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


THERAPEUTIC GOODS AMENDMENT (MEDICAL DEVICES AND OTHER MEASURES) BILL 2008

2008
The Parliament of the
Commonwealth of Australia
THE SENATE
Presented and read a first time
Therapeutic Goods Amendment
(Medical Devices and Other Measures)
Bill 2008
No. , 2008
(Health and Ageing)
A Bill for an Act to amend the Therapeutic Goods
Act 1989, and for related purposes
i Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No.
, 2008
Contents
1
Short title ............................................................................................ 1
2
Commencement .................................................................................. 1
3
Schedule(s) ......................................................................................... 2
Schedule 1--Medical devices
3
Therapeutic Goods Act 1989
3
Schedule 2--Eme rgency exemption for therapeutic goods that
are not me dical devices
16
Therapeutic Goods Act 1989
16
Schedule 3--Fit and proper person test
17
Therapeutic Goods Act 1989
17
Schedule 4--Additional default standards
26
Therapeutic Goods Act 1989
26
Schedule 5--Information disclosure provisions
33
Therapeutic Goods Act 1989
33
Schedule 6--Advertising
36
Therapeutic Goods Act 1989
36
Schedule 7--Other ame ndments
39
Therapeutic Goods Act 1989
39
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 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
5
(Medical Devices and Other Measures) Act 2008.
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 (Medical Devices and Other Measures) Bill 2008 No.
, 2008
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. Schedules 1
and 2
The day after this Act receives the Royal
Assent.
3. Schedule 3
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 4
1 Ju ly 2009.
1 Ju ly 2009
5. Schedules 5 to
7
The day after this Act receives the Royal
Assent.
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
(2) Column 3 of the table contains additional information that is not
4
part of this Act. Information in this column may be added to or
5
edited in any published version of this Act.
6
3 Schedule(s)
7
Each Act that is specified in a Schedule to this Act is amended or
8
repealed as set out in the applicable items in the Schedule
9
concerned, and any other item in a Schedule to this Act has effect
10
according to its terms.
11
12
Medical devices Schedule 1
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 3
1
Schedule 1
--
Medical devices
2
3
Therapeutic Goods Act 1989
4
1 After paragraph 41BB(c)
5
Insert:
6
(ca) exempting medical devices from various provisions of this
7
Chapter to deal with emergency situations; and
8
2 After Part 4-6
9
Insert:
10
Part 4-6A--Exempting medical devices to deal with
11
emergencies
12
13
41GR What this Part is about
14
The Minister may exempt certain medical devices from various
15
provisions of this Chapter so that the devices may be stockpiled to
16
deal with possible future emergencies or made available urgently
17
to deal with actual emergencies.
18
Note 1:
There are offences and civil penalty provisions related to the making
19
of exemptions under this Part: see Division 3A of Part 4-11.
20
Note 2:
Some of the other provisions of this Act about medical devices exempt
21
under this Part are:
22
(a)
section 41JCA (providing information to the Secretary); and
23
(b)
section 41KA (public notification and recovery of medical
24
devices); and
25
(c)
section 46A (search of premises).
26
41GS Minister may make exemptions
27
(1) The Minister may, by writing, exempt specified kinds of medical
28
devices from the operation of the following:
29
(a) Division 1 of Part 4-2 (essential principles);
30
(b) Division 1 of Part 4-3 (conformity assessment procedures);
31
Schedule 1 Medical devices
4 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No.
, 2008
(c) Part 4-4 (conformity assessment certificates);
1
(d) Part 4-5 (including medical devices in the Register).
2
(2) The Minister may make an exemption under subsection (1) only if
3
the Minister is satisfied that, in the national interest, the exemption
4
should be made so that:
5
(a) the devices may be stockpiled as quickly as possible in order
6
to create a preparedness to deal with a potential threat to
7
public health that may be caused by a possible future
8
emergency; or
9
(b) the devices can be made available urgently in Australia in
10
order to deal with an actual threat to public health caused by
11
an emergency that has occurred.
12
Period of exemption
13
(3) An exemption under subsection (1) comes into force:
14
(a) on the day the exemption is made; or
15
(b) on a later day specified in the exemption.
16
(4) An exemption under subsection (1) remains in force for the period
17
specified in the exemption, unless revoked earlier.
18
Note:
Section 41GU deals with variation and revocation of the exemption.
19
Effect of inclusion of kind of medical device in the Register
20
(5) An exemption under subsection (1) ceases to have effect in relation
21
to a particular kind of medical device when that kind of medical
22
device becomes included in the Register under Part 4-5.
23
Exemption not a legislative instrument
24
(6) An exemption under subsection (1) is not a legislative instrument.
25
Disregard section 41BE
26
(7) For the purposes of this Act, disregard section 41BE in working
27
out the kinds of medical devices covered by an exemption under
28
subsection (1) of this section.
29
Medical devices Schedule 1
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 5
41GT Conditions of exemptions
1
An exemption under section 41GS is subject to conditions
2
specified in the exemption about any of the following:
3
(a) the quantity of medical devices that are exempt;
4
(b) the source of those medical devices;
5
(c) the persons or class of persons who may import,
6
manufacture, supply or export those medical devices;
7
(d) the supply of those medical devices (including the persons or
8
class of persons to whom medical devices may be supplied
9
for use and the circumstances under which a stockpile of
10
medical devices may be supplied for use);
11
(e) the storage and security of those medical devices;
12
(f) the keeping and disclosure of, and access to, records about
13
those medical devices;
14
(g) the disposal of those medical devices;
15
(h) the manner in which any of those medical devices are to be
16
dealt with if a condition of the exemption is breached;
17
(i) any other matters that the Minister thinks appropriate.
18
Whether or not medical devices are exempt under section 41GS is
19
not affected by whether or not there is a breach of a condition
20
under this section in relation to those medical devices.
21
Note 1:
There are offences and civil penalty provisions related to the breach of
22
a condition of an exemption: see Division 3A of Part 4-11.
23
Note 2:
Section 41GU deals with variation and revocation of the conditions.
24
41GU Variation or revocation of exemption
25
Variation of exemption
26
(1) The Minister may, by writing, vary an exemption made under
27
section 41GS by removing specified kinds of medical devices from
28
the exemption.
29
Revocation of exemption
30
(2) The Minister may, by writing, revoke an exemption made under
31
section 41GS.
32
Schedule 1 Medical devices
6 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No.
, 2008
Variation or revocation of conditions
1
(3) The Minister may, by writing:
2
(a) vary the conditions of an exemption made under
3
section 41GS (including by imposing new conditions); or
4
(b) revoke the conditions of an exemption made under
5
section 41GS.
6
When variation or revocation takes effect
7
(4) A variation or revocation under this section takes effect:
8
(a) if the Minister states in the variation or revocation that the
9
variation or revocation is necessary to prevent imminent risk
10
of death, serious illness or serious injury--on the day the
11
variation or revocation is made; or
12
(b) in any other case--on a later day specified in the variation or
13
revocation (which must not be earlier than 28 days after the
14
day the variation or revocation is made).
15
41GV Informing persons of exemption etc.
