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This is a Bill, not an Act. For current law, see the Acts databases.
2002
The Parliament of
the
Commonwealth of
Australia
HOUSE OF
REPRESENTATIVES
Presented and read a first
time
Therapeutic
Goods and Other Legislation Amendment Bill
2002
No. ,
2002
(Health and
Ageing)
A Bill for an Act to amend the law
relating to therapeutic goods and industrial chemicals, and for related
purposes
Contents
Therapeutic Goods Act
1989 4
Industrial Chemicals (Notification and Assessment) Act
1989 10
National Occupational Health and Safety Commission Act
1985 13
Therapeutic Goods Act
1989 14
Therapeutic Goods Amendment (Medical Devices) Act
2002 19
Therapeutic Goods Act
1989 20
A Bill for an Act to amend the law relating to
therapeutic goods and industrial chemicals, and for related
purposes
The Parliament of Australia enacts:
This Act may be cited as the Therapeutic Goods and Other Legislation
Amendment Act 2002.
(1) Each provision of this Act specified in column 1 of the table
commences, or is taken to have commenced, on the day or at the time specified in
column 2 of the table.
|
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, items 6 and 7 |
The later of: |
|
|
3. Schedule 3, item 3 |
On the day on which this Act receives the Royal Assent, subject to
subsection (3) |
|
|
4. Schedule 3, item 4 |
Immediately after item 22 of Schedule 3 commences, subject
to subsection (3) |
|
|
5. Schedule 3, item 5 |
On the day on which this Act receives the Royal Assent, subject to
subsection (4) |
|
|
6. Schedule 3, item 22 |
Immediately after Schedule 1 to the Therapeutic Goods Amendment
(Medical Devices) Act 2002 commences, subject to
subsection (3) |
|
|
7. Schedule 4, item 1 |
Immediately after Schedule 1 to the Therapeutic Goods Amendment
(Medical Devices) Act 2002 commences |
|
|
8. Schedule 4, item 2 |
On the day on which this Act receives the Royal Assent, subject to
subsection (5) |
|
Note: This table relates only to the provisions of this Act
as originally passed by the Parliament and assented to. It will not be expanded
to deal with provisions inserted in this Act after assent.
(2) Column 3 of the table is for additional information that is not part
of this Act. This information may be included in any published version of this
Act.
(3) If Schedule 1 to the Therapeutic Goods Amendment (Medical
Devices) Act 2002 commences before this section, items 3, 4 and 22 of
Schedule 3 to this Act do not commence at all.
(4) If Schedule 1 to the Therapeutic Goods Amendment (Medical
Devices) Act 2002 does not commence before this section, item 5 of
Schedule 3 to this Act does not commence at all.
(5) If Schedule 1 to the Therapeutic Goods Amendment (Medical
Devices) Act 2002 commences before this section, item 2 of
Schedule 4 to this Act does not commence at all.
Each Act that is specified in a Schedule to this Act is amended or
repealed as set out in the applicable items in the Schedule concerned, and any
other item in a Schedule to this Act has effect according to its
terms.
1 Subsection 3(1)
Insert:
Commonwealth authority includes:
(a) a body corporate, or an unincorporated body, established for a public
purpose by or under an Act; and
(b) a tribunal or authority established by or in accordance with an
Act.
2 Subsection 3(1)
Insert:
Commonwealth officer includes:
(a) a Minister; and
(b) a person holding:
(i) an office established by or under an Act; or
(ii) an appointment made under an Act; or
(iii) an appointment made by the Governor-General or a Minister but not
under an Act; and
(c) a person who is a member or officer of a Commonwealth authority;
and
(d) a person who is in the service or employment of the Commonwealth, or
of a Commonwealth authority, or is employed or engaged under an Act or
regulations made under an Act.
3 Subsection 3(1)
Insert:
State includes the Australian Capital Territory and the
Northern Territory.
4 After subsection 3(7)
Insert:
(7A) For the purposes of this Act, a corresponding State law imposes
a duty on a Commonwealth officer or Commonwealth authority if:
(a) the corresponding State law confers a function or power on the officer
or authority; and
(b) the circumstances in which the function or power is conferred give
rise to an obligation on the officer or authority to perform the function or to
exercise the power.
5 Section 6A
Repeal the section, substitute:
(1) A corresponding State law may confer functions or powers, or impose
duties, on:
(a) a Commonwealth officer; or
(b) a Commonwealth authority.
