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This is a Bill, not an Act. For current law, see the Acts databases.
THERAPEUTIC GOODS AMENDMENT BILL 2005
B04QJ234.v08.doc 30/6/2004 9:53 AM
2004-2005
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Therapeutic Goods Amendment Bill
2005
No. , 2005
(Health and Ageing)
A Bill for an Act to amend the Therapeutic Goods
Act 1989, and for related purposes
i Therapeutic Goods Amendment Bill 2005 No. , 2005
B04QJ234.v08.doc 30/6/2004 9:53 AM
Contents
1
Short title.......................................................................................1
2
Commencement .............................................................................1
3
Schedule(s)....................................................................................2
Schedule 1--Amendments
3
Therapeutic Goods Act 1989
3
Therapeutic Goods Amendment (Medical Devices) Act 2002
102
Therapeutic Goods Amendment Bill 2005 No. , 2005 1
A Bill for an Act to amend the Therapeutic Goods
1
Act 1989, and for related purposes
2
The Parliament of Australia enacts:
3
1 Short title
4
This Act may be cited as the Therapeutic Goods Amendment Act
5
2005.
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 Bill 2005 No. , 2005
Commencement information
Column 1
Column 2
Column 3
Provision(s)
Commencement
Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day on which this Act receives the
Royal Assent.
2. Schedule 1,
items 1 to 117
The 28th day after the day on which this Act
receives the Royal Assent.
3. Schedule 1,
item 118
27 November 2003.
27 November
2003
4. Schedule 1,
items 119 to 157
The 28th day after the day on which this Act
receives the Royal Assent.
5. Schedule 1,
item 158
4 October 2007.
4 October 2007
Note:
This table relates only to the provisions of this Act as originally
1
passed by the Parliament and assented to. It will not be expanded to
2
deal with provisions inserted in this Act after assent.
3
(2) Column 3 of the table contains additional information that is not
4
part of this Act. Information in this column may be added to or
5
edited in any published version of this Act.
6
3 Schedule(s)
7
Each Act that is specified in a Schedule to this Act is amended or
8
repealed as set out in the applicable items in the Schedule
9
concerned, and any other item in a Schedule to this Act has effect
10
according to its terms.
11
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 3
1
Schedule 1--Amendments
2
3
Therapeutic Goods Act 1989
4
1 Subsection 3(1)
5
Insert:
6
civil penalty provision has the meaning given by section 42YA.
7
2 Subsection 3(1)
8
Insert:
9
oath includes affirmation.
10
3 Subsection 3(1)
11
Insert:
12
penalty unit, in relation to a civil penalty provision, has the
13
meaning given by section 42YB.
14
4 Subsection 3(8)
15
After "maximum penalty", insert ", other than a maximum civil
16
penalty,".
17
5 At the end of section 5
18
Add "or to be subject to civil proceedings for a contravention of a civil
19
penalty provision".
20
6 Section 5A
21
Repeal the section, substitute:
22
5A Application of the Criminal Code--extended geographical
23
jurisdiction
24
Section 15.2 of the Criminal Code (extended geographical
25
jurisdiction--category B) applies to offences against subsections
26
21A(1), (2) and (4) and sections 22A, 41FE, 42E and 42T.
27
7 Section 14
28
Schedule 1 Amendments
4 Therapeutic Goods Amendment Bill 2005 No. , 2005
Repeal the section, substitute:
1
14 Criminal offences for importing, supplying or exporting goods
2
that do not comply with standards
3
Offences relating to importing goods into Australia
4
(1) A person commits an offence if:
5
(a) the person imports therapeutic goods into Australia; and
6
(b) the goods are imported without the consent in writing of the
7
Secretary; and
8
(c) the goods do not conform with a standard applicable to the
9
goods; and
10
(d) either:
11
(i) the use of the goods has resulted in, or will result in,
12
harm or injury to any person; or
13
(ii) the use of the goods, if the goods were used, would
14
result in harm or injury to any person; and
15
(e) the harm or injury has resulted, will result, or would result,
16
because the goods do not conform with the standard.
17
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
18
units, or both.
19
Note:
A jury may acquit a person of an offence against this subsection and
20
may convict the person of an offence against subsection (4) instead:
21
see section 53A.
22
(2) A person commits an offence if:
23
(a) the person imports therapeutic goods into Australia; and
24
(b) the goods are imported without the consent in writing of the
25
Secretary; and
26
(c) the goods do not conform with a standard applicable to the
27
goods; and
28
(d) the use of the goods, if the goods were used, would be likely
29
to result in harm or injury to any person; and
30
(e) the harm or injury would be likely to result because the
31
goods do not conform with the standard.
32
Maximum penalty: 2,000 penalty units.
33
(3) Subsection (2) is an offence of strict liability.
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 5
Note:
For strict liability, see section 6.1 of the Criminal Code.
1
(4) A person commits an offence if:
2
(a) the person imports therapeutic goods into Australia; and
3
(b) the goods are imported without the consent in writing of the
4
Secretary; and
5
(c) the goods do not conform with a standard applicable to the
6
goods.
7
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
8
units, or both.
9
Exception
10
(5) Paragraphs (1)(a), (2)(a) and (4)(a) do not apply to goods that do
11
not conform with a standard applicable to the goods by reason only
12
of matters relating to labelling or packaging.
13
Note:
A defendant bears an evidential burden in relation to the matters in
14
subsection (5): see subsection 13.3(3) of the Criminal Code.
15
Offences relating to supplying goods for use in Australia
16
(6) A person commits an offence if:
17
(a) the person supplies therapeutic goods for use in Australia;
18
and
19
(b) the goods are supplied without the consent in writing of the
20
Secretary; and
21
(c) the goods do not conform with a standard applicable to the
22
goods; and
23
(d) either:
24
(i) the use of the goods has resulted in, or will result in,
25
harm or injury to any person; or
26
(ii) the use of the goods, if the goods were used, would
27
result in harm or injury to any person; and
28
(e) the harm or injury has resulted, will result, or would result,
29
because the goods do not conform with the standard.
30
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
31
units, or both.
32
Note:
A jury may acquit a person of an offence against this subsection and
33
may convict the person of an offence against subsection (9) instead:
34
see section 53A.
35
Schedule 1 Amendments
6 Therapeutic Goods Amendment Bill 2005 No. , 2005
(7) A person commits an offence if:
1
(a) the person supplies therapeutic goods for use in Australia;
2
and
3
(b) the goods are supplied without the consent in writing of the
4
Secretary; and
5
(c) the goods do not conform with a standard applicable to the
6
goods; and
7
(d) the use of the goods, if the goods were used, would be likely
8
to result in harm or injury to any person; and
9
(e) the harm or injury would be likely to result because the
10
goods do not conform with the standard.
11
Maximum penalty: 2,000 penalty units.
12
(8) Subsection (7) is an offence of strict liability.
13
Note:
For strict liability, see section 6.1 of the Criminal Code.
14
(9) A person commits an offence if:
15
(a) the person supplies therapeutic goods for use in Australia;
16
and
17
(b) the goods are supplied without the consent in writing of the
18
Secretary; and
19
(c) the goods do not conform with a standard applicable to the
20
goods.
21
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
22
units, or both.
23
Offences relating to exporting goods from Australia
24
(10) A person commits an offence if:
25
(a) the person exports therapeutic goods from Australia; and
26
(b) the goods are exported without the consent in writing of the
27
Secretary; and
28
(c) the goods do not conform with a standard applicable to the
29
goods (other than a standard relating to the labelling of the
30
goods for supply in Australia); and
31
(d) either:
32
(i) the use of the goods has resulted in, or will result in,
33
harm or injury to any person; or
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 7
(ii) the use of the goods, if the goods were used, would
1
result in harm or injury to any person; and
2
(e) the harm or injury has resulted, will result, or would result,
3
because the goods do not conform with the standard.
4
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
5
units, or both.
6
Note:
A jury may acquit a person of an offence against this subsection and
7
may convict the person of an offence against subsection (13) instead:
8
see section 53A.
9
(11) A person commits an offence if:
10
(a) the person exports therapeutic goods from Australia; and
11
(b) the goods are exported without the consent in writing of the
12
Secretary; and
13
(c) the goods do not conform with a standard applicable to the
14
goods (other than a standard relating to the labelling of the
15
goods for supply in Australia); and
16
(d) the use of the goods, if the goods were used, would be likely
17
to result in harm or injury to any person; and
18
(e) the harm or injury would be likely to result because the
19
goods do not conform with the standard.
20
Maximum penalty: 2,000 penalty units.
21
(12) Subsection (11) is an offence of strict liability.
22
Note:
For strict liability, see section 6.1 of the Criminal Code.
23
(13) A person commits an offence if:
24
(a) the person exports therapeutic goods from Australia; and
25
(b) the goods are exported without the consent in writing of the
26
Secretary; and
27
(c) the goods do not conform with a standard applicable to the
28
goods (other than a standard relating to the labelling of the
29
goods for supply in Australia).
30
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
31
units, or both.
32
Schedule 1 Amendments
8 Therapeutic Goods Amendment Bill 2005 No. , 2005
Decisions on whether to give consent
1
(14) The Secretary must, as soon as practicable after making a decision
2
to give a consent, cause particulars of the decision to be published
3
in the Gazette.
4
(15) The Secretary must, within 28 days after making a decision to
5
refuse to give a consent, notify the applicant in writing of the
6
decision and of the reasons for the decision.
7
14A Civil penalties for importing, supplying or exporting goods that
8
do not comply with standards
9
Civil penalty relating to importing goods into Australia
10
(1) A person contravenes this subsection if:
11
(a) the person imports therapeutic goods into Australia; and
12
(b) the person does not have the consent in writing of the
13
Secretary; and
14
(c) the goods do not conform with a standard applicable to the
15
goods (other than by reason of a matter relating to labelling
16
or packaging).
17
Maximum civil penalty:
18
(a) for an individual--5,000 penalty units; and
19
(b) for a body corporate--50,000 penalty units.
20
Civil penalty relating to supplying goods for use in Australia
21
(2) A person contravenes this subsection if:
22
(a) the person supplies therapeutic goods for use in Australia;
23
and
24
(b) the person does not have the consent in writing of the
25
Secretary; and
26
(c) the goods do not conform with a standard applicable to the
27
goods.
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
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 9
Civil penalty relating to exporting goods from Australia
1
(3) A person contravenes this subsection if:
2
(a) the person exports therapeutic goods from Australia; and
3
(b) the person does not have the consent in writing of the
4
Secretary; and
5
(c) the goods do not conform with a standard applicable to the
6
goods (other than a standard relating to the labelling of the
7
goods for supply in Australia).
8
Maximum civil penalty:
9
(a) for an individual--5,000 penalty units; and
10
(b) for a body corporate--50,000 penalty units.
11
Decisions on whether to give consent
12
(4) The Secretary must, as soon as practicable after making a decision
13
to give a consent, cause particulars of the decision to be published
14
in the Gazette.
15
(5) The Secretary must, within 28 days after making a decision to
16
refuse to give a consent, notify the applicant in writing of the
17
decision and of the reasons for the decision.
18
14B Application of Customs Act 1901
19
Where:
20
(a) the importation or exportation of goods is an offence under
21
subsection 14(1), (2), (4), (10), (11) or (13) or a
22
contravention of subsection 14A(1) or (3); and
23
(b) the Secretary notifies the Chief Executive Officer of Customs
24
in writing that the Secretary wishes the Customs Act 1901 to
25
apply to that importation or exportation;
26
the Customs Act 1901 has effect as if the goods included in that
27
importation or exportation were goods described as forfeited to the
28
Crown under section 229 of that Act because they were:
29
(c) prohibited imports within the meaning of that Act; or
30
(d) prohibited exports within the meaning of that Act;
31
as the case requires.
32
8 Section 15
33
Schedule 1 Amendments
10 Therapeutic Goods Amendment Bill 2005 No. , 2005
Repeal the section, substitute:
1
15 Criminal offences relating to breaching a condition of a consent
2
(1) The consent of the Secretary under section 14 or 14A may be
3
given:
4
(a) unconditionally or subject to conditions; or
5
(b) in respect of particular goods or classes of goods.
6
(2) A person commits an offence if:
7
(a) the person does an act or omits to do an act; and
8
(b) the act or omission breaches a condition of a consent; and
9
(c) the act or omission has resulted in, or will result in, harm or
10
injury to any person.
11
Maximum penalty: 2,000 penalty units.
12
Note:
A jury may acquit a person of an offence against this subsection and
13
may convict the person of an offence against subsection (5) instead:
14
see section 53A.
15
(3) A person commits an offence if:
16
(a) the person does an act or omits to do an act; and
17
(b) the act or omission breaches a condition of a consent; and
18
(c) the act or omission is likely to result in harm or injury to any
19
person.
20
Maximum penalty: 1,000 penalty units.
21
(4) Subsection (3) is an offence of strict liability.
22
Note:
For strict liability, see section 6.1 of the Criminal Code.
23
(5) A person commits an offence if:
24
(a) the person does an act or omits to do an act; and
25
(b) the act or omission breaches a condition of a consent.
26
Maximum penalty: 500 penalty units.
27
15AA Civil penalty relating to breaching a condition of a consent
28
A person contravenes this section if:
29
(a) the person does an act or omits to do an act; and
30
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 11
(b) the act or omission breaches a condition of a consent
1
imposed under section 15.
2
Maximum civil penalty:
3
(a) for an individual--3,000 penalty units; and
4
(b) for a body corporate--30,000 penalty units.
5
9 Subsection 18A(7) (note)
6
Omit "Note", substitute "Note 1".
7
10 At the end of subsection 18A(7)
8
Add:
9
Note 2:
A person may also contravene a civil penalty provision, see
10
section 22AA.
11
11 Subsection 18A(12) (paragraph (a) of the note)
12
Omit "and 22", substitute ", 22 and 22AA".
13
12 Subsection 18A(12) (paragraph (b) of the note)
14
Omit "section 30F", substitute "sections 30F and 30FA".
15
13 Subsection 18A(12) (paragraph (f) of the note)
16
After "sections 35,", insert "35A,".
17
14 After section 19A
18
Insert:
19
19B Criminal offences relating to registration or listing etc. of
20
imported, exported, manufactured and supplied
21
therapeutic goods
22
Offences relating to importing, exporting, manufacturing or
23
supplying goods for use in humans
24
(1) A person commits an offence if:
25
(a) the person:
26
(i) imports into Australia therapeutic goods for use in
27
humans; or
28
(ii) exports from Australia therapeutic goods for use in
29
humans; or
30
Schedule 1 Amendments
12 Therapeutic Goods Amendment Bill 2005 No. , 2005
(iii) manufactures in Australia therapeutic goods for use in
1
humans; or
2
(iv) supplies in Australia therapeutic goods for use in
3
humans; and
4
(b) none of the following subparagraphs applies in relation to the
5
goods:
6
(i) the goods are registered goods or listed goods in relation
7
to the person;
8
(ii) the goods are exempt goods;
9
(iii) the goods are exempt under section 18A;
10
(iv) the goods are the subject of an approval or authority
11
under section 19;
12
(v) the goods are the subject of an approval under
13
section 19A; and
14
(c) either:
15
(i) the use of the goods has resulted in, or will result in,
16
harm or injury to any person; or
17
(ii) the use of the goods, if the goods were used, would
18
result in harm or injury to any person.
19
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
20
units, or both.
21
Note 1:
A jury may acquit a person of an offence against this subsection and
22
may convict the person of an offence against subsection (4) instead:
23
see section 53A.
24
Note 2:
A person may commit an offence against subsection 20(2A) or (2C),
25
or may contravene section 22AA (a civil penalty provision), by
26
importing into Australia therapeutic goods that are exempt under
27
section 18A.
28
(2) A person commits an offence if:
29
(a) the person:
30
(i) imports into Australia therapeutic goods for use in
31
humans; or
32
(ii) exports from Australia therapeutic goods for use in
33
humans; or
34
(iii) manufactures in Australia therapeutic goods for use in
35
humans; or
36
(iv) supplies in Australia therapeutic goods for use in
37
humans; and
38
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 13
(b) none of the following subparagraphs applies in relation to the
1
goods:
2
(i) the goods are registered goods or listed goods in relation
3
to the person;
4
(ii) the goods are exempt goods;
5
(iii) the goods are exempt under section 18A;
6
(iv) the goods are the subject of an approval or authority
7
under section 19;
8
(v) the goods are the subject of an approval under
9
section 19A; and
10
(c) the use of the goods, if the goods were used, would be likely
11
to result in harm or injury to any person.
12
Maximum penalty: 2,000 penalty units.
13
Note:
A person may commit an offence against subsection 20(2A) or (2C),
14
or may contravene section 22AA (a civil penalty provision), by
15
importing into Australia therapeutic goods that are exempt under
16
section 18A.
17
(3) Subsection (2) is an offence of strict liability.
18
Note:
For strict liability, see section 6.1 of the Criminal Code.
19
(4) A person commits an offence if:
20
(a) the person:
21
(i) imports into Australia therapeutic goods for use in
22
humans; or
23
(ii) exports from Australia therapeutic goods for use in
24
humans; or
25
(iii) manufactures in Australia therapeutic goods for use in
26
humans; or
27
(iv) supplies in Australia therapeutic goods for use in
28
humans; and
29
(b) none of the following subparagraphs applies in relation to the
30
goods:
31
(i) the goods are registered goods or listed goods in relation
32
to the person;
33
(ii) the goods are exempt goods;
34
(iii) the goods are exempt under section 18A;
35
(iv) the goods are the subject of an approval or authority
36
under section 19;
37
Schedule 1 Amendments
14 Therapeutic Goods Amendment Bill 2005 No. , 2005
(v) the goods are the subject of an approval under
1
section 19A.
2
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
3
units, or both.
