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This is a Bill, not an Act. For current law, see the Acts databases.

THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 1) BILL 2009

2008-2009
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Therapeutic Goods Amendment (2009
Measures No. 1) Bill 2009
No. , 2009
(Health and Ageing)
A Bill for an Act to amend the Therapeutic Goods
Act 1989, and for related purposes
i Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
Contents
1
Short title ............................................................................................ 1
2
Commencement .................................................................................. 1
3
Schedule(s) ......................................................................................... 3
Schedule 1--Suspending therapeutic goods from the Register
4
Therapeutic Goods Act 1989
4
Schedule 2--Manufacturing licences
8
Therapeutic Goods Act 1989
8
Schedule 3--Monitoring powers
19
Therapeutic Goods Act 1989
19
Schedule 4--Homoeopathic and anthroposophic pre parations
22
Therapeutic Goods Act 1989
22
Schedule 5--Ingredients in therapeutic goods
28
Therapeutic Goods Act 1989
28
Schedule 6--Amendme nts relating to legislative instrume nts
33
Therapeutic Goods Act 1989
33
Schedule 7--Other ame ndments
36
Part 1--Amendments commencing on the day after Royal
Assent
36
Therapeutic Goods Act 1989
36
Part 2--Amendments commencing on a day to be fixed by
Proclamation
42
Therapeutic Goods Act 1989
42
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 1
A Bill for an Act to amend the Therapeutic Goods
1
Act 1989, and for related purposes
2
The Parliament of Australia enacts:
3
1 Short title
4
This Act may be cited as the Therapeutic Goods Amendment (2009
5
Measures No. 1) Act 2009.
6
2 Commence ment
7
(1) Each provision of this Act specified in column 1 of the table
8
commences, or is taken to have commenced, in accordance with
9
column 2 of the table. Any other statement in column 2 has effect
10
according to its terms.
11
12
2 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
Commencement information
Column 1
Column 2
Column 3
Provision(s)
Commencement
Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day on which this Act receives the
Royal Assent.
2. Schedule 1
The day after this Act receives the Royal
Assent.
3. Schedule 2
A single day to be fixed by Proclamation.
However, if any of the provision(s) do not
commence with in the period of 6 months
beginning on the day on which this Act
receives the Royal Assent, they commence
on the first day after the end of that period.
4. Schedule 3
The day after this Act receives the Royal
Assent.
5. Schedule 4
1 Ju ly 2011.
1 Ju ly 2011
6. Schedule 5
A single day to be fixed by Proclamation.
However, if any of the provision(s) do not
commence with in the period of 6 months
beginning on the day on which this Act
receives the Royal Assent, they commence
on the first day after the end of that period.
7. Schedule 6
The day after this Act receives the Royal
Assent.
8. Schedule 7,
Part 1
The day after this Act receives the Royal
Assent.
9. Schedule 7,
Part 2
A single day to be fixed by Proclamation.
However, if any of the provision(s) do not
commence with in the period of 6 months
beginning on the day on which this Act
receives the Royal Assent, they commence
on the first day after the end of that period.
Note:
This table relates only to the provisions of this Act as originally
1
passed by both Houses of the Parliament and assented to. It will not be
2
expanded to deal with provisions inserted in this Act after assent.
3
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 3
(2) Column 3 of the table contains additional information that is not
1
part of this Act. Information in this column may be added to or
2
edited in any published version of this Act.
3
3 Schedule(s)
4
Each Act that is specified in a Schedule to this Act is amended or
5
repealed as set out in the applicable items in the Schedule
6
concerned, and any other item in a Schedule to this Act has effect
7
according to its terms.
8
9
Schedule 1 Suspending therapeutic goods from the Register
4 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
1
Schedule 1
--
Suspending therapeutic goods
2
from the Register
3
4
Therapeutic Goods Act 1989
5
1 At the end of section 29
6
Add:
7
Note:
The goods are taken not to be included in the Register while their
8
registration or listing is suspended: see section 29G.
9
2 After section 29C
10
Insert:
11
29D Suspension of registration or listing
12
(1) The Secretary may, by written notice given to a person in relation
13
to whom therapeutic goods are included in the Register, suspend
14
the registration or listing of the goods if:
15
(a) the Secretary is satisfied that:
16
(i) there is a potential risk of death, serious illness or
17
serious injury if the therapeutic goods continue to be
18
included in the Register; and
19
(ii) it is likely that the person will, within the period of the
20
suspension, be able to take the action necessary to
21
ensure that the therapeutic goods would not cause a
22
potential risk of death, serious illness or serious injury if
23
the therapeutic goods were to continue to be included in
24
the Register; or
25
(b) the Secretary is satisfied that it is likely that there are grounds
26
for cancelling the registration or listing of the goods under
27
paragraph 30(1)(da), (e) or (f) or subsection 30(1A), (1C) or
28
(2).
29
Notice of proposed suspension in some cases
30
(2) However, before suspending the registration or listing of the goods
31
because of paragraph (1)(b), the Secretary must:
32
(a) inform the person by written notice that the Secretary
33
proposes the suspension and set out the reasons for it; and
34
Suspending therapeutic goods from the Register Schedule 1
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 5
(b) give the person a reasonable opportunity to make
1
submissions to the Secretary in relation to the proposed
2
suspension.
3
(3) The Secretary is not to make a decision relating to the proposed
4
suspension until the Secretary has had regard to any submissions
5
the person makes under paragraph (2)(b).
6
Period of suspension
7
(4) A notice under subsection (1) must specify the period of the
8
suspension. The period must not exceed 6 months.
9
Note:
Section 29E deals with when the suspension takes effect and
10
extensions of the suspension.
11
Publication in Gazette
12
(5) As soon as practicable after giving a notice under subsection (1),
13
the Secretary must cause to be published in the Gazette a notice
14
setting out particulars of the suspension.
15
29E When suspension takes effect etc.
16
(1) A suspension under section 29D takes effect:
17
(a) if the notice under subsection 29D(1) states that the
18
suspension is necessary to prevent a potential risk of death,
19
serious illness or serious injury--on the day on which the
20
notice is given to the person; or
21
(b) in any other case--on the day specified for the purpose in the
22
notice, being a day not earlier than 20 working days after the
23
notice is given to the person.
24
(2) The suspension has effect until:
25
(a) the Secretary revokes it under section 29F; or
26
(b) the end of:
27
(i) the period specified in the notice under subsection
28
29D(4); or
29
(ii) if the period is extended under subsection (3) of this
30
section, the period as so extended.
31
Schedule 1 Suspending therapeutic goods from the Register
6 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
Extension of suspension
1
(3) The Secretary may, by written notice given to the person, extend
2
the period specified in the notice under subsection 29D(4) by a
3
further specified period not exceeding 6 months.
4
Publication in Gazette
5
(4) As soon as practicable after giving a notice under subsection (3),
6
the Secretary must cause to be published in the Gazette a notice
7
setting out particulars of the extension.
8
29F Revocation of suspension
9
(1) The Secretary must revoke a suspension under section 29D, by
10
written notice given to the person in relation to whom the
11
therapeutic goods are included in the Register, if the Secretary is
12
satisfied that:
13
(a) the ground on which the registration or listing of the
14
therapeutic goods was suspended no longer applies; and
15
(b) there are no other grounds for suspending the registration or
16
listing of the therapeutic goods.
17
(2) The Secretary's power to revoke the suspension may be exercised:
18
(a) if the person in relation to whom the therapeutic goods are
19
included in the Register applies in writing to the Secretary; or
20
(b) on the Secretary's own initiative.
21
Publication in Gazette
22
(3) As soon as practicable after giving a notice under subsection (1),
23
the Secretary must cause to be published in the Gazette a notice
24
setting out particulars of the revocation.
25
Notice of refusal to revoke suspension
26
(4) If the Secretary decides, after an application is made under
27
paragraph (2)(a), not to revoke the suspension, the Secretary must:
28
(a) notify the applicant in writing of his or her decision; and
29
(b) state in the notice the reasons for the decision.
30
Suspending therapeutic goods from the Register Schedule 1
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 7
29G Effect of suspension
1
(1) If the registration or listing of therapeutic goods is suspended under
2
section 29D, the goods are taken, for the purposes of this Act
3
(other than sections 28, 29A, 29AA, 29E, 29F, 30 and 31), not to
4
be included in the Register while the suspension has effect.
