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THERAPEUTIC GOODS AMENDMENT (MEDICAL DEVICES) ACT 2002 NO. 24, 2002 - SCHEDULE 2

- Amendments commencing 5 years after Schedule 1

Therapeutic Goods Act 1989

1 Subsection 3(1) (definition of gazetted therapeutic devices group)

Repeal the definition.

2 Subsection 3(1) (paragraph (b) of the definition of grouped therapeutic goods)

Repeal the paragraph.

3 Subsection 3(1) (definition of listable devices)

Repeal the definition.

4 Subsection 3(1) (definition of medicine)

Repeal the definition, substitute:

"medicine" means therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal.

5 Subsection 3(1) (definition of therapeutic device)

Repeal the definition.

6 Paragraph 7B(2)(b)

Omit "or therapeutic devices".

7 Chapter 3 (note following the heading)

Repeal the note.

8 Section 10A

Omit "unless Part 3-2 applies to the device".

9 Section 15A

Repeal the section, substitute:

15A Application of this Part to medical devices

This Part does not apply to a medical device.

10 Subsection 16(2)

Omit "or therapeutic devices".

11 Subsection 16(3)

Repeal the subsection.

12 Paragraphs 20(2)(a) and (b)

Repeal the paragraphs, substitute:

(a)
the registration number or listing number of the goods is set out on the label of the goods in the prescribed manner; or
(b)
in the case of an importation, that number is so set out, or is to be so set out before the goods are supplied in Australia.

13 Section 21

Omit "(other than listable devices)".

14 Subparagraph 25(2)(a)(i)

Omit "if the goods are not therapeutic devices", substitute "if the goods are medicines".

15 Paragraph 25A(2)(a)

Repeal the paragraph, substitute:

(a)
the information was given to the Secretary in relation to an application to register therapeutic goods (the new goods ) consisting of, or containing, an active component; and

16 Section 25B

Repeal the section.

17 Subsection 26(1)

Omit ", subject to section 26AA,".

18 Paragraph 26(1)(g)

Omit "not being therapeutic devices other than devices", substitute "being medicines or other therapeutic goods".

19 Subparagraph 26(2)(a)(i)

Omit "if the goods are not therapeutic devices", substitute "if the goods are medicines".

20 Section 26AA

Repeal the section.

21 Chapter 4 (note following the heading)

Repeal the note.

22 Section 41BJ

Repeal the section.

23 Subsection 60(1) (paragraph (a) of the definition of initial decision)

Omit "under the definition of therapeutic devices in subsection 3(1) or".




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