Document ID: chunk:federal_register_of_legislation:C2009A00076:clause:5_26be
Version: federal_register_of_legislation:C2009A00076
Segment Type: clause
Provision Reference: sch 5 cl 26BE
Character Range: 43119–45345

26BE  Prohibited or limited components or ingredients

Prohibited components or ingredients
 (1) The Minister may, by legislative instrument, make a determination specifying either or both of the following in relation to therapeutic goods:
 (a) components;
 (b) ingredients.
Note 1: Under section 26, the Secretary may refuse to list therapeutic goods if the goods contain a component or ingredient specified in such a determination.
Note 2: Under section 26A, a person seeking the listing of medicine must certify that the medicine does not contain a component or ingredient specified in such a determination.

Limited components or ingredients
 (2) The Minister may, by legislative instrument, make a determination specifying either or both of the following in relation to therapeutic goods:
 (a) components and either or both of the following:
 (i) permitted concentrations of those components;
 (ii) permitted total amounts of those components;
 (b) ingredients and either or both of the following:
 (i) permitted concentrations of those ingredients;
 (ii) permitted total amounts of those ingredients.
Note 1: Under section 26, the Secretary may refuse to list therapeutic goods if the goods contain a component or ingredient that exceeds the permitted concentration of that component or ingredient or exceeds the permitted total amount of that component or ingredient.
Note 2: Under section 26A, a person seeking the listing of medicine must certify that the medicine does not contain a component or ingredient that exceeds the permitted concentration of that component or ingredient or exceeds the permitted total amount of that component or ingredient.

Scope of determination
 (3) A determination under this section may make different provision for different classes of therapeutic goods.

Incorporation of instruments
 (4) Despite subsection 14(2) of the Legislative Instruments 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.

Variation
 (5) The Minister may, by legislative instrument, vary a determination under subsection (1) or (2).