5
Note:
Dealing in therapeutic goods that are not included in the Register may
6
be an offence or may contravene a civil penalty provision: see
7
Division 1.
8
(2) While the suspension has effect, the Secretary's power under
9
section 30 to cancel the registration or listing of the therapeutic
10
goods is not affected.
11
3 Subsection 30EA(1) (after table item 6)
12
Insert:
13
6A.
The registration or listing of the goods has been
suspended under this Part
The person in relation to
whom the goods were
included in the Register
4 Section 30ED
14
After "power to", insert "suspend or".
15
Note:
The heading to section 30ED is altered by omitting "Power of" and substituting
16
"Powers of suspension and".
17
5 Paragraph 56A(1)(g)
18
After "had been", insert "suspended or".
19
6 Paragraphs 61(4)(b) and (ba)
20
After "or the", insert "suspension or".
21
7 Application
22
The amendment made by item 2 applies in relation to therapeutic goods
23
included in the Register before, on or after the commencement of that
24
item.
25
26
Schedule 2 Manufacturing licences
8 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
1
Schedule 2
--
Manufacturing licences
2
3
Therapeutic Goods Act 1989
4
1 Subsection 3(1) (definition of manufacturing premises)
5
Repeal the definition.
6
2 Subsection 3(1)
7
Insert:
8
manufacturing site means premises:
9
(a) that are for use in the manufacture of a particular kind of
10
therapeutic goods; and
11
(b) at which the same persons have control of the management of
12
the production of the goods and the procedures for quality
13
control.
14
3 Subsection 3(1)
15
Insert:
16
manufacturing site authorisation means an authorisation referred
17
to in subsection 38(2B) or 40B(4).
18
4 Paragraph 37(1)(c)
19
Omit "identify the manufacturing premises", substitute "in accordance
20
with subsections (1A) and (1B), identify one or more manufacturing
21
sites".
22
5 After subsection 37(1)
23
Insert:
24
Manufacturing sites
25
(1A) Subject to subsection (1B), an application under subsection (1)
26
must relate to one manufacturing site only. This does not prevent
27
other applications from relating to other manufacturing sites.
28
Manufacturing licences Schedule 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 9
(1B) If an applicant is of the view that, having regard to the guidelines
1
under section 38A, a licence could be granted covering 2 or more
2
manufacturing sites, the applicant may:
3
(a) identify those sites in the application; and
4
(b) state the applicant's reasons for the applicant's view.
5
6 Paragraph 37(2)(b)
6
Omit "the premises,", substitute "each manufacturing site identified in
7
the application and the".
8
Note:
The following heading to subsection 37(2) is inserted "Further information".
9
7 Paragraph 37(2)(b)
10
Omit "on those premises", substitute "at that site".
11
Note:
The following heading to subsection 37(3) is inserted "Applications or information may
12
be given electronically".
13
8 Paragraph 38(1)(a)
14
Omit "particular manufacturing premises", substitute "one or more
15
manufacturing sites".
16
9 Subsection 38(1)
17
Omit "to carry out those steps at those premises", substitute "covering
18
one or more manufacturing sites specified in the licence".
19
10 Paragraph 38(1)(f)
20
Omit "the premises", substitute "one or more of the manufacturing sites
21
identified in the application".
22
Note 1: The following heading to subsection 38(1A) is inserted "Interpretation".
23
Note 2: The following heading to subsection 38(2) is inserted "Special circumstances justifying
24
grant of licence".
25
11 After subsection 38(2)
26
Insert:
27
Guidelines
28
(2A) The Secretary must have regard to the guidelines under
29
section 38A in granting licences under this section.
30
Schedule 2 Manufacturing licences
10 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
What the licence authorises
1
(2B) For each manufacturing site covered by a licence, the Secretary
2
must authorise, in the licence, the holder of the licence to carry out
3
specified steps in the manufacture of specified therapeutic goods at
4
that manufacturing site.
5
Note 1:
For specification by class, see subsection 46(3) of the Acts
6
Interpretation Act 1901.
7
Note 2:
Sections 40A and 40B deal with variation of authorisations.
8
Note 1: The following heading to subsection 38(3) is inserted "Notice of decision".
9
Note 2: The following heading to subsection 38(4) is inserted "Publication in Gazette".
10
12 After section 38
11
Insert:
12
38A Guidelines for multi-site licences
13
The Secretary must, by legislative instrument, make guidelines
14
setting out the circumstances in which a licence may cover 2 or
15
more manufacturing sites.
16
38B Splitting multi-site licences
17
(1) This section applies if a licence (the old licence):
18
(a) either:
19
(i) was in force under this Part immediately before the
20
commencement of this section; or
21
(ii) was suspended under this Part immediately before that
22
commencement; and
23
(b) related to premises that comprise 2 or more sites (the old
24
sites).
25
(2) As soon as practicable after the commencement of this section, the
26
Secretary must:
27
(a) by writing, revoke the old licence; and
28
(b) on the day that the Secretary revokes the old licence, grant
29
new licences (each of which is a new licence) to the holder of
30
the old licence which, when considered together, cover the
31
old sites.
32
Manufacturing licences Schedule 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 11
The Secretary must give the holder written notice of the revocation
1
and grant.
2
Note:
Subsections (5) and (6) deal with when each new licence commences
3
and when the old licence ends.
4
Guidelines
5
(3) The Secretary must have regard to the guidelines under
6
section 38A in granting licences under this section.
7
Application of this Part
8
(4) Subject to this section, subsections 38(2B) and (4) and sections 39
9
to 41A apply to a new licence in the same way as they apply to a
10
licence granted under section 38.
11
Note:
This means, for example, that:
12
(a)
the Secretary must give a manufacturing site authorisation under
13
subsection 38(2B) in relation to each manufacturing site covered
14
by a new licence; and
15
(b)
the Secretary may impose conditions on a new licence under
16
subsection 40(1) and the statutory conditions under subsection
17
40(4) will apply to a new licence; and
18
(c)
the Secretary may revoke or suspend a new licence under
19
section 41.
20
Commencement of new licence
21
(5) The day specified under subsection 39(1) for the commencement
22
of each new licence granted to the holder of the old licence must be
23
the day (the transition day) after the day each new licence is
24
granted.
25
Note:
Subsection (7) deals with suspending a new licence from the transition
26
day.
27
When revocation of old licence takes effect
28
(6) The revocation of the holder's old licence takes effect immediately
29
before the start of the transition day.
30
Suspension of new licence
31
(7) If:
32
Schedule 2 Manufacturing licences
12 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
(a) subparagraph (1)(a)(ii) applies in relation to an old licence;
1
and
2
(b) the period of suspension of the old licence is due to end at the
3
end of a day (the relevant day) after the transition day;
4
the Secretary may, on the day that the Secretary grants a new
5
licence to the holder of the old licence and by notice in writing
6
given to the holder, suspend the new licence for a period starting
7
on the transition day and ending at the end of the relevant day.
8
(8) Subsection 41(2) does not apply in relation to a suspension under
9
subsection (7) of this section. However, subsections 41(4) to (6) do
10
apply in relation to the suspension.
11
(9) To avoid doubt, subsection (7) does not prevent subsection 41(1)
12
from applying in relation to a new licence.
13
Licence charges
14
(10) Subsection 4(2) of the Therapeutic Goods (Charges) Act 1989 does
15
not apply in relation to a new licence for the financial year in
16
which the new licence is granted.
17
No review of revocation of old licence
18
(11) The revocation of the old licence is taken not to be an initial
19
decision for the purposes of section 60.
20
13 Subparagraph 40(4)(b)(i)
21
Omit "the manufacturing premises to which the licence relates",
22
substitute "each manufacturing site covered by the licence".
23
14 Subparagraph 40(4)(b)(ii)
24
Repeal the subparagraph, substitute:
25
(ii) while at such a site, to inspect the site, any therapeutic
26
goods at the site and the processes relating to the
27
manufacture of therapeutic goods at the site and to
28
examine, take measurements of, conduct tests on or take
29
samples of any therapeutic goods at the site or any thing
30
at the site that relates to any therapeutic goods; and
31
(iii) while at such a site, to make any still or moving image
32
or any recording of that site or those goods or processes;
33
and
34
Manufacturing licences Schedule 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 13
15 Paragraph 40(4)(c)
1
Omit "enters premises", substitute "enters a site".
