in the order specifying the standard.

''(4) The Minister shall not be satisfied for the purposes of sub-paragraph
(1) (b) (iv) that a publication is a proper source for a standard unless he
has been advised that the publication is such a source by a committee in
respect of which a declaration under sub-section (5) was in force at the time
when the advice was given.

''(5) Where the Minister is satisfied that a committee established by the
regulations is so constituted that it would be appropriate for it to give
advice to him with respect to standards in relation to goods for therapeutic
use, he may, by writing signed by him, declare that committee to be a
therapeutic goods standards committee for the purposes of this section.

''(6) In this section, unless the contrary intention appears, 'standard'
includes a test and a labelling and packaging requirement.''.