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This is a Bill, not an Act. For current law, see the Acts databases.
2019-2020
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Therapeutic Goods Amendment (2020
Measures No. 2) Bill 2020
No. , 2020
(Health)
A Bill for an Act to amend the
Therapeutic Goods
Act 1989
, and for related purposes
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Substitution of prescription medicine by
pharmacists
3
Therapeutic Goods Act 1989
3
Schedule 2--Unique device identification system
6
Therapeutic Goods Act 1989
6
Schedule 3--Protection from criminal responsibility
9
Therapeutic Goods Act 1989
9
Schedule 4--International agreements
10
Therapeutic Goods Act 1989
10
Schedule 5--Restricted information
27
Therapeutic Goods Act 1989
27
Schedule 6--Variation of permissible ingredients
determination
29
Therapeutic Goods Act 1989
29
Schedule 7--Delegation
31
Therapeutic Goods Act 1989
31
Schedule 8--Retention of material on withdrawal of
application
32
Therapeutic Goods Act 1989
32
Schedule 9--Consents to importations or supplies of
therapeutic goods
33
Therapeutic Goods Act 1989
33
Schedule 10--Other amendments
35
Therapeutic Goods Act 1989
35
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
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 (2020 Measures
5
No. 2) Act 2020
.
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 (2020 Measures No. 2) Bill 2020
No. , 2020
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. Schedules 1 to
4
The day after this Act receives the Royal
Assent.
3. Schedules 5
and 6
The day after the end of the period of 2
months beginning on the day this Act
receives the Royal Assent.
4. Schedules 7 to
10
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
Substitution of prescription medicine by pharmacists
Schedule 1
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
3
Schedule 1--Substitution of prescription
1
medicine by pharmacists
2
3
Therapeutic Goods Act 1989
4
1 At the end of subsection 4(1)
5
Add:
6
; (c) provide for a scheme allowing pharmacists to substitute
7
certain medicine for other medicine if the Minister has
8
declared there is a serious scarcity of the other medicine.
9
2 After Division 2B of Part 3-2
10
Insert:
11
Division 2C--Substitution of prescription medicine by
12
pharmacists
13
30EK Minister may declare a serious scarcity of medicine
14
(1) The Minister may, by legislative instrument:
15
(a) declare that there is a serious scarcity of specified medicine
16
(the
scarce medicine
) across the whole or a specified part or
17
parts of Australia; and
18
(b) specify the medicine (the
substitutable medicine
) that
19
pharmacists are permitted to dispense in substitution for the
20
scarce medicine and specify the circumstances in which that
21
substitution is permitted.
22
Note 1:
For specification by class, see subsection 13(3) of the
Legislation Act
23
2003
.
24
Note 2:
For variation and revocation, see subsection 33(3) of the
Acts
25
Interpretation Act 1901
.
26
Pre-conditions to making instrument
27
(2) The Minister may make an instrument under subsection (1) only if
28
the Minister is satisfied:
29
(a) that either or both of the following apply:
30
Schedule 1
Substitution of prescription medicine by pharmacists
4
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
(i) the supply of the scarce medicine in Australia is not
1
currently meeting the demand for that medicine for all
2
of the patients in Australia who take that medicine;
3
(ii) there is an imminent risk that supply of the scarce
4
medicine in Australia will not, or will not be likely to,
5
meet the demand for that medicine for all of the patients
6
in Australia who take, or who may need to take, that
7
medicine; and
8
(b) that there is a significant risk of adverse health consequences
9
for patients in Australia if those patients are unable to take
10
the scarce medicine; and
11
(c) of any other matters prescribed by the regulations for the
12
purposes of this paragraph.
13
Kind of medicine that can be covered by instrument
14
(3) The scarce medicine, and the substitutable medicine, must be
15
medicine:
16
(a) that contains one or more substances included in Schedule 4
17
to the current Poisons Standard; and
18
(b) that does not contain any substances included in Schedule 8
19
to that standard.
20
Suitability of substitutable medicine
21
(4) Without limiting paragraph (1)(b), the circumstances may relate to:
22
(a) the class of persons for whom the substitutable medicine is
23
suitable; or
24
(b) the class of persons for whom the substitutable medicine is
25
not suitable.
26
Period instrument in force
27
(5) Unless sooner revoked, an instrument under subsection (1) remains
28
in force for the period specified in the instrument.
29
Note:
For variation, see subsection 33(3) of the
Acts Interpretation Act 1901
.
30
Substitution of prescription medicine by pharmacists
Schedule 1
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
5
Definition
1
(6) For the purposes of this section, a
pharmacist
is a person registered
2
as a pharmacist under a law of a State or Territory providing for
3
the registration of pharmacists.
4
30EL Substitution of prescription medicine by pharmacists
5
(1) If:
6
(a) an instrument is in force under subsection 30EK(1); and
7
(b) under a law of a State or Territory, a pharmacist is authorised
8
to dispense medicine (the
scarce medicine
) covered by
9
paragraph 30EK(1)(a) to a person;
10
then, despite any law of a State or Territory, the pharmacist may
11
dispense medicine covered by paragraph 30EK(1)(b) to that person
12
in substitution for the scarce medicine, provided that the
13
substitution is in the circumstances specified in the instrument
14
under subsection 30EK(1).
15
(2) For the purposes of this section, a
pharmacist
is a person registered
16
as a pharmacist under a law of a State or Territory providing for
17
the registration of pharmacists.
18
3 After subsection 57(10)
19
Insert:
20
(10AA) The power of the Minister under subsection 30EK(1) may be
21
delegated only to the Secretary or to an SES employee, or acting
22
SES employee, in the Department.
23
Schedule 2
Unique device identification system
6
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
Schedule 2--Unique device identification
1
system
2
3
Therapeutic Goods Act 1989
4
1 Subsection 3(1)
5
Insert:
6
personal information
has the same meaning as in the
Privacy Act
7
1988
.