2
16 Paragraph 40(4)(c)
3
Omit "those premises", substitute "that site".
4
17 Paragraph 40(4)(c)
5
Omit "the premises", substitute "that site".
6
18 Subparagraph 40(4)(d)(i)
7
Omit "those premises", substitute "that site".
8
19 After section 40
9
Insert:
10
40A Variation of manufacturing site authorisations--Secretary's
11
own initiative
12
(1) The Secretary may, on his or her own initiative and by notice in
13
writing given to the holder of a licence, vary a manufacturing site
14
authorisation in relation to the licence.
15
(2) A variation under subsection (1) takes effect:
16
(a) if the notice states that the variation is necessary to prevent
17
imminent risk of death, serious illness or serious injury--on
18
the day on which the notice is given to the holder; or
19
(b) in any other case--on the day specified in the notice (which
20
must not be earlier than 28 days after the notice is given to
21
the holder).
22
40B Variation of licences--application by licence holder
23
Addition of manufacturing sites
24
(1) If the holder of a licence is of the view that, having regard to the
25
guidelines under section 38A, the licence could cover one or more
26
additional manufacturing sites, the holder may apply to the
27
Secretary for a variation of the licence so that it covers one or more
28
additional manufacturing sites specified in the application.
29
(2) An application under subsection (1) must:
30
Schedule 2 Manufacturing licences
14 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
(a) be made in accordance with a form approved by the
1
Secretary; and
2
(b) identify the therapeutic goods or classes of therapeutic goods
3
that the holder proposes to manufacture at each additional
4
manufacturing site specified in the application; and
5
(c) identify the steps in the manufacture of those goods that the
6
holder proposes to carry out under the licence; and
7
(d) if the holder proposes to carry out steps in the manufacture of
8
blood or blood components under the licence--contain
9
information relating to those steps set out in regulations made
10
for the purposes of paragraph 37(1)(da); and
11
(e) state the names, qualifications and experience of the persons
12
who are to have control of the manufacture of the goods and
13
of the quality control measures that are to be employed; and
14
(f) be delivered to an office of the Department specified in the
15
form; and
16
(g) be accompanied by the prescribed application fee.
17
(3) If an application is made under subsection (1) and any applicable
18
prescribed inspection fees have been paid, the Secretary may, by
19
notice in writing given to the holder of the licence, vary the licence
20
so that the licence covers each additional manufacturing site
21
specified in the notice.
22
(4) For each manufacturing site specified under subsection (3), the
23
Secretary must, in the notice under that subsection, vary the licence
24
to authorise the holder of the licence to carry out specified steps in
25
the manufacture of specified therapeutic goods at that
26
manufacturing site.
27
Note 1:
For specification by class, see subsection 46(3) of the Acts
28
Interpretation Act 1901.
29
Note 2:
Section 40A and subsections (6) to (9) of this section deal with
30
variation of authorisations.
31
(5) A variation under subsection (3) or (4) takes effect on the day on
32
which the notice is given to the holder.
33
Variation of manufacturing site authorisations
34
(6) The holder of a licence may apply to the Secretary for a variation
35
of a manufacturing site authorisation in relation to the licence.
36
Manufacturing licences Schedule 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 15
(7) An application under subsection (6) must:
1
(a) be made in accordance with a form approved by the
2
Secretary; and
3
(b) set out the variation sought; and
4
(c) be delivered to an office of the Department specified in the
5
form; and
6
(d) be accompanied by the prescribed application fee.
7
(8) If an application is made under subsection (6) and any applicable
8
prescribed inspection fees have been paid, the Secretary may, by
9
notice in writing given to the holder of the licence, vary the
10
manufacturing site authorisation.
11
(9) A variation under subsection (8) takes effect on the day on which
12
the notice is given to the holder.
13
Further information
14
(10) The Secretary may, by notice in writing given to the holder of a
15
licence who has made an application under subsection (1) or (6),
16
require the holder:
17
(a) to give to the Secretary, within such reasonable time as is
18
specified in the notice, such further information concerning
19
the application as is specified in the notice; or
20
(b) to allow an authorised person, at any reasonable time
21
specified in the notice, to inspect each manufacturing site
22
identified in the application and the equipment, processes and
23
facilities that will be used in the manufacture of therapeutic
24
goods at that site.
25
Applications or information may be given electronically
26
(11) An approval of a form mentioned in paragraph (2)(a) or (7)(a), or a
27
notice mentioned in subsection (10), may require or permit an
28
application or information to be given in accordance with specified
29
software requirements:
30
(a) on a specified kind of data processing device; or
31
(b) by way of a specified kind of electronic transmission.
32
20 After paragraph 41(1)(e)
33
Insert:
34
Schedule 2 Manufacturing licences
16 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
(ea) the holder contravenes a manufacturing site authorisation in
1
relation to the licence; or
2
21 Before section 41A
3
Insert:
4
41AAA Transfer of licences
5
(1) The regulations may make provision for and in relation to the
6
transfer of licences.
7
(2) Regulations made for the purposes of subsection (1) may make
8
provision for and in relation to:
9
(a) the making of an application for the transfer of a licence; and
10
(b) the payment of a fee in respect of an application; and
11
(c) the assessment of an application; and
12
(d) the conditions of a licence upon the transfer of the licence;
13
and
14
(e) the review of decisions made under the regulations.
15
(3) Subsection (2) does not limit subsection (1).
16
22 Section 41A
17
Omit "premises", substitute "sites".
18
23 Paragraph 58(3)(b)
19
Omit "manufacturing premises", substitute "a manufacturing site".
20
24 Paragraph 58(3)(b)
21
Omit "those premises", substitute "that site".
22
25 Application and transitional
--
amendments made by this
23
Schedule
24
(1)
The amendments made by items 4 to 7 apply in relation to applications
25
for licences made on or after the commencement of those items.
26
(2)
The amendments made by items 8 to 11 apply in relation to applications
27
for licences:
28
(a) made on or after the commencement of those items; and
29
Manufacturing licences Schedule 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 17
(b) made before the commencement of those items that have not
1
been decided by the Secretary before that commencement.
2
(3)
In relation to an application covered by paragraph (2)(b) of this item,
3
paragraph 38(1)(a) of the Therapeutic Goods Act 1989 applies on and
4
after the commencement of this item as if the application was in respect
5
of the one or more manufacturing sites constituted by the manufacturing
6
premises the subject of the application.
7
(4)
The amendments made by items 13 to 22 apply in relation to licences
8
granted before, on or after the commencement of those items.
9
26 Transitional
--
existing licences
10
(1)
This item applies to a licence that:
11
(a) was in force under Part 3-3 of the Therapeutic Goods Act
12
1989 immediately before the commencement of this item; or
13
(b) was suspended under that Part immediately before that
14
commencement.
15
(2)
The Therapeutic Goods Act 1989 applies in relation to the licence on
16
and after that commencement as if the licence covered the one or more
17
manufacturing sites constituted by the manufacturing premises to which
18
the licence related immediately before that commencement.
19
(3)
Subitem (2) is subject to section 38B of the Therapeutic Goods Act
20
1989 (about splitting multi-site licences).
21
(4)
If section 38B of the Therapeutic Goods Act 1989 does not apply in
22
relation to the licence, that Act applies in relation to the licence on and
23
after the commencement of this item as if:
24
(a) the licence authorised the holder of the licence, at the
25
manufacturing site constituted by the manufacturing premises
26
to which the licence related immediately before that
27
commencement, to carry out the steps in the manufacture of
28
therapeutic goods that the licence allowed the holder to carry
29
out immediately before that commencement; and
30
(b) that authorisation were an authorisation referred to in
31
subsection 38(2B) of that Act.
32
(5)
Subitem (4) does not prevent the variation of that authorisation under
33
section 40A or 40B of the Therapeutic Goods Act 1989.
