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This is a Bill, not an Act. For current law, see the Acts databases.
2022
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Therapeutic Goods Amendment (2022
Measures No. 1) Bill 2022
No. , 2022
(Health and Aged Care)
A Bill for an Act to amend the Therapeutic Goods
Act 1989, and for related purposes
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Mandatory reporting of adverse events involving
medical devices
3
Therapeutic Goods Act 1989
3
Schedule 2--Export only biologicals
7
Therapeutic Goods Act 1989
7
Schedule 3--Decisions to give information gathering notices
are not reviewable decisions
14
Therapeutic Goods Act 1989
14
Schedule 4--Extension of time to pay amount under
infringement notice
15
Therapeutic Goods Act 1989
15
Schedule 5--Information gathering powers
17
Therapeutic Goods Act 1989
17
Schedule 6--Retention of seized things
22
Therapeutic Goods Act 1989
22
Schedule 7--Reducing regulatory burden for therapeutic goods
advertisers
23
Therapeutic Goods Act 1989
23
Schedule 8--Use of restricted representations
25
Therapeutic Goods Act 1989
25
Schedule 9--Approval of importation or supply of
substitutable medicine
26
Therapeutic Goods Act 1989
26
Schedule 10--Release of information
29
Therapeutic Goods Act 1989
29
Schedule 11--Reporting medicine shortages
30
ii
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Therapeutic Goods Act 1989
30
Schedule 12--Other amendments
34
Therapeutic Goods Act 1989
34
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
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 is the
Therapeutic Goods Amendment (2022 Measures
5
No. 1) Act 2022
.
6
2 Commencement
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 (2022 Measures No. 1) Bill 2022
No. , 2022
Commencement information
Column 1
Column 2
Column 3
Provisions
Commencement
Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day this Act receives the Royal Assent.
2. Schedule 1
A single day to be fixed by Proclamation.
However, if the provisions do not commence
within the period of 24 months beginning on
the day this Act receives the Royal Assent,
they commence on the day after the end of
that period.
3. Schedule 2
The day after the end of the period of 3
months beginning on the day this Act
receives the Royal Assent.
4. Schedules 3 to
10
The day after this Act receives the Royal
Assent.
5. Schedule 11
The day after the end of the period of 6
months beginning on the day this Act
receives the Royal Assent.
6. Schedule 12
The day after this Act receives the Royal
Assent.
Note:
This table relates only to the provisions of this Act as originally
1
enacted. It will not be amended to deal with any later amendments of
2
this Act.
3
(2) Any information in column 3 of the table is not part of this Act.
4
Information may be inserted in this column, or information in it
5
may be edited, in any published version of this Act.
6
3 Schedules
7
Legislation 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
Mandatory reporting of adverse events involving medical devices
Schedule 1
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
3
Schedule 1--Mandatory reporting of adverse
1
events involving medical devices
2
3
Therapeutic Goods Act 1989
4
1 Subsection 3(1)
5
Insert:
6
healthcare facility
means:
7
(a) a public hospital; or
8
(b) a private hospital; or
9
(c) any other facility prescribed by regulations made for the
10
purposes of this paragraph.
11
hospital
has the meaning given by subsection 121-5(5) of the
12
Private Health Insurance Act 2007
.
13
private hospital
means a hospital in respect of which there is in
14
force a statement under subsection 121-5(8) of the
Private Health
15
Insurance Act 2007
that the hospital is a private hospital.
16
public hospital
means a hospital in respect of which there is in
17
force a statement under subsection 121-5(8) of the
Private Health
18
Insurance Act 2007
that the hospital is a public hospital.
19
reportable medical device
means a medical device of a kind
20
prescribed by regulations made for the purposes of this definition.
21
2 Subsection 6(1)
22
After "other than", insert "Part 4-8A or".
23
3 At the end of subsection 6(1)
24
Add:
25
Note:
Part 4-8A is about mandatory reporting, by healthcare facilities, of
26
adverse events involving medical devices.
27
4 After Part 4-8
28
Insert:
29
Schedule 1
Mandatory reporting of adverse events involving medical devices
4
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Part 4-8A--Mandatory reporting of adverse events
1
by healthcare facilities
2
Division 1--Preliminary
3
41JK Simplified outline of this Part
4
The chief executive officer (however described) of a healthcare
5
facility is required to give a report to the Secretary about an
6
adverse event involving a reportable medical device in certain
7
circumstances.
8
Civil penalties apply to the chief executive officer of a healthcare
9
facility for failing to give such a report to the Secretary.
10
41JL Purposes of this Part
11
The purposes of this Part are to facilitate the following:
12
(a) monitoring and enforcing compliance with the requirements
13
of this Chapter;
14
(b) monitoring the safety and performance of medical devices;
15
(c) any activities that are incidental to the above purposes.
16
Division 2--Mandatory reporting of adverse events
17
41JM Requirement to report adverse events involving reportable
18
medical devices
19
Report to be given to the Secretary
20
(1) The chief executive officer (however described) of a healthcare
21
facility must give a report to the Secretary if subsection (2), (3) or
22
(4) applies to the healthcare facility in relation to a reportable
23
medical device and a person.
24
(2) This subsection applies to a healthcare facility if:
25
(a) a reportable medical device is used in the facility; and
26
Mandatory reporting of adverse events involving medical devices
Schedule 1
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
5
(b) the use of the device has resulted in the death, or a serious
1
deterioration in the health, of a person while the device is
2
used in the facility.
3
(3) This subsection applies to a healthcare facility if:
4
(a) a reportable medical device is not used in the facility because
5
of the intervention of a person in the facility; and
6
(b) the use of the device, if the device were used, would result in,
7
or would be likely to result in, the death, or a serious
8
deterioration in the health, of a person.
9
(4) This subsection applies to a healthcare facility if:
10
(a) a health practitioner provides treatment to a person in the
11
facility for a serious deterioration in the health of the person;
12
and
13
(b) the use of a reportable medical device has resulted in the
14
serious deterioration in the health of the person.
15
Report requirements
16
(5) The report must include the following information about the
17
reportable medical device and the person:
18
(a) the name, or a description, of the reportable medical device;
19
(b) a description of the matters covered in subsection (2), (3) or
20
(4);
21
(c) any other information prescribed by regulations made for the
22
purposes of this paragraph.
23
Note:
For the release of information included in, or relating to, a report, see
24
section 61.