8
unique device identifier
of a medical device means any
9
combination of numbers, symbols and letters given to the device to
10
enable identification of the device (whether or not that combination
11
also allows identification of information relating to the device).
12
2 Section 41C
13
Omit "compliance with essential principles.", substitute "compliance
14
with essential principles. The regulations may make provision for and in
15
relation to the Secretary causing a database of unique device identifiers
16
of medical devices to be established and maintained.".
17
3 At the end of section 41CA
18
Add:
19
(3) Regulations made for the purposes of subsection (1) may include
20
requirements in relation to the inclusion in the database referred to
21
in section 41CE of the following:
22
(a) unique device identifiers of medical devices;
23
(b) information relating to those unique device identifiers, those
24
medical devices or the import, export, manufacture or supply
25
of those medical devices.
26
(4) Subsection (3) has effect subject to subsection 41CE(2).
27
(5) Subsection (3) does not limit subsection (1).
28
4 At the end of Part 4-2
29
Add:
30
Unique device identification system
Schedule 2
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
7
Division 3--Database of unique device identifiers of
1
medical devices
2
41CE Database of unique device identifiers of medical devices
3
(1) The regulations may make provision for and in relation to the
4
Secretary causing a database to be established and maintained, to
5
be known as:
6
(a) the Australian Unique Device Identification Database; or
7
(b) if another name is prescribed by the regulations--that other
8
name.
9
Note:
The essential principles may include requirements in relation to the
10
inclusion in the database of unique device identifiers of medical
11
devices and related information: see subsection 41CA(3).
12
Personal information
13
(2) The regulations must provide that the database must not include
14
personal information, unless the personal information:
15
(a) is the name of a person in relation to whom a kind of medical
16
device is included in the Register; or
17
(b) is about an authorised representative of the manufacturer of a
18
kind of medical device; or
19
(c) is about an authorised representative of a person in relation to
20
whom a kind of medical device is included in the Register.
21
Removal of information
22
(3) The regulations may provide for the removal of information from
23
the database.
24
Corrections to information
25
(4) The regulations may provide for corrections to information in the
26
database.
27
Making the database available
28
(5) The regulations may provide for the whole or a part of the database
29
to be made:
30
(a) available to specified persons, authorities or bodies; or
31
Schedule 2
Unique device identification system
8
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
(b) publicly available.
1
(6) However, the regulations must provide that personal information
2
covered by paragraph (2)(b) or (c) must not be made publicly
3
available.
4
No limit on subsection (1)
5
(7) Subsections (2) to (6) do not limit subsection (1).
6
Database not a legislative instrument
7
(8) The database is not a legislative instrument.
8
5 After paragraph 41GT(e)
9
Insert:
10
(ea) compliance with the requirements referred to in
11
subsection 41CA(3) (about unique device identifiers of
12
medical devices);
13
Protection from criminal responsibility
Schedule 3
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
9
Schedule 3--Protection from criminal
1
responsibility
2
3
Therapeutic Goods Act 1989
4
1 After section 61A
5
Insert:
6
62 Protection from criminal responsibility
7
(1) An APS employee in the Department who, for the purpose of
8
finding out whether this Act or the regulations have been complied
9
with, obtains, possesses or conveys, or facilitates the conveyance
10
of, goods is not criminally responsible for an offence against a law
11
of the Commonwealth, or a State law, relating to the obtaining,
12
possession, conveyance or facilitation of the conveyance of the
13
goods.
14
(2) If an APS employee in the Department, in connection with finding
15
out whether this Act or the regulations have been complied with,
16
arranges for another person to convey goods, the other person is
17
not criminally responsible for an offence against a law of the
18
Commonwealth, or a State law, relating to:
19
(a) the possession of the goods by the other person, to the extent
20
the possession is in connection with that conveyance of the
21
goods; or
22
(b) that conveyance of the goods.
23
2 Application provision
24
Section 62 of the
Therapeutic Goods Act 1989
, as inserted by this
25
Schedule, applies in relation to the obtaining, possession, conveyance or
26
facilitation of the conveyance of goods on or after the commencement
27
of this item.
28
Schedule 4
International agreements
10
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
Schedule 4--International agreements
1
2
Therapeutic Goods Act 1989
3
1 After Chapter 2
4
Insert:
5
Chapter 2A--Prohibition on import, export,
6
manufacture or supply of therapeutic
7
goods--international agreements
8
9
10
9J Simplified outline of this Chapter
11
The regulations may prohibit imports into Australia, exports from
12
Australia, the manufacture in Australia and supplies in Australia of
13
therapeutic goods, or therapeutic goods containing a particular
14
ingredient or component, to give effect to international agreements
15
to which Australia is a party.
16
There is an offence and a civil penalty for contravening such a
17
prohibition.
18
9K Prohibition on import, export, manufacture or supply of
19
therapeutic goods--international agreements
20
Prohibition on therapeutic goods themselves
21
(1) If therapeutic goods are the subject of an international agreement
22
prescribed for the purposes of this subsection, the regulations may
23
prohibit one or more of the following:
24
(a) the import into Australia of the therapeutic goods;
25
(b) the export from Australia of the therapeutic goods;
26
(c) the manufacture in Australia of the therapeutic goods;
27
(d) the supply in Australia of the therapeutic goods.
28
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
11
(2) Before regulations are made prescribing an international agreement
1
for the purposes of subsection (1), the Minister must be satisfied
2
that the agreement requires parties to the agreement to take steps to
3
prohibit or restrict one or more of the import, export, manufacture
4
and supply of certain goods.
5
Prohibition on therapeutic goods containing an ingredient or
6
component
7
(3) If an ingredient or component of therapeutic goods is the subject of
8
an international agreement prescribed for the purposes of this
9
subsection, the regulations may prohibit one or more of the
10
following:
11
(a) the import into Australia of all or specified therapeutic goods
12
that contain that ingredient or component;
13
(b) the export from Australia of all or specified therapeutic
14
goods that contain that ingredient or component;
15
(c) the manufacture in Australia of all or specified therapeutic
16
goods that contain that ingredient or component;
17
(d) the supply in Australia of all or specified therapeutic goods
18
that contain that ingredient or component.