4
Defence if person was not the sponsor of the goods
5
(5) It is a defence to a prosecution under subsection (1), (2) or (4) if
6
the defendant proves that the defendant was not the sponsor of the
7
goods at the time of the importation, exportation, manufacture or
8
supply, as the case may be.
9
Note:
The defendant bears a legal burden in relation to the matter in
10
subsection (5): see section 13.4 of the Criminal Code.
11
Exception
12
(6) Subsection (1) does not apply if:
13
(a) harm or injury did not, or will not, directly result from:
14
(i) the quality, safety or efficacy of the goods; or
15
(ii) a matter relating to the labelling or packaging of the
16
goods; or
17
(iii) the improper use of the goods; or
18
(b) harm or injury would not directly result from:
19
(i) the quality, safety or efficacy of the goods; or
20
(ii) a matter relating to the labelling or packaging of the
21
goods; or
22
(iii) the improper use of the goods.
23
Note:
A defendant bears an evidential burden in relation to the matters in
24
subsection (6): see subsection 13.3(3) of the Criminal Code.
25
Application of Customs Act 1901
26
(7) Where:
27
(a) the importation or exportation of goods is an offence under
28
subsection (1), (2) or (4); and
29
(b) the Secretary notifies the Chief Executive Officer of Customs
30
in writing that the Secretary wishes the Customs Act 1901 to
31
apply to that importation or exportation;
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 15
the Customs Act 1901 has effect as if the goods included in that
1
importation or exportation were goods described as forfeited to the
2
Crown under section 229 of that Act because they were:
3
(c) prohibited imports within the meaning of that Act; or
4
(d) prohibited exports within the meaning of that Act;
5
as the case requires.
6
19C Notice required to adduce evidence in support of exception
7
under subsection 19B(6)
8
(1) If:
9
(a) a defendant is committed for trial for an offence against
10
subsection 19B(1); or
11
(b) an offence against subsection 19B(1) is to be heard and
12
determined by a court of summary jurisdiction;
13
the committing magistrate or the court must:
14
(c) inform the defendant of the requirements of this section; and
15
(d) cause a copy of this section to be given to the defendant.
16
(2) A defendant must not, without leave of the court, adduce evidence
17
in support of the exception under subsection 19B(6) unless:
18
(a) if paragraph (1)(a) applies--more than 21 days before the
19
trial begins; or
20
(b) if paragraph (1)(b) applies--more than 21 days before the
21
hearing of the offence begins;
22
he or she gives notice of particulars of the exception.
23
(3) A defendant must not, without leave of the court, call any other
24
person to give evidence in support of the exception unless:
25
(a) the notice under subsection (2) includes the name and
26
address of the person or, if the name and address is not
27
known to the defendant at the time he or she gives the notice,
28
any information in his or her possession that might be of
29
material assistance in finding the person; and
30
(b) if the name or the address is not included in the notice--the
31
court is satisfied that the defendant before giving the notice
32
took, and after giving the notice continued to take, all
33
reasonable steps to ascertain the name or address; and
34
(c) if the name or address is not included in the notice, but the
35
defendant subsequently ascertains the name or address or
36
Schedule 1 Amendments
16 Therapeutic Goods Amendment Bill 2005 No. , 2005
receives information that might be of material assistance in
1
finding the person--the defendant immediately gives notice
2
of the name, address or other information, as the case may
3
be; and
4
(d) if the defendant is told by or on behalf of the prosecutor that
5
the person has not been found by the name, or at the address,
6
given by the defendant:
7
(i) the defendant immediately gives notice of any
8
information in the defendant's possession that might be
9
of material assistance in finding the person; or
10
(ii) if the defendant later receives any such information--
11
the defendant immediately gives notice of the
12
information.
13
(4) A notice purporting to be given under this section on behalf of the
14
defendant by his or her legal practitioner is, unless the contrary is
15
proved, taken as having been given with the authority of the
16
defendant.
17
(5) Any evidence tendered to disprove that the exception applies may,
18
subject to direction by the court, be given before or after evidence
19
is given in support of the exception.
20
(6) A notice of particulars of the exception must be given, in writing,
21
to the Director of Public Prosecutions. A notice is taken as having
22
been given if it is:
23
(a) delivered to or left at the Office of the Director of Public
24
Prosecutions; or
25
(b) sent by certified mail addressed to the Director of Public
26
Prosecutions at the Office of the Director of Public
27
Prosecutions.
28
(7) In this section:
29
Director of Public Prosecutions means a person holding office as,
30
or acting as, the Director of Public Prosecutions under the Director
31
of Public Prosecutions Act 1983.
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 17
19D Civil penalties relating to registration or listing etc. of imported,
1
exported, manufactured and supplied therapeutic goods
2
Civil penalty relating to importing, exporting, manufacturing or
3
supplying goods for use in humans
4
(1) A person contravenes this subsection if:
5
(a) the person does any of the following:
6
(i) imports into Australia therapeutic goods for use in
7
humans;
8
(ii) exports from Australia therapeutic goods for use in
9
humans;
10
(iii) manufactures in Australia therapeutic goods for use in
11
humans;
12
(iv) supplies in Australia therapeutic goods for use in
13
humans; and
14
(b) none of the following subparagraphs applies in relation to the
15
goods:
16
(i) the goods are registered goods or listed goods in relation
17
to the person;
18
(ii) the goods are exempt goods;
19
(iii) the goods are exempt under section 18A;
20
(iv) the goods are the subject of an approval or authority
21
under section 19;
22
(v) the goods are the subject of an approval under
23
section 19A.
24
Maximum civil penalty:
25
(a) for an individual--5,000 penalty units; and
26
(b) for a body corporate--50,000 penalty units.
27
Note:
A person may commit an offence against subsection 20(2A) or (2C),
28
or may contravene section 22AA (a civil penalty provision), by
29
importing into Australia therapeutic goods that are exempt under
30
section 18A.
31
Exception if person was not the sponsor of the goods
32
(2) Subsection (1) does not apply if the person proves that he or she
33
was not the sponsor of the goods at the time of the importation,
34
exportation, manufacture or supply, as the case may be.
35
Schedule 1 Amendments
18 Therapeutic Goods Amendment Bill 2005 No. , 2005
Civil penalty relating to the importing of registered or listed goods
1
(3) A person contravenes this subsection if:
2
(a) therapeutic goods are registered or listed in relation to the
3
person (other than listed goods that are therapeutic devices);
4
and
5
(b) the person imports the goods into Australia; and
6
(c) the registration number or listing number of the goods is not
7
set out on the label of the goods in the prescribed manner
8
before the goods are supplied in Australia.
9
Maximum civil penalty:
10
(a) for an individual--200 penalty units; and
11
(b) for a body corporate--2,000 penalty units.
12
Civil penalty relating to the supply of registered or listed goods
13
(4) A person contravenes this subsection if:
14
(a) therapeutic goods are registered or listed in relation to the
15
person (other than listed goods that are therapeutic devices);
16
and
17
(b) the person supplies the goods in Australia; and
18
(c) the registration number or listing number of the goods is not
19
set out on the label of the goods in the prescribed manner.
20
Maximum civil penalty:
21
(a) for an individual--200 penalty units; and
22
(b) for a body corporate--2,000 penalty units.
23
Application of Customs Act 1901
24
(5) Where:
25
(a) the importation or exportation of goods contravenes
26
subsection (1); and
27
(b) the Secretary notifies the Chief Executive Officer of Customs
28
in writing that the Secretary wishes the Customs Act 1901 to
29
apply to that importation or exportation;
30
the Customs Act 1901 has effect as if the goods included in that
31
importation or exportation were goods described as forfeited to the
32
Crown under section 229 of that Act because they were:
33
(c) prohibited imports within the meaning of that Act; or
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 19
(d) prohibited exports within the meaning of that Act;
1
as the case requires.
2
15 Subsections 20(1), (1AA), (1A), (2) and (3)
3
Repeal the subsections.
4
Note:
The heading to section 20 is replaced by the heading "Criminal offences relating to
5
notifying the Secretary and to importing goods exempt under section 18A".
6
16 After section 20
7
Insert:
8
20A Civil penalty relating to the importation, exportation,
9
manufacture or supply of sponsored goods without
10
proper notification
11
(1) A person contravenes this section if:
12
(a) the person does any of the following:
13
(i) imports therapeutic goods into Australia;
14
(ii) exports therapeutic goods from Australia;
15
(iii) manufactures therapeutic goods in Australia;
16
(iv) supplies therapeutic goods in Australia; and
17
(b) the person is the sponsor of the goods for use in humans; and
18
(c) the person has not, at or before the time of the importation,
19
exportation, manufacture or supply, properly notified to the
20
Secretary either or both of the following:
21
(i) the manufacturer of the goods;
22
(ii) premises used in the manufacture of the goods.
23
Maximum civil penalty:
24
(a) for an individual--5,000 penalty units; and
25
(b) for a body corporate--50,000 penalty units.
26
Meaning of properly notified
27
(2) For the purposes of paragraph (1)(c):
28
(a) a manufacturer is properly notified to the Secretary if:
29
(i) the manufacturer was nominated, as a manufacturer of
30
the goods, in an application for the registration or listing
31
of the goods; or
32
Schedule 1 Amendments
20 Therapeutic Goods Amendment Bill 2005 No. , 2005
(ii) the Secretary was subsequently informed in writing that
1
the manufacturer is a manufacturer of the goods; and
2
(b) premises are properly notified to the Secretary if:
3
(i) the premises were nominated, as premises used in the
4
manufacture of the goods, in an application for the
5
registration or listing of the goods; or
6
(ii) the Secretary was subsequently informed in writing that
7
the premises are used in the manufacture of the goods.
8
17 After section 21
9
Insert:
10
21A General criminal offences relating to this Part
11
Offences for making a false or misleading statement
12
(1) A person commits an offence if:
13
(a) the person makes a statement; and
14
(b) the statement is made in or in connection with a certification
15
of any matter under subsection 26A(2); and
16
(c) the statement is false or misleading in a material particular;
17
and
18
(d) either:
19
(i) the use of the medicine has resulted in, or will result in,
20
harm or injury to any person; or
21
(ii) the use of the medicine, if the medicine were used,
22
would result in harm or injury to any person.
23
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
24
units, or both.
25
Note:
A jury may acquit a person of an offence against this subsection and
26
may convict the person of an offence against subsection (4) instead:
27
see section 53A.
28
(2) A person commits an offence if:
29
(a) the person makes a statement; and
30
(b) the statement is made in or in connection with a certification
31
of any matter under subsection 26A(2); and
32
(c) the statement is false or misleading in a material particular;
33
and
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 21
(d) the use of the medicine, if the medicine were used, would be
1
likely to result in harm or injury to any person.
2
Maximum penalty: 2,000 penalty units.
3
(3) Subsection (2) is an offence of strict liability.
4
Note:
For strict liability, see section 6.1 of the Criminal Code.
5
(4) A person commits an offence if:
6
(a) the person makes a statement; and
7
(b) the statement is made in or in connection with a certification
8
of any matter under subsection 26A(2); and
9
(c) the statement is false or misleading in a material particular.
10
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
11
units, or both.
12
Offences relating to breaching a condition of registration or listing
13
of therapeutic goods
14
(5) A person commits an offence if:
15
(a) therapeutic goods are registered or listed in relation to the
16
person; and
17
(b) the person does an act or omits to do an act; and
18
(c) the act or omission breaches a condition of the registration or
19
listing of the goods; and
20
(d) the act or omission has resulted in, or will result in, harm or
21
injury to any person.
22
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
23
units, or both.
24
Note:
A jury may acquit a person of an offence against this subsection and
25
may convict the person of an offence against subsection (8) instead:
26
see section 53A.
27
(6) A person commits an offence if:
28
(a) therapeutic goods are registered or listed in relation to the
29
person; and
30
(b) the person does an act or omits to do an act; and
31
(c) the act or omission breaches a condition of the registration or
32
listing of the goods; and
33
Schedule 1 Amendments
22 Therapeutic Goods Amendment Bill 2005 No. , 2005
(d) the act or omission is likely to result in harm or injury to any
1
person.
2
Maximum penalty: 2,000 penalty units.
3
(7) Subsection (6) is an offence of strict liability.
4
Note:
For strict liability, see section 6.1 of the Criminal Code.
5
(8) A person commits an offence if:
6
(a) therapeutic goods are registered or listed in relation to the
7
person; and
8
(b) the person does an act or omits to do an act; and
9
(c) the act or omission breaches a condition of the registration or
10
listing of the goods.
11
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
12
units, or both.
13
Offences relating to the supply of therapeutic goods in breach of
14
authority etc.
15
(9) A person commits an offence if:
16
(a) the Secretary has authorised, under subsection 19(5), the
17
person to supply therapeutic goods; and
18
(b) the person supplies those goods; and
19
(c) any of the following applies:
20
(i) the supply is not in accordance with the authority; or
21
(ii) the supply is not in accordance with the conditions to
22
which the authority is subject; or
23
(iii) the supply is not in accordance with regulations made
24
for the purpose of subsection 19(7); and
25
(d) either:
26
(i) the use of the goods has resulted in, or will result in,
27
harm or injury to any person; or
28
(ii) the use of the goods, if the goods were used, would
29
result in harm or injury to any person; and
30
(e) the harm or injury has resulted, will result, or would result,
31
because:
32
(i) the supply is not in accordance with the authority; or
33
(ii) the supply is not in accordance with the conditions to
34
which the authority is subject; or
35
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 23
(iii) the supply is not in accordance with regulations made
1
for the purpose of subsection 19(7).
2
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
3
units, or both.
4
Note:
A jury may acquit a person of an offence against this subsection and
5
may convict the person of an offence against subsection 22(7A)
6
instead: see section 53A.
7
(10) A person commits an offence if:
8
(a) the Secretary has authorised, under subsection 19(5), the
9
person to supply therapeutic goods; and
10
(b) the person supplies those goods; and
11
(c) any of the following applies:
12
(i) the supply is not in accordance with the authority; or
13
(ii) the supply is not in accordance with the conditions to
14
which the authority is subject; or
15
(iii) the supply is not in accordance with regulations made
16
for the purpose of subsection 19(7); and
17
(d) the use of the goods, if goods were used, would be likely to
18
result in harm or injury to any person; and
19
(e) the harm or injury would be likely to result because:
20
(i) the supply is not in accordance with the authority; or
21
(ii) the supply is not in accordance with the conditions to
22
which the authority is subject; or
23
(iii) the supply is not in accordance with regulations made
24
for the purpose of subsection 19(7).
25
Maximum penalty: 2,000 penalty units.
26
(11) Subsection (10) is an offence of strict liability.
27
Note:
For strict liability, see section 6.1 of the Criminal Code.
28
Offences relating to using therapeutic goods without approval etc.
29
(12) A person commits an offence if:
30
(a) the person uses therapeutic goods; and
31
(b) the goods are used:
32
(i) in the treatment of another person; or
33
(ii) solely for experimental purposes in humans; and
34
(c) the goods are not:
35
Schedule 1 Amendments
24 Therapeutic Goods Amendment Bill 2005 No. , 2005
(i) exempt goods; or
1
(ii) listed goods; or
2
(iii) registered goods; or
3
(iv) goods exempt under section 18A; or
4
(v) goods that are the subject of an approval under
5
section 19A; and
6
(d) the goods are not used in accordance with:
7
(i) an approval or authority under section 19; or
8
(ii) a condition applicable under regulations made for the
9
purposes of subsection 19(4A); and
10
(e) either:
11
(i) if the person used the goods in the treatment of another
12
person--the use of the goods has resulted in, or will
13
result in, harm or injury to that person; or
14
(ii) if the person used the goods solely for experimental
15
purposes in humans--the use of the goods has resulted
16
in, or will result in, harm or injury to any of those
17
persons.
18
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
19
units, or both.
20
Note:
A jury may acquit a person of an offence against this subsection and
21
may convict the person of an offence against subsection 22(8) instead:
22
see section 53A.
23
(13) A person commits an offence if:
24
(a) the person uses therapeutic goods; and
25
(b) the goods are used:
26
(i) in the treatment of another person; or
27
(ii) solely for experimental purposes in humans; and
28
(c) the goods are not:
29
(i) exempt goods; or
30
(ii) listed goods; or
31
(iii) registered goods; or
32
(iv) goods exempt under section 18A; or
33
(v) goods that are the subject of an approval under
34
section 19A; and
35
(d) the goods are not used in accordance with:
36
(i) an approval or authority under section 19; or
37
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 25
(ii) a condition applicable under regulations made for the
1
purposes of subsection 19(4A); and
2
(e) either:
3
(i) if the person used the goods in the treatment of another
4
person--the use of the goods, if the goods were used, is
5
likely to result in harm or injury to that person; or
6
(ii) if the person used the goods solely for experimental
7
purposes in humans--the use of the goods, if the goods
8
were used, is likely to result in harm or injury to any of
9
those persons.
10
Maximum penalty: 2,000 penalty units.
11
(14) Subsection (13) is an offence of strict liability.
12
Note:
For strict liability, see section 6.1 of the Criminal Code.
13
21B General civil penalties relating to this Part
14
Civil penalty for making a false or misleading statement
15
(1) A person contravenes this subsection if the person, in or in
16
connection with a certification of any matter under subsection
17
26A(2), makes a statement that is false or misleading in a material
18
particular.
19
Maximum civil penalty:
20
(a) for an individual--5,000 penalty units; and
21
(b) for a body corporate--50,000 penalty units.
22
Civil penalty relating to breaching a condition of registration or
23
listing of therapeutic goods
24
(2) A person contravenes this subsection if:
25
(a) therapeutic goods are registered or listed in relation to the
26
person; and
27
(b) the person does an act or omits to do an act that breaches a
28
condition of the registration or listing of the goods.
29
Maximum civil penalty:
30
(a) for an individual--5,000 penalty units; and
31
(b) for a body corporate--50,000 penalty units.