34
Schedule 2 Manufacturing licences
18 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
Note:
A contravention of that authorisation may lead to the licence being revoked or
1
suspended: see paragraph 41(1)(ea) of the Therapeutic Goods Act 1989.
2
3
Monitoring powers Schedule 3
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 19
1
Schedule 3
--
Monitoring powers
2
3
Therapeutic Goods Act 1989
4
1 Subsection 28(5)
5
After "the registration or listing of therapeutic goods", insert "(the
6
subject goods)".
7
2 Subsection 28(5)
8
After "person in relation to whom the", insert "subject".
9
3 Subparagraph 28(5)(a)(i)
10
After "deals with the", insert "subject".
11
4 Subparagraph 28(5)(a)(ii)
12
Repeal the subparagraph, substitute:
13
(ii) while on those premises, to inspect those premises and
14
any therapeutic goods on those premises and to
15
examine, take measurements of, conduct tests on or take
16
samples of any therapeutic goods on those premises or
17
any thing on those premises that relates to any
18
therapeutic goods; and
19
(iii) while on those premises, to make any still or moving
20
image or any recording of those premises or any thing
21
on those premises; and
22
5 Paragraph 28(5)(b)
23
After "relating to the", insert "subject".
24
6 Paragraph 28(5)(c)
25
After "each batch of the", insert "subject".
26
7 Paragraph 28(5)(e)
27
After "in relation to the", insert "subject".
28
8 Paragraph 28(5)(f)
29
After "not nominated as a manufacturer of the", insert "subject".
30
Schedule 3 Monitoring powers
20 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
9 Paragraph 28(5)(g)
1
After "not nominated as premises to be used in the manufacture of the",
2
insert "subject".
3
10 Subparagraphs 41EJ(1)(a)(ii) and (iii)
4
Repeal the subparagraphs, substitute:
5
(ii) while on those premises, to inspect those premises and
6
medical devices of any kind on those premises and to
7
examine, take measurements of, conduct tests on,
8
require tests to be conducted on or take samples of
9
medical devices of any kind on those premises or any
10
thing on those premises that relates to medical devices
11
of any kind; and
12
(iii) while on those premises, to make any still or moving
13
image or any recording of those premises or any thing
14
on those premises; and
15
11 Subparagraph 41EJ(1)(b)(i)
16
Omit "that kind", substitute "a kind covered by the certificate".
17
12 Subparagraph 41FN(1)(a)(ii)
18
Repeal the subparagraph, substitute:
19
(ii) while on those premises, to inspect those premises and
20
medical devices of any kind on those premises and to
21
examine, take measurements of, conduct tests on,
22
require tests to be conducted on or take samples of
23
medical devices of any kind on those premises or any
24
thing on those premises that relates to medical devices
25
of any kind; and
26
(iii) while on those premises, to make any still or moving
27
image or any recording of those premises or any thing
28
on those premises; and
29
13 Paragraph 41FN(1)(b)
30
Omit "that kind", substitute "the kind included in the Register".
31
14 Paragraphs 46A(1)(b) and (c)
32
Repeal the paragraphs, substitute:
33
Monitoring powers Schedule 3
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 21
(b) inspect, examine, take measurements of, conduct tests on or
1
take samples of any therapeutic goods on the premises or any
2
thing on the premises that relates to any therapeutic goods;
3
(c) make any still or moving image or any recording of the
4
premises or any thing on the premises;
5
15 Paragraphs 48(1)(b) and (c)
6
Repeal the paragraphs, substitute:
7
(b) to inspect, examine, take measurements of, conduct tests on
8
or take samples of any therapeutic goods on the premises or
9
any thing on the premises that relates to any therapeutic
10
goods;
11
(c) to make any still or moving image or any recording of the
12
premises or any thing on the premises;
13
16 Application
14
(1)
The amendments made by items 1 to 9 apply in relation to the
15
registration or listing of therapeutic goods before, on or after the
16
commencement of those items.
17
(2)
The amendments made by items 10 and 11 apply in relation to
18
conformity assessment certificates issued before, on or after the
19
commencement of those items.
20
(3)
The amendments made by items 12 and 13 apply in relation to the
21
inclusion of a kind of medical device in the Register before, on or after
22
the commencement of those items.
23
24
Schedule 4 Ho moeopathic and anthroposophic preparations
22 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
1
Schedule 4
--
Homoeopathic and
2
anthroposophic preparations
3
4
Therapeutic Goods Act 1989
5
1 Subsection 3(1)
6
Insert:
7
anthroposophic pharmacopoeia means:
8
(a) a publication specified under paragraph 3AB(3)(a), as that
9
publication is in force from time to time; or
10
(b) a part of a publication specified under paragraph 3AB(3)(b),
11
as that part is in force from time to time.
12
2 Subsection 3(1)
13
Insert:
14
anthroposophic preparation has the meaning given by subsection
15
3AB(1).
16
3 Subsection 3(1)
17
Insert:
18
anthroposophic standard has the meaning given by subsection
19
3AB(2).
20
4 Subsection 3(1)
21
Insert:
22
homoeopathic pharmacopoeia means:
23
(a) a publication specified under paragraph 3AA(3)(a), as that
24
publication is in force from time to time; or
25
(b) a part of a publication specified under paragraph 3AA(3)(b),
26
as that part is in force from time to time.
27
5 Subsection 3(1)
28
Insert:
29
Ho moeopathic and anthroposophic preparations Schedule 4
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 23
homoeopathic preparation has the meaning given by subsection
1
3AA(1).
2
6 Subsection 3(1)
3
Insert:
4
homoeopathic standard has the meaning given by subsection
5
3AA(2).
6
7 Subsection 3(1)
7
Insert:
8
mother substance means any of the following:
9
(a) an animal;
10
(b) a plant;
11
(c) an alga;
12
(d) a fungus;
13
(e) a micro-organism;
14
(f) a mineral;
15
(g) a mineral compound;
16
(h) a chemical;
17
(i) a product obtained from any of the things mentioned in
18
paragraphs (a) to (h).
19
8 Subsection 3(1) (at the end of the definition of standard)
20
(before the note)
21
Add:
22
; (e) a homoeopathic standard;
23
(f) an anthroposophic standard.
24
9 After section 3
25
Insert:
26
3AA Homoeopathic preparations and homoeopathic standards
27
Homoeopathic preparation
28
(1) For the purposes of this Act, a homoeopathic preparation is a
29
preparation:
30
Schedule 4 Ho moeopathic and anthroposophic preparations
24 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
(a) manufactured from a mother substance; and
1
(b) manufactured in accordance with a manufacturing procedure
2
described in a homoeopathic pharmacopoeia.
3
Homoeopathic standard
4
(2) For the purposes of this Act, if:
5
(a) there are therapeutic goods that are a homoeopathic
6
preparation; and
7
(b) the goods are the subject of one or more monographs (other
8
than a monograph exempt under subsection (4)) in the
9
homoeopathic pharmacopoeia describing the manufacturing
10
procedure that the preparation was manufactured in
11
accordance with;
12
then there is a homoeopathic standard, in relation to the goods,
13
that is constituted by the statements (other than statements exempt
14
under subsection (5)) in those monographs, as interpreted in
15
accordance with any interpretation sections of that homoeopathic
16
pharmacopoeia.
17
Specifying publications
18
(3) The Minister may, by legislative instrument, specify either or both
19
of the following for the purposes of the definition of homoeopathic
20
pharmacopoeia in subsection 3(1):
21
(a) publications;
22
(b) parts of publications.
23
Exempting entire monographs
24
(4) The Minister may, by legislative instrument, determine that
25
specified monographs in a specified homoeopathic pharmacopoeia
26
are exempt for the purposes of paragraph (2)(b).
27
Note:
For specification by class, see subsection 13(3) of the Legislative
28
Instruments Act 2003.
29
Exempting parts of monographs
30
(5) The Minister may, by legislative instrument, determine that
31
specified statements in specified monographs in a specified
32
homoeopathic pharmacopoeia are exempt for the purposes of
33
subsection (2).
34
Ho moeopathic and anthroposophic preparations Schedule 4
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 25
3AB Anthroposophic pre parations and anthroposophic standards
1
Anthroposophic preparation
2
(1) For the purposes of this Act, an anthroposophic preparation is a
3
preparation:
4
(a) manufactured from a mother substance; and
5
(b) manufactured in accordance with a manufacturing procedure
6
described in an anthroposophic pharmacopoeia.