19
(4) Before regulations are made prescribing an international agreement
20
for the purposes of subsection (3), the Minister must be satisfied
21
that the agreement requires parties to the agreement to take steps to
22
prohibit or restrict one or more of the import, export, manufacture
23
and supply of goods containing that ingredient or component.
24
Nature of prohibition
25
(5) A prohibition referred to in subsection (1) or (3) may be absolute
26
or be subject to such conditions as are prescribed.
27
Procedural requirements for regulations containing prohibition
28
(6) Regulations containing a prohibition referred to in subsection (1)
29
or (3) must not be made unless:
30
(a) the Minister causes to be published on the Department's
31
website a notice setting out details of:
32
(i) the international agreement; and
33
Schedule 4
International agreements
12
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
(ii) the Minister's satisfaction mentioned in subsection (2)
1
or (4); and
2
(iii) the proposed prohibition; and
3
(b) a period of 30 days has passed since the notice was
4
published.
5
Commencement of regulations containing prohibition
6
(7) Regulations containing a prohibition referred to in subsection (1)
7
or (3) must not be expressed to commence on a day earlier than the
8
day the international agreement enters into force for Australia.
9
Content of regulations containing prohibition
10
(8) Without limiting subsection (5), regulations prescribing conditions
11
referred to in that subsection may do one or more of the following:
12
(a) make provision in relation to a matter by conferring on the
13
Minister or Secretary a power to make a decision of an
14
administrative character;
15
(b) refer to the Minister or Secretary being satisfied of one or
16
more specified matters;
17
(c) make provision for and in relation to the Minister or
18
Secretary delegating powers to an SES employee, or acting
19
SES employee, in the Department.
20
9L Offence and civil penalty
21
Offence
22
(1) A person commits an offence if:
23
(a) the person:
24
(i) imports into Australia therapeutic goods; or
25
(ii) exports from Australia therapeutic goods; or
26
(iii) manufactures in Australia therapeutic goods; or
27
(iv) supplies in Australia therapeutic goods; and
28
(b) the import, export, manufacture or supply contravenes:
29
(i) an absolute prohibition in force for the purposes of
30
subsection 9K(1) or (3); or
31
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
13
(ii) one or more conditions of a prohibition in force for the
1
purposes of subsection 9K(1) or (3).
2
Penalty: 300 penalty units.
3
Civil penalty
4
(2) A person contravenes this subsection if:
5
(a) the person:
6
(i) imports into Australia therapeutic goods; or
7
(ii) exports from Australia therapeutic goods; or
8
(iii) manufactures in Australia therapeutic goods; or
9
(iv) supplies in Australia therapeutic goods; and
10
(b) the import, export, manufacture or supply contravenes:
11
(i) an absolute prohibition in force for the purposes of
12
subsection 9K(1) or (3); or
13
(ii) one or more conditions of a prohibition in force for the
14
purposes of subsection 9K(1) or (3).
15
Maximum civil penalty:
16
(a) for an individual--300 penalty units; and
17
(b) for a body corporate--3,000 penalty units.
18
9M Application of
Customs Act 1901
19
If:
20
(a) the importation or exportation of goods is an offence under
21
subsection 9L(1) or a contravention of subsection 9L(2); and
22
(b) the Secretary notifies the Comptroller-General of Customs in
23
writing that the Secretary wishes the
Customs Act 1901
to
24
apply to that importation or exportation;
25
the
Customs Act 1901
has effect as if the goods included in that
26
importation or exportation were goods described as forfeited to the
27
Crown under section 229 of that Act because they were:
28
(c) prohibited imports within the meaning of that Act; or
29
(d) prohibited exports within the meaning of that Act;
30
as the case requires.
31
Schedule 4
International agreements
14
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
9N Constitutional basis
1
(1) This Chapter, and any other provision of this Act to the extent it
2
relates to this Chapter, relies on the Commonwealth's legislative
3
power under paragraph 51(xxix) of the Constitution to give effect
4
to an international agreement prescribed for the purposes of
5
subsection 9K(1) or (3).
6
(2) This section does not limit section 6.
7
2 At the end of subsection 23B(2)
8
Add:
9
; (g) if there are one or more absolute prohibitions in force for the
10
purposes of subsection 9K(1) or (3)--the application must be
11
accompanied by a statement from the applicant certifying
12
that:
13
(i) if those prohibitions cover imports--any imports into
14
Australia of the goods by, or on behalf of the applicant,
15
will not contravene those prohibitions; and
16
(ii) if those prohibitions cover exports--any exports from
17
Australia of the goods by, or on behalf of the applicant,
18
will not contravene those prohibitions; and
19
(iii) if those prohibitions cover supplies--any supplies in
20
Australia of the goods by, or on behalf of the applicant,
21
will not contravene those prohibitions; and
22
(h) if there are one or more prohibitions in force for the purposes
23
of subsection 9K(1) or (3) that are subject to conditions--the
24
application must be accompanied by a statement from the
25
applicant certifying that:
26
(i) if those prohibitions cover imports--any imports into
27
Australia of the goods by, or on behalf of the applicant,
28
will not contravene those conditions; and
29
(ii) if those prohibitions cover exports--any exports from
30
Australia of the goods by, or on behalf of the applicant,
31
will not contravene those conditions; and
32
(iii) if those prohibitions cover supplies--any supplies in
33
Australia of the goods by, or on behalf of the applicant,
34
will not contravene those conditions.