25
(6) The report must be given to the Secretary:
26
(a) within the period prescribed by regulations made for the
27
purposes of this subparagraph or such longer period as the
28
Secretary allows in a particular case; and
29
(b) in the manner prescribed by regulations made for the
30
purposes of this subparagraph.
31
Schedule 1
Mandatory reporting of adverse events involving medical devices
6
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Exception
1
(7) Subsection (1) does not apply if the chief executive officer
2
(however described) of the healthcare facility has reported the
3
matters covered by subsection (2), (3) or (4) to:
4
(a) the chief executive officer of the Australian Commission on
5
Safety and Quality in Health Care; or
6
(b) the head (however described) of a Department of State of a
7
State or Territory that has responsibility for matters relating
8
to health; or
9
(c) any other person prescribed by regulations made for the
10
purposes of this paragraph.
11
Civil penalty
12
(8) A person contravenes this subsection if:
13
(a) the person is required to give a report to the Secretary in
14
accordance with this section; and
15
(b) the person fails to comply with the requirement.
16
Maximum civil penalty:
30 penalty units.
17
5 Application provision
18
Section 41JM of the
Therapeutic Goods Act 1989
, as inserted by this
19
Schedule, applies in relation to:
20
(a) a reportable medical device that is used, on or after the
21
commencement of this Schedule, in a healthcare facility; or
22
(b) a reportable medical device that is not used in a healthcare
23
facility because of the intervention, on or after that
24
commencement, of a person in the facility; or
25
(c) treatment provided, on or after that commencement, by a
26
health practitioner to a person in a healthcare facility for a
27
serious deterioration in the health of the person.
28
Export only biologicals
Schedule 2
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
7
Schedule 2--Export only biologicals
1
2
Therapeutic Goods Act 1989
3
1 Subsection 3(1) (paragraph (a) of the definition of biological
4
number)
5
After "32DB(2),", insert "32DCB(2),".
6
2 Subsection 3(1) (definition of Class 1 biological)
7
After "biological", insert ", other than an export only biological,".
8
3 Subsection 3(1)
9
Insert:
10
export only biological
means a biological that is:
11
(a) manufactured in Australia for export only; or
12
(b) imported into Australia for export only.
13
4 Paragraph 9(1)(aa)
14
After "Class 1 biological", insert "or an export only biological".
15
5 Paragraph 9A(4)(ca)
16
After "32DB(2),", insert "32DCB(2),".
17
6 Section 32D
18
Repeal the section, substitute:
19
32D Simplified outline of this Division
20
A Class 1 biological can be included in the Register if a proper
21
application is made and the applicant certifies various matters (see
22
Subdivision B).
23
An export only biological can be included in the Register if a
24
proper application is made, the applicant certifies various matters
25
and, if steps in the manufacture of the biological have been carried
26
out outside Australia, the Secretary has certified (where
27
Schedule 2
Export only biologicals
8
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
appropriate) that the manufacturing and quality control procedures
1
used in those steps are acceptable (see Subdivision BA).
2
A biological, other than a Class 1 biological or an export only
3
biological, can be included in the Register if a proper application is
4
made and the Secretary is satisfied the biological is suitable for
5
inclusion following an evaluation of the biological (see
6
Subdivision C).
7
7 After Subdivision B of Division 4 of Part 3-2A
8
Insert:
9
Subdivision BA--Export only biologicals
10
32DCA Application for inclusion in the Register
11
Application
12
(1) A person may make an application to the Secretary to include an
13
export only biological in the Register.
14
(2) The application must:
15
(a) be made in accordance with a form that is approved, in
16
writing, by the Secretary; and
17
(b) be accompanied by a statement made by the applicant
18
certifying the matters mentioned in subsection (4); and
19
(c) be accompanied by the fee prescribed by regulations made
20
for the purposes of this paragraph.
21
(3) An approval of a form may require or permit an application to be
22
given in accordance with specified software requirements:
23
(a) on a specified kind of data processing device; or
24
(b) by way of a specified kind of electronic transmission.
25
Certification of matters
26
(4) The matters the applicant must certify are:
27
(a) that the biological is an export only biological; and
28
(b) that the biological is safe for the purposes for which it is to
29
be used; and
30
Export only biologicals
Schedule 2
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
9
(c) that the presentation of the biological is not unacceptable;
1
and
2
(d) that the biological conforms to every standard (if any)
3
applicable to it; and
4
(e) that the requirements (if any) relating to advertising
5
applicable under Part 5-1 or under the regulations are
6
complied with in relation to the biological; and
7
(f) that the biological complies with all prescribed quality or
8
safety criteria that are applicable to it; and
9
(g) that all the manufacturers of the biological are nominated as
10
manufacturers in the application; and
11
(h) if a step in the manufacture of the biological has been carried
12
out in Australia--that the biological is exempt from the
13
operation of Part 3-3 or that the step has been carried out by a
14
person who:
15
(i) is the holder of a licence to carry out that step; or
16
(ii) is exempt from the operation of that Part in relation to
17
that step; and
18
(i) that the biological does not contain substances that are
19
prohibited imports for the purposes of the
Customs Act 1901
;
20
and
21
(j) if there are one or more absolute prohibitions in force for the
22
purposes of subsection 9K(1) or (3):
23
(i) if those prohibitions cover imports--that any imports
24
into Australia of the biological by, or on behalf of the
25
applicant, will not contravene those prohibitions; and
26
(ii) if those prohibitions cover exports--that any exports
27
from Australia of the biological by, or on behalf of the
28
applicant, will not contravene those prohibitions; and
29
(k) if there are one or more prohibitions in force for the purposes
30
of subsection 9K(1) or (3) that are subject to conditions:
31
(i) if those prohibitions cover imports--that any imports
32
into Australia of the biological by, or on behalf of the
33
applicant, will not contravene those conditions; and
34
(ii) if those prohibitions cover exports--that any exports
35
from Australia of the biological by, or on behalf of the
36
applicant, will not contravene those conditions; and
37
Schedule 2
Export only biologicals
10
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
(l) any other matter prescribed by regulations made for the
1
purposes of this paragraph.
2
Manufacturing steps outside Australia
3
(5) Subject to subsection (7), if one or more steps in the manufacture
4
of the biological have been carried out outside Australia, the
5
Secretary must certify, or refuse to certify, that the manufacturing
6
and quality control procedures used in each such step are
7
acceptable.