7
Anthroposophic standard
8
(2) For the purposes of this Act, if:
9
(a) there are therapeutic goods that are an anthroposophic
10
preparation; and
11
(b) the goods are the subject of one or more monographs (other
12
than a monograph exempt under subsection (4)) in the
13
anthroposophic pharmacopoeia describing the manufacturing
14
procedure that the preparation was manufactured in
15
accordance with;
16
then there is an anthroposophic standard, in relation to the goods,
17
that is constituted by the statements (other than statements exempt
18
under subsection (5)) in those monographs, as interpreted in
19
accordance with any interpretation sections of that anthroposophic
20
pharmacopoeia.
21
Specifying publications
22
(3) The Minister may, by legislative instrument, specify either or both
23
of the following for the purposes of the definition of
24
anthroposophic pharmacopoeia in subsection 3(1):
25
(a) publications;
26
(b) parts of publications.
27
Exempting entire monographs
28
(4) The Minister may, by legislative instrument, determine that
29
specified monographs in a specified anthroposophic
30
pharmacopoeia are exempt for the purposes of paragraph (2)(b).
31
Note:
For specification by class, see subsection 13(3) of the Legislative
32
Instruments Act 2003.
33
Schedule 4 Ho moeopathic and anthroposophic preparations
26 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
Exempting parts of monographs
1
(5) The Minister may, by legislative instrument, determine that
2
specified statements in specified monographs in a specified
3
anthroposophic pharmacopoeia are exempt for the purposes of
4
subsection (2).
5
10 Subsection 10(1)
6
Omit "or the United States Pharmacopeia-National Formulary",
7
substitute ", the United States Pharmacopeia-National Formulary, a
8
homoeopathic pharmacopoeia or an anthroposophic pharmacopoeia".
9
11 Subparagraph 10(2)(a)(iv)
10
Omit "or the United States Pharmacopeia-National Formulary",
11
substitute ", the United States Pharmacopeia-National Formulary, a
12
homoeopathic pharmacopoeia or an anthroposophic pharmacopoeia".
13
12 After section 13
14
Insert:
15
13A Special provisions relating to homoeopathic standards and
16
anthroposophic standards
17
(1) For the purposes of this Act, if a statement (the main statement) in
18
a monograph in a homoeopathic pharmacopoeia or an
19
anthroposophic pharmacopoeia refers to a statement in a
20
monograph in another publication, the main statement is taken to
21
include the other statement.
22
(2) If:
23
(a) a standard under section 10 (the Ministerial standard)
24
applies to therapeutic goods; and
25
(b) requirements applicable to the goods are specified in a
26
homoeopathic standard or an anthroposophic standard; and
27
(c) those requirements are inconsistent with the requirements
28
specified in the Ministerial standard;
29
the requirements referred to in paragraph (b) are, so far as they are
30
inconsistent, to be disregarded for the purposes of this Act.
31
Note:
The heading to section 13 is altered by omitting "standards" and substituting
32
"Ministerial standards and default standards".
33
Ho moeopathic and anthroposophic preparations Schedule 4
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 27
13 Section 56
1
Omit "and the United States Pharmacopeia-National Formulary",
2
substitute ", the United States Pharmacopeia-National Formulary, a
3
homoeopathic pharmacopoeia and an anthroposophic pharmacopoeia".
4
5
Schedule 5 Ingredients in therapeutic goods
28 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
1
Schedule 5
--
Ingredients in therapeutic goods
2
3
Therapeutic Goods Act 1989
4
1 After paragraph 26(1)(e)
5
Insert:
6
(ea) the goods contain a component or ingredient that is specified
7
in a determination under subsection 26BE(1) that applies in
8
relation to the goods; or
9
(eb) the goods contain a component or ingredient:
10
(i) that is specified in a determination under subsection
11
26BE(2) that applies in relation to the goods; and
12
(ii) that exceeds the permitted concentration of that
13
component or ingredient, or exceeds the permitted total
14
amount of that component or ingredient, that is
15
specified in that determination; or
16
2 After paragraph 26A(2)(c)
17
Insert:
18
(ca) if a determination under section 26BB applies in relation to
19
the medicine--the only active ingredients the medicine
20
contains are active ingredients specified in that determination
21
in relation to the medicine; and
22
(cb) if:
23
(i) the medicine contains an active ingredient that is
24
specified in a determination under section 26BB that
25
applies in relation to the medicine; and
26
(ii) that determination specifies a permitted concentration of
27
the active ingredient or a permitted total amount of the
28
active ingredient;
29
the active ingredient does not exceed that permitted
30
concentration or that permitted total amount; and
31
(cc) if a determination under subsection 26BE(1) applies in
32
relation to the medicine--the medicine does not contain a
33
component or ingredient specified in that determination in
34
relation to the medicine; and
35
(cd) if the medicine contains a component or ingredient that is
36
specified in a determination under subsection 26BE(2) that
37
Ingredients in therapeutic goods Schedule 5
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 29
applies in relation to the medicine--the component or
1
ingredient does not exceed the permitted concentration of
2
that component or ingredient, or the permitted total amount
3
of that component or ingredient, that is specified in that
4
determination; and
5
3 After section 26BA
6
Insert:
7
26BB Permissible active ingredients
8
(1) The Minister may, by legislative instrument, make a determination
9
specifying:
10
(a) active ingredients in relation to medicine; and
11
(b) either or both of the following:
12
(i) permitted concentrations of some or all of those
13
ingredients;
14
(ii) permitted total amounts of some or all of those
15
ingredients.
16
Note:
Under section 26A, a person seeking the listing of medicine must
17
certify that the only active ingredients the medicine contains are active
18
ingredients specified in such a determination. If relevant, the person
19
must also certify that an active ingredient does not exceed the
20
permitted concentration of the ingredient or the permitted total amount
21
of the ingredient.
22
Scope of determination
23
(2) A determination under this section may make different provision
24
for different classes of medicine.
25
Incorporation of instruments
26
(3) Despite subsection 14(2) of the Legislative Instruments Act 2003, a
27
determination under this section may make provision in relation to
28
a matter by applying, adopting or incorporating any matter
29
contained in an instrument or other writing as in force or existing
30
from time to time.
31
26BC Variation of list of active ingredients--Minister's initiative
32
The Minister may, on his or her own initiative and by legislative
33
instrument, vary a determination under section 26BB.
34
Schedule 5 Ingredients in therapeutic goods
30 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
26BD Variation of list of active ingredients--application by person
1
(1) A person may apply to the Minister for a variation of a
2
determination under section 26BB.
3
(2) An application under subsection (1) must:
4
(a) be made in accordance with a form approved by the
5
Secretary; and
6
(b) set out the variation sought; and
7
(c) be delivered to an office of the Department specified in the
8
form; and
9
(d) be accompanied by the prescribed application fee.
10
(3) If an application is made under subsection (1) and any applicable
11
prescribed evaluation fee has been paid, the Minister may, by
12
legislative instrument, vary the determination.
13
Further information
14
(4) The Minister may, by notice in writing given to the person, require
15
the person to give to the Minister, within such reasonable time as is
16
specified in the notice, such further information concerning the
17
application as is specified in the notice.
18
Applications or information may be given electronically
19
(5) An approval of a form mentioned in paragraph (2)(a), or a notice
20
mentioned in subsection (4), may require or permit an application
21
or information to be given in accordance with specified software
22
requirements:
23
(a) on a specified kind of data processing device; or
24
(b) by way of a specified kind of electronic transmission.
25
26BE Prohibited or limited components or ingredients
26
Prohibited components or ingredients
27
(1) The Minister may, by legislative instrument, make a determination
28
specifying either or both of the following in relation to therapeutic
29
goods:
30
(a) components;
31
(b) ingredients.
32
Ingredients in therapeutic goods Schedule 5
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 31
Note 1:
Under section 26, the Secretary may refuse to list therapeutic goods if
1
the goods contain a component or ingredient specified in such a
2
determination.
3
Note 2:
Under section 26A, a person seeking the listing of medicine must
4
certify that the medicine does not contain a component or ingredient
5
specified in such a determination.