35
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
15
3 At the end of subsection 23C(2) (before the note)
1
Add:
2
; and (f) if there are one or more absolute prohibitions in force for the
3
purposes of subsection 9K(1) or (3)--the application is
4
accompanied by a statement from the applicant certifying
5
that:
6
(i) if those prohibitions cover imports--any imports into
7
Australia of the goods by, or on behalf of the applicant,
8
will not contravene those prohibitions; and
9
(ii) if those prohibitions cover exports--any exports from
10
Australia of the goods by, or on behalf of the applicant,
11
will not contravene those prohibitions; and
12
(iii) if those prohibitions cover supplies--any supplies in
13
Australia of the goods by, or on behalf of the applicant,
14
will not contravene those prohibitions; and
15
(g) if there are one or more prohibitions in force for the purposes
16
of subsection 9K(1) or (3) that are subject to conditions--the
17
application is accompanied by a statement from the applicant
18
certifying that:
19
(i) if those prohibitions cover imports--any imports into
20
Australia of the goods by, or on behalf of the applicant,
21
will not contravene those conditions; and
22
(ii) if those prohibitions cover exports--any exports from
23
Australia of the goods by, or on behalf of the applicant,
24
will not contravene those conditions; and
25
(iii) if those prohibitions cover supplies--any supplies in
26
Australia of the goods by, or on behalf of the applicant,
27
will not contravene those conditions.
28
4 After paragraph 25(1)(h)
29
Insert:
30
(i) if there are one or more absolute prohibitions in force for the
31
purposes of subsection 9K(1) or (3)--whether, if the
32
Secretary were to register the goods, the Secretary is satisfied
33
that imports into Australia, exports from Australia or supplies
34
in Australia of the goods would contravene those
35
prohibitions; and
36
Schedule 4
International agreements
16
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
(ia) if there are one or more prohibitions in force for the purposes
1
of subsection 9K(1) or (3) that are subject to conditions--
2
whether, if the Secretary were to register the goods, the
3
Secretary is satisfied that imports into Australia, exports from
4
Australia or supplies in Australia of the goods would
5
contravene those conditions; and
6
5 After paragraph 26(1)(k)
7
Insert:
8
(l) if there are one or more absolute prohibitions in force for the
9
purposes of subsection 9K(1) or (3)--imports into Australia,
10
exports from Australia or supplies in Australia of the goods
11
would contravene one or more of those prohibitions; or
12
(la) if there are one or more prohibitions in force for the purposes
13
of subsection 9K(1) or (3) that are subject to conditions--
14
imports into Australia, exports from Australia or supplies in
15
Australia of the goods would contravene one or more of
16
those conditions; or
17
6 After subsection 30(4B)
18
Insert:
19
(4C) The Secretary must, by notice in writing given to a person in
20
relation to whom therapeutic goods are included in the Register,
21
cancel the registration or listing of the goods if the Secretary is
22
satisfied that:
23
(a) if there are one or more absolute prohibitions in force for the
24
purposes of subsection 9K(1) or (3)--imports into Australia,
25
exports from Australia or supplies in Australia of the goods
26
would contravene one or more of those prohibitions; or
27
(b) if there are one or more prohibitions in force for the purposes
28
of subsection 9K(1) or (3) that are subject to conditions--
29
imports into Australia, exports from Australia or supplies in
30
Australia of the goods would contravene one or more of
31
those conditions.
32
7 Paragraph 30(5)(a)
33
Omit "or (1D)", substitute ", (1D) or (4C)".
34
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
17
8 Subsection 30EA(1) (after table item 4)
1
Insert:
2
4A.
The goods are supplied and the Secretary is
satisfied that:
(a) if there are one or more absolute
prohibitions in force for the purposes of
subsection 9K(1) or (3)--the supply
contravenes one or more of those
prohibitions; or
(b) if there are one or more prohibitions in force
for the purposes of subsection 9K(1) or (3)
that are subject to conditions--the supply
contravenes one or more of those conditions
The person supplying the
goods
9 After paragraph 31(1)(ha)
3
Insert:
4
(hb) if the goods are registered in relation to the person and there
5
are one or more absolute prohibitions in force for the
6
purposes of subsection 9K(1) or (3)--whether any supplies in
7
Australia, any imports into Australia or any exports from
8
Australia of the goods contravene those prohibitions;
9
(hc) if the goods are registered in relation to the person and there
10
are one or more prohibitions in force for the purposes of
11
subsection 9K(1) or (3) that are subject to conditions--
12
whether any supplies in Australia, any imports into Australia
13
or any exports from Australia of the goods contravene those
14
conditions;
15
10 After paragraph 31(2)(ga)
16
Insert:
17
(gb) if the goods are listed in relation to the person and there are
18
one or more absolute prohibitions in force for the purposes of
19
subsection 9K(1) or (3)--whether any supplies in Australia,
20
any imports into Australia or any exports from Australia of
21
the goods contravene those prohibitions;
22
(gc) if the goods are listed in relation to the person and there are
23
one or more prohibitions in force for the purposes of
24
subsection 9K(1) or (3) that are subject to conditions--
25
whether any supplies in Australia, any imports into Australia
26
Schedule 4
International agreements
18
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
or any exports from Australia of the goods contravene those
1
conditions;
2
11 At the end of subsection 32DA(3)
3
Add:
4
; and (g) if there are one or more absolute prohibitions in force for the
5
purposes of subsection 9K(1) or (3):
6
(i) if those prohibitions cover imports--any imports into
7
Australia of the biological by, or on behalf of the
8
applicant, will not contravene those prohibitions; and
9
(ii) if those prohibitions cover exports--any exports from
10
Australia of the biological by, or on behalf of the
11
applicant, will not contravene those prohibitions; and
12
(iii) if those prohibitions cover supplies--any supplies in
13
Australia of the biological by, or on behalf of the
14
applicant, will not contravene those prohibitions; and
15
(h) if there are one or more prohibitions in force for the purposes
16
of subsection 9K(1) or (3) that are subject to conditions:
17
(i) if those prohibitions cover imports--any imports into
18
Australia of the biological by, or on behalf of the
19
applicant, will not contravene those conditions; and
20
(ii) if those prohibitions cover exports--any exports from
21
Australia of the biological by, or on behalf of the
22
applicant, will not contravene those conditions; and
23
(iii) if those prohibitions cover supplies--any supplies in
24
Australia of the biological by, or on behalf of the
25
applicant, will not contravene those conditions.