16
If the Minister makes an exemption under section 41GS, the
17
Minister must take reasonable steps to give a copy of the following
18
to each person covered by paragraph 41GT(c):
19
(a) the exemption;
20
(b) any variation or revocation of the exemption under
21
section 41GU.
22
41GW Notification and tabling
23
Notification
24
(1) The Secretary must cause a notice setting out particulars of the
25
following:
26
(a) an exemption made under section 41GS because of paragraph
27
41GS(2)(b);
28
(b) a variation or revocation under section 41GU, to the extent
29
that the variation or revocation relates to an exemption made
30
under section 41GS because of paragraph 41GS(2)(b);
31
to be published in the Gazette within 5 working days after the day
32
on which the exemption, variation or revocation is made. However,
33
Medical devices Schedule 1
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 7
the exemption, variation or revocation is not invalid merely
1
because of a failure to comply with this subsection.
2
Tabling
3
(2) The Minister must cause a document setting out particulars of the
4
following:
5
(a) an exemption made under section 41GS because of paragraph
6
41GS(2)(b);
7
(b) a variation or revocation under section 41GU, to the extent
8
that the variation or revocation relates to an exemption made
9
under section 41GS because of paragraph 41GS(2)(b);
10
to be tabled in each House of the Parliament within 5 sitting days
11
of that House after the day on which the exemption, variation or
12
revocation is made. However, the exemption, variation or
13
revocation is not invalid merely because of a failure to comply
14
with this subsection.
15
41GX Exclusion of liability of the Commonwealth etc.
16
An exemption under section 41GS does not render the
17
Commonwealth, the Minister or a delegate of the Minister liable to
18
a person for loss, damage or injury of any kind suffered by the
19
person as a result of, or arising out of, the use by that person or
20
another person of a medical device of a kind covered by the
21
exemption.
22
41GY Disposal of unused medical devices
23
(1) This section applies to a medical device if:
24
(a) an exemption under section 41GS in relation to that kind of
25
medical device ceases to have effect otherwise than because
26
that kind of medical device becomes included in the Register
27
under Part 4-5; and
28
(b) the medical device has not been used before the exemption so
29
ceases to have effect.
30
(2) The Secretary may arrange for the disposal of the medical device
31
in accordance with the regulations.
32
Schedule 1 Medical devices
8 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No.
, 2008
(3) Regulations made for the purposes of subsection (2) may set out
1
the methods by which the medical device is to be stored, supplied,
2
destroyed, exported or otherwise disposed of.
3
(4) A method set out in the regulations under subsection (3) must not
4
enable or permit any benefit to be conferred on a person (including
5
the Commonwealth) other than the owner of the medical device.
6
3 Part 4-7 (heading)
7
Repeal the heading, substitute:
8
Part 4-7--Other exemptions from including
9
medical devices in the Register
10
4 Section 41H
11
Omit "There are 3", substitute "In addition to Part 4-6A, there are 3
12
other".
13
5 Section 41J
14
After "exemptions under", insert "Part 4-6A or".
15
6 Before section 41JD
16
Insert:
17
41JCA Secretary may require information etc. about me dical
18
devices exempt unde r Part 4-6A
19
(1) This section applies to a person who is required to comply with a
20
condition of an exemption of a kind of medical device under
21
section 41GS.
22
(2) The Secretary may, by written notice given to the person, require
23
the person to give to the Secretary specified information or
24
documents relating to one or more of the following:
25
(a) the supply of devices of that kind;
26
(b) the handling of devices of that kind;
27
(c) the monitoring of the supply of devices of that kind;
28
(d) the results of the supply of devices of that kind;
29
(e) any other matter prescribed by the regulations for the
30
purposes of this paragraph in relation to devices of that kind.
31
Medical devices Schedule 1
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 9
(3) The notice must specify a reasonable period within which the
1
person to whom the notice is given must comply. The period must
2
be at least 10 working days starting on the day on which the notice
3
is given.
4
(4) The notice may require information to be given in accordance with
5
specified software requirements:
6
(a) on a specified kind of data processing device; or
7
(b) by way of a specified kind of electronic transmission.
8
7 Paragraph 41JG(a)
9
After "section", insert "41JCA,".
10
8 Section 41JG (note)
11
After "sections", insert "41JCA,".
12
9 Section 41JH
13
After "section", insert "41JCA,".
14
10 Paragraph 41JI(1)(c)
15
After "section", insert "41JCA,".
16
11 Subsection 41JJ(1)
17
After "section", insert "41JCA,".
18
12 Subsection 41KA(1) (after paragraph (a) of the cell at table
19
item
5, column headed "Circums
tance relating to a kind
20
of medical device")
21
Insert:
22
(aa) it is not covered by an exemption in
force under section 41GS; and
13 Subsection 41KA(1) (after table item 5)
23
Insert:
24
25
5A.
It is supplied while it is covered by an
exemption in force under section 41GS, and
the Secretary is satisfied that it is not fit to be
used for its intended purpose
The person supplying the
kind of medical device
Schedule 1 Medical devices
10 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
14 Section 41M
1
After "Divisions 3", insert ", 3A".
2
15 After paragraphs 41MA(1)(c) and (2)(c)
3
Insert:
4
(ca) the device is not of a kind covered by an exemption in force
5
under section 41GS; and
6
16 After paragraph 41MA(4)(c)
7
Insert:
8
; and (d) the device is not of a kind covered by an exemption in force
9
under section 41GS.
10
17 After paragraphs 41MA(5)(c) and (6)(c)
11
Insert:
12
(ca) the device is not of a kind covered by an exemption in force
13
under section 41GS; and
14
18 After paragraph 41MA(8)(c)
15
Insert:
16
; and (d) the device is not of a kind covered by an exemption in force
17
under section 41GS.
18
19 After paragraphs 41MA(9)(c) and (10)(c)
19
Insert:
20
(ca) the device is not of a kind covered by an exemption in force
21
under section 41GS; and
22
20 After paragraph 41MA(12)(c)
23
Insert:
24
; and (d) the device is not of a kind covered by an exemption in force
25
under section 41GS.
26
21 After paragraphs 41MAA(1)(c), (2)(c) and (3)(c)
27
Insert:
28
; and (d) the device is not of a kind covered by an exemption in force
29
under section 41GS.
30
Medical devices Schedule 1
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 11
22 After paragraphs 41ME(1)(c) and (2)(c)
1
Insert:
2
(ca) the device is not of a kind covered by an exemption in force
3
under section 41GS; and
4
23 After paragraph 41ME(4)(c)
5
Insert:
6
; and (d) the device is not of a kind covered by an exemption in force
7
under section 41GS.
8
24 After paragraphs 41ME(5)(c) and (6)(c)
9
Insert:
10
(ca) the device is not of a kind covered by an exemption in force
11
under section 41GS; and
12
25 After paragraph 41ME(8)(c)
13
Insert:
14
; and (d) the device is not of a kind covered by an exemption in force
15
under section 41GS.
16
26 After paragraphs 41MEA(1)(c) and (2)(c)
17
Insert:
18
; and (d) the device is not of a kind covered by an exemption in force
19
under section 41GS.