32
Schedule 1 Amendments
26 Therapeutic Goods Amendment Bill 2005 No. , 2005
Civil penalty for falsely representing therapeutic goods
1
(3) A person contravenes this subsection if:
2
(a) the person represents therapeutic goods that are not included
3
in the Register as being so included; or
4
(b) the person represents therapeutic goods that are not exempt
5
goods as being exempt goods; or
6
(c) the person represents therapeutic goods that are not goods
7
exempt under section 18A as being goods exempt under that
8
section; or
9
(d) the person represents therapeutic goods that are included in
10
one part of the Register as being included in another part of
11
the Register; or
12
(e) the person represents therapeutic goods that are not the
13
subject of an approval or authority under section 19 as being
14
the subject of such an approval or authority; or
15
(f) the person represents therapeutic goods that are not the
16
subject of an approval under section 19A as being the subject
17
of such an approval.
18
Maximum civil penalty:
19
(a) for an individual--5,000 penalty units; and
20
(b) for a body corporate--50,000 penalty units.
21
18 Subsections 22(2A), (3), (3A) and (4)
22
Repeal the subsections.
23
19 Subsection 22(7AB) (penalty)
24
Omit "300 penalty units", substitute "2,000 penalty units".
25
20 Subsection 22(7AB) (note 1)
26
Repeal the note, substitute:
27
Note 1:
A person may commit an offence against subsection 20(2A) or (2C),
28
or contravene section 22AA (a civil penalty provision), by breaching a
29
condition of an exemption of therapeutic goods under section 18A that
30
relates to the importation of the goods.
31
21 Subsection 22(7A) (penalty)
32
Repeal the penalty, substitute:
33
Maximum penalty: 500 penalty units.
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 27
22 Subsection 22(8) (penalty)
1
Repeal the penalty, substitute:
2
Maximum penalty: 500 penalty units.
3
23 After section 22
4
Insert:
5
22AA Civil penalty for breaching a condition of an exemption
6
A person contravenes this section if:
7
(a) the person does an act or omits to do an act in relation to
8
therapeutic goods; and
9
(b) the goods are exempt under section 18A; and
10
(c) the act or omission breaches a condition of the exemption.
11
Maximum civil penalty:
12
(a) for an individual--5,000 penalty units; and
13
(b) for a body corporate--50,000 penalty units.
14
24 Section 22A
15
Repeal the section, substitute:
16
22A Criminal offences for false statements in applications for
17
registration
18
(1) A person commits an offence if:
19
(a) the person makes a statement; and
20
(b) the statement is made in or in connection with an application
21
for registration of therapeutic goods; and
22
(c) the statement is false or misleading in a material particular;
23
and
24
(d) either:
25
(i) the use of the goods has resulted in, or will result in,
26
harm or injury to any person; or
27
(ii) the use of the goods, if the goods were used, would
28
result in harm or injury to any person.
29
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
30
units, or both.
31
Schedule 1 Amendments
28 Therapeutic Goods Amendment Bill 2005 No. , 2005
Note:
A jury may acquit a person of an offence against this subsection and
1
may convict the person of an offence against subsection (4) instead:
2
see section 53A.
3
(2) A person commits an offence if:
4
(a) the person makes a statement; and
5
(b) the statement is made in or in connection with an application
6
for registration of therapeutic goods; and
7
(c) the statement is false or misleading in a material particular;
8
and
9
(d) the use of the goods, if the goods were used, would be likely
10
to result in harm or injury to any person.
11
Maximum penalty: 2,000 penalty units.
12
(3) Subsection (2) is an offence of strict liability.
13
Note:
For strict liability, see section 6.1 of the Criminal Code.
14
(4) A person commits an offence if:
15
(a) the person makes a statement; and
16
(b) the statement is made in or in connection with an application
17
for registration of therapeutic goods; and
18
(c) the statement is false or misleading in a material particular.
19
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
20
units, or both.
21
22B Civil penalty for false statements in applications for registration
22
A person contravenes this section if the person in or in connection
23
with an application for registration of therapeutic goods, makes a
24
statement that is false or misleading in a material particular.
25
Maximum civil penalty:
26
(a) for an individual--5,000 penalty units; and
27
(b) for a body corporate--50,000 penalty units.
28
25 Subsection 29A(1) (penalty)
29
Repeal the penalty, substitute:
30
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
31
units, or both.
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 29
Note:
The heading to section 29A is replaced by the heading "Criminal offence for failing to
1
notify adverse effects etc. of goods".
2
26 After section 29A
3
Insert:
4
29AA Civil penalty for failing to notify adverse effects etc. of goods
5
(1) A person contravenes this section if:
6
(a) therapeutic goods are registered or listed in relation to a
7
person; and
8
(b) the person becomes aware of information of a kind
9
mentioned in subsection (2) relating to the goods; and
10
(c) the person does not give the information to the Secretary in
11
writing as soon as he or she becomes aware of it.
12
Maximum civil penalty:
13
(a) for an individual--3,000 penalty units; and
14
(b) for a body corporate--30,000 penalty units.
15
(2) The information with which subsection (1) is concerned is
16
information of the following kinds:
17
(a) information that contradicts information already given by the
18
person under this Act;
19
(b) information that indicates that the use of the goods in
20
accordance with the recommendations for their use may have
21
an unintended harmful effect;
22
(c) information that indicates that the goods, when used in
23
accordance with the recommendations for their use, may not
24
be as effective as the application for registration or listing of
25
the goods or information already given by the person under
26
this Act suggests;
27
(d) information that indicates that the quality, safety or efficacy
28
of the goods is unacceptable.
29
27 Paragraph 29B(1)(a)
30
After "subsection 29A(2)", insert " or 29AA(2)".
31
28 Subsection 29B(3) (penalty)
32
Repeal the penalty, substitute:
33
Schedule 1 Amendments
30 Therapeutic Goods Amendment Bill 2005 No. , 2005
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
1
units, or both.
2
29 Subsection 29B(4) (penalty)
3
Repeal the penalty, substitute:
4
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
5
units, or both.
6
30 After section 29B
7
Insert:
8
29C Civil penalties for failing to notify adverse effects etc. where
9
application withdrawn or lapses
10
Civil penalty for failing to comply with requirements of a notice
11
(1) A person contravenes this subsection if the person does not comply
12
with the requirements of a notice under subsection 29B(1) within
13
30 days after the day on which the notice is given to the person.
14
Maximum civil penalty:
15
(a) for an individual--3,000 penalty units; and
16
(b) for a body corporate--30,000 penalty units.
17
Civil penalty for giving false or misleading information in
18
purported compliance with requirements of a notice
19
(2) A person contravenes this subsection if the person, in purported
20
compliance with a notice under subsection 29B(1), gives
21
information that is false or misleading in a material particular.
22
Maximum civil penalty:
23
(a) for an individual--3,000 penalty units; and
24
(b) for a body corporate--30,000 penalty units.
25
31 Paragraph 30(2)(ca)
26
After "subsection 29A(1)", insert "or 29AA(1)".
27
32 Subsection 30EA(1) (table item 5)
28
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 31
Omit "20(1) or 42E(1)", substitute "19B(1), (2) or (4), 19D(1), 42E(1)
1
or 42EA(1)".
2
33 Section 30EC
3
Repeal the section, substitute:
4
30EC Criminal offences for non-compliance with requirements
5
(1) A person commits an offence if:
6
(a) the person does an act or omits to do an act; and
7
(b) the act or omission breaches a requirement imposed on the
8
person under section 30EA; and
9
(c) the act or omission has resulted in, or will result in, harm or
10
injury to any person.
11
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
12
units, or both.
13
Note:
A jury may acquit a person of an offence against this subsection and
14
may convict the person of an offence against subsection (4) instead:
15
see section 53A.
16
(2) A person commits an offence if:
17
(a) the person does an act or omits to do an act; and
18
(b) the act or omission breaches a requirement imposed on the
19
person under section 30EA; and
20
(c) the act or omission is likely to result in harm or injury to any
21
person.
22
Maximum penalty: 2,000 penalty units.
23
(3) Subsection (2) is an offence of strict liability.
24
Note:
For strict liability, see section 6.1 of the Criminal Code.
25
(4) A person commits an offence if:
26
(a) the person does an act or omits to do an act; and
27
(b) the act or omission breaches a requirement imposed on the
28
person under section 30EA.
29
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
30
units, or both.
31
Schedule 1 Amendments
32 Therapeutic Goods Amendment Bill 2005 No. , 2005
30ECA Civil penalty for non-compliance with requirements
1
A person contravenes this section if:
2
(a) the person does an act or omits to do an act; and
3
(b) the act or omission breaches a requirement imposed on the
4
person under section 30EA.
5
Maximum civil penalty:
6
(a) for an individual--5,000 penalty units; and
7
(b) for a body corporate--50,000 penalty units.
8
34 After subsection 30F(4)
9
Insert:
10
Written notice is not a legislative instrument
11
(4A) A written notice given to a person by the Secretary under this
12
section is not a legislative instrument for the purposes of the
13
Legislative Instruments Act 2003.
14
Offences
15
(4B) A person commits an offence if:
16
(a) the Secretary gives a notice to the person under
17
subsection (2); and
18
(b) the notice specifies a particular requirement mentioned in
19
subsection (3); and
20
(c) the person fails to comply with that requirement; and
21
(d) either:
22
(i) the use of the goods has resulted in, or will result in,
23
harm or injury to any person; or
24
(ii) the use of the goods, if the goods were used, would
25
result in harm or injury to any person; and
26
(e) the harm or injury has resulted, will result, or would result,
27
because the person failed to comply with that requirement.
28
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
29
units, or both.
30
Note:
A jury may acquit a person of an offence against this subsection and
31
may convict the person of an offence against subsection (5) instead:
32
see section 53A.
33
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 33
(4C) A person commits an offence if:
1
(a) the Secretary gives a notice to the person under
2
subsection (2); and
3
(b) the notice specifies a particular requirement mentioned in
4
subsection (3); and
5
(c) the person fails to comply with that requirement; and
6
(d) the use of the goods, if the goods were used, would be likely
7
to result in harm or injury to any person; and
8
(e) the harm or injury would be likely to result because the
9
person failed to comply with that requirement.
10
Maximum penalty: 2,000 penalty units.
11
(4D) Subsection (4C) is an offence of strict liability.
12
Note:
For strict liability, see section 6.1 of the Criminal Code.
13
Note:
The heading to section 30F is altered by omitting "Goods" and substituting "Criminal
14
offences for goods".
15
35 Subsection 30F(5) (penalty)
16
Repeal the penalty, substitute:
17
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
18
units, or both.
19
36 After section 30F
20
Insert:
21
30FA Civil penalty for goods exempt under section 18A not
22
conforming to standards etc.
23
A person contravenes this section if:
24
(a) the Secretary gives a notice to the person under subsection
25
30F(2); and
26
(b) the notice specifies a particular requirement mentioned in
27
subsection 30F(3); and
28
(c) the person does not comply with the requirement.
29
Maximum civil penalty:
30
(a) for an individual--5,000 penalty units; and
31
(b) for a body corporate--50,000 penalty units.
32
Schedule 1 Amendments
34 Therapeutic Goods Amendment Bill 2005 No. , 2005
37 Subsection 31(4) (penalty)
1
Repeal the penalty, substitute:
2
Maximum penalty: 500 penalty units.
3
38 After subsection 31(5)
4
Insert:
5
(5A) A person commits an offence if:
6
(a) a medicine is listed under section 26A in relation to the
7
person; and
8
(b) the person provides information in purported compliance
9
with a notice under section 31 relating to the medicine; and
10
(c) the information is false or misleading in a material particular;
11
and
12
(d) either:
13
(i) the use of the medicine has resulted in, or will result in,
14
harm or injury to any person; or
15
(ii) the use of the medicine, if the medicine were used,
16
would result in harm or injury to any person.
17
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
18
units, or both.
19
Note:
A jury may acquit a person of an offence against this subsection and
20
may convict the person of an offence against subsection (6) instead:
21
see section 53A.
22
(5B) A person commits an offence if:
23
(a) a medicine is listed under section 26A in relation to the
24
person; and
25
(b) the person provides information in purported compliance
26
with a notice under section 31 relating to the medicine; and
27
(c) the information is false or misleading in a material particular;
28
and
29
(d) the use of the medicine, if the medicine were used, would be
30
likely to result in harm or injury to any person.
31
Maximum penalty: 2,000 penalty units.
32
(5C) Subsection (5B) is an offence of strict liability.
33
Note:
For strict liability, see section 6.1 of the Criminal Code.
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 35
39 Subsection 31(6)
1
Repeal the penalty, substitute:
2
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
3
units, or both.
4
40 After section 31
5
Insert:
6
31AAA Civil penalty for providing false or misleading information
7
in relation to medicines listed under section 26A
8
A person contravenes this section if:
9
(a) a medicine is listed under section 26A in relation to the
10
person; and
11
(b) the person provides information in purported compliance
12
with a notice under section 31 relating to the medicine; and
13
(c) the information is false or misleading in a material particular.
14
Maximum civil penalty:
15
(a) for an individual--5,000 penalty units; and
16
(b) for a body corporate--50,000 penalty units.
17
41 At the end of section 31A
18
Add:
19
Information may need to be given in accordance with specified
20
software requirements
21
(4) A notice under subsection (1) or (2) may require information 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
42 At the end of section 31AA
26
Add:
27
Schedule 1 Amendments
36 Therapeutic Goods Amendment Bill 2005 No. , 2005
Information may need to be given in accordance with specified
1
software requirements
2
(4) The notice may require information to be given in accordance with
3
specified software requirements:
4
(a) on a specified kind of data processing device; or
5
(b) by way of a specified kind of electronic transmission.
6
43 At the end of section 31B
7
Add:
8
Information may need to be given in accordance with specified
9
software requirements
10
(5) A notice under subsection (1), (2) or (3) may require information to
11
be given in accordance with specified software requirements:
12
(a) on a specified kind of data processing device; or
13
(b) by way of a specified kind of electronic transmission.
14
44 Section 31C
15
Repeal the section, substitute:
16
31C Criminal offence for failing to give information or documents
17
sought under section 31A, 31AA or 31B
18
A person commits an offence if:
19
(a) the person is given a notice under section 31A, 31AA or 31B;
20
and
21
(b) the person fails to comply with the notice.
22
Maximum penalty: 400 penalty units.
23
Note:
The privilege against self incrimination is not a reasonable excuse for
24
the purposes of this section. However, the information given, and the
25
fact that a document was given under this section (and other
26
information, documents or things obtained because of giving the
27
information or document) generally cannot be used in a prosecution
28
(see section 31F).
29
45 Paragraph 31D(1)(a)
30
Omit "subsection 31C(1)", substitute "the notice".
31
46 Subsection 31D(1) (penalty)
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 37
Repeal the penalty, substitute:
1
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
2
units, or both.
3
47 Paragraph 31E(1)(c)
4
Omit "subsection 31C(1)", substitute "a notice given under section 31A,
5
31AA or 31B".
6
48 Subsection 31E(1) (penalty)
7
Repeal the penalty, substitute:
8
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
9
units, or both.
10
49 Subsection 31F(1)
11
Omit "section 31C", substitute "a notice given under section 31A,
12
31AA or 31B".
13
50 Subsection 31F(2)
14
Omit all the words after paragraph (c), substitute:
15
is not admissible in evidence in:
16
(d) criminal proceedings against the individual, except
17
proceedings under, or arising out of, section 31D or 31E; or
18
(e) proceedings for a pecuniary penalty order against the
19
individual for a contravention of a civil penalty provision.
20
51 Section 35
21
Repeal the section, substitute:
22
35 Criminal offences relating to manufacturing therapeutic goods
23
(1) A person commits an offence if:
24
(a) the person, at premises in Australia, carries out a step in the
25
manufacture of therapeutic goods (other than goods exempt
26
under section 18A); and
27
(b) the goods are for supply for use in humans; and
28
(c) none of the following applies:
29
(i) the goods are exempt goods;
30
Schedule 1 Amendments
38 Therapeutic Goods Amendment Bill 2005 No. , 2005
(ii) the person is an exempt person in relation to the
1
manufacture of the goods;
2
(iii) the person is the holder of a licence that is in force that
3
authorises the carrying out of that step in relation to the
4
goods at those premises; and
5
(d) either:
6
(i) the use of the goods has resulted in, or will result in,
7
harm or injury to any person; or
8
(ii) the use of the goods, if the goods were used, would
9
result in harm or injury to any person; and
10
(e) the harm or injury has resulted, will result, or would result,
11
because the person carried out the step in the manufacture of
12
the goods.
13
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
14
units, or both.
15
Note:
A jury may acquit a person of an offence against this subsection and
16
may convict the person of an offence against subsection (4) instead:
17
see section 53A.
18
(2) A person commits an offence if:
19
(a) the person, at premises in Australia, carries out a step in the
20
manufacture of therapeutic goods (other than goods exempt
21
under section 18A); and
22
(b) the goods are for supply for use in humans; and
23
(c) none of the following applies:
24
(i) the goods are exempt goods;
25
(ii) the person is an exempt person in relation to the
26
manufacture of the goods;
27
(iii) the person is the holder of a licence that is in force that
28
authorises the carrying out of that step in relation to the
29
goods at those premises; and
30
(d) the use of the goods, if the goods were used, would be likely
31
to result in harm or injury to any person; and
32
(e) the harm or injury would be likely to result because the
33
person carried out the step in the manufacture of the goods.
34
Maximum penalty: 2,000 penalty units.
35
(3) Subsection (2) is an offence of strict liability.
36
Note:
For strict liability, see section 6.1 of the Criminal Code.