8
Note:
See also subsections 32EA(5), (7A) and (7B) and section 32EB in
9
relation to conditions and certifications for the manufacture of a
10
biological outside Australia after the biological is included in the
11
Register.
12
(6) In deciding whether so to certify for the purposes of subsection (5),
13
the matters that may be taken into account include:
14
(a) whether the applicant has provided:
15
(i) if a step in the manufacture of the biological has been
16
carried out in a country that is a member of the
17
European Community or a member of EFTA--an
18
EC/EFTA attestation of conformity in relation to the
19
biological; or
20
(ii) if a step in the manufacture of the biological has been
21
carried out in a country declared by the Minister under
22
section 3B to be covered by a non-EC/EFTA MRA--a
23
non-EC/EFTA attestation of conformity, for the
24
non-EC/EFTA MRA, in relation to the biological; or
25
(iii) in any other case--an acceptable form of evidence from
26
a relevant overseas authority establishing that the
27
manufacture of the biological is of an acceptable
28
standard; and
29
(b) whether the applicant has agreed to provide, if the Secretary
30
considers inspection of the manufacturing procedures used in
31
the manufacture of the biological to be necessary:
32
(i) funds for the carrying out of that inspection by, or on
33
behalf of, the Secretary; and
34
(ii) evidence that the manufacturer has agreed to such an
35
inspection; and
36
Export only biologicals
Schedule 2
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
11
(c) whether the applicant has complied with any requirements
1
made by the Secretary under section 32JA in relation to the
2
manufacture of the biological.
3
(7) If:
4
(a) one or more steps in the manufacture of the biological have
5
been carried out outside Australia; and
6
(b) had the biological been manufactured in Australia, it would
7
have been exempt from the operation of Part 3-3 because of
8
the operation of subsection 34(1);
9
subsection (5) of this section does not apply in relation to those
10
steps.
11
32DCB Inclusion of export only biological in the Register
12
Secretary must include biological in Register
13
(1) The Secretary must include an export only biological in the
14
Register in relation to a person if:
15
(a) an application is made under subsection 32DCA(1) for the
16
biological to be included in the Register in relation to the
17
person; and
18
(b) the application complies with subsection 32DCA(2); and
19
(c) if one or more steps in the manufacture of the biological have
20
been carried out outside Australia and the Secretary is
21
required to make a decision under subsection 32DCA(5)--
22
the Secretary has certified, under that subsection, that the
23
manufacturing and quality control procedures used in each
24
such step are acceptable.
25
Biological number
26
(2) If the Secretary includes the biological in the Register, the
27
Secretary must assign a unique number to the biological. The
28
number assigned may be any combination of numbers and either or
29
both of letters and symbols.
30
Note:
The number assigned is the biological number of the biological.
31
Schedule 2
Export only biologicals
12
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Certificate
1
(3) As soon as practicable after the biological has been included in the
2
Register, the Secretary must give to the applicant a certificate of
3
the inclusion of the biological in the Register.
4
(4) The certificate must:
5
(a) specify the biological number of the biological; and
6
(b) specify the day on which the inclusion of the biological in the
7
Register commences.
8
Duration of inclusion in the Register
9
(5) The biological remains included in the Register in relation to the
10
person until the Secretary cancels the entry of the biological from
11
the Register under this Part.
12
Note:
The biological is taken not to be included in the Register while it is
13
suspended: see section 32FD.
14
32DCC Refusal to include export only biological in the Register
15
If:
16
(a) a person makes an application under subsection 32DCA(1) to
17
include an export only biological in the Register; and
18
(b) the Secretary refuses the application;
19
the Secretary must, as soon as practicable after the refusal, give the
20
person notice of the refusal and of the reasons for the refusal.
21
8 Subdivision C of Division 4 of Part 3-2A (heading)
22
Repeal the heading, substitute:
23
Subdivision C--Biologicals other than Class 1 biologicals or
24
export only biologicals
25
9 Section 32DD
26
After "Class 1 biological", insert "or an export only biological".
27
10 Subsection 32EA(7)
28
Omit "the evaluation", substitute "any evaluation".
29
Export only biologicals
Schedule 2
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
13
11 After subsection 32EA(7)
1
Insert:
2
(7A) Paragraph (5)(b) does not apply in relation to a step that:
3
(a) is the subject of a certification in force under
4
subsection 32DCA(5); or
5
(b) was not required to be the subject of a decision under that
6
subsection because of subsection 32DCA(7).
7
(7B) Paragraph (7A)(a) ceases to apply in relation to that step if either or
8
both of the following occur:
9
(a) that step begins to be carried out at premises that are different
10
from the premises in respect of which that certification was
11
given;
12
(b) that step begins to be carried out by a manufacturer that is
13
different from the manufacturer in respect of which that
14
certification was given.
15
12 After subsection 32GA(1)
16
Insert:
17
(1AA) Paragraph (1)(k) does not apply to export only biologicals.
18
13 Paragraph 32GB(1)(b)
19
After "32DA(3)", insert "or 32DCA(4)".
20
Schedule 3
Decisions to give information gathering notices are not reviewable
decisions
14
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Schedule 3--Decisions to give information
1
gathering notices are not reviewable
2
decisions
3
4
Therapeutic Goods Act 1989
5
1 Subsection 60(1) (paragraph (i) of the definition of initial
6
decision)
7
Repeal the paragraph.
8
2 After subsection 60(1)
9
Insert:
10
(1AA) A decision under a provision of this Act to give a notice to a person
11
requiring the person to give information, or give or produce
12
documents, to the Secretary is not an initial decision for the
13
purposes of this section.
14
3 Application provision
15
The amendments made by this Schedule apply in relation to a notice
16
given on or after the commencement of this item.
17
Extension of time to pay amount under infringement notice
Schedule 4
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
15
Schedule 4--Extension of time to pay amount
1
under infringement notice
2
3
Therapeutic Goods Act 1989
4
1 Section 42YKB
5
Repeal the section, substitute:
6
42YKB Extension of time to pay amount--application by person
7
(1) A person to whom an infringement notice has been given may
8
apply to the Secretary for an extension of the period (the
current
9
period
) for paying the amount stated in the notice.
10
Note:
The current period for paying the amount may be the 28-day period
11
referred to in paragraph 42YKA(1)(h) or an extended period under
12
this section or section 42YKBA.
13
(2) If the application is made before the end of the current period, the
14
Secretary may, in writing, extend that period. The Secretary may
15
do so before or after the end of that period.