20
27 After paragraph 41MF(1)(b)
21
Insert:
22
(ba) the device is not of a kind covered by an exemption in force
23
under section 41GS; and
24
28 After paragraph 41MF(2)(b)
25
Insert:
26
; and (c) the device is not of a kind covered by an exemption in force
27
under section 41GS.
28
29 After paragraph 41MF(3)(b)
29
Insert:
30
Schedule 1 Medical devices
12 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
(ba) the device is not of a kind covered by an exemption in force
1
under section 41GS; and
2
30 After paragraph 41MF(4)(b)
3
Insert:
4
; and (c) the device is not of a kind covered by an exemption in force
5
under section 41GS.
6
31 After subparagraphs 41MI(1)(b)(i), (2)(b)(i) and (4)(b)(i)
7
Insert:
8
(ia) the device is of a kind covered by an exemption in force
9
under section 41GS;
10
32 Paragraph 41MIB(1)(b)
11
Omit "paragraphs", substitute "subparagraphs".
12
33 After subparagraph 41MIB(1)(b)(i)
13
Insert:
14
(ia) the device is of a kind covered by an exemption in force
15
under section 41GS;
16
34 After subparagraph 41MK(b)(i)
17
Insert:
18
(ia) the device is of a kind covered by an exemption in force
19
under section 41GS;
20
35 After Division 3 of Part 4-11
21
Insert:
22
Division 3A--Offences and civil penalties related to
23
exemptions under Part 4-6A
24
41MNB Criminal offences for breaching a condition of an
25
exemption
26
(1) A person commits an offence if:
27
(a) the person does an act or omits to do an act in relation to a
28
medical device; and
29
Medical devices Schedule 1
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 13
(b) the device is of a kind covered by an exemption in force
1
under section 41GS; and
2
(c) the act or omission results in the breach of a condition of the
3
exemption; and
4
(d) the act or omission is likely to cause a serious risk to public
5
health.
6
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
7
(2) Strict liability applies to paragraph (1)(b).
8
Note:
For strict liability, see section 6.1 of the Criminal Code.
9
(3) A person commits an offence if:
10
(a) the person does an act or omits to do an act in relation to a
11
medical device; and
12
(b) the device is of a kind covered by an exemption in force
13
under section 41GS; and
14
(c) the act or omission results in the breach of a condition of the
15
exemption.
16
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
17
(4) Strict liability applies to paragraph (3)(b).
18
Note:
For strict liability, see section 6.1 of the Criminal Code.
19
(5) A person commits an offence if:
20
(a) the person does an act or omits to do an act in relation to a
21
medical device; and
22
(b) the device is of a kind covered by an exemption in force
23
under section 41GS; and
24
(c) the act or omission results in the breach of a condition of the
25
exemption.
26
Penalty: 60 penalty units.
27
(6) An offence against subsection (5) is an offence of strict liability.
28
Note:
For strict liability, see section 6.1 of the Criminal Code.
29
41MNC Civil penalty for breaching a condition of an exemption
30
A person contravenes this section if:
31
Schedule 1 Medical devices
14 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
(a) the person does an act or omits to do an act in relation to a
1
medical device; and
2
(b) the device is of a kind covered by an exemption in force
3
under section 41GS; and
4
(c) the act or omission results in the breach of a condition of the
5
exemption.
6
Maximum civil penalty:
7
(a) for an individual--5,000 penalty units; and
8
(b) for a body corporate--50,000 penalty units.
9
41MND Civil penalty for making misrepresentations about medical
10
devices
11
A person contravenes this section if:
12
(a) the person makes a representation that medical devices are of
13
a kind covered by an exemption in force under section 41GS;
14
and
15
(b) the representation is false or misleading.
16
Maximum civil penalty:
17
(a) for an individual--5,000 penalty units; and
18
(b) for a body corporate--50,000 penalty units.
19
36 After subparagraph 46A(4)(a)(ii)
20
Insert:
21
(iiaa) who is required to comply with a condition of an
22
exemption of a kind of medical device under
23
section 41GS; or
24
37 After paragraph 56A(1)(a)
25
Insert:
26
(aaa) there was no exemption in force under section 41GS in
27
relation to a particular kind of medical device; or
28
38 Subsection 57(1)
29
Omit "(10)", substitute "(11)".
30
39 At the end of section 57
31
Add:
32
Medical devices Schedule 1
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 15
(11) The power of the Minister under subsection 41GS(1) may be
1
delegated only to the Secretary.
2
40 Subsection 61(3A)
3
After "31B,", insert "41JCA,".
4
5
Schedule 2 Emergency exemption for therapeutic goods that are not medical devices
16 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
1
Schedule 2
--
Emergency exemption for
2
therapeutic goods that are not medical
3
devices
4
5
Therapeutic Goods Act 1989
6
1 Subsection 18A(9A)
7
Repeal the subsection, substitute:
8
Exemption not a legislative instrument
9
(9A) An exemption under subsection (1) is not a legislative instrument.
10
Informing persons of exemption etc.
11
(9B) If the Minister makes an exemption under subsection (1), the
12
Minister must take reasonable steps to give a copy of the following
13
to each person covered by paragraph (7)(d):
14
(a) the exemption;
15
(b) any revocation or variation of the exemption under this
16
section.
17
2 Paragraphs 18A(10)(b) and (11)(b)
18
Omit "subsection (8)", substitute "this section".
19
3 Subsection 57(10)
20
Omit "paragraph 18A(2)(a)", substitute "subsection 18A(1)".
21
4 Application
22
(1)
The amendment made by item 1 applies in relation to an exemption
23
made on or after the commencement of that item.
24
(2)
The amendment made by item 2 applies in relation to a revocation or
25
variation made on or after the commencement of that item (whether the
26
exemption was made before, on or after that commencement).
27
28
Fit and proper person test Schedule 3
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 17
1
Schedule 3
--
Fit and proper person test
2
3
Therapeutic Goods Act 1989
4
1 Subsection 3(1)
5
Insert:
6
major interest holder of a body corporate means a person who:
7
(a) is in a position to cast, or control the casting of, more than
8
one-fifth of the maximum number of votes that might be cast
9
at a general meeting of the body corporate; or
10
(b) holds more than one-fifth of the issued share capital of the
11
body corporate (excluding any part of that issued share
12
capital that carries no right to participate beyond a specified
13
amount in a distribution of either profits or capital).
14
2 Paragraphs 38(1)(g) to (i)
15
Repeal the paragraphs, substitute:
16
(g) at least one of the following persons:
17
(i) the applicant;
18
(ii) a person (a manager) who makes, or participates in
19
making, decisions that affect the whole, or a substantial
20
part, of the applicant's affairs;
21
(iii) if the applicant is a body corporate--a major interest
22
holder of the body corporate;
23
has, within the 10 years immediately before the application:
24
(iv) been convicted of an offence against this Act or a
25
corresponding State law; or
26
(v) been convicted of an offence against a law of the
27
Commonwealth or a law of a State or Territory
28
involving fraud or dishonesty; or
29
(vi) been ordered to pay a pecuniary penalty for the
30
contravention of a civil penalty provision of this Act or
31
a corresponding State law; or
32
(vii) been ordered to pay a pecuniary penalty for the
33
contravention of a civil penalty provision of a law of the
34
Commonwealth or a law of a State or Territory
35
involving fraud or dishonesty; or
36
Schedule 3 Fit and proper person test
18 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
(viii) breached a condition of a manufacturing licence; or
1
(ix) had a manufacturing licence suspended or revoked; or
2
(x) been a manager, or a major interest holder, of a body
3
corporate in respect of which subparagraph (iv), (v),
4
(vi), (vii), (viii) or (ix) applies in that 10 year period, if
5
the conduct resulting in that subparagraph applying
6
occurred when the person was a manager or major
7
interest holder of the body corporate; or
8
(h) any other circumstances prescribed by the regulations for the
9
purposes of this paragraph exist.
