Commonwealth Numbered Acts

THERAPEUTIC GOODS AMENDMENT (MEDICAL DEVICES AND OTHER MEASURES) ACT 2009 (NO. 38, 2009) - SCHEDULE 5

Therapeutic Goods Act 1989

1  Subsection 9C(1)

Omit "The Register is not open for public inspection, but a", substitute "A".

2  Subsection 61(1) (definition of therapeutic goods information )

Omit "came into the possession of the Department in connection with", substitute "is held by the Department and relates to".

3  Application

The amendment made by item 2 applies in relation to information held by the Department on or after the commencement of this item (regardless of whether the information came into existence before, on or after that commencement).

4  Paragraphs 61(2)(a) and (b)

Omit "the Director‑General of".

5  Subsection 61(3)

Omit "the head of".

6  Paragraph 61(3A)(a)

Omit "the head of an authority, or an authority,", substitute "an authority".

7  Subsection 61(4)

Omit "the head of".

8  Paragraphs 61(4A)(a), (b) and (ba)

Omit "the head of".

9  After paragraph 61(4A)(d)

Insert:

                    (da)  action taken by the Secretary under section 30EA (about notification and recovery of therapeutic goods);

10  Paragraph 61(4A)(e)

After "of", insert "Part 5‑2 or".

11  After paragraph 61(4A)(f)

Insert:

                    (fa)  any cases, or possible cases, of counterfeit therapeutic goods;

12  Subsection 61(5)

Omit "the head of" (wherever occurring).

13  After subsection 61(5)

Insert:

       (5AA)  The Secretary may release to a person, body or authority that is specified, or is of a kind specified, under subsection (5AB) therapeutic goods information of a kind specified under that subsection for a purpose specified under that subsection.

        (5AB)  For the purpose of subsection (5AA), the Minister may, by legislative instrument, specify one or more of the following:

                     (a)  a person, body or authority;

                     (b)  kinds of persons, bodies or authorities;

                     (c)  kinds of therapeutic goods information;

                     (d)  purposes.

14  After subsection 61(5B)

Insert:

          (5C)  The Secretary may release to the public therapeutic goods information of a kind specified under subsection (5D).

          (5D)  The Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection (5C).

15  Paragraph 61(6A)(b)

Omit "persons; and", substitute "persons.".

16  Paragraph 61(6A)(c)

Repeal the paragraph.

17  At the end of section 61

Add:

           (12)  The subsections of this section permitting the release of information have effect independently of each other.