37
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 39
(4) A person commits an offence if:
1
(a) the person, at premises in Australia, carries out a step in the
2
manufacture of therapeutic goods (other than goods exempt
3
under section 18A); and
4
(b) the goods are for supply for use in humans; and
5
(c) none of the following applies:
6
(i) the goods are exempt goods;
7
(ii) the person is an exempt person in relation to the
8
manufacture of the goods;
9
(iii) the person is the holder of a licence that is in force that
10
authorises the carrying out of that step in relation to the
11
goods at those premises.
12
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
13
units, or both.
14
(5) A person commits an offence if:
15
(a) the person, at premises in Australia, carries out a step in the
16
manufacture of therapeutic goods; and
17
(b) the goods are for supply for use in humans; and
18
(c) the goods are exempt under section 18A; and
19
(d) the person is not the holder of a licence that:
20
(i) is in force; and
21
(ii) authorises the carrying out of that step in relation to the
22
goods at those premises; and
23
(e) either:
24
(i) the use of the goods has resulted in, or will result in,
25
harm or injury to any person; or
26
(ii) the use of the goods, if the goods were used, would
27
result in harm or injury to any person; and
28
(f) the harm or injury has resulted, will result, or would result,
29
because the person carried out the step in the manufacture of
30
the goods.
31
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
32
units, or both.
33
Note:
A jury may acquit a person of an offence against this subsection and
34
may convict the person of an offence against subsection (9) instead:
35
see section 53A.
36
(6) Strict liability applies to paragraph (5)(c).
37
Schedule 1 Amendments
40 Therapeutic Goods Amendment Bill 2005 No. , 2005
Note:
For strict liability, see section 6.1 of the Criminal Code.
1
(7) A person commits an offence if:
2
(a) the person, at premises in Australia, carries out a step in the
3
manufacture of therapeutic goods; and
4
(b) the goods are for supply for use in humans; and
5
(c) the goods are exempt under section 18A; and
6
(d) the person is not the holder of a licence that:
7
(i) is in force; and
8
(ii) authorises the carrying out of that step in relation to the
9
goods at those premises; and
10
(e) the use of the goods, if the goods were used, would be likely
11
to result in harm or injury to any person; and
12
(f) the harm or injury would be likely to result because the
13
person carried out the step in the manufacture of the goods.
14
Maximum penalty: 2,000 penalty units.
15
(8) Subsection (7) is an offence of strict liability.
16
Note:
For strict liability, see section 6.1 of the Criminal Code.
17
(9) A person commits an offence if:
18
(a) the person, at premises in Australia, carries out a step in the
19
manufacture of therapeutic goods; and
20
(b) the goods are for supply for use in humans; and
21
(c) the goods are exempt under section 18A; and
22
(d) the person is not the holder of a licence that:
23
(i) is in force; and
24
(ii) authorises the carrying out of that step in relation to the
25
goods at those premises.
26
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
27
units, or both.
28
(10) Strict liability applies to paragraph (9)(c).
29
Note:
For strict liability, see section 6.1 of the Criminal Code.
30
35A Civil penalties relating to manufacturing therapeutic goods
31
(1) A person contravenes this subsection if:
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 41
(a) the person carries out a step in the manufacture of therapeutic
1
goods at premises in Australia; and
2
(b) the goods are for supply for use in humans; and
3
(c) the goods are not exempt under section 18A; and
4
(d) none of the following applies:
5
(i) the goods are exempt goods;
6
(ii) the person is an exempt person in relation to the
7
manufacture of the goods;
8
(iii) the person is the holder of a licence that is in force that
9
authorises the carrying out of that step in relation to the
10
goods at those premises.
11
Maximum civil penalty:
12
(a) for an individual--5,000 penalty units; and
13
(b) for a body corporate--50,000 penalty units.
14
(2) A person contravenes this subsection if:
15
(a) the person carries out a step in the manufacture of therapeutic
16
goods at premises in Australia; and
17
(b) the goods are for supply for use in humans; and
18
(c) the goods are exempt under section 18A; and
19
(d) the person is not the holder of a licence that:
20
(i) is in force; and
21
(ii) authorises the carrying out of that step in relation to the
22
goods at those premises.
23
Maximum civil penalty:
24
(a) for an individual--5,000 penalty units; and
25
(b) for a body corporate--50,000 penalty units.
26
35B Criminal offences relating to breaching a condition of a licence
27
(1) A person commits an offence if:
28
(a) the person holds a licence; and
29
(b) the person does an act or omits to do an act; and
30
(c) the act or omission breaches a condition of the licence; and
31
(d) the act or omission has resulted in, or will result in, harm or
32
injury to any person.
33
Schedule 1 Amendments
42 Therapeutic Goods Amendment Bill 2005 No. , 2005
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
1
units, or both.
2
Note:
A jury may acquit a person of an offence against this subsection and
3
may convict the person of an offence against subsection (4) instead:
4
see section 53A.
5
(2) A person commits an offence if:
6
(a) the person holds a licence; and
7
(b) the person does an act or omits to do an act; and
8
(c) the act or omission breaches a condition of the licence; and
9
(d) the act or omission is likely to result in harm or injury to any
10
person.
11
Maximum penalty: 2,000 penalty units.
12
(3) Subsection (2) is an offence of strict liability.
13
Note:
For strict liability, see section 6.1 of the Criminal Code.
14
(4) A person commits an offence if:
15
(a) the person holds a licence; and
16
(b) the person does an act or omits to do an act; and
17
(c) the act or omission breaches a condition of the licence.
18
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
19
units, or both.
20
35C Civil penalty relating to breaching a condition of a licence
21
A person contravenes this section if:
22
(a) the person holds a licence; and
23
(b) the person does an act or omits to do an act; and
24
(c) the act or omission breaches a condition of the licence.
25
Maximum civil penalty:
26
(a) for an individual--5,000 penalty units; and
27
(b) for a body corporate--50,000 penalty units.
28
52 After paragraph 38(1A)(b)
29
Insert:
30
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 43
(ba) an order requiring any of the following persons to pay a
1
pecuniary penalty for the contravention of a civil penalty
2
provision:
3
(i) the applicant or person;
4
(ii) another person who controls the applicant or person
5
(whether directly, or indirectly through one or more
6
interposed entities);
7
(iii) another person whom the applicant or person controlled
8
(whether directly, or indirectly through one or more
9
interposed entities) at the time the civil penalty
10
provision was contravened or at the time of the order; or
11
53 Paragraphs 41(1)(aa), (ab) and (ac)
12
Repeal the paragraphs, substitute:
13
(aa) the holder has been ordered to pay a pecuniary penalty for the
14
contravention of a civil penalty provision; or
15
(ab) the holder controls another person (whether directly, or
16
indirectly through one or more interposed entities) and that
17
other person:
18
(i) has been convicted of an offence against this Act or a
19
law of a State or Territory relating to therapeutic goods;
20
or
21
(ii) has been ordered to pay a pecuniary penalty for the
22
contravention of a civil penalty provision; or
23
(ac) the holder controlled another person (whether directly, or
24
indirectly through one or more interposed entities) when that
25
other person:
26
(i) committed an offence against this Act or a law of a
27
State or Territory relating to therapeutic goods, being an
28
offence for which the person was convicted; or
29
(ii) contravened a civil penalty provision, being a
30
contravention for which the person was ordered to pay a
31
pecuniary penalty; or
32
(ad) the holder is controlled by another person (whether directly,
33
or indirectly through one or more interposed entities) when
34
that other person:
35
(i) has been convicted of an offence against this Act or a
36
law of a State or Territory relating to therapeutic goods;
37
or
38
Schedule 1 Amendments
44 Therapeutic Goods Amendment Bill 2005 No. , 2005
(ii) has been ordered to pay a pecuniary penalty for the
1
contravention of a civil penalty provision; or
2
54 Subsection 41(1A)
3
After "(b)", insert ", (ba)".
4
55 At the end of paragraph 41B(c)
5
Add "and civil penalty provisions".
6
56 Section 41BC
7
After "contains offences", insert "and civil penalty provisions".
8
57 Section 41BC (note)
9
After "some offences", insert "and civil penalty provisions".
10
58 Section 41C (note)
11
After "offence", insert "or may contravene a civil penalty provision".
12
59 Section 41D (note 1)
13
After "offence", insert "or may contravene a civil penalty provision".
14
60 Subsection 41EB(2) (note)
15
Repeal the note, substitute:
16
Note:
A person might also commit an offence, or contravene a civil penalty
17
provision, if the person makes a statement in an application that is
18
false or misleading in a material particular: see sections 41EI and
19
41EIA.
20
61 After paragraph 41EC(4)(b)
21
Insert:
22
(ba) an order requiring any of the following persons to pay a
23
pecuniary penalty for the contravention of a civil penalty
24
provision:
25
(i) the applicant or person;
26
(ii) another person who controls the applicant or person
27
(whether directly, or indirectly through one or more
28
interposed entities);
29
(iii) another person whom the applicant or person controlled
30
(whether directly, or indirectly through one or more
31
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 45
interposed entities) at the time the civil penalty
1
provision was contravened or at the time of the order; or
2
62 Section 41EI
3
Repeal the section, substitute:
4
41EI Criminal offences for making a false statement
5
(1) A person commits an offence if:
6
(a) the person makes a statement (whether orally, in a document
7
or in any other way); and
8
(b) the statement is made in or in connection with an application
9
for a conformity assessment certificate; and
10
(c) the person knows that the statement is false or misleading in
11
a material particular; and
12
(d) either:
13
(i) the use of the kind of medical device has resulted in, or
14
will result in, harm or injury to any person; or
15
(ii) the use of the kind of medical device, if the kind of
16
medical device were used, would result in harm or
17
injury to any person.
18
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
19
units, or both.
20
Note:
A jury may acquit a person of an offence against this subsection and
21
may convict the person of an offence against subsection (4) instead:
22
see section 53A.
23
(2) A person commits an offence if:
24
(a) the person makes a statement (whether orally, in a document
25
or in any other way); and
26
(b) the statement is in or in connection with an application for a
27
conformity assessment certificate; and
28
(c) the statement is false or misleading in a material particular;
29
and
30
(d) the use of the kind of medical device, if the kind of medical
31
device were used, would be likely to result in harm or injury
32
to any person.
33
Maximum penalty: 2,000 penalty units.
34
Schedule 1 Amendments
46 Therapeutic Goods Amendment Bill 2005 No. , 2005
(3) Subsection (2) is an offence of strict liability.
1
Note:
For strict liability, see section 6.1 of the Criminal Code.
2
(4) A person commits an offence if:
3
(a) the person makes a statement (whether orally, in a document
4
or in any other way); and
5
(b) the statement is in or in connection with an application for a
6
conformity assessment certificate; and
7
(c) the person knows that the statement is false or misleading in
8
a material particular.
9
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
10
units, or both.
11
41EIA Civil penalty for making a false statement
12
A person contravenes this section if:
13
(a) the person makes a statement (whether orally, in a document
14
or in any other way); and
15
(b) the statement is false or misleading in a material particular;
16
and
17
(c) the statement is in or in connection with an application for a
18
conformity assessment certificate.
19
Maximum civil penalty:
20
(a) for an individual--5,000 penalty units; and
21
(b) for a body corporate--50,000 penalty units.
22
63 Division 2 of Part 4-4 (note to heading)
23
Repeal the note, substitute:
24
Note:
Breaching conditions of the conformity assessment certificate may lead to suspension or
25
revocation of the certificate (see Divisions 3 and 4), may be an offence (see subsections
26
41MN(5), (6) and (8)), and may contravene a civil penalty provision (see subsection
27
41MNA(2)).
28
64 Subsection 41ET(1A)
29
After "(b)", insert ", (ba)".
30
65 Section 41FA (note 2)
31
After "offence", insert "or may contravene a civil penalty provision".
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 47
66 Subsection 41FC(2) (note)
1
Repeal the note, substitute:
2
Note:
A person might also commit an offence, or contravene a civil penalty
3
provision, if the person makes a statement in an application that is
4
false or misleading in a material particular: see sections 41FE and
5
41FEA.
6
67 Section 41FE
7
Repeal the section, substitute:
8
41FE Criminal offences for making a false statement
9
(1) A person commits an offence if:
10
(a) the person makes a statement (whether orally, in a document
11
or in any other way); and
12
(b) the person knows that the statement is false or misleading in
13
a material particular; and
14
(c) the statement is in or in connection with:
15
(i) an application for including a kind of medical device in
16
the Register under this Chapter; or
17
(ii) a certification or purported certification under
18
section 41FD; and
19
(d) either:
20
(i) the use of the kind of medical device has resulted in, or
21
will result in, harm or injury to any person; or
22
(ii) the use of the kind of medical device, if the kind of
23
medical device were used, would result in harm or
24
injury to any person.
25
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
26
units, or both.
27
Note:
A jury may acquit a person of an offence against this subsection and
28
may convict the person of an offence against subsection (4) instead:
29
see section 53A.
30
(2) A person commits an offence if:
31
(a) the person makes a statement (whether orally, in a document
32
or in any other way); and
33
(b) the statement is false or misleading in a material particular;
34
and
35
(c) the statement is in or in connection with:
36
Schedule 1 Amendments
48 Therapeutic Goods Amendment Bill 2005 No. , 2005
(i) an application for including a kind of medical device in
1
the Register under this Chapter; or
2
(ii) a certification or purported certification under
3
section 41FD; and
4
(d) the use of the kind of medical device, if the kind of medical
5
device were used, would be likely to result in harm or injury
6
to any person.
7
Maximum penalty: 2,000 penalty units.
8
(3) Subsection (2) is an offence of strict liability.
9
Note:
For strict liability, see section 6.1 of the Criminal Code.
10
(4) A person commits an offence if:
11
(a) the person makes a statement (whether orally, in a document
12
or in any other way); and
13
(b) the person knows that the statement is false or misleading in
14
a material particular; and
15
(c) the statement is in or in connection with:
16
(i) an application for including a kind of medical device in
17
the Register under this Chapter; or
18
(ii) a certification or purported certification under
19
section 41FD.
20
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
21
units, or both.
22
41FEA Civil penalty for making a false statement
23
A person contravenes this section if:
24
(a) the person makes a statement (whether orally, in a document
25
or in any other way); and
26
(b) the statement is false or misleading in a material particular;
27
and
28
(c) the statement is in or in connection with:
29
(i) an application for including a kind of medical device in
30
the Register under this Chapter; or
31
(ii) a certification or purported certification under
32
section 41FD.
33
Maximum civil penalty:
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 49
(a) for an individual--5,000 penalty units; and
1
(b) for a body corporate--50,000 penalty units.
2
68 Division 2 of Part 4-5 (note to heading)
3
Repeal the note, substitute:
4
Note:
Breaching conditions of the inclusion of a kind of medical device may lead to
5
suspension or cancellation of the entry of the kind of device from the Register (see
6
Part 4-6), may be an offence (see subsections 41MN(1), (2) and (4)), and may
7
contravene a civil penalty provision (see subsection 41MNA(1)).
8
69 Paragraph 41FN(3)(d)
9
After "subsection 41MP(2)", insert "or 41MPA(2)".
10
70 Section 41GI (note)
11
After "offence", insert "or may contravene a civil penalty provision".
12
71 Paragraph 41GN(1)(d)
13
After "subsection 41MP(1)", insert "or 41MPA(1)".
14
72 Subsection 41HA(1) (note)
15
After "offences", insert "and civil penalty provisions".
16
73 Subsection 41HA(2) (note)
17
Omit "subsection 41MN(3)", substitute "subsection 41MN(9)".
18
74 Subsections 41HB(2) and (7) (notes)
19
Omit "subsection 41MN(3)", substitute "subsection 41MN(9)".
20
75 Section 41J (note)
21
Omit "sections 41MP and 41MQ", substitute "sections 41MP, 41MPA,
22
41MQ and 41MR".
23
76 Subsections 41JB(3) and (4)
24
Repeal the subsections, substitute:
25
Offence for failing to comply with a notice
26
(3) A person commits an offence if:
27
(a) the person is given a notice under section 41JA; and
28
(b) the person fails to comply with the notice.
29
Schedule 1 Amendments
50 Therapeutic Goods Amendment Bill 2005 No. , 2005
Maximum penalty: 500 penalty units.
1
Note:
Failure to comply with the notice might also lead to suspension or
2
revocation of a conformity assessment certificate (see Divisions 3 and
3
4 of Part 4-4) or suspension or cancellation of the entry of a kind of
4
medical device in the Register (see Part 4-6).
5
Offences for giving false or misleading information in purported
6
compliance with a notice
7
(4) A person commits an offence if:
8
(a) the person is given a notice under section 41JA in relation to
9
a kind of medical device; and
10
(b) the person gives information in purported compliance with
11
the notice; and
12
(c) the information is false or misleading in a material particular;
13
and
14
(d) either:
15
(i) the use of the kind of medical device has resulted in, or
16
will result in, harm or injury to any person; or
17
(ii) the use of the kind of medical device, if the kind of
18
medical device were used, would result in harm or
19
injury to any person.
20
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
21
units, or both.
22
Note:
A jury may acquit a person of an offence against this subsection and
23
may convict the person of an offence against subsection (7) instead:
24
see section 53A.
25
(5) A person commits an offence if:
26
(a) the person is given a notice under section 41JA in relation to
27
a kind of medical device; and
28
(b) the person gives information in purported compliance with
29
the notice; and
30
(c) the information is false or misleading in a material particular;
31
and
32
(d) the use of the kind of medical device, if the kind of medical
33
device were used, would be likely to result in harm or injury
34
to any person.
35
Maximum penalty: 2,000 penalty units.
36
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 51
(6) Subsection (5) is an offence of strict liability.
1
Note:
For strict liability, see section 6.1 of the Criminal Code.
2
(7) A person commits an offence if:
3
(a) the person is given a notice under section 41JA; and
4
(b) the person gives information in purported compliance with
5
the notice; and
6
(c) the information is false or misleading in a material particular.