6
Limited components or ingredients
7
(2) The Minister may, by legislative instrument, make a determination
8
specifying either or both of the following in relation to therapeutic
9
goods:
10
(a) components and either or both of the following:
11
(i) permitted concentrations of those components;
12
(ii) permitted total amounts of those components;
13
(b) ingredients and either or both of the following:
14
(i) permitted concentrations of those ingredients;
15
(ii) permitted total amounts of those ingredients.
16
Note 1:
Under section 26, the Secretary may refuse to list therapeutic goods if
17
the goods contain a component or ingredient that exceeds the
18
permitted concentration of that component or ingredient or exceeds
19
the permitted total amount of that component or ingredient.
20
Note 2:
Under section 26A, a person seeking the listing of medicine must
21
certify that the medicine does not contain a component or ingredient
22
that exceeds the permitted concentration of that component or
23
ingredient or exceeds the permitted total amount of that component or
24
ingredient.
25
Scope of determination
26
(3) A determination under this section may make different provision
27
for different classes of therapeutic goods.
28
Incorporation of instruments
29
(4) Despite subsection 14(2) of the Legislative Instruments Act 2003, a
30
determination under this section may make provision in relation to
31
a matter by applying, adopting or incorporating any matter
32
contained in an instrument or other writing as in force or existing
33
from time to time.
34
Schedule 5 Ingredients in therapeutic goods
32 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
Variation
1
(5) The Minister may, by legislative instrument, vary a determination
2
under subsection (1) or (2).
3
4 Paragraph 30(1)(e)
4
After "26A(2)(a),", insert "(ca), (cb), (cc), (cd),".
5
5 Application
6
The amendments made by items 1 and 2 apply in relation to
7
applications for listings made on or after the commencement of those
8
items.
9
10
Amend ments relating to legislative instruments Schedule 6
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 33
1
Schedule 6
--
Amendments relating to
2
legislative instruments
3
4
Therapeutic Goods Act 1989
5
1 Subsection 10(1)
6
Omit "by order published in the Gazette, determine", substitute "by
7
legislative instrument, make an order determining".
8
2 At the end of subsection 10(1)
9
Add:
10
Note:
Section 12 of the Legislative Instruments Act 2003 deals with when a
11
legislative instrument takes effect.
12
3 After subsection 10(3)
13
Insert:
14
(3A) The Minister may, by legislative instrument, vary or revoke an
15
order made under subsection (1).
16
Note:
Section 12 of the Legislative Instruments Act 2003 deals with when a
17
legislative instrument takes effect.
18
4 Subsection 10(4)
19
Omit "The Minister must not determine a standard or amend or revoke a
20
standard", substitute "The Minister must not make an order under
21
subsection (1), or vary or revoke an order made under subsection (1),".
22
5 Sections 11 and 12
23
Repeal the sections.
24
6 Subsection 19A(5)
25
Omit "disallowable instruments for the purposes of section 46A of the
26
Acts Interpretation Act 1901", substitute "legislative instruments".
27
7 Subsection 36(4)
28
Omit "disallowable instruments for the purposes of section 46A of the
29
Acts Interpretation Act 1901", substitute "legislative instruments".
30
Schedule 6 A mendments relating to legislative instruments
34 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
8 Subsection 41CB(1)
1
Omit "by order published in the Gazette, determine", substitute "by
2
legislative instrument, make an order determining".
3
9 At the end of subsection 41CB(1)
4
Add:
5
Note:
Section 12 of the Legislative Instruments Act 2003 deals with when a
6
legislative instrument takes effect.
7
10 Subsections 41CB(2) and (3)
8
Repeal the subsections, substitute:
9
(2) The Minister may, by legislative instrument, vary or revoke an
10
order made under subsection (1).
11
11 Subsection 41DC(1)
12
Omit "by order published in the Gazette, determine", substitute "by
13
legislative instrument, make an order determining".
14
12 At the end of subsection 41DC(1)
15
Add:
16
Note:
Section 12 of the Legislative Instruments Act 2003 deals with when a
17
legislative instrument takes effect.
18
13 Subsections 41DC(3) and (4)
19
Repeal the subsections, substitute:
20
(3) The Minister may, by legislative instrument, vary or revoke an
21
order made under subsection (1).
22
14 Saving and transitional
23
Standards
24
(1)
The amendment made by item 1 does not affect the validity of an order
25
made under section 10 of the Therapeutic Goods Act 1989 before the
26
commencement of this item.
27
(2)
The repeal of section 11 of the Therapeutic Goods Act 1989 by this
28
Schedule does not apply to an order made under section 10 of that Act
29
before the commencement of this item.
30
Amend ments relating to legislative instruments Schedule 6
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 35
Medical device standards
1
(3)
The amendment made by item 8 does not affect the validity of an order
2
made under section 41CB of the Therapeutic Goods Act 1989 before the
3
commencement of this item.
4
(4)
Subsection 41CB(2) of the Therapeutic Goods Act 1989, as in force
5
immediately before the commencement of this item, continues to apply
6
on and after that commencement in relation to an order made under
7
section 41CB of that Act before that commencement.
8
Conformity assessment standards
9
(5)
The amendment made by item 11 does not affect the validity of an order
10
made under section 41DC of the Therapeutic Goods Act 1989 before
11
the commencement of this item.
12
(6)
Subsection 41DC(3) of the Therapeutic Goods Act 1989, as in force
13
immediately before the commencement of this item, continues to apply
14
on and after that commencement in relation to an order made under
15
section 41DC of that Act before that commencement.
16
17
Schedule 7 Other amendments
Part 1 A mend ments commencing on the day after Royal Assent
36 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
1
Schedule 7
--
Other amendments
2
Part 1
--
Amendments commencing on the day after
3
Royal Assent
4
Therapeutic Goods Act 1989
5
1 Subsection 3(1) (definition of accessory)
6
Repeal the definition, substitute:
7
accessory, in relation to a medical device covered by paragraph
8
41BD(1)(a), (aa) or (ab), means a thing that the manufacturer of
9
the thing specifically intended to be used together with the device
10
to enable the device to be used as the manufacturer of the device
11
intended.
12
2 Subsection 3(1) (paragraph (b) of the definition of listable
13
goods)
14
Omit "subsection 17(5)", substitute "subsection 9A(5)".
15
3 After section 7B
16
Insert:
17
7C Secretary may arrange for use of computer programs to make
18
decisions
19
(1) The Secretary may arrange for the use, under the Secretary's
20
control, of computer programs for any purposes for which the
21
Secretary may make decisions under this Act or the regulations.
22
(2) A decision made by the operation of a computer program under
23
such an arrangement is taken to be a decision made by the
24
Secretary.
25
(3) The Secretary may substitute a decision (the substituted decision)
26
for a decision (the initial decision) made by the operation of a
27
computer program under such an arrangement if the Secretary is
28
satisfied that the initial decision is incorrect.
29
Other amend ments Schedule 7
Amend ments commencing on the day after Royal Assent Part 1
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 37
(4) However, the substituted decision may only be made before the
1
end of the period of 60 days beginning on the day the initial
2
decision is made.
3
4 Subsection 24D(5)
4
After "subsection 25(3)", insert "or (4)".
5
5 Paragraph 26A(1)(c)
6
Omit "subsection (3)", substitute "subsections (2A), (3) and (4A)".
7
6 Paragraph 26A(2)(e)
8
Omit "granted under section 38".
9
7 Paragraph 26A(2)(f)
10
After "criteria", insert "that are applicable to the medicine".
11
8 After paragraph 26A(2)(f)
12
Insert:
13
(fa) the medicine's specifications comply with any requirements
14
that are prescribed by the regulations for the purposes of this
15
paragraph and that are applicable to the medicine; and
16
(fb) the medicine's label:
17
(i) complies with any requirements that are prescribed by
18
the regulations for the purposes of this subparagraph
19
and that are applicable to the medicine; and
20
(ii) does not make a claim that is inconsistent with any
21
claim made by the applicant in relation to the medicine
22
in, or in connection with, the application; and
23
(fc) the applicant holds information or evidence showing the
24
medicine's specifications will be maintained under the
25
conditions set out on the medicine's label until the
26
medicine's expiry date; and
27
9 After subsection 26A(2)
28
Insert:
29
(2A) The applicant must also certify any other matters prescribed by the
30
regulations for the purposes of this subsection.