10
3 Subsection 38(1A)
11
Repeal the subsection, substitute:
12
(1A) A reference in paragraph (1)(g) to a person convicted of an offence
13
includes a reference to a person in respect of whom an order has
14
been made relating to the offence under:
15
(a) section 19B of the Crimes Act 1914; or
16
(b) a corresponding provision of a law of a State or Territory.
17
Note:
Section 19B of the Crimes Act 1914 empowers a court that has found
18
a person to have committed an offence to take action without
19
proceeding to record a conviction.
20
(1AA) Paragraph (1)(g) does not limit paragraph (1)(h).
21
4 Subsection 38(1B)
22
Omit "subsection (1A)", substitute "paragraph (1)(g)".
23
5 Subsection 38(2)
24
Omit "paragraphs (1)(g), (h) and (i)", substitute "paragraph (1)(g)".
25
6 Subsection 38(2)
26
Omit "one or more of those paragraphs", substitute "that paragraph".
27
7 After paragraph 40(4)(ab)
28
Insert:
29
(ac) give the Secretary the information specified in a notice under
30
subsection (6) within the period, and in the manner, specified
31
in the notice; and
32
Fit and proper person test Schedule 3
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 19
8 At the end of section 40
1
Add:
2
(6) The Secretary may, by notice in writing given to the holder of a
3
licence, require the holder to give the Secretary, within the
4
specified period and in the specified manner, specified information
5
to be used by the Secretary in deciding whether to revoke or
6
suspend the licence under section 41 in the circumstances referred
7
to in paragraph 41(1)(a).
8
(7) The period specified in a notice given under subsection (6) must be
9
at least 14 days after the notice is given.
10
9 Paragraphs 41(1)(a) to (cd)
11
Repeal the paragraphs, substitute:
12
(a) at least one of the following persons:
13
(i) the holder;
14
(ii) a person (a manager) who makes, or participates in
15
making, decisions that affect the whole, or a substantial
16
part, of the holder's affairs;
17
(iii) if the holder is a body corporate--a major interest
18
holder of the body corporate;
19
has:
20
(iv) been convicted of an offence against this Act or a
21
corresponding State law; or
22
(v) been convicted of an offence against a law of the
23
Commonwealth or a law of a State or Territory
24
involving fraud or dishonesty; or
25
(vi) been ordered to pay a pecuniary penalty for the
26
contravention of a civil penalty provision of this Act or
27
a corresponding State law; or
28
(vii) been ordered to pay a pecuniary penalty for the
29
contravention of a civil penalty provision of a law of the
30
Commonwealth or a law of a State or Territory
31
involving fraud or dishonesty; or
32
(viii) breached a condition of a manufacturing licence; or
33
(ix) had a manufacturing licence suspended or revoked; or
34
(x) been a manager, or a major interest holder, of a body
35
corporate in respect of which subparagraph (iv), (v),
36
(vi), (vii), (viii) or (ix) applies, if the conduct resulting
37
Schedule 3 Fit and proper person test
20 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
in that subparagraph applying occurred when the person
1
was a manager or major interest holder of the body
2
corporate; or
3
10 At the end of subsection 41(1)
4
Add:
5
; or (h) any other circumstances prescribed by the regulations for the
6
purposes of this paragraph exist.
7
11 Subsection 41(1A)
8
Repeal the subsection, substitute:
9
(1A) A reference in paragraph (1)(a) to a person convicted of an offence
10
includes a reference to a person in respect of whom an order has
11
been made relating to the offence under:
12
(a) section 19B of the Crimes Act 1914; or
13
(b) a corresponding provision of a law of a State or Territory.
14
Note:
Section 19B of the Crimes Act 1914 empowers a court that has found
15
a person to have committed an offence to take action without
16
proceeding to record a conviction.
17
(1B) Paragraph (1)(a) does not limit paragraph (1)(h).
18
(1C) In paragraph (1)(a):
19
manufacturing licence means:
20
(a) a licence granted under this Part; or
21
(b) a licence, granted under a law of a State or Territory relating
22
to therapeutic goods, relating to manufacturing therapeutic
23
goods.
24
12 After section 41
25
Insert:
26
41AA Spent convictions scheme
27
Nothing in section 40 or 41 affects the operation of Part VIIC of
28
the Crimes Act 1914 (which includes provisions that, in certain
29
circumstances, relieve persons from the requirement to disclose
30
spent convictions and require persons aware of such convictions to
31
disregard them).
32
Fit and proper person test Schedule 3
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 21
13 Paragraphs 41EC(3)(a) to (c)
1
Repeal the paragraphs, substitute:
2
(a) whether at least one of the following persons:
3
(i) the applicant;
4
(ii) a person (a manager) who makes, or participates in
5
making, decisions that affect the whole, or a substantial
6
part, of the applicant's affairs;
7
(iii) if the applicant is a body corporate--a major interest
8
holder of the body corporate;
9
has, within the 10 years immediately before the application:
10
(iv) been convicted of an offence against this Act or a
11
corresponding State law; or
12
(v) been convicted of an offence against a law of the
13
Commonwealth or a law of a State or Territory
14
involving fraud or dishonesty; or
15
(vi) been ordered to pay a pecuniary penalty for the
16
contravention of a civil penalty provision of this Act or
17
a corresponding State law; or
18
(vii) been ordered to pay a pecuniary penalty for the
19
contravention of a civil penalty provision of a law of the
20
Commonwealth or a law of a State or Territory
21
involving fraud or dishonesty; or
22
(viii) breached a condition of a conformity assessment
23
certificate; or
24
(ix) had a conformity assessment certificate suspended or
25
revoked; or
26
(x) been a manager, or a major interest holder, of a body
27
corporate in respect of which subparagraph (iv), (v),
28
(vi), (vii), (viii) or (ix) applies in that 10 year period, if
29
the conduct resulting in that subparagraph applying
30
occurred when the person was a manager or major
31
interest holder of the body corporate; or
32
(b) whether any other circumstances prescribed by the
33
regulations for the purposes of this paragraph exist.
34
14 Subsection 41EC(4)
35
Repeal the subsection, substitute:
36
Schedule 3 Fit and proper person test
22 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
(4) A reference in paragraph (3)(a) to a person convicted of an offence
1
includes a reference to a person in respect of whom an order has
2
been made relating to the offence under:
3
(a) section 19B of the Crimes Act 1914; or
4
(b) a corresponding provision of a law of a State or Territory.