26
12 At the end of subsection 32DDA(2)
27
Add:
28
; (f) if there are one or more absolute prohibitions in force for the
29
purposes of subsection 9K(1) or (3)--the application must be
30
accompanied by a statement from the applicant certifying
31
that:
32
(i) if those prohibitions cover imports--any imports into
33
Australia of the biological by, or on behalf of the
34
applicant, will not contravene those prohibitions; and
35
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
19
(ii) if those prohibitions cover exports--any exports from
1
Australia of the biological by, or on behalf of the
2
applicant, will not contravene those prohibitions; and
3
(iii) if those prohibitions cover supplies--any supplies in
4
Australia of the biological by, or on behalf of the
5
applicant, will not contravene those prohibitions; and
6
(g) if there are one or more prohibitions in force for the purposes
7
of subsection 9K(1) or (3) that are subject to conditions--the
8
application must be accompanied by a statement from the
9
applicant certifying that:
10
(i) if those prohibitions cover imports--any imports into
11
Australia of the biological by, or on behalf of the
12
applicant, will not contravene those conditions; and
13
(ii) if those prohibitions cover exports--any exports from
14
Australia of the biological by, or on behalf of the
15
applicant, will not contravene those conditions; and
16
(iii) if those prohibitions cover supplies--any supplies in
17
Australia of the biological by, or on behalf of the
18
applicant, will not contravene those conditions.
19
13 After paragraph 32DE(1)(f)
20
Insert:
21
(fa) if there are one or more absolute prohibitions in force for the
22
purposes of subsection 9K(1) or (3)--whether, if the
23
Secretary were to include the biological in the Register, the
24
Secretary is satisfied that imports into Australia, exports from
25
Australia or supplies in Australia of the biological would
26
contravene those prohibitions; and
27
(fb) if there are one or more prohibitions in force for the purposes
28
of subsection 9K(1) or (3) that are subject to conditions--
29
whether, if the Secretary were to include the biological in the
30
Register, the Secretary is satisfied that imports into Australia,
31
exports from Australia or supplies in Australia of the
32
biological would contravene those conditions; and
33
14 After subsection 32GA(1)
34
Insert:
35
Schedule 4
International agreements
20
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
(1A) The Secretary must, by written notice given to the person in
1
relation to whom a biological is included in the Register, cancel the
2
entry of the biological from the Register if the Secretary is satisfied
3
that:
4
(a) if there are one or more absolute prohibitions in force for the
5
purposes of subsection 9K(1) or (3)--imports into Australia,
6
exports from Australia or supplies in Australia of the
7
biological would contravene one or more of those
8
prohibitions; or
9
(b) if there are one or more prohibitions in force for the purposes
10
of subsection 9K(1) or (3) that are subject to conditions--
11
imports into Australia, exports from Australia or supplies in
12
Australia of the biological would contravene one or more of
13
those conditions.
14
15 Subsection 32GA(2)
15
After "subsection (1)", insert "or (1A)".
16
16 Subsection 32HA(1) (after table item 4)
17
Insert:
18
4A.
It is supplied and the Secretary is satisfied that:
(a) if there are one or more absolute
prohibitions in force for the purposes of
subsection 9K(1) or (3)--the supply
contravenes one or more of those
prohibitions; or
(b) if there are one or more prohibitions in force
for the purposes of subsection 9K(1) or (3)
that are subject to conditions--the supply
contravenes one or more of those conditions
The person supplying it
17 After paragraph 32JA(1)(n)
19
Insert:
20
(na) if the biological is included in the Register in relation to the
21
person and there are one or more absolute prohibitions in
22
force for the purposes of subsection 9K(1) or (3)--whether
23
any supplies in Australia, any imports into Australia or any
24
exports from Australia of the biological contravene those
25
prohibitions;
26
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
21
(nb) if the biological is included in the Register in relation to the
1
person and there are one or more prohibitions in force for the
2
purposes of subsection 9K(1) or (3) that are subject to
3
conditions--whether any supplies in Australia, any imports
4
into Australia or any exports from Australia of the biological
5
contravene those conditions;
6
18 At the end of subsection 37(1)
7
Add:
8
; and (h) if there are one or more absolute prohibitions in force for the
9
purposes of subsection 9K(1) or (3)--be accompanied by a
10
statement from the applicant certifying that the manufacture
11
in Australia of the therapeutic goods or classes of therapeutic
12
goods the subject of the application will not contravene those
13
prohibitions; and
14
(i) if there are one or more prohibitions in force for the purposes
15
of subsection 9K(1) or (3) that are subject to conditions--be
16
accompanied by a statement from the applicant certifying
17
that the manufacture in Australia of the therapeutic goods or
18
classes of therapeutic goods the subject of the application
19
will not contravene those conditions.