31
10 After subsection 26A(4)
32
Schedule 7 Other amendments
Part 1 A mend ments commencing on the day after Royal Assent
38 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
Insert:
1
(4A) If the medicine includes any ingredient of animal origin, the
2
Secretary must have certified, prior to the application being made,
3
that he or she is satisfied of the safety of the ingredient.
4
11 Paragraph 30(1)(e)
5
After "subsection 26A(3)", insert "or (4A)".
6
12 Paragraph 30(2)(ba)
7
After "(f),", insert "(fa), (fb), (fc),".
8
13 Paragraph 30(2)(ba)
9
After "(k)", insert "or subsection 26A(2A)".
10
14 After section 30
11
Insert:
12
30A Revocation of cancellation of registration or listing upon
13
request
14
(1) If:
15
(a) the Secretary cancels the registration or listing of therapeutic
16
goods because of the request of a person made under
17
paragraph 30(1)(c); and
18
(b) before the end of the period of 90 days beginning on the day
19
the goods ceased to be registered or listed, the person
20
requests, in writing, the Secretary to revoke the cancellation;
21
and
22
(c) the request is accompanied by the prescribed application fee;
23
the Secretary may, by notice in writing given to the person, revoke
24
the cancellation.
25
(2) If the cancellation is revoked, the cancellation is taken never to
26
have occurred.
27
15 Subsection 30EA(1) (table item 5)
28
Omit ", 42E(1) or 42EA(1)", substitute "or 42E(1) or section 42EA".
29
16 Subparagraph 41BD(1)(a)(ii)
30
Other amend ments Schedule 7
Amend ments commencing on the day after Royal Assent Part 1
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 39
Omit "handicap", substitute "disability".
1
17 After paragraph 41BD(1)(a)
2
Insert:
3
(aa) any instrument, apparatus, appliance, material or other article
4
specified under subsection (2A); or
5
(ab) any instrument, apparatus, appliance, material or other article
6
that is included in a class of instruments, apparatus,
7
appliances, materials or other articles specified under
8
subsection (2B); or
9
18 Paragraph 41BD(1)(b)
10
Omit "such".
11
19 At the end of paragraph 41BD(1)(b)
12
Add "covered by paragraph (a), (aa) or (ab)".
13
20 Subsection 41BD(2)
14
Repeal the subsection, substitute:
15
(2) For the purposes of paragraph (1)(a), the purpose for which an
16
instrument, apparatus, appliance, material or other article (the main
17
equipment) is to be used is to be ascertained from the information
18
supplied, by the person under whose name the main equipment is
19
or is to be supplied, on or in any one or more of the following:
20
(a) the labelling on the main equipment;
21
(b) the instructions for using the main equipment;
22
(c) any advertising material relating to the main equipment;
23
(d) technical documentation describing the mechanism of action
24
of the main equipment.
25
21 After subsection 41BD(2)
26
Insert:
27
(2A) The Secretary may, by notice published in the Gazette, specify a
28
particular instrument, apparatus, appliance, material or other article
29
for the purposes of paragraph (1)(aa). The notice is not a legislative
30
instrument.
31
Schedule 7 Other amendments
Part 1 A mend ments commencing on the day after Royal Assent
40 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
(2B) The Secretary may, by legislative instrument, specify a particular
1
class of instruments, apparatus, appliances, materials or other
2
articles for the purposes of paragraph (1)(ab).
3
22 Subsection 41BE(3)
4
Repeal the subsection, substitute:
5
Device nomenclature codes
6
(3) The Minister may, by legislative instrument, determine device
7
nomenclature codes for medical devices.
8
23 At the end of paragraphs 41BG(2)(f) and (3)(c)
9
Add:
10
; (iv) technical documentation describing the mechanism of
11
action of the device.
12
24 At the end of section 41BG
13
Add:
14
(4) A person is not the manufacturer of a medical device if the person
15
is included in a class of persons prescribed by the regulations for
16
the purposes of this subsection.
17
25 Subsection 60(1) (after paragraph (a) of the definition of
18
initial decision)
19
Insert:
20
(aa) under subsection 7C(3); or
21
26 Application
--
listings of medicines
22
The amendments made by items 5 to 10 apply in relation to applications
23
for listings of medicines made on or after the commencement of those
24
items.
25
27 Application
--
revocation of cancellation of registration or
26
listing upon request
27
The amendment made by item 14 applies in relation to cancellations
28
occurring before, on or after the commencement of that item.
29
28 Saving
--
device nomenclature codes
30
Other amend ments Schedule 7
Amend ments commencing on the day after Royal Assent Part 1
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 41
Despite the amendment made by item 22, regulations in force for the
1
purposes of subsection 41BE(3) of the Therapeutic Goods Act 1989
2
immediately before the commencement of this item continue in force,
3
after that commencement, until the first determination made under that
4
subsection (as inserted by this Act) takes effect.
5
6
Schedule 7 Other amendments
Part 2 A mend ments commencing on a day to be fixed by Proclamation
42 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
1
Part 2
--
Amendments commencing on a day to be
2
fixed by Proclamation
3
Therapeutic Goods Act 1989
4
29 Subsection 3(1) (definition of Therapeutic Goods
5
Advertising Code)
6
Repeal the definition, substitute:
7
Therapeutic Goods Advertising Code means the code in force
8
under section 42BAA.
9
30 Subsections 28(1) and (2)
10
Repeal the subsections, substitute:
11
(1) The registration or listing of therapeutic goods is subject to the
12
conditions set out in a determination under subsection (2).
13
(2) The Minister may, by legislative instrument, make a determination
14
setting out conditions for the purposes of subsection (1), being
15
conditions that relate to:
16
(a) the manufacture of the goods; or
17
(b) the custody, use, supply, disposal or destruction of the goods;
18
or
19
(c) the keeping of records relating to the goods; or
20
(d) matters dealt with in, or matters additional to matters dealt
21
with in, standards applicable to the goods; or
22
(e) such other matters relating to the goods as the Minister thinks
23
appropriate.
24
(2A) Without limiting subsection (2), different conditions may be
25
specified for:
26
(a) the registration of therapeutic goods; and
27
(b) the listing of therapeutic goods; and
28
(c) different classes of therapeutic goods.
29
(2B) If the Secretary includes therapeutic goods in the Register in
30
relation to a person, the Secretary may, by notice in writing given
31
Other amend ments Schedule 7
Amend ments commencing on a day to be fixed by Proclamation Part 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 43
to the person, impose conditions on the registration or listing of
1
those goods.
2
31 Subsection 28(3)
3
Omit "existing conditions", substitute "conditions imposed under
4
subsection (2B) or this subsection".
5
32 Subsection 28(4)
6
After "variation", insert "or removal".
7
33 Subsection 28(5)
8
After "subsection (1)", insert ", (2B)".
9
34 Before paragraph 28(5)(a)
10
Insert:
11
(aa) not supply a batch of the subject goods in Australia, or export
12
a batch of the subject goods from Australia, after the expiry
13
date for the goods; and
14
(ab) not, by any means, advertise the subject goods for an
15
indication other than those accepted in relation to the
16
inclusion of the goods in the Register; and
17
35 Subsection 28(5A)
18
After "subsection (1),", insert "(2B),".
19
36 After subsection 28(5A)
20
Insert:
21
(5B) The listing of a medicine under section 26A is subject to a
22
condition that:
23
(a) each step in the manufacture of the medicine that is carried
24
out in Australia is carried out by a person who is the holder
25
of a licence to carry out that step or who is exempt from the
26
operation of Part 3-3 in relation to that step; and
27
(b) each step in the manufacture of the medicine that is carried
28
out outside Australia is the subject of a certification in force
29
under subsection 26A(3) or 28A(2).
30
(5C) Subsection (5B) does not apply if the medicine is exempt from the
31
operation of Part 3-3.