5
Note:
Section 19B of the Crimes Act 1914 empowers a court that has found
6
a person to have committed an offence to take action without
7
proceeding to record a conviction.
8
(5) Paragraph (3)(a) does not limit paragraph (3)(b).
9
15 Paragraph 41EG(c)
10
Omit "relating to a kind of medical device to which the application
11
relates".
12
16 After subsection 41EJ(5)
13
Insert:
14
Conditions in regulations
15
(5A) A conformity assessment certificate is subject to any conditions
16
prescribed by the regulations for the purposes of this subsection.
17
17 Paragraph 41ET(1)(c)
18
Repeal the paragraph, substitute:
19
(c) the Secretary gives to the person a notice under section 41JA
20
that requires the person to give to the Secretary information
21
or documents and the person fails to comply with that notice
22
within a further 10 working days from the day specified in
23
that notice; or
24
18 Paragraphs 41ET(1)(e) to (g)
25
Repeal the paragraphs, substitute:
26
(e) at least one of the following persons:
27
(i) the person (the holder) in relation to whom the
28
certificate is issued;
29
(ii) a person (a manager) who makes, or participates in
30
making, decisions that affect the whole, or a substantial
31
part, of the holder's affairs;
32
Fit and proper person test Schedule 3
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 23
(iii) if the holder is a body corporate--a major interest
1
holder of the body corporate;
2
has:
3
(iv) been convicted of an offence against this Act or a
4
corresponding State law; or
5
(v) been convicted of an offence against a law of the
6
Commonwealth or a law of a State or Territory
7
involving fraud or dishonesty; or
8
(vi) been ordered to pay a pecuniary penalty for the
9
contravention of a civil penalty provision of this Act or
10
a corresponding State law; or
11
(vii) been ordered to pay a pecuniary penalty for the
12
contravention of a civil penalty provision of a law of the
13
Commonwealth or a law of a State or Territory
14
involving fraud or dishonesty; or
15
(viii) breached a condition of a conformity assessment
16
certificate; or
17
(ix) had a conformity assessment certificate suspended or
18
revoked; or
19
(x) been a manager, or a major interest holder, of a body
20
corporate in respect of which subparagraph (iv), (v),
21
(vi), (vii), (viii) or (ix) applies, if the conduct resulting
22
in that subparagraph applying occurred when the person
23
was a manager or major interest holder of the body
24
corporate; or
25
(f) any other circumstances prescribed by the regulations for the
26
purposes of this paragraph exist.
27
19 Subsection 41ET(1A)
28
Repeal the subsection, substitute:
29
(1A) A reference in paragraph (1)(e) to a person convicted of an offence
30
includes a reference to a person in respect of whom an order has
31
been made relating to the offence under:
32
(a) section 19B of the Crimes Act 1914; or
33
(b) a corresponding provision of a law of a State or Territory.
34
Note:
Section 19B of the Crimes Act 1914 empowers a court that has found
35
a person to have committed an offence to take action without
36
proceeding to record a conviction.
37
(1B) Paragraph (1)(e) does not limit paragraph (1)(f).
38
Schedule 3 Fit and proper person test
24 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
20 At the end of section 41ET
1
Add:
2
(4) Nothing in this section affects the operation of Part VIIC of the
3
Crimes Act 1914 (which includes provisions that, in certain
4
circumstances, relieve persons from the requirement to disclose
5
spent convictions and require persons aware of such convictions to
6
disregard them).
7
21 After subsection 41JA(1)
8
Insert:
9
(1A) The Secretary may, by written notice given to a person who is an
10
applicant for a conformity assessment certificate, require the
11
person to give to the Secretary such further information concerning
12
the application as is specified in the notice.
13
(1B) Requirements under subsections (1) and (1A) may be included in
14
the same notice.
15
(1C) The Secretary may, by written notice given to a person who holds a
16
conformity assessment certificate, require the person to give to the
17
Secretary specified information to be used by the Secretary in
18
deciding whether to suspend the certificate under section 41EM, or
19
to revoke the certificate under section 41ET, in relation to the
20
circumstances referred to in paragraph 41ET(1)(e).
21
(1D) Requirements under subsections (1) and (1C) may be included in
22
the same notice.
23
22 At the end of section 41JA
24
Add:
25
(3) Nothing in this section affects the operation of Part VIIC of the
26
Crimes Act 1914 (which includes provisions that, in certain
27
circumstances, relieve persons from the requirement to disclose
28
spent convictions and require persons aware of such convictions to
29
disregard them).
30
23 Application and transitional
31
Fit and proper person test Schedule 3
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 25
(1)
The amendments of section 38 of the Therapeutic Goods Act 1989
1
made by this Schedule apply in relation to applications for licences
2
made on or after the commencement of this item.
3
(2)
The amendments of sections 40 and 41 of the Therapeutic Goods Act
4
1989 made by this Schedule apply in relation to licences granted before,
5
on or after the commencement of this item.
6
(3)
The amendments of section 41EC of the Therapeutic Goods Act 1989
7
made by this Schedule apply in relation to applications for conformity
8
assessment certificates made on or after the commencement of this
9
item.
10
(4)
The amendment of section 41EG of the Therapeutic Goods Act 1989
11
made by this Schedule applies in relation to notices given on or after the
12
commencement of this item.
13
(5)
The amendment of section 41EJ of the Therapeutic Goods Act 1989
14
made by this Schedule applies in relation to conformity assessment
15
certificates issued before, on or after the commencement of this item.
16
(6)
The amendments of section 41ET of the Therapeutic Goods Act 1989
17
made by this Schedule apply in relation to conformity assessment
18
certificates issued before, on or after the commencement of this item.
19
(7)
Paragraph 41ET(1)(c) of the Therapeutic Goods Act 1989, as in force
20
immediately before the commencement of this item, continues to apply
21
on and after that commencement in relation to a notice given before that
22
commencement.
23
(8)
Subsection 41JA(1A) of the Therapeutic Goods Act 1989 applies in
24
relation to applications for conformity assessment certificates made on
25
or after the commencement of this item.
26
(9)
Subsection 41JA(1C) of the Therapeutic Goods Act 1989 applies in
27
relation to conformity assessment certificates issued before, on or after
28
the commencement of this item.
29
30
Schedule 4 Additional defau lt standards
26 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
1
Schedule 4
--
Additional default standards
2
3
Therapeutic Goods Act 1989
4
1 Subsection 3(1) (definition of British Pharmacopoeia)
5
Repeal the definition, substitute:
6
British Pharmacopoeia means the edition of the publication of that
7
name, including any additions or amendments, that was in effect
8
for the purposes of this Act immediately before the commencement
9
of Schedule 4 to the Therapeutic Goods Amendment (Medical
10
Devices and Other Measures) Act 2008 and, if additions or
11
amendments of that publication are made after that
12
commencement, or new editions of that publication are published
13
after that commencement, includes those additions or amendments,
14
or those new editions, from the effective date published by the
15
British Pharmacopoeia Commission or any replacement body.
16
2 Subsection 3(1) (definition of British Pharmacopoeia
17
(Veterinary))
18
Repeal the definition.