7
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
8
units, or both.
9
77 After section 41JB
10
Insert:
11
41JBA Civil penalty for giving false or misleading information in
12
purported compliance with a notice
13
A person contravenes this section if:
14
(a) the person is given a notice under section 41JA; and
15
(b) the person gives information in purported compliance with
16
the notice; and
17
(c) the information is false or misleading in a material particular.
18
Maximum civil penalty:
19
(a) for an individual--5,000 penalty units; and
20
(b) for a body corporate--50,000 penalty units.
21
78 Subsection 41JC(2)
22
Omit all the words after paragraph (c), substitute:
23
is not admissible in evidence in:
24
(d) criminal proceedings against the individual, except
25
proceedings under, or arising out of, subsection 41JB(4), (5)
26
or (7); or
27
(e) proceedings for a pecuniary penalty order against the
28
individual for a contravention of a civil penalty provision,
29
except civil proceedings under, or arising out of,
30
section 41JBA.
31
79 At the end of section 41JD
32
Schedule 1 Amendments
52 Therapeutic Goods Amendment Bill 2005 No. , 2005
Add:
1
(4) A notice under this section may require information to be given in
2
accordance with specified software requirements:
3
(a) on a specified kind of data processing device; or
4
(b) by way of a specified kind of electronic transmission.
5
80 At the end of section 41JE
6
Add:
7
Information may need to be given in accordance with specified
8
software requirements
9
(4) A notice under this section may require information to be given in
10
accordance with specified software requirements:
11
(a) on a specified kind of data processing device; or
12
(b) by way of a specified kind of electronic transmission.
13
81 At the end of section 41JF
14
Add:
15
(3) The notice may require information to be given in accordance with
16
specified software requirements:
17
(a) on a specified kind of data processing device; or
18
(b) by way of a specified kind of electronic transmission.
19
82 Section 41JG
20
Repeal the section, substitute:
21
41JG Criminal offences for failing to give information or documents
22
sought under this Division
23
A person commits an offence if:
24
(a) the person is given a notice under section 41JD, 41JE or
25
41JF; and
26
(b) the person fails to comply with the notice.
27
Maximum penalty: 400 penalty units.
28
Note:
The privilege against self incrimination is not a reasonable excuse for
29
the purposes of this section. However, section 41JJ limits the use in
30
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 53
prosecutions of information etc. obtained under sections 41JD, 41JE
1
and 41JF.
2
83 Paragraph 41JH(c)
3
Omit "subsection 41JG(1)", substitute "the notice".
4
84 Section 41JH (penalty)
5
Repeal the penalty, substitute:
6
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
7
units, or both.
8
85 Paragraph 41JI(1)(c)
9
Omit "subsection 41JG(1)", substitute "a notice given under
10
section 41JD, 41JE or 41JF".
11
86 Subsection 41JI(1) (penalty)
12
Repeal the penalty, substitute:
13
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
14
units, or both.
15
87 Subsection 41JJ(1)
16
Omit "section 41JG", substitute "a notice given under section 41JD,
17
41JE or 41JF".
18
88 Subsection 41JJ(2)
19
Omit all the words after paragraph (c), substitute:
20
is not admissible in evidence in:
21
(d) criminal proceedings against the individual, except
22
proceedings under, or arising out of, section 41JH or 41JI; or
23
(e) proceedings for a pecuniary penalty order against the
24
individual for a contravention of a civil penalty provision.
25
89 Section 41KC
26
Repeal the section, substitute:
27
Schedule 1 Amendments
54 Therapeutic Goods Amendment Bill 2005 No. , 2005
41KC Criminal offences for failing to comply with requirements
1
relating to a kind of medical device
2
(1) A person commits an offence if:
3
(a) the person does an act or omits to do an act; and
4
(b) the act or omission breaches a requirement imposed on the
5
person under section 41KA; and
6
(c) the act or omission has resulted in, or will result in, harm or
7
injury to any person.
8
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
9
units, or both.
10
Note:
A jury may acquit a person of an offence against this subsection and
11
may convict the person of an offence against subsection (4) instead:
12
see section 53A.
13
(2) A person commits an offence if:
14
(a) the person does an act or omits to do an act; and
15
(b) the act or omission breaches a requirement imposed on the
16
person under section 41KA; and
17
(c) the act or omission is likely to result in harm or injury to any
18
person.
19
Maximum penalty: 2,000 penalty units.
20
(3) Subsection (2) is an offence of strict liability.
21
Note:
For strict liability, see section 6.1 of the Criminal Code.
22
(4) A person commits an offence if:
23
(a) the person does an act or omits to do an act; and
24
(b) the act or omission breaches a requirement imposed on the
25
person under section 41KA.
26
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
27
units, or both.
28
41KCA Civil penalty for failing to comply with requirements
29
relating to a kind of medical device
30
A person contravenes this section if:
31
(a) the person does an act or omits to do an act; and
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 55
(b) the act or omission contravenes a requirement imposed on
1
the person under section 41KA.
2
Maximum civil penalty:
3
(a) for an individual--5,000 penalty units; and
4
(b) for a body corporate--50,000 penalty units.
5
90 Part 4-11 (heading)
6
Repeal the heading, substitute:
7
Part 4-11--Offences and civil penalty provisions
8
relating to medical devices
9
91 Section 41M
10
After "contains offences", insert "and civil penalty provisions".
11
92 Section 41M (note)
12
After "some offences", insert "and civil penalty provisions".
13
93 Section 41MA
14
Repeal the section, substitute:
15
41MA Criminal offences for importing, supplying or exporting a
16
medical device that does not comply with essential
17
principles
18
Offences relating to importing a medical device
19
(1) A person commits an offence if:
20
(a) the person imports a medical device into Australia; and
21
(b) the medical device does not comply with the essential
22
principles relating to matters other than the labelling of the
23
device; and
24
(c) the Secretary has not consented to the importation; and
25
(d) either:
26
(i) the use of the device has resulted in, or will result in,
27
harm or injury to any person; or
28
(ii) the use of the device, if the device were used, would
29
result in harm or injury to any person; and
30
Schedule 1 Amendments
56 Therapeutic Goods Amendment Bill 2005 No. , 2005
(e) the harm or injury has resulted, will result, or would result,
1
because the device does not comply with the essential
2
principles.
3
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
4
units, or both.
5
Note:
A jury may acquit a person of an offence against this subsection and
6
may convict the person of an offence against subsection (4) instead:
7
see section 53A.
8
(2) A person commits an offence if:
9
(a) the person imports a medical device into Australia; and
10
(b) the medical device does not comply with the essential
11
principles relating to matters other than the labelling of the
12
device; and
13
(c) the Secretary has not consented to the importation; and
14
(d) the use of the device, if the device were used, would be likely
15
to result in harm or injury to any person; and
16
(e) the harm or injury would be likely to result because the
17
device does not comply with the essential principles.
18
Maximum penalty: 2,000 penalty units.
19
(3) Subsection (2) is an offence of strict liability.
20
Note:
For strict liability, see section 6.1 of the Criminal Code.
21
(4) A person commits an offence if:
22
(a) the person imports a medical device into Australia; and
23
(b) the medical device does not comply with the essential
24
principles relating to matters other than the labelling of the
25
device; and
26
(c) the Secretary has not consented to the importation.
27
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
28
units, or both.
29
Offences relating to supplying a medical device
30
(5) A person commits an offence if:
31
(a) the person supplies a medical device for use in Australia; and
32
(b) the medical device does not comply with the essential
33
principles; and
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 57
(c) the Secretary has not consented to the supply; and
1
(d) either:
2
(i) the use of the device has resulted in, or will result in,
3
harm or injury to any person; or
4
(ii) the use of the device, if device were used, would result
5
in harm or injury to any person; and
6
(e) the harm or injury has resulted, will result, or would result,
7
because the device does not comply with the essential
8
principles.
9
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
10
units, or both.
11
Note:
A jury may acquit a person of an offence against this subsection and
12
may convict the person of an offence against subsection (8) instead:
13
see section 53A.
14
(6) A person commits an offence if:
15
(a) the person supplies a medical device for use in Australia; and
16
(b) the medical device does not comply with the essential
17
principles; and
18
(c) the Secretary has not consented to the supply; and
19
(d) the use of the device, if the device were used, would be likely
20
to result in harm or injury to any person; and
21
(e) the harm or injury would be likely to result because the
22
device does not comply with the essential principles.
23
Maximum penalty: 2,000 penalty units.
24
(7) Subsection (6) is an offence of strict liability.
25
Note:
For strict liability, see section 6.1 of the Criminal Code.
26
(8) A person commits an offence if:
27
(a) the person supplies a medical device for use in Australia; and
28
(b) the medical device does not comply with the essential
29
principles; and
30
(c) the Secretary has not consented to the supply.
31
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
32
units, or both.
33
Schedule 1 Amendments
58 Therapeutic Goods Amendment Bill 2005 No. , 2005
Offences relating to exporting a medical device
1
(9) A person commits an offence if:
2
(a) the person exports a medical device from Australia; and
3
(b) the medical device does not comply with the essential
4
principles; and
5
(c) the Secretary has not consented to the exportation; and
6
(d) either:
7
(i) the use of the device has resulted in, or will result in,
8
harm or injury to any person; or
9
(ii) the use of the device, if the device were used, would
10
result in harm or injury to any person; and
11
(e) the harm or injury has resulted, will result, or would result,
12
because the device does not comply with the essential
13
principles.
14
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
15
units, or both.
16
Note:
A jury may acquit a person of an offence against this subsection and
17
may convict the person of an offence against subsection (12) instead:
18
see section 53A.
19
(10) A person commits an offence if:
20
(a) the person exports a medical device from Australia; and
21
(b) the medical device does not comply with the essential
22
principles; and
23
(c) the Secretary has not consented to the exportation; and
24
(d) the use of the device, if the device were used, would be likely
25
to result in harm or injury to any person; and
26
(e) the harm or injury would be likely to result because the
27
device does not comply with the essential principles.
28
Maximum penalty: 2,000 penalty units.
29
(11) Subsection (10) is an offence of strict liability.
30
Note:
For strict liability, see section 6.1 of the Criminal Code.
31
(12) A person commits an offence if:
32
(a) the person exports a medical device from Australia; and
33
(b) the medical device does not comply with the essential
34
principles; and
35
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 59
(c) the Secretary has not consented to the exportation.
1
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
2
units, or both.
3
Exception
4
(13) Paragraphs (9)(b), (10)(b) and (12)(b) do not apply to the extent
5
that the essential principles in question relate to labelling medical
6
devices for supply in Australia.
7
Note:
A defendant bears an evidential burden in relation to the matters in
8
this subsection: see subsection 13.3(3) of the Criminal Code.
9
41MAA Civil penalties for importing, supplying or exporting a
10
medical device that does not comply with essential
11
principles
12
Civil penalty relating to importing a medical device
13
(1) A person contravenes this subsection if:
14
(a) the person imports a medical device into Australia; and
15
(b) the medical device does not comply with the essential
16
principles relating to matters other than the labelling of the
17
device; and
18
(c) the Secretary has not consented to the importation.
19
Maximum civil penalty:
20
(a) for an individual--5,000 penalty units; and
21
(b) for a body corporate--50,000 penalty units.
22
Civil penalty relating to supplying a medical device
23
(2) A person contravenes this subsection if:
24
(a) the person supplies a medical device for use in Australia; and
25
(b) the medical device does not comply with the essential
26
principles; and
27
(c) the Secretary has not consented to the supply.
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 1 Amendments
60 Therapeutic Goods Amendment Bill 2005 No. , 2005
Civil penalty relating to exporting a medical device
1
(3) A person contravenes this subsection if:
2
(a) the person exports a medical device from Australia; and
3
(b) the medical device does not comply with the essential
4
principles; and
5
(c) the Secretary has not consented to the exportation.
6
Maximum civil penalty:
7
(a) for an individual--5,000 penalty units; and
8
(b) for a body corporate--50,000 penalty units.
9
94 Subsection 41MB(1)
10
Omit "Section 41MA does", substitute "Sections 41MA and 41MAA
11
do".
12
95 Subsection 41MB(2) (note)
13
Repeal the note, substitute:
14
Note 1:
In the prosecution for an offence, the defendant bears an evidential
15
burden in relation to the matters in this section (see subsection 13.3(3)
16
of the Criminal Code).
17
Note 2:
In proceedings for the contravention of a civil penalty provision, the
18
defendant must prove the matters in this section.
19
96 Section 41MC
20
Repeal the section, substitute:
21
41MC Criminal offences relating to breaching a condition of a
22
consent
23
(1) The consent of the Secretary under section 41MA or 41MAA may
24
be given:
25
(a) unconditionally or subject to conditions; or
26
(b) in respect of particular medical devices or kinds of medical
27
devices.
28
(2) A person commits an offence if:
29
(a) the person does an act or omits to do an act; and
30
(b) the act or omission breaches a condition of a consent; and
31
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 61
(c) the act or omission has resulted, or will result in, harm or
1
injury to any person.
2
Maximum penalty: 2,000 penalty units.
3
Note:
A jury may acquit a person of an offence against this subsection and
4
may convict the person of an offence against subsection (5) instead:
5
see section 53A.
6
(3) A person commits an offence if:
7
(a) the person does an act or omits to do an act; and
8
(b) the act or omission breaches a condition of a consent; and
9
(c) the act or omission is likely to result in harm or injury to any
10
person.
11
Maximum penalty: 1,000 penalty units.
12
(4) Subsection (3) is an offence of strict liability.
13
Note:
For strict liability, see section 6.1 of the Criminal Code.
14
(5) A person commits an offence if:
15
(a) the person does an act or omits to do an act; and
16
(b) the act or omission breaches a condition of a consent.
17
Maximum penalty: 500 penalty units.
18
41MCA Civil penalty relating to breaching a condition of a consent
19
A person contravenes this section if:
20
(a) the person does an act or omits to do an act; and
21
(b) the act or omission breaches a condition of a consent
22
imposed under section 41MC.
23
Maximum civil penalty:
24
(a) for an individual--3,000 penalty units; and
25
(b) for a body corporate--30,000 penalty units.
26
97 Paragraph 41MD(a)
27
Repeal the paragraph, substitute:
28
(a) the importation or exportation of a medical device is an
29
offence under subsection 41MA(1), (2), (4), (9), (10) or (12)
30
or a contravention of subsection 41MAA(1) or (3); and
31
Schedule 1 Amendments
62 Therapeutic Goods Amendment Bill 2005 No. , 2005
98 Section 41ME
1
Repeal the section, substitute:
2
41ME Criminal offences for failing to apply conformity assessment
3
procedures--manufacturers
4
Offences relating to supplying a medical device
5
(1) A person commits an offence if:
6
(a) the person manufactures a medical device; and
7
(b) the person supplies the device in Australia; and
8
(c) the conformity assessment procedures have not been applied
9
to the device; and
10
(d) either:
11
(i) the use of the device has resulted in, or will result in,
12
harm or injury to any person; or
13
(ii) the use of the device, if the device were used, would
14
result in harm or injury to any person; and
15
(e) the harm or injury has resulted, will result, or would result,
16
because the conformity assessment procedures have not been
17
applied to the device.
18
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
19
units, or both.
20
Note:
A jury may acquit a person of an offence against this subsection and
21
may convict the person of an offence against subsection (4) instead:
22
see section 53A.
23
(2) A person commits an offence if:
24
(a) the person manufactures a medical device; and
25
(b) the person supplies the device in Australia; and
26
(c) the conformity assessment procedures have not been applied
27
to the device; and
28
(d) the use of the device, if the device were used, would be likely
29
to result in harm or injury to any person; and
30
(e) the harm or injury would be likely to result because the
31
conformity assessment procedures have not been applied to
32
the device.
33
Maximum penalty: 2,000 penalty units.
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 63
(3) Subsection (2) is an offence of strict liability.
1
Note:
For strict liability, see section 6.1 of the Criminal Code.
2
(4) A person commits an offence if:
3
(a) the person manufactures a medical device; and
4
(b) the person supplies the device in Australia; and
5
(c) the conformity assessment procedures have not been applied
6
to the device.
7
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
8
units, or both.
9
Offences relating to exporting a medical device
10
(5) A person commits an offence if:
11
(a) the person manufactures a medical device; and
12
(b) the person exports the device from Australia; and
13
(c) the conformity assessment procedures have not been applied
14
to the device; and
15
(d) either:
16
(i) the use of the device has resulted in, or will result in,
17
harm or injury to any person; or
18
(ii) the use of the device, if the device were used, would
19
result in harm or injury to any person; and
20
(e) the harm or injury has resulted, will result, or would result,
21
because the conformity assessment procedures have not been
22
applied to the device.
23
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
24
units, or both.
25
Note:
A jury may acquit a person of an offence against this subsection and
26
may convict the person of an offence against subsection (8) instead:
27
see section 53A.
28
(6) A person commits an offence if:
29
(a) the person manufactures a medical device; and
30
(b) the person exports the device from Australia; and
31
(c) the conformity assessment procedures have not been applied
32
to the device; and
33
(d) the use of the device, if the device were used, would be likely
34
to result in harm or injury to any person; and
35
Schedule 1 Amendments
64 Therapeutic Goods Amendment Bill 2005 No. , 2005
(e) the harm or injury would be likely to result because the
1
conformity assessment procedures have not been applied to
2
the device.
3
Maximum penalty: 2,000 penalty units.
4
(7) Subsection (6) is an offence of strict liability.
5
Note:
For strict liability, see section 6.1 of the Criminal Code.
6
(8) A person commits an offence if:
7
(a) the person manufactures a medical device; and
8
(b) the person exports the device from Australia; and
9
(c) the conformity assessment procedures have not been applied
10
to the device.
11
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
12
units, or both.