16
(3) For the purposes of this Part, if the Secretary extends the current
17
period, the period within which the amount stated in the notice is to
18
be paid is the extended period.
19
(4) For the purposes of this Part, if the Secretary does not extend the
20
current period, the period within which the amount stated in the
21
notice is to be paid is the period that ends at the end of the later of
22
the following days:
23
(a) the day that is the last day of the current period;
24
(b) the day that is 7 days after the day the person was given
25
notice of the Secretary's decision not to extend.
26
(5) The Secretary may give more than one extension under this section
27
in relation to the infringement notice.
28
Schedule 4
Extension of time to pay amount under infringement notice
16
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
42YKBA Extension of time to pay amount--extension by Secretary
1
on own initiative
2
(1) If the Secretary gives a person an infringement notice, the
3
Secretary may, on the Secretary's own initiative and in writing,
4
extend the period for paying the amount stated in the notice. The
5
Secretary may do so before or after the end of that period.
6
Note:
The period for paying the amount may be the 28-day period referred
7
to in paragraph 42YKA(1)(h) or an extended period under
8
section 42YKB or this section.
9
(2) For the purposes of this Part, if the Secretary extends that period,
10
the period within which the amount stated in the notice is to be
11
paid is the extended period.
12
(3) The Secretary must give the person notice of the Secretary's
13
decision.
14
(4) The Secretary may give more than one extension under this section
15
in relation to the infringement notice.
16
2 Subsection 42YKD(1)
17
Omit "referred to in paragraph 42YKA(1)(h)", substitute "within which
18
the amount is to be paid".
19
3 Application provision
20
The amendments made by this Schedule apply in relation to the
21
following:
22
(a) an infringement notice given on or after the commencement
23
of this item;
24
(b) an infringement notice given before that commencement,
25
where the period within which the amount stated in the notice
26
is to be paid had not ended before that commencement.
27
Information gathering powers
Schedule 5
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
17
Schedule 5--Information gathering powers
1
2
Therapeutic Goods Act 1989
3
1 Subsection 6(1)
4
After "This Act", insert "(other than Part 6-1A)".
5
2 After Part 6-1
6
Insert:
7
Part 6-1A--Information gathering powers
8
Division 1--Preliminary
9
45AA Simplified outline of this Part
10
The Secretary can gather information or documents that are
11
relevant to a contravention or possible contravention of this Act or
12
the regulations.
13
Division 2--Obtaining information or documents
14
45AB Secretary may require information or documents
15
(1) The Secretary may, by written notice given to a person, require the
16
person to give to the Secretary any information, or produce to the
17
Secretary any documents, specified in the notice that are relevant
18
to a contravention, or possible contravention, of a provision of this
19
Act or the regulations.
20
(2) The notice must specify a reasonable period within which the
21
person must comply with the notice. The period must be at least 14
22
days starting on the day on which the notice is given.
23
(3) The notice must set out the effect of the following:
24
(a) section 45AC (about failure to comply with notice);
25
Schedule 5
Information gathering powers
18
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
(b) section 45AD (about giving false or misleading information
1
or documents);
2
(c) section 137.1 of the
Criminal Code
(about giving false or
3
misleading information);
4
(d) section 137.2 of the
Criminal Code
(about producing false or
5
misleading documents).
6
(4) The notice may require the information to be given, or the
7
documents to be produced, in accordance with specified software
8
requirements:
9
(a) on a specified kind of data processing device; or
10
(b) by way of a specified kind of electronic transmission.
11
45AC Offences for failing to comply with notice
12
Fault-based offence
13
(1) A person commits an offence if:
14
(a) the person is given a notice under section 45AB; and
15
(b) the person fails to comply with the notice.
16
Penalty: 500 penalty units.
17
Strict liability offence
18
(2) A person commits an offence of strict liability if:
19
(a) the person is given a notice under section 45AB; and
20
(b) the person fails to comply with the notice.
21
Penalty: 100 penalty units.
22
Exception
23
(3) Subsection (1) or (2) does not apply if the person has a reasonable
24
excuse.
25
Note:
A defendant bears an evidential burden in relation to the matter in
26
subsection (3): see subsection 13.3(3) of the
Criminal Code
.
27
Information gathering powers
Schedule 5
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
19
45AD Offences and civil penalty for giving false or misleading
1
information or documents
2
Fault-based offence
3
(1) A person commits an offence if:
4
(a) the person is given a notice under section 45AB; and
5
(b) the person gives information, or produces a document, in
6
compliance or purported compliance with the notice; and
7
(c) the information or document is false or misleading in a
8
material particular.
9
Note:
For the liability of an executive officer of a body corporate, see
10
sections 54B and 54BA.
11
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
12
both.
13
Strict liability offence
14
(2) A person commits an offence of strict liability if:
15
(a) the person is given a notice under section 45AB; and
16
(b) the person gives information, or produces a document, in
17
compliance or purported compliance with the notice; and
18
(c) the information or document is false or misleading in a
19
material particular.
20
Penalty: 100 penalty units.
21
Civil penalty provision
22
(3) A person contravenes this subsection if:
23
(a) the person is given a notice under section 45AB; and
24
(b) the person gives information, or produces a document, in
25
compliance or purported compliance with the notice; and
26
(c) the information or document is false or misleading in a
27
material particular.
28
Maximum civil penalty:
29
(a) for an individual--5,000 penalty units; and
30
(b) for a body corporate--50,000 penalty units.
31
Schedule 5
Information gathering powers
20
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
45AE Self-incrimination
1
(1) An individual is not excused from giving information or producing
2
a document under section 45AB on the ground that giving the
3
information or producing the document might tend to incriminate
4
the individual in relation to an offence.
5
Note:
A body corporate is not entitled to claim the privilege against
6
self-incrimination.
7
(2) However:
8
(a) the information given or document produced; and
9
(b) the giving of the information or the production of the
10
document; and
11
(c) any information, document or thing obtained as a direct or
12
indirect consequence of the giving of the information or the
13
production of the document;
14
are not admissible in evidence against the individual in criminal
15
proceedings other than proceedings for an offence against:
16
(d) subsection 45AC(1) or (2); or
17
(e) subsection 45AD(1) or (2); or
18
(f) section 137.1 or 137.2 of the
Criminal Code
in relation to
19
giving the information or producing the document.
20
(3) If, at general law, an individual would otherwise be able to claim
21
the privilege against self-exposure to a penalty (other than a
22
penalty for an offence) in relation to giving information or
23
producing a document under section 45AB, the individual is not
24
excused from giving the information or producing the document
25
under that provision on that ground.
