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 or on the Department's website, 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.