32
Schedule 7 Other amendments
Part 2 A mend ments commencing on a day to be fixed by Proclamation
44 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
37 After section 28
1
Insert:
2
28A Certification of manufacturing steps outside Australia following
3
application for listing
4
(1) The person in relation to whom medicine is listed under
5
section 26A may apply to the Secretary for a certification under
6
this section of a step in the manufacture of the medicine that is to
7
be carried out outside Australia.
8
Note:
The listing of medicine is subject to the condition that each step in the
9
manufacture of the medicine that is carried out outside Australia is the
10
subject of a certification in force under subsection 26A(3) or
11
subsection (2) of this section: see subsection 28(5B).
12
(2) If an application is made to the Secretary under this section, the
13
Secretary may, by writing, certify that the manufacturing and
14
quality control procedures used in that step are acceptable. The
15
Secretary must give the person written notice of the certification.
16
(3) In deciding whether to give the certification, subsection 26A(4)
17
applies in a way corresponding to the way in which it applies for
18
the purposes of subsection 26A(3).
19
38 After paragraph 41JA(1)(b)
20
Insert:
21
(ba) who held, at any time during the notice period under
22
subsection (2), a conformity assessment certificate that
23
related to a kind of medical device; or
24
39 Paragraph 41JA(1)(d)
25
Omit ", or was at any time during the notice period under
26
subsection (2),".
27
40 After paragraph 41JA(1)(d)
28
Insert:
29
or (da) in relation to whom a kind of medical device was, at any time
30
during the notice period under subsection (2), included in the
31
Register;
32
41 After paragraph 41JA(1)(i)
33
Other amend ments Schedule 7
Amend ments commencing on a day to be fixed by Proclamation Part 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 45
Insert:
1
(ia) the safety and efficacy of the devices for the purposes for
2
which they are to be used;
3
(ib) the regulatory history of the devices in another country;
4
42 After subsection 41JA(1)
5
Insert:
6
(1AA) If a notice is given under subsection (1) to a person covered by
7
paragraph (1)(ba), then paragraphs (1)(e) to (j) (to the extent to
8
which they are relevant) apply in relation to the period the person
9
held the certificate.
10
(1AB) If a notice is given under subsection (1) to a person covered by
11
paragraph (1)(da), then paragraphs (1)(e) to (j) (to the extent to
12
which they are relevant) apply in relation to the period the kind of
13
medical device was included in the Register.
14
43 Subsection 41JA(2)
15
Omit "paragraph (1)(d)", substitute "paragraphs (1)(ba) and (da)".
16
44 Paragraph 42AA(1)(a)
17
Omit "veterinary surgeons,".
18
45 Paragraph 42AA(1)(a)
19
After "pharmacists,", insert "optometrists, chiropractors,".
20
46 Paragraph 42AA(1)(a)
21
Omit "dietitians, scientists working in medical laboratories or nurses",
22
substitute "nurses, midwives, dental hygienists, dental prosthetists,
23
dental therapists or osteopaths".
24
47 Paragraph 42AA(1)(c)
25
Omit "chiropractors,".
26
48 Paragraph 42AA(1)(c)
27
Omit ", podiatrists or osteopaths", substitute "or podiatrists".
28
49 At the end of subsection 42AA(1)
29
Add:
30
Schedule 7 Other amendments
Part 2 A mend ments commencing on a day to be fixed by Proclamation
46 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
; or (d) a class of persons specified under subsection (1A).
1
50 After subsection 42AA(1)
2
Insert:
3
(1A) The Minister may, by legislative instrument, specify a class of
4
persons for the purposes of paragraph (1)(d).
5
51 At the end of Division 1 of Part 5-1
6
Add:
7
42BAA The rapeutic Goods Adve rtising Code
8
The Minister may, by legislative instrument, make a code relating
9
to advertisements about therapeutic goods.
10
52 Section 42DD
11
Omit "a serious form of a disease, condition, ailment or defect specified
12
in a part of the Therapeutic Goods Advertising Code that is prescribed
13
by the regulations for the purposes of this section", substitute "a form of
14
a disease, condition, ailment or defect identified in a part of the
15
Therapeutic Goods Advertising Code as a serious form of a disease,
16
condition, ailment or defect".
17
53 Paragraph 42DF(4)(b)
18
Repeal the paragraph, substitute:
19
(b) any advice of a committee that is established under the
20
regulations and is prescribed by the regulations for the
21
purposes of this paragraph; and
22
54 Paragraph 42DF(4)(c)
23
Omit "a part of the Therapeutic Goods Advertising Code that is
24
prescribed by the regulations made for the purposes of this paragraph",
25
substitute "the part of the Therapeutic Goods Advertising Code dealing
26
with restricted representations".
27
55 Part 6-4
28
Repeal the Part.
29
56 Saving
--
Therapeutic Goods Advertising Code
30
Other amend ments Schedule 7
Amend ments commencing on a day to be fixed by Proclamation Part 2
Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009 47
(1)
Despite the amendment made by item 29, the Therapeutic Goods
1
Advertising Code as in force immediately before the commencement of
2
this item continues in force, after that commencement, until the first
3
instrument made under section 42BAA of the Therapeutic Goods Act
4
1989, as inserted by this Act, takes effect.
5
(2)
Despite the amendment made by item 52, regulations in force for the
6
purposes of section 42DD of the Therapeutic Goods Act 1989
7
immediately before the commencement of this item continue in force,
8
after that commencement, until the first instrument made under
9
section 42BAA of the Therapeutic Goods Act 1989, as inserted by this
10
Act, takes effect.
11
(3)
Despite the amendment made by item 54, regulations in force for the
12
purposes of paragraph 42DF(4)(c) of the Therapeutic Goods Act 1989
13
immediately before the commencement of this item continue in force,
14
after that commencement, until the first instrument made under
15
section 42BAA of the Therapeutic Goods Act 1989, as inserted by this
16
Act, takes effect.
17
57 Application and transitional
--
registration or listing
18
conditions
19
(1)
Subsection 28(1) of the Therapeutic Goods Act 1989, as inserted by this
20
Act, applies in relation to the registration or listing of therapeutic goods
21
occurring before, on or after the commencement of this item.
22
(2)
Subsection 28(2B) of the Therapeutic Goods Act 1989, as inserted by
23
this Act, applies in relation to the registration or listing of therapeutic
24
goods occurring on or after the commencement of this item.
25
(3)
Conditions in force under subsection 28(1) of the Therapeutic Goods
26
Act 1989 immediately before the commencement of this item continue
27
in force, on and after that commencement, as if they had been imposed,
28
on that commencement, under subsection 28(2B) of the Therapeutic
29
Goods Act 1989.
30
(4)
Subitem (3) does not prevent the variation or removal of the conditions
31
under subsection 28(3) of the Therapeutic Goods Act 1989 on or after
32
the commencement of this item.
33
(5)
The amendment made by item 31 applies in relation to:
34
Schedule 7 Other amendments
Part 2 A mend ments commencing on a day to be fixed by Proclamation
48 Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 No. , 2009
(a) conditions imposed under subsection 28(2B) of the
1
Therapeutic Goods Act 1989 on or after the commencement
2
of that item (including because of subitem (3)); and
3
(b) conditions imposed under subsection 28(3) of the
4
Therapeutic Goods Act 1989 before, on or after the
5
commencement of that item.
6
(6)
The amendment made by item 34 applies in relation to the registration
7
or listing of therapeutic goods occurring before, on or after the
8
commencement of that item.
9
(7)
The amendment made by item 36 applies in relation to the listing of
10
medicine occurring before, on or after the commencement of that item.
11
(8)
This item does not affect the conditions to which the registration or
12
listing of therapeutic goods is subject before the commencement of this
13
item.
14
58 Application
--
information gathering
15
(1)
The amendments made by items 38 and 40 apply in relation to periods
16
beginning before, on or after the commencement of those items.
17
(2)
The amendment made by item 41 applies in relation to things occurring
18
before, on or after the commencement of that item.
19
(3)
Regulations in force for the purposes of subsection 41JA(2) of the
20
Therapeutic Goods Act 1989 immediately before the commencement of
21
this item continue in force for the purposes of that subsection on and
22
after that commencement.
23
59 Application
--
advertisements
24
The amendments made by items 44 to 50 apply in relation to
25
advertisements published or broadcast on or after the commencement of
26
those items.
27

 

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