13
41MEA Civil penalties for failing to apply conformity assessment
14
procedures--manufacturers
15
Civil penalty relating to supplying a medical device
16
(1) A person contravenes this subsection if:
17
(a) the person supplies a medical device in Australia; and
18
(b) the person has manufactured the device; and
19
(c) the conformity assessment procedures have not been applied
20
to the device.
21
Maximum civil penalty:
22
(a) for an individual--5,000 penalty units; and
23
(b) for a body corporate--50,000 penalty units.
24
Civil penalty relating to exporting a medical device
25
(2) A person contravenes this subsection if:
26
(a) the person exports a medical device from Australia; and
27
(b) the person has manufactured the device; and
28
(c) the conformity assessment procedures have not been applied
29
to the device.
30
Maximum civil penalty:
31
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 65
(a) for an individual--5,000 penalty units; and
1
(b) for a body corporate--50,000 penalty units.
2
99 Section 41MF
3
Repeal the section, substitute:
4
41MF Criminal offences for failing to apply conformity assessment
5
procedures--sponsors
6
Offences relating to supplying a medical device
7
(1) A person commits an offence if:
8
(a) the person supplies a medical device in Australia; and
9
(b) the conformity assessment procedures have not been applied
10
to the device; and
11
(c) either:
12
(i) the use of the device has resulted in, or will result in,
13
harm or injury to any person; or
14
(ii) the use of the device, if the device were used, would
15
result in harm or injury to any person; and
16
(d) the harm or injury has resulted, will result, or would result,
17
because the conformity assessment procedures have not been
18
applied to the device.
19
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
20
units, or both.
21
Note:
A jury may acquit a person of an offence against this subsection and
22
may convict the person of an offence against subsection (2) instead:
23
see section 53A.
24
(2) A person commits an offence if:
25
(a) the person supplies a medical device in Australia; and
26
(b) the conformity assessment procedures have not been applied
27
to the device.
28
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
29
units, or both.
30
Offences relating to exporting a medical device
31
(3) A person commits an offence if:
32
Schedule 1 Amendments
66 Therapeutic Goods Amendment Bill 2005 No. , 2005
(a) the person exports a medical device from Australia; and
1
(b) the conformity assessment procedures have not been applied
2
to the device; and
3
(c) either:
4
(i) the use of the device has resulted in, or will result in,
5
harm or injury to any person; or
6
(ii) the use of the device, if the device were used, would
7
result in harm or injury to any person; and
8
(d) the harm or injury has resulted, will result, or would result,
9
because the conformity assessment procedures have not been
10
applied to the device.
11
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
12
units, or both.
13
Note:
A jury may acquit a person of an offence against this subsection and
14
may convict the person of an offence against subsection (4) instead:
15
see section 53A.
16
(4) A person commits an offence if:
17
(a) the person exports a medical device from Australia; and
18
(b) the conformity assessment procedures have not been applied
19
to the device.
20
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
21
units, or both.
22
Exception
23
(5) This section does not apply if the defendant was not the sponsor of
24
the device at the time of the supply or exportation, as the case may
25
be.
26
Note:
A defendant bears an evidential burden in relation to the matters in
27
subsection (5): see subsection 13.3(3) of the Criminal Code.
28
100 Subsection 41MG(1)
29
After "41ME", insert ", 41MEA".
30
101 Subsection 41MG(2) (note)
31
Repeal the note, substitute:
32
Note 1:
In the prosecution for an offence, the defendant bears an evidential
33
burden in relation to the matters in this section (see subsection 13.3(3)
34
of the Criminal Code).
35
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 67
Note 2:
In proceedings for the contravention of a civil penalty provision, the
1
defendant must prove the matters in this section.
2
102 At the end of Division 2 of Part 4-11
3
Add:
4
41MHA Civil penalty for making false statements in declarations
5
A person contravenes this section if:
6
(a) the person manufactures a medical device; and
7
(b) the person makes a statement in or in connection with a
8
declaration relating to the application of conformity
9
assessment procedures to the device; and
10
(c) the statement is false or misleading in a material particular.
11
Maximum civil penalty:
12
(a) for an individual--3,000 penalty units; and
13
(b) for a body corporate--30,000 penalty units.
14
Note:
The heading to section 41MH is replaced by the heading "Criminal offence for
15
making false statements in declarations".
16
103 Section 41MI
17
Repeal the section, substitute:
18
41MI Criminal offences for importing, exporting, supplying or
19
manufacturing a medical device not included in the
20
Register
21
(1) A person commits an offence if:
22
(a) the person:
23
(i) imports a medical device into Australia; or
24
(ii) exports a medical device from Australia; or
25
(iii) supplies a medical device in Australia; or
26
(iv) manufactures a medical device in Australia; and
27
(b) none of the following subparagraphs applies in relation to the
28
device:
29
(i) the device is of a kind included in the Register in
30
relation to the person;
31
(ii) the device is an exempt device;
32
Schedule 1 Amendments
68 Therapeutic Goods Amendment Bill 2005 No. , 2005
(iii) the device is the subject of an approval under
1
section 41HB or an authority under section 41HC; and
2
(c) either:
3
(i) the use of the device has resulted in, or will result in,
4
harm or injury to any person; or
5
(ii) the use of the device, if the device were used, would
6
result in harm or injury to any person.
7
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
8
units, or both.
9
Note:
A jury may acquit a person of an offence against this subsection and
10
may convict the person of an offence against subsection (4) instead:
11
see section 53A.
12
(2) A person commits an offence if:
13
(a) the person:
14
(i) imports a medical device into Australia; or
15
(ii) exports a medical device from Australia; or
16
(iii) supplies a medical device in Australia; or
17
(iv) manufactures a medical device in Australia; and
18
(b) none of the following subparagraphs applies in relation to the
19
device:
20
(i) the device is of a kind included in the Register in
21
relation to the person;
22
(ii) the device is an exempt device;
23
(iii) the device is the subject of an approval under
24
section 41HB or an authority under section 41HC; and
25
(c) the use of the device, if the device were used, would be likely
26
to result in harm or injury to any person.
27
Maximum penalty: 2,000 penalty units.
28
(3) Subsection (2) is an offence of strict liability.
29
Note:
For strict liability, see section 6.1 of the Criminal Code.
30
(4) A person commits an offence if:
31
(a) the person:
32
(i) imports a medical device into Australia; or
33
(ii) exports a medical device from Australia; or
34
(iii) supplies a medical device in Australia; or
35
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 69
(iv) manufactures a medical device in Australia; and
1
(b) none of the following subparagraphs applies in relation to the
2
device:
3
(i) the device is of a kind included in the Register in
4
relation to the person;
5
(ii) the device is an exempt device;
6
(iii) the device is the subject of an approval under
7
section 41HB or an authority under section 41HC.
8
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
9
units, or both.
10
(5) Strict liability applies to paragraph (4)(b).
11
Note:
For strict liability, see section 6.1 of the Criminal Code.
12
Defence if person was not the sponsor of the goods
13
(6) It is a defence to a prosecution under subsection (1), (2) or (4) if
14
the defendant proves that the defendant was not the sponsor of the
15
device at the time of the importation, exportation, supply, or
16
manufacture, as the case may be.
17
Note:
A defendant bears a legal burden in relation to the matters in
18
subsection (6): see section 13.4 of the Criminal Code.
19
Exception
20
(7) Subsection (1) does not apply if:
21
(a) harm or injury did not, or will not, directly result from:
22
(i) the quality, safety or performance of the medical device;
23
or
24
(ii) a matter relating to the labelling or packaging of the
25
medical device; or
26
(iii) the improper use of the medical device; or
27
(b) harm or injury would not directly result from:
28
(i) the quality, safety or performance of the medical device;
29
or
30
(ii) a matter relating to the labelling or packaging of the
31
medical device; or
32
(iii) the improper use of the medical device.
33
Note:
A defendant bears an evidential burden in relation to the matters in
34
subsection (7): see subsection 13.3(3) of the Criminal Code.
35
Schedule 1 Amendments
70 Therapeutic Goods Amendment Bill 2005 No. , 2005
41MIA Notice required to adduce evidence in support of exception
1
under subsection 41MI(7)
2
(1) If:
3
(a) a defendant is committed for trial for an offence against
4
subsection 41MI(1); or
5
(b) an offence against subsection 41MI(1) is to be heard and
6
determined by a court of summary jurisdiction;
7
the committing magistrate or the court must:
8
(c) inform the defendant of the requirements of this section; and
9
(d) cause a copy of this section to be given to the defendant.
10
(2) A defendant must not, without leave of the court, adduce evidence
11
in support of the exception under subsection 41MI(7) unless:
12
(a) if paragraph (1)(a) applies--more than 21 days before the
13
trial begins; or
14
(b) if paragraph (1)(b) applies--more than 21 days before the
15
hearing of the offence begins;
16
he or she gives notice of particulars of the exception.
17
(3) A defendant must not, without leave of the court, call any other
18
person to give evidence in support of the exception unless:
19
(a) the notice under subsection (2) includes the name and
20
address of the person or, if the name and address is not
21
known to the defendant at the time he or she gives the notice,
22
any information in his or her possession that might be of
23
material assistance in finding the person; and
24
(b) if the name or the address is not included in the notice--the
25
court is satisfied that the defendant before giving the notice
26
took, and after giving the notice continued to take, all
27
reasonable steps to ascertain the name or address; and
28
(c) if the name or address is not included in the notice, but the
29
defendant subsequently ascertains the name or address or
30
receives information that might be of material assistance in
31
finding the person--the defendant immediately gives notice
32
of the name, address or other information, as the case may
33
be; and
34
(d) if the defendant is told by or on behalf of the prosecutor that
35
the person has not been found by the name, or at the address,
36
given by the defendant:
37
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 71
(i) the defendant immediately gives notice of any
1
information in the defendant's possession that might be
2
of material assistance in finding the person; or
3
(ii) if the defendant later receives any such information--
4
the defendant immediately gives notice of the
5
information.
6
(4) A notice purporting to be given under this section on behalf of the
7
defendant by his or her legal practitioner is, unless the contrary is
8
proved, taken as having been given with the authority of the
9
defendant.
10
(5) Any evidence tendered to disprove that the exception applies may,
11
subject to direction by the court, be given before or after evidence
12
is given in support of the exception.
13
(6) A notice of particulars of the exception must be given, in writing,
14
to the Director of Public Prosecutions. A notice is taken as having
15
been given if it is:
16
(a) delivered to or left at the Office of the Director of Public
17
Prosecutions; or
18
(b) sent by certified mail addressed to the Director of Public
19
Prosecutions at the Office of the Director of Public
20
Prosecutions.
21
(7) In this section:
22
Director of Public Prosecutions means a person holding office as,
23
or acting as, the Director of Public Prosecutions under the Director
24
of Public Prosecutions Act 1983.
25
41MIB Civil penalty for importing, exporting, supplying or
26
manufacturing a medical device not included in the
27
Register
28
(1) A person contravenes this section if:
29
(a) the person does any of the following:
30
(i) imports a medical device into Australia;
31
(ii) exports a medical device from Australia;
32
(iii) supplies a medical device in Australia;
33
(iv) manufactures a medical device in Australia; and
34
Schedule 1 Amendments
72 Therapeutic Goods Amendment Bill 2005 No. , 2005
(b) none of the following paragraphs apply in relation to the
1
device:
2
(i) the device is of a kind included in the Register in
3
relation to the person;
4
(ii) the device is an exempt device;
5
(iii) the device is the subject of an approval under
6
section 41HB or an authority under section 41HC.
7
Maximum civil penalty:
8
(a) for an individual--5,000 penalty units; and
9
(b) for a body corporate--50,000 penalty units.
10
Exception
11
(2) Subsection (1) does not apply if the defendant proves that the
12
defendant was not the sponsor of the device at the time of the
13
importation, exportation, supply, or manufacture, as the case may
14
be.
15
104 Paragraph 41MJ(a)
16
Repeal the paragraph, substitute:
17
(a) the importation or exportation of a medical device is an
18
offence under subsection 41MI(1), (2) or (4) or a
19
contravention of section 41MIB; and
20
105 Subsections 41ML(1) and (2)
21
Repeal the subsections.
22
Note:
The heading to section 41ML is replaced by the heading "False advertising about
23
medical devices".
24
106 After section 41ML
25
Insert:
26
41MLA Civil penalty for making misrepresentations about medical
27
devices
28
(1) A person contravenes this section if:
29
(a) the person makes a representation of a kind referred to in
30
subsection (2); and
31
(b) the representation is false or misleading.
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 73
Maximum civil penalty:
1
(a) for an individual--5,000 penalty units; and
2
(b) for a body corporate--50,000 penalty units.
3
(2) Subsection (1) applies to the following representations:
4
(a) representations that medical devices are of a kind included in
5
the Register;
6
(b) representations that medical devices are exempt devices;
7
(c) representations that medical devices are the subject of an
8
approval under section 41HB or an authority under
9
section 41HC.
10
107 Section 41MN
11
Repeal the section, substitute:
12
41MN Criminal offences relating to breaches of conditions
13
Offences relating to breaching a condition of the inclusion of a
14
kind of medical device in the Register
15
(1) A person commits an offence if:
16
(a) a kind of medical device is included in the Register in
17
relation to the person; and
18
(b) the person does an act or omits to do an act; and
19
(c) the act or omission breaches a condition of the inclusion of
20
the kind of device in the Register; and
21
(d) the act or omission has resulted in, or will result in, harm or
22
injury to any person.
23
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
24
units, or both.
25
Note:
A jury may acquit a person of an offence against this subsection and
26
may convict the person of an offence against subsection (4) instead:
27
see section 53A.
28
(2) A person commits an offence if:
29
(a) a kind of medical device is included in the Register in
30
relation to the person; and
31
(b) the person does an act or omits to do an act; and
32
(c) the act or omission breaches a condition of the inclusion of
33
the kind of device in the Register; and
34
Schedule 1 Amendments
74 Therapeutic Goods Amendment Bill 2005 No. , 2005
(d) the act or omission is likely to result in harm or injury to any
1
person.
2
Maximum penalty: 2,000 penalty units.
3
(3) Subsection (2) is an offence of strict liability.
4
Note:
For strict liability, see section 6.1 of the Criminal Code.
5
(4) A person commits an offence if:
6
(a) a kind of medical device is included in the Register in
7
relation to the person; and
8
(b) the person does an act or omits to do an act; and
9
(c) the act or omission breaches a condition of the inclusion of
10
the kind of device in the Register.
11
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
12
units, or both.
13
Offences relating to breaching a condition of a conformity
14
assessment certificate
15
(5) A person commits an offence if:
16
(a) a conformity assessment certificate is issued in respect of the
17
person; and
18
(b) the person does an act or omits to do an act; and
19
(c) the act or omission breaches a condition of the conformity
20
assessment certificate; and
21
(d) the act or omission has resulted in, or will result in, harm or
22
injury to a person.
23
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
24
units, or both.
25
Note:
A jury may acquit a person of an offence against this subsection and
26
may convict the person of an offence against subsection (8) instead:
27
see section 53A.
28
(6) A person commits an offence if:
29
(a) a conformity assessment certificate is issued in respect of the
30
person; and
31
(b) the person does an act or omits to do an act; and
32
(c) the act or omission breaches a condition of the conformity
33
assessment certificate; and
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 75
(d) the act or omission is likely to result in harm or injury to a
1
person.
2
Maximum penalty: 2,000 penalty units.
3
(7) Subsection (6) is an offence of strict liability.
4
Note:
For strict liability, see section 6.1 of the Criminal Code.
5
(8) A person commits an offence if:
6
(a) a conformity assessment certificate is issued in respect of the
7
person; and
8
(b) the person does an act or omits to do an act; and
9
(c) the act or omission breaches a condition of the conformity
10
assessment certificate.
11
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
12
units, or both.
13
Offence relating to breaching a condition of an exemption or
14
approval, or a condition applicable under regulations
15
(9) A person commits an offence if:
16
(a) the person does an act or omits to do an act; and
17
(b) the act or omission breaches:
18
(i) a condition of an exemption applicable under
19
regulations made for the purposes of section 41HA; or
20
(ii) a condition of an approval under section 41HB; or
21
(iii) a condition applicable under regulations made for the
22
purposes of subsection 41HB(7).
23
Maximum penalty: 60 penalty units.
24
41MNA Civil penalties for breaching conditions
25
(1) A person contravenes this subsection if:
26
(a) a kind of medical device is included in the Register in
27
relation to the person; and
28
(b) the person does an act or omits to do an act; and
29
(c) the act or omission breaches a condition of the inclusion of
30
the kind of device in the Register.
31
Maximum civil penalty:
32
Schedule 1 Amendments
76 Therapeutic Goods Amendment Bill 2005 No. , 2005
(a) for an individual--5,000 penalty units; and
1
(b) for a body corporate--50,000 penalty units.
2
(2) A person contravenes this subsection if:
3
(a) a conformity assessment certificate is issued in respect of the
4
person; and
5
(b) the person does an act or omits to do an act; and
6
(c) the act or omission breaches a condition of the conformity
7
assessment certificate.
8
Maximum civil penalty:
9
(a) for an individual--5,000 penalty units; and
10
(b) for a body corporate--50,000 penalty units.
11
108 Division 4 of Part 4-11 (heading)
12
Repeal the heading, substitute:
13
Division 4--Other offences and civil penalty provisions
14
109 Section 41MO
15
Repeal the section, substitute:
16
41MO Criminal offences for misusing medical devices exempted for
17
special or experimental uses
18
(1) A person commits an offence if:
19
(a) the person has been granted an authority under section 41HC
20
relating to a specified kind of medical device; and
21
(b) the person supplies a medical device of that kind:
22
(i) otherwise than in accordance with the authority; or
23
(ii) otherwise than in accordance with any conditions to
24
which the authority is subject; or
25
(iii) otherwise than in accordance with any regulations made
26
for the purpose of subsection 41HC(5); and
27
(c) either:
28
(i) the use of the device has resulted in, or will result in,
29
harm or injury to any person; or
30
(ii) the use of the device, if the device were used, would
31
result in harm or injury to any person; and
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 77
(d) the harm or injury has resulted, will result, or would result,
1
because:
2
(i) the supply is not in accordance with the authority; or
3
(ii) the supply is not in accordance with the conditions to
4
which the authority is subject; or
5
(iii) the supply is not in accordance with regulations made
6
for the purpose of subsection 41HC(5).
