Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 13

             (1)  For the purposes of this Act, if a statement (the main statement ) in a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary refers to a statement in a monograph in another publication, the main statement is taken to include the other statement.

             (2)  If:

                     (a)  a standard under section 10 (the Ministerial standard ) applies to therapeutic goods; and

                     (b)  requirements applicable to the goods are specified in a default standard; and

                     (c)  those requirements are inconsistent with the requirements specified in the Ministerial standard;

the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.

             (3)  If:

                     (a)  a default standard applies to a class of therapeutic goods; and

                     (b)  another default standard applies to only some of the therapeutic goods within that class; and

                     (c)  those standards are inconsistent;

the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b).

             (4)  If:

                     (a)  therapeutic goods consist, or are represented to consist, of a mixture of ingredients or of a combination of component parts; and

                     (b)  a default standard is applicable to one or more of the ingredients or one or more of the component parts; and

                     (c)  a default standard is applicable to the mixture or combination;

the standard referred to in paragraph (b) does not apply in relation to the goods.

             (5)  If:

                     (a)  therapeutic goods consist, or are represented to consist, of a mixture of ingredients or of a combination of component parts; and

                     (b)  there is no standard applicable to the mixture or combination but a standard is applicable to one or more of the ingredients or one or more of the component parts;

the Minister may, by order published in the Gazette , determine that the standard does not apply to the goods. The order has effect accordingly.

             (6)  An order under subsection (5) is not a legislative instrument.

             (7)  For the purposes of this Act, in working out at a particular time if therapeutic goods conform with a default standard applicable to the goods, if:

                     (a)  after applying subsections (2) to (5), 2 or more default standards are applicable to the goods at that time; and

                     (b)  at that time, the goods conform with at least one of those standards but do not conform with at least one of those standards;

then the default standards that the goods do not conform with are taken not to apply to the goods at that time.