20
19 After paragraph 38(1)(f)
21
Insert:
22
(fa) if there are one or more absolute prohibitions in force for the
23
purposes of subsection 9K(1) or (3)--the manufacture in
24
Australia of the goods would contravene one or more of
25
those prohibitions; or
26
(fb) if there are one or more prohibitions in force for the purposes
27
of subsection 9K(1) or (3) that are subject to conditions--the
28
manufacture in Australia of the goods would contravene one
29
or more of those conditions; or
30
20 After paragraph 41(1)(ga)
31
Insert:
32
(gb) if there are one or more absolute prohibitions in force for the
33
purposes of subsection 9K(1) or (3)--the Secretary is
34
satisfied that the manufacture in Australia of the goods to
35
Schedule 4
International agreements
22
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
which the licence relates would contravene one or more of
1
those prohibitions; or
2
(gc) if there are one or more prohibitions in force for the purposes
3
of subsection 9K(1) or (3) that are subject to conditions--the
4
Secretary is satisfied that the manufacture in Australia of the
5
goods to which the licence relates would contravene one or
6
more of those conditions; or
7
21 After paragraph 41FD(h)
8
Insert:
9
(ha) if there are one or more absolute prohibitions in force for the
10
purposes of subsection 9K(1) or (3):
11
(i) if those prohibitions cover imports--any imports into
12
Australia of devices of that kind by, or on behalf of the
13
applicant, will not contravene those prohibitions; and
14
(ii) if those prohibitions cover exports--any exports from
15
Australia of devices of that kind by, or on behalf of the
16
applicant, will not contravene those prohibitions; and
17
(iii) if those prohibitions cover manufacture--any
18
manufacture in Australia of devices of that kind by, or
19
on behalf of the applicant, will not contravene those
20
prohibitions; and
21
(iv) if those prohibitions cover supplies--any supplies in
22
Australia of devices of that kind by, or on behalf of the
23
applicant, will not contravene those prohibitions; and
24
(hb) if there are one or more prohibitions in force for the purposes
25
of subsection 9K(1) or (3) that are subject to conditions:
26
(i) if those prohibitions cover imports--any imports into
27
Australia of devices of that kind by, or on behalf of the
28
applicant, will not contravene those conditions; and
29
(ii) if those prohibitions cover exports--any exports from
30
Australia of devices of that kind by, or on behalf of the
31
applicant, will not contravene those conditions; and
32
(iii) if those prohibitions cover manufacture--any
33
manufacture in Australia of devices of that kind by, or
34
on behalf of the applicant, will not contravene those
35
conditions; and
36
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
23
(iv) if those prohibitions cover supplies--any supplies in
1
Australia of devices of that kind by, or on behalf of the
2
applicant, will not contravene those conditions; and
3
22 Section 41GK
4
Before "The", insert "(1)".
5
23 At the end of section 41GK
6
Add:
7
(2) The Secretary must, by written notice given to the person in
8
relation to whom a kind of medical device is included in the
9
Register, cancel the entry of the kind of device from the Register if
10
the Secretary is satisfied that:
11
(a) if there are one or more absolute prohibitions in force for the
12
purposes of subsection 9K(1) or (3)--imports into Australia,
13
exports from Australia, the manufacture in Australia or
14
supplies in Australia of the kind of device would contravene
15
one or more of those prohibitions; or
16
(b) if there are one or more prohibitions in force for the purposes
17
of subsection 9K(1) or (3) that are subject to conditions--
18
imports into Australia, exports from Australia, the
19
manufacture in Australia or supplies in Australia of the kind
20
of device would contravene one or more of those conditions.
21
24 After paragraph 41JA(1)(i)
22
Insert:
23
(iaa) if the kind of medical device is included in the Register in
24
relation to the person and there are one or more absolute
25
prohibitions in force for the purposes of subsection 9K(1) or
26
(3)--whether any supplies in Australia, any imports into
27
Australia, any exports from Australia or any manufacture in
28
Australia of medical devices of that kind contravene those
29
prohibitions;
30
(iab) if the kind of medical device is included in the Register in
31
relation to the person and there are one or more prohibitions
32
in force for the purposes of subsection 9K(1) or (3) that are
33
subject to conditions--whether any supplies in Australia, any
34
imports into Australia, any exports from Australia or any
35
Schedule 4
International agreements
24
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
manufacture in Australia of medical devices of that kind
1
contravene those conditions;
2
25 Subsection 41KA(1) (after table item 4)
3
Insert:
4
4A.
It is supplied and the Secretary is satisfied that:
(a) if there are one or more absolute
prohibitions in force for the purposes of
subsection 9K(1) or (3)--the supply
contravenes one or more of those
prohibitions; or
(b) if there are one or more prohibitions in force
for the purposes of subsection 9K(1) or (3)
that are subject to conditions--the supply
contravenes one or more of those conditions
The person supplying the
kind of medical device
26 Before section 53
5
Insert:
6
52G Exemptions, approvals and authorities to be consistent with
7
prohibitions under Chapter 2A
8
(1) If there are one or more absolute prohibitions in force for the
9
purposes of subsection 9K(1) or (3), a thing referred to in
10
subsection (3) of this section must not be made or given in relation
11
to therapeutic goods the subject of those prohibitions.
12
(2) If there are one or more prohibitions in force for the purposes of
13
subsection 9K(1) or (3) that are subject to conditions (the
first
14
conditions
), a thing referred to in subsection (3) of this section
15
must not be made or given in relation to therapeutic goods the
16
subject of those prohibitions unless the thing is made or given
17
subject to conditions that are consistent with the first conditions.
18
(3) The things are the following:
19
(a) an exemption under subsection 18(1) or 18A(1);
20
(b) an approval under subsection 19(1);
21
(c) an authority under subsection 19(5);
22
(d) an authorisation under subsection 19(7A);
23
(e) an approval under subsection 19A(1), (1A) or (2);
24
International agreements
Schedule 4
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
25
(f) an exemption under section 32CA or 32CB;
1
(g) an approval under subsection 32CK(1);
2
(h) an authority under subsection 32CM(1);
3
(i) an authorisation under subsection 32CM(7A);
4
(j) an approval under subsection 32CO(1), (1A) or (2);
5
(k) an exemption under section 41GS or 41HA;
6
(l) an approval under subsection 41HB(1);
7
(m) an authority under subsection 41HC(1);
8
(n) an authorisation under subsection 41HC(6);
9
(o) an approval under subsection 41HD(1), (1A) or (2);
10
(p) a variation of a thing mentioned in any of the above
11
paragraphs.
12
27 Application provisions
--registration or listing of
13
therapeutic goods
14
(1)
The amendments of sections 23B, 23C, 25 and 26 of the
Therapeutic
15
Goods Act 1989
made by this Schedule apply in relation to an
16
application made under section 23 of that Act on or after the
17
commencement of this item.
18
(2)
The amendments of sections 30 and 31 of the
Therapeutic Goods Act
19
1989
made by this Schedule apply on and after the commencement of
20
this item in relation to therapeutic goods included in the Register
21
before, on or after that commencement.