19
3 Subsection 3(1)
20
Insert:
21
default standard means any of the following:
22
(a) a standard referred to in paragraph (b) of the definition of
23
standard in this subsection;
24
(b) a standard referred to in paragraph (c) of that definition;
25
(c) a standard referred to in paragraph (d) of that definition.
26
4 Subsection 3(1)
27
Insert:
28
European Pharmacopoeia means the English edition of the
29
publication of that name, including any additions or amendments,
30
that was in effect immediately before the commencement of this
31
definition and, if additions or amendments of that publication are
32
made after that commencement, or new editions of that publication
33
Additional default standards Schedule 4
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 27
are published after that commencement, includes those additions or
1
amendments, or those new editions, from the effective date
2
published by the Council of Europe or any replacement body.
3
5 Subsection 3(1) (paragraph (a) of the definition of medicine)
4
Omit "or animal".
5
6 Subsection 3(1) (definition of standard)
6
Repeal the definition, substitute:
7
standard, in relation to therapeutic goods, means any of the
8
following:
9
(a) a standard that is constituted by the matters specified in an
10
order under section 10 that is applicable to the goods;
11
(b) if the goods are the subject of one or more monographs (other
12
than a monograph exempt under subsection 3C(1)) in the
13
British Pharmacopoeia--a standard that is constituted by the
14
statements (other than statements exempt under subsection
15
3C(2)) in those monographs, as interpreted in accordance
16
with the General Notices section of the British
17
Pharmacopoeia;
18
(c) if the goods are the subject of one or more monographs (other
19
than a monograph exempt under subsection 3C(1)) in the
20
European Pharmacopoeia--a standard that is constituted by
21
the statements (other than statements exempt under
22
subsection 3C(2)) in those monographs, as interpreted in
23
accordance with the General Notices section of the European
24
Pharmacopoeia;
25
(d) if the goods are the subject of one or more monographs (other
26
than a monograph exempt under subsection 3C(1)) in the
27
United States Pharmacopeia-National Formulary--a standard
28
that is constituted by the statements (other than statements
29
exempt under subsection 3C(2)) in those monographs, as
30
interpreted in accordance with the General Notices section of
31
the United States Pharmacopeia-National Formulary.
32
Note:
See also section 13.
33
7 Subsection 3(1) (paragraph (c) of the definition of supply)
34
Omit "or animals".
35
Schedule 4 Additional defau lt standards
28 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
8 Subsection 3(1) (paragraph (d) of the definition of supply)
1
Omit "or animal".
2
9 Subsection 3(1) (definition of therapeutic use)
3
Omit "or animals" (wherever occurring).
4
10 Subsection 3(1)
5
Insert:
6
United States Pharmacopeia-National Formulary means the
7
English edition of the publication of that name, including any
8
additions or amendments, that was in effect immediately before the
9
commencement of this definition and, if additions or amendments
10
of that publication are made after that commencement, or new
11
editions of that publication are published after that commencement,
12
includes those additions or amendments, or those new editions,
13
from the effective date published by the United States
14
Pharmacopeial Convention or any replacement body.
15
11 Subsection 3(2)
16
Repeal the subsection, substitute:
17
(2) For the purposes of this Act, therapeutic goods are taken to be for
18
use in humans if they are not solely for use in animals.
19
12 After section 3B
20
Insert:
21
3C Exe mpting monographs in pharmacopoeias
22
Exempting entire monographs
23
(1) The Minister may, by legislative instrument, determine that
24
specified monographs in the British Pharmacopoeia, the European
25
Pharmacopoeia or the United States Pharmacopeia-National
26
Formulary are exempt for the purposes of paragraph (b), (c) or (d)
27
of the definition of standard in subsection 3(1).
28
Note:
For specification by class, see subsection 13(3) of the Legislative
29
Instruments Act 2003.
30
Additional default standards Schedule 4
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 29
Exempting parts of monographs
1
(2) The Minister may, by legislative instrument, determine that
2
specified statements in specified monographs in the British
3
Pharmacopoeia, the European Pharmacopoeia or the United States
4
Pharmacopeia-National Formulary are exempt for the purposes of
5
paragraph (b), (c) or (d) of the definition of standard in subsection
6
3(1).
7
13 Subsection 10(1)
8
Omit "or the British Pharmacopoeia (Veterinary)", substitute ", the
9
European Pharmacopoeia or the United States Pharmacopeia-National
10
Formulary".
11
14 Subparagraph 10(2)(a)(iv)
12
Omit "or the British Pharmacopoeia (Veterinary)", substitute ", the
13
European Pharmacopoeia or the United States Pharmacopeia-National
14
Formulary".
15
15 Section 13
16
Repeal the section, substitute:
17
13 Special provisions relating to standards
18
(1) For the purposes of this Act, if a statement (the main statement) in
19
a monograph in the British Pharmacopoeia, the European
20
Pharmacopoeia or the United States Pharmacopeia-National
21
Formulary refers to a statement in a monograph in another
22
publication, the main statement is taken to include the other
23
statement.
24
(2) If:
25
(a) a standard under section 10 (the Ministerial standard)
26
applies to therapeutic goods; and
27
(b) requirements applicable to the goods are specified in a
28
default standard; and
29
(c) those requirements are inconsistent with the requirements
30
specified in the Ministerial standard;
31
the requirements referred to in paragraph (b) are, so far as they are
32
inconsistent, to be disregarded for the purposes of this Act.
33
Schedule 4 Additional defau lt standards
30 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
(3) If:
1
(a) a default standard applies to a class of therapeutic goods; and
2
(b) another default standard applies to only some of the
3
therapeutic goods within that class; and
4
(c) those standards are inconsistent;
5
the standard referred to in paragraph (a) does not apply in relation
6
to the goods referred to in paragraph (b).
7
(4) If:
8
(a) therapeutic goods consist, or are represented to consist, of a
9
mixture of ingredients or of a combination of component
10
parts; and
11
(b) a default standard is applicable to one or more of the
12
ingredients or one or more of the component parts; and
13
(c) a default standard is applicable to the mixture or
14
combination;
15
the standard referred to in paragraph (b) does not apply in relation
16
to the goods.
17
(5) If:
18
(a) therapeutic goods consist, or are represented to consist, of a
19
mixture of ingredients or of a combination of component
20
parts; and
21
(b) there is no standard applicable to the mixture or combination
22
but a standard is applicable to one or more of the ingredients
23
or one or more of the component parts;
24
the Minister may, by order published in the Gazette, determine that
25
the standard does not apply to the goods. The order has effect
26
accordingly.
27
(6) An order under subsection (5) is not a legislative instrument.
28
(7) For the purposes of this Act, in working out at a particular time if
29
therapeutic goods conform with a default standard applicable to the
30
goods, if:
31
(a) after applying subsections (2) to (5), 2 or more default
32
standards are applicable to the goods at that time; and
33
(b) at that time, the goods conform with at least one of those
34
standards but do not conform with at least one of those
35
standards;
36
Additional default standards Schedule 4
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 31
then the default standards that the goods do not conform with are
1
taken not to apply to the goods at that time.
2
16 Subsection 30F(2)
3
Omit "or animal".
4
17 Paragraph 41CC(1)(b)
5
Omit "United States Pharmacopoeia", substitute "United States
6
Pharmacopeia-National Formulary".