26
Note:
A body corporate is not entitled to claim the privilege against
27
self-exposure to a penalty.
28
Division 3--Inspecting, copying and retaining documents
29
45AF Secretary may inspect and copy documents
30
The Secretary may inspect a document produced under
31
section 45AB and make and retain copies of the whole or a part of
32
the document.
33
Information gathering powers
Schedule 5
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
21
45AG Secretary may retain documents
1
Retention of documents
2
(1) The Secretary may take possession of a document produced under
3
section 45AB and retain it for as long as is reasonably necessary.
4
Certified copy of documents
5
(2) The person otherwise entitled to possession of a document
6
produced under section 45AB is entitled to be supplied, as soon as
7
practicable, with a copy certified by the Secretary to be a true copy.
8
(3) The certified copy must be received in all courts and tribunals as
9
evidence as if it were the original.
10
(4) Until a certified copy is supplied, the Secretary must provide the
11
person otherwise entitled to possession of the document, or a
12
person authorised by that person, reasonable access to the
13
document for the purposes of inspecting and making copies of the
14
whole or a part of the document.
15
3 Section 54BA (after table item 47)
16
Insert:
17
47A
Subsection 45AD(1)
4 Application provision
18
Part 6-1A of the
Therapeutic Goods Act 1989
, as inserted by this
19
Schedule, applies in relation to notices given under section 45AB of
20
that Act on or after the commencement of this item, whether the
21
contravention, or possible contravention, mentioned in that section
22
occurs before, on or after that commencement.
23
Schedule 6
Retention of seized things
22
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Schedule 6--Retention of seized things
1
2
Therapeutic Goods Act 1989
3
1 Section 48H
4
Omit "90" (wherever occurring), substitute "120".
5
2 Paragraph 48J(1)(a)
6
Omit "90", substitute "120".
7
3 Application provision
8
The amendments made by this Schedule apply in relation to things
9
seized, under Part 6-2 of the
Therapeutic Goods Act 1989
, on or after
10
the commencement of this item.
11
Reducing regulatory burden for therapeutic goods advertisers
Schedule 7
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
23
Schedule 7--Reducing regulatory burden for
1
therapeutic goods advertisers
2
3
Therapeutic Goods Act 1989
4
1 Paragraph 42AA(1)(a)
5
Repeal the paragraph, substitute:
6
(a) health practitioners; or
7
(aa) persons who, under a law of a State or internal Territory, are
8
registered or licensed to practice in any of the following
9
health professions:
10
(i) chiropractic;
11
(ii) dental therapy, dental hygiene, dental prosthetics or oral
12
health therapy;
13
(iii) osteopathy;
14
(iv) paramedicine; or
15
2 After subparagraph 42AA(1)(b)(ii)
16
Insert:
17
(iii) purchasing therapeutic goods on behalf of a registered
18
charity; or
19
(iv) purchasing therapeutic goods on behalf of a government
20
or government authority (including a foreign
21
government or foreign government authority); or
22
(v) purchasing officers, or practice managers, for a person
23
mentioned in paragraph (a) or (aa) (other than a person
24
in a retail pharmacy who, under a law of a State or
25
internal Territory, is registered or licensed to practice in
26
the health profession of pharmacy); or
27
3 Paragraph 42AA(1)(c)
28
Omit ", practitioners of traditional Chinese medicine or podiatrists",
29
substitute "or practitioners of traditional Chinese medicine".
30
4 Subsection 42AA(4)
31
After "paragraph (1)(a)", insert ", (aa)".
32
Schedule 7
Reducing regulatory burden for therapeutic goods advertisers
24
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
5 Section 42B
1
Insert:
2
registered charity
means an entity that is registered under the
3
Australian Charities and Not-for-profits Commission Act 2012
as
4
the type of entity mentioned in column 1 of item 1 of the table in
5
subsection 25-5(5) of that Act.
6
6 Application provision
7
The amendments made by this Schedule apply in relation to
8
advertisements occurring on or after the commencement of this item.
9
Use of restricted representations
Schedule 8
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
25
Schedule 8--Use of restricted representations
1
2
Therapeutic Goods Act 1989
3
1 Subparagraph 42DI(1)(b)(i)
4
After "safety", insert "or efficacy".
5
2 Application provision
6
The amendment made by this Schedule applies in relation to approvals
7
given on or after the commencement of this item.
8
Schedule 9
Approval of importation or supply of substitutable medicine
26
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Schedule 9--Approval of importation or
1
supply of substitutable medicine
2
3
Therapeutic Goods Act 1989
4
1 Subparagraphs 19A(1)(c)(i), (1A)(e)(i) and (2)(c)(i)
5
Omit "of the Therapeutic Goods Regulations", substitute "to the
6
Therapeutic Goods Regulations 1990
".
7
2 After subsection 19A(2)
8
Insert:
9
(2A) The Secretary may, by notice in writing, grant an approval to a
10
person for the importation into Australia, or the supply in
11
Australia, of specified therapeutic goods (the
subject goods
) if the
12
Secretary is satisfied:
13
(a) that there are no registered goods that could act as a
14
substitute for the subject goods; and
15
(b) either:
16
(i) that previously registered goods could act as a substitute
17
for the subject goods; or
18
(ii) that therapeutic goods whose registration is suspended
19
under section 29D could act as a substitute for the
20
subject goods; and
21
(c) that the subject goods are registered or approved for general
22
marketing in at least one foreign country specified by the
23
Secretary in a determination under subsection (3); and
24
(d) that the subject goods are of a kind included in Schedule 10
25
to the
Therapeutic Goods Regulations 1990
; and
26
(e) that the approval is necessary in the interests of public health.
27
(2B) The Secretary may, by notice in writing, grant an approval to a
28
person for the importation into Australia, or the supply in
29
Australia, of specified therapeutic goods (the
subject goods
) if the
30
Secretary is satisfied:
31
(a) that there are no registered goods that could act as a
32
substitute for the subject goods; and
33
Approval of importation or supply of substitutable medicine
Schedule 9
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
27
(b) either:
1
(i) that previously registered goods could act as a substitute
2
for the subject goods; or
3
(ii) that therapeutic goods whose registration is suspended
4
under section 29D could act as a substitute for the
5
subject goods; and
6
(c) that all of the following apply:
7
(i) the subject goods are not registered or approved for
8
general marketing in any of the foreign countries
9
specified by the Secretary in a determination under
10
subsection (3);
11
(ii) the subject goods are registered or approved for general
12
marketing in at least one foreign country that is not
13
specified by the Secretary in a determination under
14
subsection (3);
15
(iii) the manufacturing and quality control procedures used
16
in the manufacture of the subject goods are acceptable;
17
and
18
(d) that the subject goods are of a kind included in Schedule 10
19
to the
Therapeutic Goods Regulations 1990
; and
20
(e) that the approval is necessary in the interests of public health.