22
(3)
The amendment of section 30EA of the
Therapeutic Goods Act 1989
23
made by this Schedule applies in relation to the supply of goods on or
24
after the commencement of this item.
25
28 Application provisions
--biologicals
26
(1)
The amendment of section 32DA of the
Therapeutic Goods Act 1989
27
made by this Schedule applies in relation to an application made under
28
subsection 32DA(1) of that Act on or after the commencement of this
29
item.
30
(2)
The amendments of section 32DDA and 32DE of the
Therapeutic
31
Goods Act 1989
made by this Schedule apply in relation to an
32
application made under section 32DD of that Act on or after the
33
commencement of this item.
34
Schedule 4
International agreements
26
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
(3)
The amendments of sections 32GA and 32JA of the
Therapeutic Goods
1
Act 1989
made by this Schedule apply on and after the commencement
2
of this item in relation to a biological included in the Register before, on
3
or after that commencement.
4
(4)
The amendment of section 32HA of the
Therapeutic Goods Act 1989
5
made by this Schedule applies in relation to the supply of a biological
6
on or after the commencement of this item.
7
29 Application provisions
--manufacturing of therapeutic
8
goods
9
(1)
The amendments of sections 37 and 38 of the
Therapeutic Goods Act
10
1989
made by this Schedule apply in relation to an application for a
11
licence made on or after the commencement of this item.
12
(2)
The amendment of section 41 of the
Therapeutic Goods Act 1989
made
13
by this Schedule applies on and after the commencement of this item in
14
relation to a licence granted before, on or after that commencement.
15
30 Application provisions
--medical devices
16
(1)
The amendment of section 41FD of the
Therapeutic Goods Act 1989
17
made by this Schedule applies in relation to an application made under
18
section 41FC of that Act on or after the commencement of this item.
19
(2)
The amendments of sections 41GK and 41JA of the
Therapeutic Goods
20
Act 1989
made by this Schedule apply on and after the commencement
21
of this item in relation to a kind of medical device included in the
22
Register before, on or after that commencement.
23
(3)
The amendment of section 41KA of the
Therapeutic Goods Act 1989
24
made by this Schedule applies in relation to the supply of a kind of
25
medical device on or after the commencement of this item.
26
Restricted information
Schedule 5
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
27
Schedule 5--Restricted information
1
2
Therapeutic Goods Act 1989
3
1 Paragraphs 26AF(2)(b), (c) and (d)
4
Repeal the paragraphs, substitute:
5
(b) the information is derived from a clinical trial in relation to
6
an indication of the existing medicine, where:
7
(i) the trial number of that trial is specified in the
8
application for the listing of the existing medicine; and
9
(ii) the Secretary is satisfied that the trial number of that
10
trial is set out in a registry prescribed by the regulations
11
for the purposes of this subparagraph; and
12
(c) that indication is either:
13
(i) a use of the existing medicine in preventing, curing or
14
alleviating a disease, ailment, defect or injury in
15
persons, other than a form of the disease, ailment, defect
16
or injury that, under the Therapeutic Goods Advertising
17
Code, is a serious form; or
18
(ii) a use of the existing medicine in connection with
19
alleviating a disease, ailment, defect or injury in
20
persons, being a form of the disease, ailment, defect or
21
injury that, under the Therapeutic Goods Advertising
22
Code, is a serious form; and
23
(d) at the time (the
relevant time
) the application for the listing
24
of the existing medicine was made:
25
(i) that indication was not covered by a determination
26
under paragraph 26BF(1)(a); and
27
(ii) no other medicine with that indication, and with the
28
same active ingredients as the existing medicine, was
29
included in the Register under section 26AE; and
30
(da) no other medicine with that indication, and with the same
31
active ingredients as the existing medicine, had been
32
included in the Register under section 26AE at any time
33
before the relevant time; and
34
Schedule 5
Restricted information
28
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
2 After paragraph 26AF(2)(e)
1
Insert:
2
(ea) the Secretary relied on the information in deciding to list the
3
existing medicine; and
4
(eb) at all times during the period:
5
(i) beginning on the day the application for the listing of
6
the existing medicine was made; and
7
(ii) ending at the end of the day before the day that the
8
existing medicine was included in the Register;
9
the information (except information set out in a registry
10
prescribed for the purposes of subparagraph (b)(ii)) was not
11
available to the public; and
12
3 At the end of section 26AF
13
Add:
14
(3) A registry prescribed for the purposes of subparagraph (2)(b)(ii):
15
(a) may be a registry established within or outside Australia; and
16
(b) must be a registry that is accessible by the public.
17
4 Application provision
18
The amendments made by this Schedule apply in relation to an
19
application referred to in paragraph 26AF(2)(a) of the
Therapeutic
20
Goods Act 1989
that is made on or after the commencement of this
21
item.
22
Variation of permissible ingredients determination
Schedule 6
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
29
Schedule 6--Variation of permissible
1
ingredients determination
2
3
Therapeutic Goods Act 1989
4
1 At the end of section 26BDA
5
Add:
6
; or (c) the evaluation fee prescribed for the purposes of
7
paragraph 26BE(3)(b) has not been paid before the end of the
8
period worked out in accordance with the regulations.
9
2 Paragraph 26BE(5B)(b)
10
Omit "recommendations under this section", substitute "a decision
11
under paragraph (4)(a) or (b)".
12
3 Paragraph 26BE(5B)(c)
13
Omit "a recommendation", substitute "a decision under paragraph (4)(a)
14
or (b)".
15
4 Paragraph 26BE(5C)(a)
16
Omit "recommendations under this section", substitute "a decision
17
under paragraph (4)(a) or (b)".
18
5 Paragraph 26BE(5C)(b)
19
Omit "a recommendation", substitute "a decision under paragraph (4)(a)
20
or (b)".
21
6 Subsection 26BE(5D)
22
Omit "the recommendation", substitute "a decision under
23
paragraph (4)(a) or (b)".