7
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
8
units, or both.
9
Note:
A jury may acquit a person of an offence against this subsection and
10
may convict the person of an offence against subsection (4) instead:
11
see section 53A.
12
(2) A person commits an offence if:
13
(a) the person has been granted an authority under section 41HC
14
relating to a specified kind of medical device; and
15
(b) the person supplies a medical device of that kind:
16
(i) otherwise than in accordance with the authority; or
17
(ii) otherwise than in accordance with any conditions to
18
which the authority is subject; or
19
(iii) otherwise than in accordance with any regulations made
20
for the purpose of subsection 41HC(5); and
21
(c) the use of the device, if the device were used, would be likely
22
to result in harm or injury to any person; and
23
(d) the harm or injury would be likely to result because:
24
(i) the supply is not in accordance with the authority; or
25
(ii) the supply is not in accordance with the conditions to
26
which the authority is subject; or
27
(iii) the supply is not in accordance with regulations made
28
for the purpose of subsection 41HC(5).
29
Maximum penalty: 2,000 penalty units.
30
(3) Subsection (2) is an offence of strict liability.
31
Note:
For strict liability, see section 6.1 of the Criminal Code.
32
(4) A person commits an offence if:
33
(a) the person has been granted an authority under section 41HC
34
relating to a specified kind of medical device; and
35
(b) the person supplies a medical device of that kind:
36
Schedule 1 Amendments
78 Therapeutic Goods Amendment Bill 2005 No. , 2005
(i) otherwise than in accordance with the authority; or
1
(ii) otherwise than in accordance with any conditions to
2
which the authority is subject; or
3
(iii) otherwise than in accordance with any regulations made
4
for the purpose of subsection 41HC(5).
5
Maximum penalty: 500 penalty units.
6
(5) A person commits an offence if:
7
(a) the person has been granted an approval under section 41HB
8
relating to a specified medical device or specified kind of
9
medical device; and
10
(b) the person uses a medical device of that kind:
11
(i) in the treatment of another person; or
12
(ii) solely for experimental purposes in humans;
13
otherwise than in accordance with the approval; and
14
(c) either:
15
(i) the use of the device has resulted in, or will result in,
16
harm or injury to any person; or
17
(ii) the use of the device, if the device were used, would
18
result in harm or injury to any person.
19
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
20
units, or both.
21
Note:
A jury may acquit a person of an offence against this subsection and
22
may convict the person of an offence against subsection (8) instead:
23
see section 53A.
24
(6) A person commits an offence if:
25
(a) the person has been granted an approval under section 41HB
26
relating to a specified medical device or specified kind of
27
medical device; and
28
(b) the person uses a medical device of that kind:
29
(i) in the treatment of another person; or
30
(ii) solely for experimental purposes in humans;
31
otherwise than in accordance with the approval; and
32
(c) the use of the device, if the device were used, would be likely
33
to result in harm or injury to any person.
34
Maximum penalty: 2,000 penalty units.
35
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 79
(7) Subsection (6) is an offence of strict liability.
1
Note:
For strict liability, see section 6.1 of the Criminal Code.
2
(8) A person commits an offence if:
3
(a) the person has been granted an approval under section 41HB
4
relating to a specified medical device or specified kind of
5
medical device; and
6
(b) the person uses a medical device of that kind:
7
(i) in the treatment of another person; or
8
(ii) solely for experimental purposes in humans;
9
otherwise than in accordance with the approval.
10
Maximum penalty: 500 penalty units.
11
110 Subsection 41MP(1) (penalty)
12
Repeal the penalty, substitute:
13
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
14
units, or both.
15
Note:
The heading to section 41MP is replaced by the heading "Criminal offence for failing
16
to notify adverse events etc.".
17
111 Subparagraphs 41MP(2)(a)(i) and (ii)
18
Omit "a kind", substitute "the kind".
19
112 After section 41MP
20
Insert:
21
41MPA Civil penalty for failing to notify adverse events etc.
22
(1) A person contravenes this section if:
23
(a) a kind of medical device is included in the Register in
24
relation to the person; and
25
(b) the information is of a kind mentioned in subsection (2); and
26
(c) the person does not give information of a kind mentioned in
27
subsection (2) to the Secretary within the period specified in
28
the regulations (whether or not the person has already given
29
to the Secretary other information relating to the same
30
matter).
31
Maximum civil penalty:
32
Schedule 1 Amendments
80 Therapeutic Goods Amendment Bill 2005 No. , 2005
(a) for an individual--3,000 penalty units; and
1
(b) for a body corporate--30,000 penalty units.
2
(2) The information with which subsection (1) is concerned is
3
information of the following kinds:
4
(a) information relating to:
5
(i) any malfunction or deterioration in the characteristics or
6
performance of the kind of device; or
7
(ii) any inadequacy in the design, production, labelling,
8
instructions for use or advertising materials of the kind
9
of device; or
10
(iii) any use in accordance with, or contrary to, the use
11
intended by the manufacturer of the kind of device;
12
that might lead, or might have led, to the death of a patient or
13
user of the device, or to a serious deterioration in his or her
14
state of health;
15
(b) information relating to any technical or medical reason for a
16
malfunction or deterioration of a kind referred to in
17
subparagraph (a)(i) that has led the manufacturer to take steps
18
to recover devices of that kind that have been distributed;
19
(c) information that indicates that a device of that kind does not
20
comply with the essential principles;
21
(d) information that indicates that a certificate (other than one
22
issued under this Act) used for the purpose of an application
23
under subsection 41FC(1) to signify:
24
(i) compliance with the essential principles; or
25
(ii) the application of relevant conformity assessment
26
procedures to a particular device;
27
has been restricted, suspended, revoked or is no longer in
28
effect.
29
41MPB Relief from liability for contraventions for failing to notify
30
adverse events etc.
31
(1) If:
32
(a) proceedings for the contravention of section 41MPA (a civil
33
penalty provision) are brought against a person; and
34
(b) in the proceedings it appears to the Court that the person has,
35
or may have, contravened that section but that:
36
(i) the person has a reasonable excuse; and
37
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 81
(ii) having regard to all the circumstances of the case, the
1
person ought fairly to be excused for the contravention;
2
the Court may relieve the person either wholly or partly from a
3
liability to which the person would otherwise be subject, or that
4
might otherwise be imposed on the person, because of the
5
contravention.
6
(2) If a person thinks that proceedings for the contravention of
7
section 41MPA will or may be begun against them, they may apply
8
to the Court for relief.
9
(3) On an application under subsection (2), the Court may grant relief
10
under subsection (1) as if proceedings had been begun in the Court.
11
(4) For the purposes of subsection (2) as applying for the purposes of a
12
case tried by a judge with a jury:
13
(a) a reference in that subsection to the Court is a reference to
14
the judge; and
15
(b) the relief that may be granted includes withdrawing the case
16
in whole or in part from the jury and directing judgment to be
17
entered for the person on such terms as to costs as the judge
18
thinks appropriate.
19
113 Paragraph 41MQ(1)(a)
20
After "subsection 41MP(2)", insert "or 41MPA(2)".
21
114 Subsection 41MQ(3) (penalty)
22
Repeal the penalty, substitute:
23
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
24
units, or both.
25
115 Subsection 41MQ(4) (penalty)
26
Repeal the penalty, substitute:
27
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
28
units, or both.
29
116 At the end of Division 4 of Part 4-11
30
Add:
31
Schedule 1 Amendments
82 Therapeutic Goods Amendment Bill 2005 No. , 2005
41MR Civil penalties for failing to notify adverse effects etc. where
1
application withdrawn or lapses
2
Civil penalty for failing to comply with requirements of a notice
3
(1) A person contravenes this subsection if the person does not comply
4
with the requirements of a notice under subsection 41MQ(1) within
5
20 working days after the day on which the notice is given to the
6
person.
7
Maximum civil penalty:
8
(a) for an individual--3,000 penalty units; and
9
(b) for a body corporate--30,000 penalty units.
10
Civil penalty for giving false or misleading information in
11
purported compliance with requirements of a notice
12
(2) A person contravenes this subsection if:
13
(a) the person gives information in purported compliance with a
14
notice under subsection 41MQ(1); and
15
(b) the information is false or misleading in a material particular.
16
Maximum civil penalty:
17
(a) for an individual--3,000 penalty units; and
18
(b) for a body corporate--30,000 penalty units.
19
117 At the end of subsections 42C(1) and (2)
20
Add:
21
Note:
Advertising that requires approval under Part 2 of the Therapeutic
22
Goods Regulations 1990 must also comply with the Therapeutic
23
Goods Advertising Code.
24
118 Paragraph 42C(4)(a)
25
Omit all the words from and including "in specified media", substitute:
26
a particular advertisement in specified media referred to in
27
paragraph (a), (c) or (d) of the definition of specified media;
28
and
29
119 At the end of subsections 42C(4) and (6)
30
Add:
31
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 83
Note:
Advertising that requires approval under Part 2 of the Therapeutic
1
Goods Regulations 1990 must also comply with the Therapeutic
2
Goods Advertising Code.
3
120 At the end of subsection 42E(1)
4
Add:
5
Maximum penalty: 7 years imprisonment or 2,000 penalty units,
6
or both.
7
121 Subsection 42E(4)
8
Repeal the subsection.
9
122 After section 42E
10
Insert:
11
42EA Civil penalty relating to dealing with counterfeit therapeutic
12
goods
13
A person contravenes this section if:
14
(a) the person does any of the following:
15
(i) manufactures goods in Australia;
16
(ii) supplies goods in Australia;
17
(iii) imports goods into Australia;
18
(iv) exports goods from Australia; and
19
(b) the goods are therapeutic goods; and
20
(c) the goods are counterfeit.
21
Maximum civil penalty:
22
(a) for an individual--5,000 penalty units; and
23
(b) for a body corporate--50,000 penalty units.
24
42EB Relief from liability for certain contraventions relating to
25
dealing with counterfeit therapeutic goods
26
(1) If:
27
(a) proceedings for the contravention of section 42EA (a civil
28
penalty provision) are brought against a person; and
29
(b) in the proceedings it appears to the Court that the person has,
30
or may have, contravened that section but that:
31
Schedule 1 Amendments
84 Therapeutic Goods Amendment Bill 2005 No. , 2005
(i) the person has a reasonable excuse; and
1
(ii) having regard to all the circumstances of the case, the
2
person ought fairly to be excused for the contravention;
3
the Court may relieve the person either wholly or partly from a
4
liability to which the person would otherwise be subject, or that
5
might otherwise be imposed on the person, because of the
6
contravention.
7
(2) If a person thinks that proceedings for the contravention of
8
section 42EA will or may be begun against them, they may apply
9
to the Court for relief.
10
(3) On an application under subsection (2), the Court may grant relief
11
under subsection (1) as if proceedings had been begun in the Court.
12
(4) For the purposes of subsection (2) as applying for the purposes of a
13
case tried by a judge with a jury:
14
(a) a reference in that subsection to the Court is a reference to
15
the judge; and
16
(b) the relief that may be granted includes withdrawing the case
17
in whole or in part from the jury and directing judgment to be
18
entered for the person on such terms as to costs as the judge
19
thinks appropriate.
20
Exception
21
(5) This section does not apply to civil proceedings against a person
22
for manufacturing therapeutic goods in Australia that are
23
counterfeit (see subparagraph 42EA(a)(i)).
24
123 Subsection 42T(1) (penalty)
25
Repeal the penalty, substitute:
26
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
27
units, or both.
28
124 Subsection 42T(2) (penalty)
29
Repeal the penalty, substitute:
30
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
31
units, or both.
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 85
125 Subsection 42V(6)
1
Repeal the subsection, substitute:
2
(6) A person commits an offence if:
3
(a) the person fails to comply with a requirement under
4
subsection (1) in relation to a supply of therapeutic goods;
5
and
6
(b) either:
7
(i) the use of the goods has resulted in, or will result in,
8
harm or injury to any person; or
9
(ii) the use of the goods, if the goods were used, would
10
result in harm or injury to any person; and
11
(c) the harm or injury has resulted, will result, or would result,
12
because the person failed to comply with the requirement.
13
Maximum penalty: Imprisonment for 5 years or 4,000 penalty
14
units, or both.
15
Note:
A jury may acquit a person of an offence against this subsection and
16
may convict the person of an offence against subsection (6C) instead:
17
see section 53A.
18
(6A) A person commits an offence if:
19
(a) the person fails to comply with a requirement under
20
subsection (1) in relation to a supply of therapeutic goods;
21
and
22
(b) the use of the goods, if the goods were used, would be likely
23
to result in harm or injury to any person; and
24
(c) the harm or injury would be likely to result because the
25
person failed to comply with the requirement.
26
Maximum penalty: 2,000 penalty units.
27
(6B) Subsection (6A) is an offence of strict liability.
28
Note:
For strict liability, see section 6.1 of the Criminal Code.
29
(6C) A person commits an offence if the person fails to comply with a
30
requirement under subsection (1) in relation to a supply of
31
therapeutic goods.
32
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
33
units, or both.
34
Schedule 1 Amendments
86 Therapeutic Goods Amendment Bill 2005 No. , 2005
126 After section 42V
1
Insert:
2
42VA Civil penalty relating to the recovery of therapeutic goods
3
because of actual or potential tampering
4
A person contravenes this section if the person fails to comply with
5
a requirement under subsection 42V(1) in relation to a supply of
6
therapeutic goods.
7
Maximum civil penalty:
8
(a) for an individual--5,000 penalty units; and
9
(b) for a body corporate--50,000 penalty units.
10
42VB Relief from liability for contraventions relating to the
11
recovery of therapeutic goods because of actual or
12
potential tampering
13
(1) If:
14
(a) proceedings for the contravention of section 42VA (a civil
15
penalty provision) are brought against a person; and
16
(b) in the proceedings it appears to the Court that the person has,
17
or may have, contravened that section but that:
18
(i) the person has acted honestly; and
19
(ii) having regard to all the circumstances of the case, the
20
person ought fairly to be excused for the contravention;
21
the Court may relieve the person either wholly or partly from a
22
liability to which the person would otherwise be subject, or that
23
might otherwise be imposed on the person, because of the
24
contravention.
25
(2) If a person thinks that proceedings for the contravention of
26
section 42VA will or may be begun against them, they may apply
27
to the Court for relief.
28
(3) On an application under subsection (2), the Court may grant relief
29
under subsection (1) as if proceedings had been begun in the Court.
30
(4) For the purposes of subsection (2) as applying for the purposes of a
31
case tried by a judge with a jury:
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 87
(a) a reference in that subsection to the Court is a reference to
1
the judge; and
2
(b) the relief that may be granted includes withdrawing the case
3
in whole or in part from the jury and directing judgment to be
4
entered for the person on such terms as to costs as the judge
5
thinks appropriate.
6
127 Subsection 42W(1) (penalty)
7
Repeal the penalty, substitute:
8
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
9
units, or both.
10
128 Subsection 42W(2) (penalty)
11
Repeal the penalty, substitute:
12
Maximum penalty: Imprisonment for 12 months or 1,000 penalty
13
units, or both.
14
129 After Chapter 5
15
Insert:
16
Chapter 5A--Enforcement
17
Part 5A-1--Civil penalties
18
Division 1--Obtaining an order for a civil penalty
19
42Y Federal Court may order person to pay pecuniary penalty for
20
contravening civil penalty provision
21
Application for order
22
(1) Within 6 years of a person (the wrongdoer) contravening a civil
23
penalty provision, the Secretary may apply on behalf of the
24
Commonwealth to the Federal Court for an order that the
25
wrongdoer pay the Commonwealth a pecuniary penalty.
26
Schedule 1 Amendments
88 Therapeutic Goods Amendment Bill 2005 No. , 2005
Court may order wrongdoer to pay pecuniary penalty
1
(2) If the Court is satisfied that the wrongdoer has contravened a civil
2
penalty provision, the Court may order the wrongdoer to pay to the
3
Commonwealth for each contravention the pecuniary penalty that
4
the Court determines is appropriate (but not more than the
5
maximum amount specified for the provision).
6
Determining amount of pecuniary penalty
7
(3) In determining the pecuniary penalty, the Court must have regard
8
to all relevant matters, including:
9
(a) the nature and extent of the contravention; and
10
(b) the nature and extent of any loss or damage suffered as a
11
result of the contravention; and
12
(c) the circumstances in which the contravention took place; and
13
(d) whether the person has previously been found by the Court in
14
proceedings under this Act to have engaged in any similar
15
conduct.
16
Civil evidence and procedure rules apply
17
(4) The Court must apply the rules of evidence and procedure for civil
18
matters when hearing and determining an application for an order
19
under this section.
20
Note:
The standard of proof in civil proceedings is the balance of
21
probabilities: see section 140 of the Evidence Act 1995.
22
Conduct contravening more than one civil penalty provision
23
(5) If conduct constitutes a contravention of 2 or more civil penalty
24
provisions, proceedings may be instituted under this Act against a
25
person in relation to the contravention of any one or more of those
26
provisions. However, the person is not liable to more than one
27
pecuniary penalty under this section in respect of the same
28
conduct.
29
42YA What is a civil penalty provision?
30
A subsection of this Act (or a section of this Act that is not divided
31
into subsections) is a civil penalty provision if the words "civil
32
penalty" and one or more amounts in penalty units are set out at the
33
foot of the subsection (or section).