21
3 Subsection 19A(3)
22
Repeal the subsection, substitute:
23
(3) The Secretary may make written determinations specifying foreign
24
countries for the purposes of this section.
25
4 Paragraph 19A(9)(a)
26
Omit "or paragraph (2)(a), (b), (ba), (c) or (d)", substitute
27
"paragraph (2)(a), (b), (ba), (c) or (d), paragraph (2A)(a), (b), (c), (d) or
28
(e) or paragraph (2B)(a), (b), (c), (d) or (e)".
29
5 Subsection 19A(11)
30
Omit "or (2)", substitute ", (2), (2A) or (2B)".
31
6 Subsection 31BA(1)
32
Omit "or (2)", substitute ", (2), (2A) or (2B)".
33
Schedule 9
Approval of importation or supply of substitutable medicine
28
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
7 Paragraph 52G(3)(e)
1
Omit "or (2)", substitute ", (2), (2A) or (2B)".
2
8 Saving provision
3
A determination that was in force under subsection 19A(3) of the
4
Therapeutic Goods Act 1989
immediately before the commencement of
5
this item continues in force (and may be dealt with) on and after that
6
commencement as if it had been made under that subsection as
7
substituted by this Schedule.
8
Release of information
Schedule 10
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
29
Schedule 10--Release of information
1
2
Therapeutic Goods Act 1989
3
1 At the end of section 61
4
Add:
5
(13) The Secretary is not required to observe any requirements of the
6
natural justice hearing rule in relation to releasing information
7
under this section.
8
(14) Subsection (13) is not to be taken to imply that the natural justice
9
hearing rule applies in relation to any other exercise of power
10
under this Act or the regulations.
11
2 Application provision
12
The amendment made by this Schedule applies in relation to the release
13
of information on or after the commencement of this item, whether the
14
information started to be held, or was obtained, before, on or after that
15
commencement.
16
Schedule 11
Reporting medicine shortages
30
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Schedule 11--Reporting medicine shortages
1
2
Therapeutic Goods Act 1989
3
1 Subsection 3(1)
4
Insert:
5
period
of a shortage of a medicine in Australia has the meaning
6
given by section 30EIA.
7
2 Subsection 30EF(1)
8
After "any shortage of the medicine in Australia", insert "at a particular
9
time".
10
3 Paragraph 30EF(1)(a)
11
After "critical impact", insert "at that time".
12
4 After paragraph 30EF(4)(a)
13
Insert:
14
(aa) specify the period of the shortage of the medicine in
15
Australia; and
16
5 Paragraph 30EF(4)(b)
17
Omit "the", substitute "any other".
18
6 At the end of subsection 30EF(4)
19
Add:
20
Note:
For
period
of a shortage of a medicine in Australia, see section 30EIA.
21
7 Subsection 30EF(7) (heading)
22
Repeal the heading, substitute:
23
Exceptions
24
8 At the end of section 30EF
25
Add:
26
Reporting medicine shortages
Schedule 11
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
31
(8) A person is not subject to a requirement under subsection (1), in
1
relation to a shortage (the
relevant shortage
) of a medicine in
2
Australia at a particular time, if:
3
(a) the person has complied with the requirement under
4
subsection (1) in relation to a shortage (the
notified shortage
)
5
of the same medicine at an earlier time; and
6
(b) the period of the shortage of the medicine in respect of the
7
notified shortage (including any change to that period) is the
8
same as the period of the shortage of the medicine in respect
9
of the relevant shortage.
10
Example: There is a shortage of a medicine in Australia on 1 January 2024
11
because, at a time in the 6 months after that day, the supply of the
12
medicine in Australia will not meet demand for the medicine (see
13
section 30EI). The period of the shortage of the medicine will start on
14
1 March 2024 and end on 31 March 2024 (see section 30EIA).
15
The person in relation to whom the medicine is included in the
16
Register has notified the Secretary of the shortage under this section.
17
On 1 February 2024 the period of the shortage of the medicine
18
changes to a period that will start on 1 May 2024 and end on 31 May
19
2024.
20
The person must notify the change to the period of the shortage (see
21
subsection 30EFA(1)). The person is not required to notify, under this
22
section, of another shortage of the same medicine in respect of that
23
same period starting on 1 May 2024 and ending on 31 May 2024.
24
9 After section 30EF
25
Insert:
26
30EFA Reporting changes to the period of a medicine shortage and
27
resolution of a medicine shortage
28
Reporting changes to the period of a shortage
29
(1) A person who has notified the period of a shortage of a medicine in
30
Australia in accordance with section 30EF or this section must
31
notify the Secretary of any change to that period. The person must
32
do so:
33
(a) if the shortage was first required to be notified in accordance
34
with paragraph 30EF(1)(a)--as soon as possible, but no later
35
than 2 working days, after the first day the person knows, or
36
Schedule 11
Reporting medicine shortages
32
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
ought reasonably to have known, of the change to that
1
period; or
2
(b) in any other case--before the end of 10 working days
3
beginning on the first day the person knows, or ought
4
reasonably to have known, of the change to that period.
5
Reporting the resolution of a shortage
6
(2) A person who has notified the period of a shortage of a medicine in
7
Australia in accordance with section 30EF or this section must
8
notify the Secretary of any resolution of the shortage. The person
9
must do so:
10
(a) if the shortage was first required to be notified in accordance
11
with paragraph 30EF(1)(a)--as soon as possible, but no later
12
than 2 working days, after the first day the person knows, or
13
ought reasonably to have known, that the period of the
14
shortage has ended; or
15
(b) in any other case--before the end of 10 working days
16
beginning on the first day the person knows, or ought
17
reasonably to have known, that the period of the shortage has
18
ended.
