Document ID: chunk:federal_register_of_legislation:C2004A04631:body:0:p10
Version: federal_register_of_legislation:C2004A04631
Segment Type: other
Provision Reference: 
Character Range: 23516–26341

goods are of 2 or more kinds; and

  (b) the package does not contain any therapeutic devices; and

     (c) the therapeutic goods are for administration as a single treatment or as a single course of treatment; and

     (d) it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.

"(3) To avoid doubt, it is declared that a kit constitutes therapeutic goods.".

Therapeutic goods and gazetted groups

  35. Section 16 of the Principal Act is amended:

  (a) by inserting after subsection (3) the following subsection:

     "(3A) The Secretary may, by order published in the Gazette, determine that a group of kits identified in the order is a gazetted kits group.";

     (b) by omitting from subsection (4) "subsection (2) or (3)" and substituting "subsection (2), (3) or (3A)".

Applications generally

36.(1) Section 23 of the Principal Act is amended by omitting paragraph (2)(a) and substituting the following paragraph:

  "(a) the prescribed application fee has been paid; and".

(2) The amendment made by subsection (1) does not apply to an application delivered to an office of the Department in accordance with subsection 23(1) of the Principal Act before the commencement of this section.

Evaluation of therapeutic goods

  37. Section 25 of the Principal Act is amended:

  (a) by inserting after subsection (2A) the following subsections:

     "(2B) If therapeutic goods are exempt from the operation of Part 4 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.

     "(2C) If a person is exempt from the operation of Part 4 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 4 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.

      "(2D) If:

      (a) therapeutic goods were made outside Australia; and

        (b) had the goods been made in Australia, they would have been exempt from the operation of Part 4;

    subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.";

  (b) by inserting after subsection (2D) the following subsections:

    "(2E) A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:

        (a) the general standards of manufacturing practice of a particular manufacturer; or

        (b) the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.

    "(2F) For the