7
18 Subsection 42V(3)
8
Omit "or animal".
9
19 Section 56
10
Omit "and of the British Pharmacopoeia (Veterinary)", substitute ", the
11
European Pharmacopoeia and the United States Pharmacopeia-National
12
Formulary".
13
20 Application and transitional
14
(1)
If:
15
(a) immediately before the commencement of this item,
16
therapeutic goods were registered goods or listed goods; and
17
(b) at a particular time within the period of 12 months beginning
18
on the day on which this item commences:
19
(i) a standard referred to in paragraph (c) or (d) of the
20
definition of standard in subsection 3(1) of the
21
Therapeutic Goods Act 1989 (as amended by this Act)
22
would, apart from this subitem, apply to the goods; and
23
(ii) the goods do not conform with that standard;
24
then that standard is taken not to apply to the goods at that time.
25
(2)
To avoid doubt, paragraph (a) of the definition of standard in
26
subsection 3(1) of the Therapeutic Goods Act 1989 (as amended by this
27
Act) applies in relation to orders made under section 10 of the
28
Therapeutic Goods Act 1989 before, on or after the commencement of
29
this item.
30
(3)
An order in force under paragraph 13(7)(c) of the Therapeutic Goods
31
Act 1989 immediately before the commencement of this item has effect,
32
Schedule 4 Additional defau lt standards
32 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
on and after that commencement, as if it were an order in force under
1
subsection 13(5) of that Act.
2
3
Information disclosure provisions Schedule 5
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 33
1
Schedule 5
--
Information disclosure
2
provisions
3
4
Therapeutic Goods Act 1989
5
1 Subsection 9C(1)
6
Omit "The Register is not open for public inspection, but a", substitute
7
"A".
8
2 Subsection 61(1) (definition of therapeutic goods
9
information)
10
Omit "came into the possession of the Department in connection with",
11
substitute "is held by the Department and relates to".
12
3 Application
13
The amendment made by item 2 applies in relation to information held
14
by the Department on or after the commencement of this item
15
(regardless of whether the information came into existence before, on or
16
after that commencement).
17
4 Paragraphs 61(2)(a) and (b)
18
Omit "the Director-General of".
19
5 Subsection 61(3)
20
Omit "the head of".
21
6 Paragraph 61(3A)(a)
22
Omit "the head of an authority, or an authority,", substitute "an
23
authority".
24
7 Subsection 61(4)
25
Omit "the head of".
26
8 Paragraphs 61(4A)(a), (b) and (ba)
27
Omit "the head of".
28
9 After paragraph 61(4A)(d)
29
Schedule 5 Information disclosure provisions
34 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
Insert:
1
(da) action taken by the Secretary under section 30EA (about
2
notification and recovery of therapeutic goods);
3
10 Paragraph 61(4A)(e)
4
After "of", insert "Part 5-2 or".
5
11 After paragraph 61(4A)(f)
6
Insert:
7
(fa) any cases, or possible cases, of counterfeit therapeutic goods;
8
12 Subsection 61(5)
9
Omit "the head of" (wherever occurring).
10
13 After subsection 61(5)
11
Insert:
12
(5AA) The Secretary may release to a person, body or authority that is
13
specified, or is of a kind specified, under subsection (5AB)
14
therapeutic goods information of a kind specified under that
15
subsection for a purpose specified under that subsection.
16
(5AB) For the purpose of subsection (5AA), the Minister may, by
17
legislative instrument, specify one or more of the following:
18
(a) a person, body or authority;
19
(b) kinds of persons, bodies or authorities;
20
(c) kinds of therapeutic goods information;
21
(d) purposes.
22
14 After subsection 61(5B)
23
Insert:
24
(5C) The Secretary may release to the public therapeutic goods
25
information of a kind specified under subsection (5D).
26
(5D) The Minister may, by legislative instrument, specify kinds of
27
therapeutic goods information for the purpose of subsection (5C).
28
15 Paragraph 61(6A)(b)
29
Omit "persons; and", substitute "persons.".
30
Information disclosure provisions Schedule 5
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 35
16 Paragraph 61(6A)(c)
1
Repeal the paragraph.
2
17 At the end of section 61
3
Add:
4
(12) The subsections of this section permitting the release of
5
information have effect independently of each other.
6
7
Schedule 6 Advertising
36 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
1
Schedule 6
--
Advertising
2
3
Therapeutic Goods Act 1989
4
1 Subsection 42AC(2)
5
Omit "Section 42DC", substitute "Section 42DKB".
6
2 Section 42B (definition of restricted representation)
7
Omit "subsection 42DD(1)", substitute "section 42DD".
8
3 Section 42DA
9
Repeal the section, substitute:
10
42DA Simplified outline
11
The following is a simplified outline of this Division:
12
This Division has 2 kinds of application.
13
First, Part 2 of the Therapeutic Goods Regulations 1990 deals with
14
the Secretary approving certain advertisements and it refers to
15
provisions of this Division.
16
Second, the offences in Division 3A of this Part refer to provisions
17
of this Division.
18
4 Section 42DC
19
Repeal the section.
20
5 Subsection 42DD(1)
21
Omit "(1)".
22
6 Subsection 42DD(1)
23
Omit "subsection", substitute "section".
24
7 At the end of subsection 42DD(1)
25
Add:
26
Advertising Schedule 6
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 37
Note:
Under subsection 42DL(1) it is an offence for a person to publish or
1
broadcast an advertisement about therapeutic goods that contains a
2
restricted representation, about those goods, the use of which has not
3
been approved under subsection 42DF(1) or permitted under
4
subsection 42DK(1).
5
8 Subsection 42DD(2)
6
Repeal the subsection.
7
9 Before section 42DL
8
Insert:
9
Division 3A--Therapeutic goods advertisements for which
10
an approval is not required
11
42DKA Application of Division
12
This Division applies to advertisements about therapeutic goods
13
other than advertisements for which an approval is required under
14
Part 2 of the Therapeutic Goods Regulations 1990.
15
42DKB Certain representations not to be published or broadcast
16
(1) If a representation in an advertisement about therapeutic goods is
17
false or misleading, the Secretary may, by notice given to the
18
person apparently responsible for publishing or broadcasting the
19
advertisement, prevent that person from publishing or
20
broadcasting, or causing to be published or broadcast, an
21
advertisement containing that representation (whether express or
22
implied) about those goods.
23
(2) A notice under subsection (1) is not a legislative instrument.
24
10 Paragraph 42DL(1)(d)
25
Repeal the paragraph, substitute:
26
(d) that is in contravention of a notice referred to in
27
section 42DKB that was given to the person; or
28
11 Paragraph 42DL(2)(b)
29
Repeal the paragraph, substitute:
30
Schedule 6 Advertising
38 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
(b) that the notice referred to in paragraph (1)(d) is a notice
1
referred to in section 42DKB;
2
12 Saving and transitional
3
(1)
A notice in force under section 42DC of the Therapeutic Goods Act
4
1989 immediately before the commencement of this item has effect, on
5
and after that commencement, as if it were a notice given and in force
6
under section 42DKB of that Act.