19
Notification requirements
20
(3) A notification under subsection (1) or (2) must:
21
(a) be in accordance with a form that is approved, in writing, by
22
the Secretary; and
23
(b) for a notification under subsection (1)--specify the period of
24
the shortage of the medicine in Australia; and
25
(c) for a notification under subsection (2)--specify the day the
26
period of the shortage of the medicine in Australia ended;
27
and
28
(d) contain any other information required by that form.
29
(4) An approval of a form may require or permit information to be
30
given in accordance with specified software requirements:
31
(a) on a specified kind of data processing device; or
32
(b) by way of a specified kind of electronic transmission.
33
Reporting medicine shortages
Schedule 11
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
33
Civil penalty
1
(5) A person contravenes this subsection if:
2
(a) the person is subject to a requirement under subsection (1) or
3
(2); and
4
(b) the person contravenes the requirement.
5
Maximum civil penalty:
6
(a) for an individual--100 penalty units; and
7
(b) for a body corporate--1,000 penalty units.
8
10 After section 30EI
9
Insert:
10
30EIA What is the period of a medicine shortage?
11
The
period
of a shortage of a medicine in Australia is the period:
12
(a) starting on the day the supply of that medicine in Australia
13
will not, or will not be likely to, meet the demand for the
14
medicine for all of the patients in Australia who take, or who
15
may need to take, the medicine; and
16
(b) ending on the day before the day the supply of that medicine
17
in Australia will, or will be likely to, meet that demand.
18
11 Application provisions
19
(1)
The amendment of the
Therapeutic Goods Act 1989
made by item 4 of
20
this Schedule applies in relation to a notification of a shortage of a
21
medicine in Australia that is made on or after the commencement of this
22
item.
23
(2)
The amendments of the
Therapeutic Goods Act 1989
made by items 8
24
and 9 of this Schedule apply in relation to a period of a shortage of a
25
medicine in Australia that ends on or after the commencement of this
26
item, whether the shortage was first notified before, on or after that
27
commencement.
28
Schedule 12
Other amendments
34
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
Schedule 12--Other amendments
1
2
Therapeutic Goods Act 1989
3
1 Subsection 3(1) (definition of listable goods)
4
Repeal the definition, substitute:
5
listable goods
means therapeutic goods that are required under the
6
regulations to be included in the part of the Register relating to
7
listed goods.
8
2 Subsection 3(1) (paragraph (b) of the definition of standard)
9
After "subsection 3C(1)", insert "in relation to the goods".
10
3 Subsection 3(1) (paragraph (b) of the definition of standard)
11
After "subsection 3C(2)", insert "in relation to the goods".
12
4 Subsection 3(1) (paragraph (c) of the definition of standard)
13
After "subsection 3C(1)", insert "in relation to the goods".
14
5 Subsection 3(1) (paragraph (c) of the definition of standard)
15
After "subsection 3C(2)", insert "in relation to the goods".
16
6 Subsection 3(1) (paragraph (d) of the definition of standard)
17
After "subsection 3C(1)", insert "in relation to the goods".
18
7 Subsection 3(1) (paragraph (d) of the definition of standard)
19
After "subsection 3C(2)", insert "in relation to the goods".
20
8 Subsection 3C(1)
21
After "are exempt", insert "in relation to specified therapeutic goods".
22
9 At the end of subsection 3C(1) (before the note)
23
Add "The determination applies to those monographs as in force from
24
time to time.".
25
Other amendments
Schedule 12
No. , 2022
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
35
10 Subsection 3C(2)
1
After "are exempt", insert "in relation to specified therapeutic goods".
2
11 At the end of subsection 3C(2)
3
Add "The determination applies to those statements and monographs as
4
in force from time to time.".
5
12 At the end of section 3C
6
Add:
7
Incorporation of other instruments
8
(3) Despite subsection 14(2) of the
Legislation Act 2003
, a
9
determination under subsection (1) or (2) of this section may make
10
provision in relation to a matter by applying, adopting or
11
incorporating, with or without modification, any matter contained
12
in an instrument or other writing as in force or existing from time
13
to time.
14
13 Subsection 7(3)
15
Repeal the subsection.
16
14 Subsections 9A(5) and (6)
17
Repeal the subsections.
18
15 At the end of section 26BF
19
Add:
20
(6) Despite subsection 14(2) of the
Legislation Act 2003
, a
21
determination under subsection (1) of this section may make
22
provision in relation to a matter by applying, adopting or
23
incorporating, with or without modification, any matter contained
24
in an instrument or other writing as in force or existing from time
25
to time.
26
16 After subsection 28(2A)
27
Insert:
28
(2AA) Despite subsection 14(2) of the
Legislation Act 2003
, a
29
determination under subsection (2) of this section may make
30
Schedule 12
Other amendments
36
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
provision in relation to a matter by applying, adopting or
1
incorporating, with or without modification, any matter contained
2
in an instrument or other writing as in force or existing from time
3
to time.
4
17 After paragraph 32BF(6)(c)
5
Insert:
6
(ca) the person does not have the consent in writing of the
7
Secretary; and
8
18 At the end of section 32BF
9
Add:
10
Decisions on whether to give consent
11
(8) The Secretary must, as soon as practicable after making a decision
12
to give a consent mentioned in subsection (6), cause particulars of
13
the decision to be published on the Department's website.
14
(9) The Secretary must, within 28 days after making a decision to
15
refuse to give a consent mentioned in subsection (6), notify the
16
applicant in writing of the decision and of the reasons for the
17
decision.
18
19 Subsection 32CM(4)
19
Repeal the subsection, substitute:
20
(4) An authority under subsection (1) may only be given to a medical
21
practitioner:
22
(a) who is included in a class of medical practitioners prescribed
23
by the regulations for the purposes of this paragraph; and
24
(b) who has the approval of an ethics committee to supply the
25
specified biological.
26
Paragraph (b) does not apply in the circumstances (if any)
27
prescribed by the regulations for the purposes of this subsection.
28
20 At the end of section 36
29
Add:
30
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37
(5) Despite subsection 14(2) of the
Legislation Act 2003
, the
1
manufacturing principles may make provision in relation to a
2
matter by applying, adopting or incorporating, with or without
3
modification, any matter contained in an instrument or other
4
writing as in force or existing from time to time.
5
21 At the end of subsection 41BD(2A)
6
Add "The notice takes effect on the day on which the notice is
7
published in the Gazette or on the Department's website or on such later
8
day as is specified in the notice.".
9
22 Subsection 41BD(3)
10
Omit "by order published in the Gazette or on the Department's
11
website", substitute "by legislative instrument".