(2) Subsection (1) does not authorise the conferral of a function or
power, or the imposition of a duty, by a corresponding State law to the extent
to which:
(a) the conferral or imposition, or the authorisation, would contravene
any constitutional doctrines restricting the duties that may be imposed on
Commonwealth officers or Commonwealth authorities; or
(b) the authorisation would otherwise exceed the legislative power of the
Commonwealth.
(3) Subsection (1) does not extend to a function, power or duty of a
kind specified in regulations made for the purposes of this
subsection.
(4) This Act is not intended to exclude or limit the operation of a
corresponding State law that confers any functions or powers, or imposes any
duties, on a Commonwealth officer or Commonwealth authority to the extent to
which that law:
(a) is consistent with subsections (1) to (3); and
(b) is capable of operating concurrently with this Act.
Application
(1) This section applies if a corresponding State law purports to impose a
duty on a Commonwealth officer or Commonwealth authority.
State legislative power sufficient to support duty
(2) The duty is taken not to be imposed by this Act (or any other law of
the Commonwealth) to the extent to which:
(a) imposing the duty is within the legislative powers of the State
concerned; and
(b) imposing the duty by the corresponding State law is consistent with
the constitutional doctrines restricting the duties that may be imposed on a
Commonwealth officer or Commonwealth authority.
Note: If this subsection applies, the duty will be taken to
be imposed by force of the corresponding State law (the Commonwealth having
consented under section 6AAA to the imposition of the duty by the
corresponding State law).
Commonwealth legislative power sufficient to support duty but State
legislative powers are not
(3) If, to ensure the validity of the purported imposition of the duty, it
is necessary that the duty be imposed by a law of the Commonwealth (rather than
by force of the corresponding State law), the duty is taken to be imposed by
this Act to the extent necessary to ensure that validity.
(4) If, because of subsection (3), this Act is taken to impose the
duty, it is the intention of the Parliament to rely on all powers available to
it under the Constitution to support the imposition of the duty by this
Act.
(5) The duty is taken to be imposed by this Act in accordance with
subsection (3) only to the extent to which imposing the duty:
(a) is within the legislative powers of the Commonwealth; and
(b) is consistent with the constitutional doctrines restricting the duties
that may be imposed on a Commonwealth officer or Commonwealth
authority.
(6) To avoid doubt, neither this Act (nor any other law of the
Commonwealth) imposes a duty on the Commonwealth officer or Commonwealth
authority to the extent to which imposing such a duty would:
(a) contravene any constitutional doctrine restricting the duties that may
be imposed on a Commonwealth officer or Commonwealth authority; or
(b) otherwise exceed the legislative power of the Commonwealth.
(7) Subsections (1) to (6) do not limit section 6AAA.
(1) This section:
(a) applies only for the purposes of the application of the provisions of
this Act or another law of the Commonwealth (with or without modification) as a
law of a State by a provision of a corresponding State law; and
(b) does not apply for those purposes if the corresponding State law
otherwise provides.
(2) If the corresponding State law purports to impose a duty on a
Commonwealth officer or Commonwealth authority to do a particular thing, the
duty is taken to be imposed by the corresponding State law to the extent to
which imposing the duty:
(a) is within the legislative powers of the State; and
(b) is consistent with the constitutional doctrines restricting the duties
that may be imposed on a Commonwealth officer or Commonwealth
authority.
(3) To avoid doubt, the corresponding State law does not impose the duty
on the Commonwealth officer or Commonwealth authority to the extent to which
imposing the duty would:
(a) contravene any constitutional doctrine restricting the duties that may
be imposed on a Commonwealth officer or Commonwealth authority; or
(b) otherwise exceed the legislative powers of the State.
(4) If imposing on the Commonwealth officer or Commonwealth authority the
duty to do that thing would:
(a) contravene any constitutional doctrine restricting the duties that may
be imposed on a Commonwealth officer or Commonwealth authority; or
(b) otherwise exceed the legislative powers of both the State and the
Commonwealth;
the corresponding State law is taken instead to confer on the officer or
authority a power to do that thing at the discretion of the officer or
authority.
If:
(a) a provision of a corresponding State law purports to apply a provision
of a law of the Commonwealth (the applied provision) as a law of
the State; and
(b) the applied provision purports to confer jurisdiction in relation to a
matter on a federal court;
the jurisdiction in relation to that matter is taken to be conferred on the
court by this section.
(1) If a corresponding State law confers on a Commonwealth officer or
Commonwealth authority:
(a) the function of including goods in the Register; or
(b) the power to include goods in the Register;
the officer or authority may include the goods in the Register in
accordance with the corresponding State law.
