Commonwealth Numbered Acts Commonwealth Numbered Acts
1 After paragraph 26(1)(e)
Insert:
(ea) the goods contain a component or ingredient that is specified in a determination under subsection 26BE(1) that applies in relation to the goods; or
(eb) the goods contain a component or ingredient:
(i) that is specified in a determination under subsection 26BE(2) that applies in relation to the goods; and
(ii) that exceeds the permitted concentration of that component or ingredient, or exceeds the permitted total amount of that component or ingredient, that is specified in that determination; or
2 After paragraph 26A(2)(c)
Insert:
(ca) if a determination under section 26BB applies in relation to the medicine--the only active ingredients the medicine contains are active ingredients specified in that determination in relation to the medicine; and
(cb) if:
(i) the medicine contains an active ingredient that is specified in a determination under section 26BB that applies in relation to the medicine; and
(ii) that determination specifies a permitted concentration of the active ingredient or a permitted total amount of the active ingredient;
the active ingredient does not exceed that permitted concentration or that permitted total amount; and
(cc) if a determination under subsection 26BE(1) applies in relation to the medicine--the medicine does not contain a component or ingredient specified in that determination in relation to the medicine; and
(cd) if the medicine contains a component or ingredient that is specified in a determination under subsection 26BE(2) that applies in relation to the medicine--the component or ingredient does not exceed the permitted concentration of that component or ingredient, or the permitted total amount of that component or ingredient, that is specified in that determination; and
3 After section 26BA
Insert:
26BB Permissible active ingredients
(1) The Minister may, by legislative instrument, make a determination specifying:
(a) active ingredients in relation to medicine; and
(b) either or both of the following:
(i) permitted concentrations of some or all of those ingredients;
(ii) permitted total amounts of some or all of those ingredients.
Note: Under section 26A, a person seeking the listing of medicine must certify that the only active ingredients the medicine contains are active ingredients specified in such a determination. If relevant, the person must also certify that an active ingredient does not exceed the permitted concentration of the ingredient or the permitted total amount of the ingredient.
Scope of determination
(2) A determination under this section may make different provision for different classes of medicine.
Incorporation of instruments
(3) 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.
26BC Variation of list of active ingredients--Minister's initiative
The Minister may, on his or her own initiative and by legislative instrument, vary a determination under section 26BB.
26BD Variation of list of active ingredients--application by person
(1) A person may apply to the Minister for a variation of a determination under section 26BB.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved by the Secretary; and
(b) set out the variation sought; and
(c) be delivered to an office of the Department specified in the form; and
(d) be accompanied by the prescribed application fee.
(3) If an application is made under subsection (1) and any applicable prescribed evaluation fee has been paid, the Minister may, by legislative instrument, vary the determination.
Further information
(4) The Minister may, by notice in writing given to the person, require the person to give to the Minister, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice.
Applications or information may be given electronically
(5) An approval of a form mentioned in paragraph (2)(a), or a notice mentioned in subsection (4), may require or permit an application or information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
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).
4 Paragraph 30(1)(e)
After "26A(2)(a),", insert "(ca), (cb), (cc), (cd),".
5 Application
The amendments made by items 1 and 2 apply in relation to applications for listings made on or after the commencement of those items.