Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 13

             (1)  Unless the contrary intention appears in a standard, the standard applies to therapeutic goods for use in humans and therapeutic goods for use in animals.

             (2)  For the purposes of this Part, where a statement in a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary) refers to a statement in a monograph in another publication, the first‑mentioned statement is to be taken to include the other statement.

             (3)  Subject to subsection (4), where:

                     (a)  a standard applicable to therapeutic goods is constituted by statements in a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary); and

                     (b)  requirements applicable to the labelling or packaging of the goods are specified in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary); and

                     (c)  the goods are not labelled or packaged in accordance with those requirements;

the goods are to be taken not to comply with that standard.

             (4)  Where:

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

                     (b)  requirements applicable to the goods are specified in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary); and

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

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

             (5)  Where:

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

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

                     (c)  those standards are inconsistent;

the standard referred to in paragraph (a) is, to the extent of the inconsistency, of no effect in relation to the goods referred to in paragraph (b).

             (6)  Where:

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

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

that standard takes precedence over any standard that is applicable to the ingredients or the component parts.

             (7)  Where:

                     (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 goods but a standard is applicable to at least one of the ingredients or component parts; and

                     (c)  the Minister has, by order published in the Gazette , determined that the standard does not apply to the goods;

the standard is to be disregarded in so far as it would otherwise apply to the goods.