Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 26BB

Permissible ingredients

             (1)  The Minister may, by legislative instrument, make a determination specifying either or both of the following:

                     (a)  ingredients;

                     (b)  for some or all of those ingredients--requirements in relation to those ingredients being contained in medicine.

Note:          A person seeking the listing of a medicine under section 26A or 26AB must certify that:

(a)    the medicine does not contain an ingredient that is not specified in the determination; and

(b)    none of the requirements specified in the determination in relation to ingredients being contained in the medicine have been contravened.

Requirements

             (2)  The requirements referred to in paragraph (1)(b) may relate to particular ingredients not being contained in particular medicine.

          (2A)  The requirements referred to in paragraph (1)(b) may relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient.

             (3)  The requirements referred to in paragraph (1)(b) may relate to permitted concentrations or permitted total amounts of ingredients.

             (4)  Subsections (2), (2A) and (3) do not limit paragraph (1)(b).

             (5)  A determination under paragraph (1)(b) may make different provision for different classes of medicine.

Limitations on determination under subsection (1)

             (6)  The Minister may, by legislative instrument, make a determination specifying either or both of the following:

                     (a)  ingredients that must not be specified under paragraph (1)(a);

                     (b)  requirements that must not be specified under paragraph (1)(b) in relation to ingredients being contained in medicine.

             (7)  A determination under paragraph (6)(b) may make different provision for different classes of medicine.

Incorporation of instruments

             (8)  Despite subsection 14(2) of the Legislation Act 2003 , a determination under this section may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time.



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