(2) If a corresponding State law authorises or requires a Commonwealth
officer or Commonwealth authority to cancel the inclusion of goods in the
Register, the officer or authority may cancel the inclusion of the goods in the
Register in accordance with the corresponding State law.
(3) The inclusion of goods in the Register under subsection (1) does
not subject any person to any liability whatever under this Act, except a
liability under Part 5.
(4) A Commonwealth officer or Commonwealth authority may make any
notations in the Register that the officer or authority considers necessary to
identify entries that relate to goods included in the Register under
subsection (1).
(5) Goods may be included in the Register under subsection (1) even
though the same goods have already been included in the Register under another
provision of this Act.
(6) A reference in this section to the inclusion of goods in the Register
is a reference to the inclusion of the goods:
(a) in the part of the Register for goods known as registered goods;
or
(b) in the part of the Register for goods known as listed goods.
6 Subsection 6AAE(3)
Omit “Part 5”, substitute
“Part 6-1”.
7 At the end of subsection
6AAE(6)
Add:
; or (c) in the part of the Register for medical devices included under
Chapter 4.
Industrial Chemicals
(Notification and Assessment) Act 1989
1 Section 5 (definition of
Chairperson)
Repeal the definition.
2 Section 5 (definition of Chief
Executive Officer)
Repeal the definition.
3 Section 5 (definition of
Commission)
Repeal the definition.
4 Subsection 91(2)
Omit “Chief Executive Officer”, substitute “Secretary of
the Department”.
5 Subsection 91(3)
Repeal the subsection, substitute:
(3) The Secretary of the Department may require the Director to perform
functions or carry out duties for the Department in relation to chemicals to the
extent to which they do not interfere with the performance of functions referred
to in subsection (1) or (2).
6 Subsection 99(1)
Repeal the subsection, substitute:
(1) The Secretary of the Department may make the services of employees in
the Department available for the purposes of assessing chemicals under this Act
or assisting in the administration of this Act.
Note: The heading to section 99 is altered by omitting
“Commission” and substituting
“Department”.
7 Subsection 99(3)
Repeal the subsection, substitute:
(3) The functions or duties of the Director referred to in subsection
91(3) may be functions or duties relating to the control of employees in the
Department referred to in subsection (1) of this section while they are
performing functions and duties for the Department.
8 Subsection 100(1)
Omit “Chairperson”, substitute “Secretary of the
Department”.
9 At the end of Part 5
Add:
(1) The Industrial Chemicals Account is established.
(2) The Account is a Special Account for the purposes of the Financial
Management and Accountability Act 1997.
(1) There must be credited to the Account the following:
(a) all money appropriated by the Parliament for the purposes of the
Account;
(b) any amount of registration charge or amount on account of registration
charge paid under section 80F, 80K or 80S;
(c) any registration charge actually paid on an assessment under
section 80QA or on a reconsideration or review of such an
assessment;
(d) any fees received under subsection 110(1);
(e) amounts equal to amounts received by the Commonwealth in connection
with the performance of the Director’s functions under this Act or the
regulations;
(f) amounts equal to money received by the Commonwealth for services
provided or to be provided, by or on behalf of the Commonwealth, using money
from the Account;
(g) amounts equal to interest received by the Commonwealth from the
investment of money from the Account;
(h) amounts equal to money received by the Commonwealth in relation to
property paid for with money from the Account;
(i) amounts equal to amounts of any gifts given or bequests made for the
purposes of the Account;
(j) amounts equal to receipts relating to the recovery of debts (other
than debts in respect of statutory fines and penalties) by the Commonwealth that
are associated with expenditure of money from the Account;
(k) an amount equal to the sum of the amounts that:
(i) were payable to the National Occupational Health and Safety Commission
under section 58A of the National Occupational Health and Safety
Commission Act 1985; and
(ii) had not been paid to the Commission before this section
commences;
(l) amounts payable under subsection (2).
(2) The National Occupational Health and Safety Commission must pay to the
Commonwealth an amount equal to the sum of the amounts that:
(a) were paid to the Commission, under section 58A of the National
Occupational Health and Safety Commission Act 1985, before this section
commences; and
(b) have not been expended by the Commission.