24
7 Paragraph 63(2)(daaa)
25
Omit "evaluations under section 26BE in relation to recommendations
26
to vary a section 26BB determination are to be completed", substitute
27
"a decision under paragraph 26BE(4)(a) or (b), in relation to an
28
application under subsection 26BD(1), must be made".
29
Schedule 6
Variation of permissible ingredients determination
30
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
8 Application provision
1
The amendments made by this Schedule apply in relation to an
2
application under subsection 26BD(1) of the
Therapeutic Goods Act
3
1989
that is made on or after the commencement of this item.
4
Delegation
Schedule 7
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
31
Schedule 7--Delegation
1
2
Therapeutic Goods Act 1989
3
1 After subsection 57(5)
4
Insert:
5
(5A) The powers of the Secretary under subsection 19(5) may be
6
delegated only to a person referred to in paragraph (1)(a) or (c) of
7
this section who is registered, or eligible for registration, in a State
8
or internal Territory as a medical or dental practitioner or as a
9
pharmacist.
10
2 Subsection 57(6)
11
Omit "19(5),".
12
3 Saving provision
13
The amendments made by this Schedule do not affect the validity of an
14
instrument in force under subsection 57(1) of the
Therapeutic Goods
15
Act 1989
immediately before the commencement of this item.
16
Schedule 8
Retention of material on withdrawal of application
32
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
Schedule 8--Retention of material on
1
withdrawal of application
2
3
Therapeutic Goods Act 1989
4
1 After paragraph 53(b)
5
Insert:
6
(baa) a recommendation by the Secretary that the Minister vary a
7
section 26BB determination; or
8
(bab) a recommendation by the Secretary that the Minister vary a
9
determination under section 26BF; or
10
2 Application provision
11
The amendment made by this Schedule applies in relation to an
12
application that is withdrawn on or after the commencement of this
13
item.
14
Consents to importations or supplies of therapeutic goods
Schedule 9
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
33
Schedule 9--Consents to importations or
1
supplies of therapeutic goods
2
3
Therapeutic Goods Act 1989
4
1 After paragraph 19D(3)(b)
5
Insert:
6
(ba) the person does not have the consent in writing of the
7
Secretary; and
8
2 After paragraph 19D(4)(b)
9
Insert:
10
(ba) the person does not have the consent in writing of the
11
Secretary; and
12
3 At the end of section 19D
13
Add:
14
Decisions on whether to give consent
15
(6) The Secretary must, as soon as practicable after making a decision
16
to give a consent mentioned in subsection (3) or (4), cause
17
particulars of the decision to be published on the Department's
18
website.
19
(7) The Secretary must, within 28 days after making a decision to
20
refuse to give a consent mentioned in subsection (3) or (4), notify
21
the applicant in writing of the decision and of the reasons for the
22
decision.
23
4 After subsection 56A(4)
24
Insert:
25
(4A) In proceedings for the contravention of subsection 19D(3) or (4)
26
(civil penalty provisions), a certificate by the Secretary, to the
27
effect that the Secretary did not consent to the importation or
28
supply that is the subject of the proceedings, is prima facie
29
evidence of the matters specified in the certificate.
30
Schedule 9
Consents to importations or supplies of therapeutic goods
34
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
5 Application provisions
1
(1)
The amendment of subsection 19D(3) of the
Therapeutic Goods Act
2
1989
made by this Schedule applies in relation to importations that
3
occur on or after the commencement of this item.
4
(2)
The amendment of subsection 19D(4) of the
Therapeutic Goods Act
5
1989
made by this Schedule applies in relation to supplies that occur on
6
or after the commencement of this item.
7
Other amendments
Schedule 10
No. , 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
35
Schedule 10--Other amendments
1
2
Therapeutic Goods Act 1989
3
1 Subsection 7(1)
4
Omit "particular goods or".
5
2 Subsection 7(1)
6
Omit "Secretary may, by order published in the
Gazette
or on the
7
Department's website, declare that the goods, or the goods", substitute
8
"Secretary may, by legislative instrument, make an order declaring that
9
the classes of goods, or the classes of goods".
10
3 Subsection 7(1A)
11
Omit "particular goods or".
12
4 Paragraph 7(4)(a)
13
Omit "particular goods or".
14
5 Section 41HB (heading)
15
Repeal the heading, substitute:
16
41HB Approvals for special and experimental uses
17
6 Section 52EC
18
Repeal the section, substitute:
19
52F Incorporation of current Poisons Standard
20
(1) Despite subsection 14(2) of the
Legislation Act 2003
, a legislative
21
instrument, or a notifiable instrument, under this Act may make
22
provision in relation to a matter by applying, adopting or
23
incorporating, with or without modification, any matter contained
24
in the current Poisons Standard as in force or existing from time to
25
time.
26
(2) Despite subsection 46AA(2) of the
Acts Interpretation Act 1901
, an
27
instrument under this Act (other than a legislative instrument or a
28
Schedule 10
Other amendments
36
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020
No. , 2020
notifiable instrument) may make provision in relation to a matter
1
by applying, adopting or incorporating, with or without
2
modification, any matter contained in the current Poisons Standard
3
as in force or existing from time to time.
4
7 Subsection 60(1) (paragraph (a) of the definition of
initial
5
decision
)
6
Repeal the paragraph, substitute:
7
(a) refusing to make, or refusing to vary or repeal, a declaration
8
under section 7 upon an application made under
9
subsection 7(2); or
10
8 Subsection 60(1) (after paragraph (d) of the definition of
11
initial decision
)
12
Insert:
13
(da) under subsection 41BD(3); or
14
9 Saving provisions
15
(1)
The amendments made by this Schedule do not affect the validity of an
16
order in force under section 7 of the
Therapeutic Goods Act 1989
17
immediately before the commencement of this item.
18
(2)
Section 60 of the
Therapeutic Goods Act 1989
, as in force immediately
19
before the commencement of this item, continues to apply on and after
20
that commencement in relation to a decision made under
21
subsection 7(1) of that Act before that commencement.
22