12
23 Subsection 41BD(4)
13
Repeal the subsection.
14
24 Subparagraph 41FN(3)(a)(ii)
15
Omit "devices setting out the matters required by the regulations",
16
substitute "device".
17
25 Subparagraph 41FN(3)(a)(ii)
18
Omit "within the period specified in the regulations", substitute "within
19
20 working days".
20
26 Paragraph 41FN(3)(b)
21
Repeal the paragraph, substitute:
22
(b) at all times while the inclusion in the Register has effect, the
23
person in relation to whom the kind of device is included in
24
the Register:
25
(i) has available sufficient information to substantiate that
26
the conformity assessment procedures have been
27
applied to the kind of medical device or that
28
requirements, comparable to those procedures, have
29
been applied to the kind of medical device to the
30
satisfaction of an overseas regulator; or
31
(ii) has procedures in place, including a written agreement
32
with the manufacturer of the kind of device, to ensure
33
Schedule 12
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38
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
that such information can be obtained from the
1
manufacturer within 20 working days; and
2
(ba) at all times while the inclusion in the Register has effect, the
3
person in relation to whom the kind of device is included in
4
the Register:
5
(i) has available information relating to changes to the kind
6
of medical device, the product range or quality
7
management system by the manufacturer of the kind of
8
device; or
9
(ii) has procedures in place, including a written agreement
10
with the manufacturer of the kind of device, to ensure
11
that such information can be obtained from the
12
manufacturer within 20 working days; and
13
27 Subsection 56A(4A)
14
After "19D(3) or (4)", insert "or 32BF(6)".
15
28 Subsections 57(10) to (11)
16
Repeal the subsections, substitute:
17
(10) The power of the Minister under subsection 18A(1) may be
18
delegated only to:
19
(a) the Secretary; or
20
(b) an SES employee who holds, or performs the duties of, an
21
SES Band 3 position in the Department; or
22
(c) a person who is registered, in a State or internal Territory, as
23
a medical practitioner and who holds, or performs the duties
24
of, a position that is equivalent to, or higher than, an SES
25
Band 2 position in the Department.
26
(10AA) The power of the Minister under subsection 30EK(1) may be
27
delegated only to:
28
(a) the Secretary; or
29
(b) an SES employee, or acting SES employee, in the
30
Department; or
31
(c) a person who is registered, in a State or internal Territory, as
32
a medical practitioner and who holds, or performs the duties
33
of, a position that is equivalent to, or higher than, an SES
34
Band 2 position in the Department.
35
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39
(10A) The power of the Minister under subsection 32CB(1) may be
1
delegated only to:
2
(a) the Secretary; or
3
(b) an SES employee who holds, or performs the duties of, an
4
SES Band 3 position in the Department; or
5
(c) a person who is registered, in a State or internal Territory, as
6
a medical practitioner and who holds, or performs the duties
7
of, a position that is equivalent to, or higher than, an SES
8
Band 2 position in the Department.
9
(11) The power of the Minister under subsection 41GS(1) may be
10
delegated only to:
11
(a) the Secretary; or
12
(b) an SES employee who holds, or performs the duties of, an
13
SES Band 3 position in the Department; or
14
(c) a person who is registered, in a State or internal Territory, as
15
a medical practitioner and who holds, or performs the duties
16
of, a position that is equivalent to, or higher than, an SES
17
Band 2 position in the Department.
18
29 Subsection 60(1) (paragraph (da) of the definition of initial
19
decision)
20
Repeal the paragraph.
21
30 After subsection 61(8C)
22
Insert:
23
(9) Despite subsection 14(2) of the
Legislation Act 2003
, an instrument
24
under subsection (5AB) or (5D) of this section may make provision
25
in relation to a matter by applying, adopting or incorporating, with
26
or without modification, any matter contained in an instrument or
27
other writing as in force or existing from time to time.
28
31 After paragraph 63(2)(g)
29
Insert:
30
(ga) make provision for the reporting of matters relating to
31
therapeutic goods; and
32
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Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
32 Application and saving provisions
1
(1)
The amendments of section 3C of the
Therapeutic Goods Act 1989
2
made by this Schedule apply in relation to determinations made on or
3
after the commencement of this item.
4
(2)
Subsection 26BF(6) of the
Therapeutic Goods Act 1989
, as added by
5
this Schedule, applies in relation to determinations made under
6
subsection 26BF(1) of that Act on or after the commencement of this
7
item.
8
(3)
Subsection 28(2AA) of the
Therapeutic Goods Act 1989
, as inserted by
9
this Schedule, applies in relation to determinations made under
10
subsection 28(2) of that Act on or after the commencement of this item.
11
(4)
Paragraph 32BF(6)(ca) of the
Therapeutic Goods Act 1989
, as inserted
12
by this Schedule, applies in relation to supplies occurring on or after the
13
commencement of this item.
14
(5)
The repeal and substitution of subsection 32CM(4) of the
Therapeutic
15
Goods Act 1989
made by this Schedule applies in relation to authorities
16
given on or after the commencement of this item.
17
(6)
The repeal and substitution of subsection 32CM(4) of the
Therapeutic
18
Goods Act 1989
made by this Schedule does not affect the continuity of
19
regulations that were made for the purposes of paragraph 32CM(4)(a) or
20
subsection 32CM(4) of that Act and were in force immediately before
21
the commencement of this item.
22
(7)
Subsection 36(5) of the
Therapeutic Goods Act 1989
, as added by this
23
Schedule, applies in relation to manufacturing principles determined on
24
or after the commencement of this item.
25
(8)
The amendments of subsection 41BD(3) and section 60 of the
26
Therapeutic Goods Act 1989
made by this Schedule apply in relation to
27
declarations made on or after the commencement of this item.
28
(9)
A declaration that was in force under subsection 41BD(3) of the
29
Therapeutic Goods Act 1989
immediately before the commencement of
30
this item continues in force (and may be dealt with) on and after that
31
commencement as if it had been made under that subsection as
32
amended by this Schedule.
33
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(10)
The repeal and substitution of subsections 57(10) to (11) of the
1
Therapeutic Goods Act 1989
made by this Schedule does not affect the
2
validity of a delegation that was in force immediately before the
3
commencement of this item.
4
(11)
Subsection 61(9) of the
Therapeutic Goods Act 1989
, as inserted by this
5
Schedule, applies in relation to an instrument made under
6
subsection 61(5AB) or (5D) of that Act on or after the commencement
7
of this item.
8