7
(2)
Regulations in force for the purposes of subsection 42DD(1) of the
8
Therapeutic Goods Act 1989 immediately before the commencement of
9
this item continue in force on and after that commencement as if they
10
were regulations in force for the purposes of section 42DD of that Act.
11
12
Other amend ments Schedule 7
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 39
1
Schedule 7
--
Other amendments
2
3
Therapeutic Goods Act 1989
4
1 Subsection 3(8)
5
Repeal the subsection.
6
2 Subsection 8(2) (penalty)
7
Omit "Maximum penalty", substitute "Penalty".
8
3 Subsections 14(1), (2), (4), (6), (7), (9), (10), (11) and (13)
9
(penalty)
10
Omit "Maximum penalty", substitute "Penalty".
11
4 Subsections 15(2), (3) and (5) (penalty)
12
Omit "Maximum penalty", substitute "Penalty".
13
5 Subsections 19B(1), (2) and (4) (penalty)
14
Omit "Maximum penalty", substitute "Penalty".
15
6 Subsections 20(1B), (2A) and (2C) (penalty)
16
Omit "Maximum penalty", substitute "Penalty".
17
7 Section 21 (penalty)
18
Omit "Maximum penalty", substitute "Penalty".
19
8 Subsections 21A(1), (2), (4), (5), (6), (8), (9), (10), (12) and
20
(13) (penalty)
21
Omit "Maximum penalty", substitute "Penalty".
22
9 Subsections 22(1), (5), (6), (7AB), (7AD), (7A) and (8)
23
(penalty)
24
Omit "Maximum penalty", substitute "Penalty".
25
10 Subsections 22A(1), (2) and (4) (penalty)
26
Omit "Maximum penalty", substitute "Penalty".
27
Schedule 7 Other amendments
40 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
11 Subsection 26B(2) (penalty)
1
Omit "Maximum penalty", substitute "Penalty".
2
12 Subsection 26C(5) (penalty)
3
Repeal the penalty.
4
13 After subsection 26C(5)
5
Insert:
6
(5A) A pecuniary penalty ordered under subsection (5) must not exceed
7
$10,000,000.
8
14 Subsection 29A(1) (penalty)
9
Omit "Maximum penalty", substitute "Penalty".
10
15 Subsections 29B(3) and (4) (penalty)
11
Omit "Maximum penalty", substitute "Penalty".
12
16 Subsections 30EC(1), (2) and (4) (penalty)
13
Omit "Maximum penalty", substitute "Penalty".
14
17 Subsections 30F(4B), (4C) and (5) (penalty)
15
Omit "Maximum penalty", substitute "Penalty".
16
18 Subsections 30H(1) and (3) (penalty)
17
Omit "Maximum penalty", substitute "Penalty".
18
19 Subsections 31(4), (5A), (5B) and (6) (penalty)
19
Omit "Maximum penalty", substitute "Penalty".
20
20 Section 31C (penalty)
21
Omit "Maximum penalty", substitute "Penalty".
22
21 Subsection 31D(1) (penalty)
23
Omit "Maximum penalty", substitute "Penalty".
24
22 Subsection 31E(1) (penalty)
25
Omit "Maximum penalty", substitute "Penalty".
26
Other amend ments Schedule 7
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 41
23 Subsections 35(1), (2), (4), (5), (7) and (9) (penalty)
1
Omit "Maximum penalty", substitute "Penalty".
2
24 Subsections 35B(1), (2) and (4) (penalty)
3
Omit "Maximum penalty", substitute "Penalty".
4
25 Subsections 41EI(1), (2) and (4) (penalty)
5
Omit "Maximum penalty", substitute "Penalty".
6
26 Subsections 41FE(1), (2) and (4) (penalty)
7
Omit "Maximum penalty", substitute "Penalty".
8
27 Subsections 41JB(3), (4), (5) and (7) (penalty)
9
Omit "Maximum penalty", substitute "Penalty".
10
28 Sections 41JG and 41JH (penalty)
11
Omit "Maximum penalty", substitute "Penalty".
12
29 Subsection 41JI(1) (penalty)
13
Omit "Maximum penalty", substitute "Penalty".
14
30 Subsections 41KC(1), (2) and (4) (penalty)
15
Omit "Maximum penalty", substitute "Penalty".
16
31 Subsections 41MA(1), (2), (4), (5), (6), (8), (9), (10) and (12)
17
(penalty)
18
Omit "Maximum penalty", substitute "Penalty".
19
32 Subsections 41MC(2), (3) and (5) (penalty)
20
Omit "Maximum penalty", substitute "Penalty".
21
33 Subsections 41ME(1), (2), (4), (5), (6) and (8) (penalty)
22
Omit "Maximum penalty", substitute "Penalty".
23
34 Subsections 41MF(1), (2), (3) and (4) (penalty)
24
Omit "Maximum penalty", substitute "Penalty".
25
35 Section 41MH (penalty)
26
Schedule 7 Other amendments
42 Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008
No. , 2008
Omit "Maximum penalty", substitute "Penalty".
1
36 Subsections 41MI(1), (2) and (4) (penalty)
2
Omit "Maximum penalty", substitute "Penalty".
3
37 Section 41MK (penalty)
4
Omit "Maximum penalty", substitute "Penalty".
5
38 Subsection 41ML(3)
6
Omit "(3)".
7
39 Subsection 41ML(3) (penalty)
8
Omit "Maximum penalty", substitute "Penalty".
9
40 Section 41MM (penalty)
10
Omit "Maximum penalty", substitute "Penalty".
11
41 Subsections 41MN(1), (2), (4), (5), (6), (8) and (9) (penalty)
12
Omit "Maximum penalty", substitute "Penalty".
13
42 Subsections 41MO(1), (2), (4), (5), (6) and (8) (penalty)
14
Omit "Maximum penalty", substitute "Penalty".
15
43 Subsection 41MP(1) (penalty)
16
Omit "Maximum penalty", substitute "Penalty".
17
44 Subsections 41MQ(3) and (4) (penalty)
18
Omit "Maximum penalty", substitute "Penalty".
19
45 Subsection 42E(1) (penalty)
20
Omit "Maximum penalty", substitute "Penalty".
21
46 Subsections 42T(1) and (2) (penalty)
22
Omit "Maximum penalty", substitute "Penalty".
23
47 Subsections 42V(6), (6A) and (6C) (penalty)
24
Omit "Maximum penalty", substitute "Penalty".
25
48 Subsections 42W(1) and (2) (penalty)
26
Other amend ments Schedule 7
Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 No. ,
2008 43
Omit "Maximum penalty", substitute "Penalty".
1
49 Subsection 42YE(5) (penalty)
2
Omit "Maximum penalty", substitute "Penalty".
3
50 Subsection 48(3) (penalty)
4
Omit "Maximum penalty", substitute "Penalty".
5
51 Subsections 51B(1) and (2) (penalty)
6
Omit "Maximum penalty", substitute "Penalty".
7
52 Subsection 52(3) (penalty)
8
Omit "Maximum penalty", substitute "Penalty".
9
53 Subsection 54AB(1) (penalty)
10
Omit "Maximum penalty", substitute "Penalty".
11

 


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