(1) The purposes of the Account are to make payments:
(a) to further the object of this Act (as set out in section 3);
and
(b) without limiting paragraph (a):
(i) to enable the Director to perform functions under this Act and the
regulations; and
(ii) to enable the Director to make payments, on behalf of the
Commonwealth, under Part 3A; and
(c) to enable the Commonwealth to participate:
(i) in the international harmonisation of regulatory controls or standards
on industrial chemicals and other related activities; and
(ii) the development of international agreements and arrangements in
relation to industrial chemicals; and
(d) otherwise in connection with the performance of the Director’s
functions under this Act or the regulations; and
(e) to reimburse the National Occupational Health and Safety Commission
for amounts expended by the Commission, or to allow the Commission to meet
obligations incurred, before the commencement of this section for the purposes
of:
(i) enabling the Director of Chemicals Notification and Assessment to
perform functions under this Act or the regulations; or
(ii) enabling the Director to make payments, on behalf of the
Commonwealth, under Part 3A.
(2) Without limiting paragraph (1)(d), payments in connection with
the performance of the Director’s functions under this Act or the
regulations include payments in connection with litigation, administrative
review or other proceedings in relation to the performance of those
functions.
National Occupational Health
and Safety Commission Act 1985
10 Subsection 8(2A)
Repeal the subsection.
11 Section 58A
Repeal the section.
12 Section 59
Omit “, or for application as described in subsection
58A(2),”.
1 Subsection 3(1) (definition of approved
conformity assessment body)
Repeal the definition.
2 Subsection 3(1) (definition of conformity
assessment body)
Repeal the definition.
3 Subsection 3(1) (definition of conformity
assessment certificate)
Repeal the definition.
Note: If Schedule 1 to the Therapeutic Goods
Amendment (Medical Devices) Act 2002 commences before section 2 of this
Act, this item does not commence at all. See subsection 2(3) of this
Act.
4 Subsection 3(1)
Insert:
conformity assessment certificate means a certificate issued
under section 41EE.
Note: If Schedule 1 to the Therapeutic Goods
Amendment (Medical Devices) Act 2002 commences before section 2 of this
Act, this item does not commence at all. See subsection 2(3) of this
Act.
5 Subsection 3(1) (definition of conformity
assessment certificate)
Repeal the definition, substitute:
conformity assessment certificate means a certificate issued
under section 41EE.
Note: If Schedule 1 to the Therapeutic Goods
Amendment (Medical Devices) Act 2002 does not commence before section 2
of this Act, this item does not commence at all. See subsection 2(4) of this
Act.
6 Subsection 3(1)
Insert:
EC/EFTA attestation of conformity means an attestation of
conformity (within the meaning of the EC Mutual Recognition Agreement or the
EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment
body that is approved by the Secretary in writing.
7 Subsection 3(1)
Insert:
EC/EFTA conformity assessment body means a Conformity
Assessment Body designated in one of the following Sectoral Annexes to the EC
Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement:
(a) Sectoral Annex (Medical Devices);
(b) Sectoral Annex (Medicinal Products GMP Inspection and Batch
Certification).
8 Subsection 3(1)
Insert:
international instrument means:
(a) any treaty, convention, protocol, agreement or other instrument that
is binding in international law; and
(b) a part of such a treaty, convention, protocol, agreement or other
instrument.
9 Subsection 3(1)
Insert:
non-EC/EFTA attestation of conformity, for a non-EC/EFTA MRA,
means an attestation of conformity issued, after the non-EC/EFTA MRA has come
into force, by a conformity assessment body that is designated in the
non-EC/EFTA MRA and approved by the Secretary in writing for the non-EC/EFTA
MRA.
10 Subsection 3(1)
Insert:
non-EC/EFTA MRA means an international instrument that
Australia is bound by, or is a party to, if:
(a) a purpose of the instrument is the recognition of attestations of
conformity; and
(b) the instrument satisfies the requirements (if any) set out in
regulations made for the purposes of this paragraph;
but does not include:
(c) the EC Mutual Recognition Agreement; or
(d) the EFTA Mutual Recognition Agreement.
11 After section 3A
Insert:
(1) The Minister may declare, in writing, that a country specified in the
declaration is covered by the non-EC/EFTA MRA specified in the
declaration.
(2) A declaration under subsection (1) must be published in the
Gazette.
12 At the end of
section 24D
Add:
(6) Despite subsection (5), if:
(a) the Secretary has given the applicant all evaluation reports relating
to the application; and
(b) the Secretary has given those reports, or proposes to give those
reports, to a committee established under the regulations to advise the
Secretary on applications to register therapeutic goods to which
subsection (1) applies; and
(c) the applicant withdraws the application after being given the reports,
and before the end of the period mentioned in subsection (1);
the evaluation is taken for the purposes of subsections (2), (3) and
(4) to be completed immediately before the time of withdrawal.
13 Subparagraph 25(2)(a)(i)
Repeal the subparagraph, substitute:
(i) if the goods are not therapeutic devices and a step in the manufacture
of the goods has been carried out in a country that is a member of the European
Community or a member of EFTA—an EC/EFTA attestation of conformity in
relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a country declared by the
Minister under section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to
the goods; or
14 Paragraph 25B(1)(b)
Omit “a conformity assessment certificate”, substitute
“an EC/EFTA attestation of conformity”.
Note: The heading to section 25B is altered by omitting
“conformity assessment certificate” and substituting
“EC/EFTA attestation of conformity”.
15 Subparagraph 26(2)(a)(i)
Repeal the subparagraph, substitute:
(i) if the goods are not therapeutic devices and a step in the manufacture
of the goods has been carried out in a country that is a member of the European
Community or a member of EFTA—an EC/EFTA attestation of conformity in
relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a country declared by the
Minister under section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to
the goods; or
16 Paragraph 26AA(1)(b)
Omit “a conformity assessment certificate”, substitute
“an EC/EFTA attestation of conformity”.
Note: The heading to section 26AA is altered by
omitting “conformity assessment certificate” and substituting
“EC/EFTA attestation of conformity”.
17 Subparagraph
26A(4)(a)(i)
Repeal the subparagraph, substitute:
(i) if a step in the manufacture of the medicine has been carried out in a
country that is a member of the European Community or a member of EFTA—an
EC/EFTA attestation of conformity in relation to the medicine; or
(ia) if a step in the manufacture of the medicine has been carried out in
a country declared by the Minister under section 3B to be covered by a
non-EC/EFTA MRA—a non-EC/EFTA attestation of conformity, for the
non-EC/EFTA MRA, in relation to the medicine; or
18 After paragraph 37(1)(d)
Insert:
(da) if the applicant proposes to carry out steps in the manufacture of
blood or blood components under the licence—contain information relating
to those steps set out in regulations made for the purposes of this paragraph;
and
19 After paragraph 40(4)(a)
Insert:
(aa) if:
(i) the holder of the licence carries out, or proposes to carry out, steps
in the manufacture of blood or blood components under the licence; and
(ii) regulations made for the purposes of this paragraph set out
particular information relating to those steps;
comply with a request by the Secretary to provide such information, in
accordance with those regulations; and
20 Application
(1) The amendment made by item 12 applies in relation to applications
made on or after the commencement of that item.
(2) The amendment made by item 18 applies in relation to applications
for licences made on or after the commencement of that item.
(3) Paragraph 40(4)(a) of the Therapeutic Goods Act 1989 as amended
by this Schedule applies in relation to a request made under that paragraph on
or after the commencement of this item, even if the licence to which the request
relates was granted before that commencement.
21 Transitional
(1) An approval of a body as an approved conformity assessment body that
was in force under the Therapeutic Goods Act 1989 immediately before the
commencement time has effect after the commencement time as if it were an
approval of the body by the Secretary in writing for the purposes of the
definition of EC/EFTA attestation of conformity in subsection 3(1)
of the Therapeutic Goods Act 1989 as in force after the commencement
time.
(2) In subitem (1):
commencement time means the time at which this item
commences.
Therapeutic Goods Amendment
(Medical Devices) Act
2002
22 Item 7 of
Schedule 1
Repeal the item.
Note: If Schedule 1 to the Therapeutic Goods
Amendment (Medical Devices) Act 2002 commences before section 2 of this
Act, item 22 of this Schedule does not commence at all. See subsection 2(3)
of this Act.
1 Subsection 9A(5)
Repeal the subsection, substitute:
(5) The Minister may, by notice published in the Gazette:
(a) require that specified therapeutic goods be included in the part of
the Register for listed goods; and
(b) specify the conditions subject to which such goods may be included in
that part of the Register.
2 Subsection 17(5)
Repeal the subsection, substitute:
(5) The Minister may, by notice published in the Gazette:
(a) require that specified therapeutic goods be included in the part of
the Register for listed goods; and
(b) specify the conditions subject to which such goods may be included in
that part of the Register.
Note: If Schedule 1 to the Therapeutic Goods
Amendment (Medical Devices) Act 2002 commences before section 2 of this
Act, this item does not commence at all. See subsection 2(5) of this
Act.