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 89
42YB Meaning of penalty unit
1
In this Act, penalty unit, in relation to a civil penalty provision, has
2
the same meaning as given by section 4AA of the Crimes Act
3
1914.
4
42YC Persons involved in contravening civil penalty provision
5
(1) A person must not:
6
(a) aid, abet, counsel or procure a contravention of a civil
7
penalty provision; or
8
(b) induce (by threats, promises or otherwise) a contravention of
9
a civil penalty provision; or
10
(c) conspire to contravene a civil penalty provision.
11
(2) This Act applies to a person who contravenes subsection (1) in
12
relation to a civil penalty provision as if the person had
13
contravened the civil penalty provision.
14
42YD Recovery of a pecuniary penalty
15
If the Federal Court orders a person to pay a pecuniary penalty:
16
(a) the penalty is payable to the Commonwealth; and
17
(b) the Commonwealth may enforce the order as if it were a
18
judgment of the Court.
19
42YE Gathering information for application for pecuniary penalty
20
(1) This section applies if it appears to the Secretary that a person (the
21
wrongdoer) may have contravened a civil penalty provision.
22
(2) If the Secretary, on reasonable grounds, suspects that a person
23
other than the wrongdoer can give information relevant to an
24
application for a civil penalty order in relation to the contravention,
25
whether or not such an application has been made, the Secretary
26
may, by writing given to the person, require the person to give all
27
reasonable assistance in connection with such an application.
28
(3) Subsection (2) does not apply in relation to a duly qualified legal
29
practitioner who is acting, or has acted, for the wrongdoer.
30
Schedule 1 Amendments
90 Therapeutic Goods Amendment Bill 2005 No. , 2005
(4) If a person fails to give assistance as required under subsection (2),
1
the Federal Court may, on the application of the Secretary, order
2
the person to comply with the requirement as specified in the order.
3
(5) If a person fails to give assistance as required under subsection (2),
4
the person commits an offence against this subsection.
5
Maximum penalty: 30 penalty units.
6
Division 2--Civil penalty proceedings and criminal
7
proceedings
8
42YF Civil proceedings after criminal proceedings
9
The Federal Court must not make a pecuniary penalty order against
10
a person for a contravention of a civil penalty provision if the
11
person has been convicted of an offence constituted by conduct
12
that is substantially the same as the conduct constituting the
13
contravention.
14
42YG Criminal proceedings during civil proceedings
15
(1) Proceedings for a pecuniary penalty order against a person for a
16
contravention of a civil penalty provision are stayed if:
17
(a) criminal proceedings are started or have already been started
18
against the person for an offence; and
19
(b) the offence is constituted by conduct that is substantially the
20
same as the conduct alleged to constitute the contravention.
21
(2) The proceedings for the order may be resumed if the person is not
22
convicted of the offence. Otherwise, the proceedings for the order
23
are dismissed.
24
42YH Criminal proceedings after civil proceedings
25
Criminal proceedings may not be started against a person for
26
conduct that is substantially the same as conduct constituting a
27
contravention of a civil penalty provision if a pecuniary penalty
28
order has been made against the person in respect of that conduct.
29
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 91
42YI Evidence given in proceedings for civil penalty not admissible
1
in criminal proceedings
2
Evidence of information given or evidence of production of
3
documents by an individual is not admissible in criminal
4
proceedings against the individual if:
5
(a) the individual previously gave the evidence or produced the
6
documents in proceedings for a pecuniary penalty order
7
against the individual for a contravention of a civil penalty
8
provision (whether or not the order was made); and
9
(b) the conduct alleged to constitute the offence is substantially
10
the same as the conduct that was claimed to constitute the
11
contravention.
12
However, this does not apply to a criminal proceeding in respect of
13
the falsity of the evidence given by the individual in the
14
proceedings for the pecuniary penalty order.
15
Part 5A-2--Infringement notices
16
17
42YJ Infringement notices in respect of offences
18
(1) The regulations may make provision enabling a person who is
19
alleged to have committed an offence against this Act to pay to the
20
Commonwealth, as an alternative to prosecution, a specified
21
penalty.
22
Note:
An offence against this Act includes an offence against the
23
regulations: see subsection 3(7).
24
(2) If an individual is alleged to have committed an offence against
25
this Act, the penalty must not exceed an amount equal to one-fifth
26
of the maximum penalty that could have been imposed on the
27
individual for that offence.
28
(3) If a body corporate is alleged to have committed an offence against
29
this Act, the penalty must not exceed an amount equal to 5 times
30
the amount specified under subsection (2) in relation to that
31
offence.
32
Schedule 1 Amendments
92 Therapeutic Goods Amendment Bill 2005 No. , 2005
42YK Infringement notices in respect of civil penalty provisions
1
(1) The regulations may make provision enabling a person who is
2
alleged to have contravened a civil penalty provision to pay to the
3
Commonwealth, as an alternative to civil penalty proceedings
4
against the person, a specified penalty.
5
(2) The penalty must not exceed an amount equal to one-tenth of the
6
maximum penalty prescribed for contravening that provision.
7
Part 5A-3--Enforceable undertakings
8
9
42YL Enforcement of undertakings
10
(1) The Secretary may accept a written undertaking given by a person
11
in connection with a matter in relation to which the Secretary has a
12
power or function under this Act or the regulations.
13
(2) The person may withdraw or vary the undertaking at any time, but
14
only with the consent of the Secretary.
15
(3) The Secretary must publish details of the undertaking, as in force
16
from time to time, on the Internet.
17
(4) If the Secretary considers that the person who gave the undertaking
18
has breached any of its terms, the Secretary may apply to the
19
Federal Court for an order under subsection (5).
20
(5) If the Court is satisfied that the person has breached a term of the
21
undertaking, the Court may make all or any of the following
22
orders:
23
(a) an order directing the person to comply with that term of the
24
undertaking;
25
(b) an order directing the person to pay to the Commonwealth an
26
amount up to the amount of any financial benefit that the
27
person has obtained directly or indirectly and that is
28
reasonably attributable to the breach;
29
(c) any order that the Court considers appropriate directing the
30
person to compensate any other person who has suffered loss
31
or damage as a result of the breach;
32
(d) any other order that the Court considers appropriate.
33
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 93
130 Section 45A (definition of evidential material)
1
Repeal the definition, substitute:
2
evidential material means:
3
(a) in respect of an offence against this Act:
4
(i) any thing with respect to which the offence has been
5
committed or is suspected, on reasonable grounds, to
6
have been committed; or
7
(ii) any thing as to which there are reasonable grounds for
8
suspecting that it will afford evidence as to the
9
commission of the offence; or
10
(iii) any thing as to which there are reasonable grounds for
11
suspecting that it is intended to be used for the purpose
12
of committing the offence; and
13
(b) in respect of a contravention of a civil penalty provision:
14
(i) any thing with respect to which the civil penalty
15
provision has been contravened or is suspected, on
16
reasonable grounds, of having been contravened; or
17
(ii) any thing as to which there are reasonable grounds for
18
suspecting that it will afford evidence as to the
19
contravention of the civil penalty provision; or
20
(iii) any thing as to which there are reasonable grounds for
21
suspecting that it is intended to be used for the purpose
22
of contravening the civil penalty provision.
23
131 Subsection 47(1)
24
After "evidential material", insert "(within the meaning of paragraph (a)
25
of the definition of that expression)".
26
132 Paragraph 47(4)(a)
27
After "evidential material", insert "(within the meaning of paragraph (a)
28
of the definition of that expression)".
29
133 After section 47
30
Insert:
31
Schedule 1 Amendments
94 Therapeutic Goods Amendment Bill 2005 No. , 2005
47A Searches and seizures related to contraventions of civil penalty
1
provisions
2
(1) Subject to subsections (2) and (3), if an authorised person has
3
reasonable grounds for suspecting that there may be evidential
4
material (within the meaning of paragraph (b) of the definition of
5
that expression) on any premises, the authorised person may:
6
(a) enter the premises; and
7
(b) exercise the powers set out in subsection (4) and subsection
8
48(1); and
9
(c) if the authorised person finds the thing on the premises--
10
seize it.
11
(2) The authorised person must not enter the premises unless:
12
(a) the occupier of the premises has consented to the entry; or
13
(b) the entry is made under a warrant issued under section 51AA.
14
(3) An authorised person is not entitled to exercise any powers under
15
subsection (1) in relation to premises if:
16
(a) the occupier of the premises has required the authorised
17
person to produce his or her identity card for inspection by
18
the occupier; and
19
(b) the authorised person fails to comply with the requirement.
20
(4) If:
21
(a) in the course of searching, in accordance with a warrant, for a
22
particular thing, an authorised person finds another thing that
23
the authorised person believes on reasonable grounds to be
24
evidential material (within the meaning of paragraph (b) of
25
the definition of that expression); and
26
(b) the authorised person believes, on reasonable grounds, that it
27
is necessary to seize that other thing in order to prevent its
28
concealment, loss or destruction, or its use in contravening,
29
continuing to contravene, or repeating a contravention of a
30
civil penalty provision;
31
the warrant is taken to authorise the authorised person to seize that
32
other thing.
33
134 Subsection 48(1)
34
Omit "and 47(1)(b)", substitute ", 47(1)(b) and 47A(1)(b)".
35
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 95
135 At the end of subsection 48(1)
1
Add:
2
; (i) to secure a thing, until a warrant is obtained to seize it, being
3
a thing:
4
(i) that the authorised person finds during the exercise of
5
monitoring powers under section 46 or 49 on the
6
premises; and
7
(ii) that the authorised person believes on reasonable
8
grounds is evidential material (within the meaning of
9
paragraph (b) of the definition of that expression); and
10
(iii) that the authorised person believes on reasonable
11
grounds would be lost, destroyed or tampered with
12
before the warrant can be obtained.
13
136 Section 48C
14
After "evidential material" (wherever occurring), insert "(within the
15
meaning of paragraph (a) of the definition of that expression)".
16
137 At the end of paragraph 48E(2)(b)
17
Add "or the contravention of a civil penalty provision".
18
138 Paragraphs 48J(2)(a) and (b)
19
Repeal the paragraphs, substitute:
20
(a) if the thing was seized in accordance with section 47:
21
(i) for the purposes of an investigation as to whether an
22
offence against this Act has been committed; or
23
(ii) to enable evidence of an offence against this Act to be
24
secured for the purposes of a prosecution; or
25
(b) if the thing was seized in accordance with section 47A:
26
(i) for the purposes of an investigation as to whether a civil
27
penalty provision has been contravened; or
28
(ii) to enable evidence of the contravention of a civil
29
penalty provision to be secured for the purposes of civil
30
proceedings;
31
139 At the end of subsection 50(2)
32
Add "(within the meaning of paragraph (a) of the definition of that
33
expression)".
34
Schedule 1 Amendments
96 Therapeutic Goods Amendment Bill 2005 No. , 2005
140 After section 51
1
Insert:
2
51AA Civil penalty contravention warrants
3
(1) An authorised person may apply to a magistrate for a warrant
4
under this section in relation to premises.
5
(2) Subject to subsection (3), the magistrate may issue the warrant if
6
the magistrate is satisfied, by information on oath, that there are
7
reasonable grounds for suspecting that there is, or there may be
8
within the next 72 hours, in or on the premises evidential material
9
(within the meaning of paragraph (b) of the definition of that
10
expression).
11
(3) The magistrate must not issue the warrant unless the authorised
12
person or some other person has given to the magistrate, either
13
orally or by affidavit, such further information (if any) as the
14
magistrate requires concerning the grounds on which the issue of
15
the warrant is being sought.
16
(4) The warrant must:
17
(a) name one or more authorised persons; and
18
(b) authorise the persons so named, with such assistance and by
19
such force as is necessary and reasonable:
20
(i) to enter the premises; and
21
(ii) to exercise the powers set out in subsections 47A(4) and
22
48(1); and
23
(iii) to seize the evidential material; and
24
(c) state whether the entry is authorised to be made at any time
25
of the day or night or during specified hours of the day or
26
night; and
27
(d) specify the day (not more than one week after the issue of the
28
warrant) on which the warrant ceases to have effect; and
29
(e) state the purpose for which the warrant is issued.
30
141 After section 53
31
Insert:
32
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 97
53A Alternative verdicts for various offences
1
If a jury acquits a person of an offence against a provision listed in
2
column 2 of an item in the following table, but is satisfied beyond
3
reasonable doubt of facts that prove that the person is guilty of the
4
offence listed in column 3 of that item, the jury may convict the
5
person of the offence listed in column 3 of that item:
6
7
Alternative verdicts for various offences
Column 1
Column 2
Column 3
Item
If a prosecution is for
an offence against...
the jury may instead
convict the person of an
offence against...
1
subsection 14(1)
subsection 14(4)
2
subsection 14(6)
subsection 14(9)
3
subsection 14(10)
subsection 14(13)
4
subsection 15(2)
subsection 15(5)
5
subsection 19B(1)
subsection 19B(4)
6
subsection 21A(1)
subsection 21A(4)
7
subsection 21A(5)
subsection 21A(8)
8
subsection 21A(9)
subsection 22(7A)
9
subsection 21A(12)
subsection 22(8)
10
subsection 22A(1)
subsection 22A(4)
11
subsection 30EC(1)
subsection 30EC(4)
12
subsection 30F(4B)
subsection 30F(5)
13
subsection 31(5A)
subsection 31(6)
14
subsection 35(1)
subsection 35(4)
15
subsection 35(5)
subsection 35(9)
16
subsection 35B(1)
subsection 35B(4)
17
subsection 41EI(1)
subsection 41EI(4)
18
subsection 41FE(1)
subsection 41FE(4)
19
subsection 41JB(4)
subsection 41JB(7)
20
subsection 41KC(1)
subsection 41KC(4)
21
subsection 41MA(1)
subsection 41MA(4)
22
subsection 41MA(5)
subsection 41MA(8)
23
subsection 41MA(9)
subsection 41MA(12)
Schedule 1 Amendments
98 Therapeutic Goods Amendment Bill 2005 No. , 2005
Alternative verdicts for various offences
Column 1
Column 2
Column 3
Item
If a prosecution is for
an offence against...
the jury may instead
convict the person of an
offence against...
24
subsection 41MC(2)
subsection 41MC(5)
25
subsection 41ME(1)
subsection 41ME(4)
26
subsection 41ME(5)
subsection 41ME(8)
27
subsection 41MF(1)
subsection 41MF(2)
28
subsection 41MF(3)
subsection 41MF(4)
29
subsection 41MI(1)
subsection 41MI(4)
30
subsection 41MN(1)
subsection 41MN(4)
31
subsection 41MN(5)
subsection 41MN(8)
32
subsection 41MO(1)
subsection 41MO(4)
33
subsection 41MO(5)
subsection 41MO(8)
34
subsection 42V(6)
subsection 42V(6C)
142 Subsections 54(1) and (3)
1
Repeal the subsections, substitute:
2
(3) If a court:
3
(a) convicts a person of an offence against this Act; or
4
(b) orders a person to pay a pecuniary penalty for the
5
contravention of a civil penalty provision;
6
in relation to any therapeutic goods, the court may order that the
7
goods be forfeited to the Commonwealth and, if an order is made,
8
the goods become the property of the Commonwealth.
9
Note:
The heading to section 54 is replaced by the heading "Offences and forfeiture".
10
143 Subsection 54AB(1) (penalty)
11
Repeal the penalty, substitute:
12
Maximum penalty: 7 years imprisonment or 2,000 penalty units,
13
or both.
14
Note:
The heading to section 54AB is replaced by the heading "Criminal offence for
15
damaging etc. documents".
16
144 After section 54AB
17
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 99
Insert:
1
54AC Civil penalty for damaging etc. documents
2
A person contravenes this section if:
3
(a) the person damages, destroys, alters, conceals or falsifies a
4
document; and
5
(b) the document is created, retained or issued for the purposes
6
of this Act, or for purposes that include the purposes of this
7
Act; and
8
(c) the damage, destruction, alteration, concealment or
9
falsification is likely to interfere with the proper
10
administration of this Act or the regulations.
11
Maximum civil penalty:
12
(a) for an individual--5,000 penalty units; and
13
(b) for a body corporate--50,000 penalty units.
14
145 After section 54A
15
Insert:
16
54B Application of this Act to an executive officer of a body
17
corporate
18
(1) An executive officer of a body corporate commits an offence if:
19
(a) the body corporate commits an offence against this Act; and
20
(b) the officer knew that the offence would be committed; and
21
(c) the officer was in a position to influence the conduct of the
22
body in relation to the commission of the offence; and
23
(d) the officer failed to take all reasonable steps to prevent the
24
commission of the offence.
25
Note:
An offence against this Act includes an offence against the
26
regulations: see subsection 3(7).
27
(2) The maximum penalty for an offence against subsection (1) is the
28
maximum penalty that a Court could impose in respect of an
29
individual for the offence committed by the body corporate.
30
(3) An executive officer of a body corporate contravenes this
31
subsection if:
32
(a) the body corporate contravenes a civil penalty provision; and
33
Schedule 1 Amendments
100 Therapeutic Goods Amendment Bill 2005 No. , 2005
(b) the officer knew that the contravention would occur; and
1
(c) the officer was in a position to influence the conduct of the
2
body in relation to the contravention; and
3
(d) the officer failed to take all reasonable steps to prevent the
4
contravention.
5
(4) The maximum civil penalty for a contravention of subsection (3) is
6
the maximum civil penalty that a Court could impose in respect of
7
an individual for the civil penalty provision contravened by the
8
body corporate.
9
(5) In this section:
10
executive officer of a body corporate means a person, by whatever
11
name called and whether or not a director of the body, who is
12
concerned in, or takes part in, the management of the body.
13
54C Establishing whether an executive officer took reasonable steps
14
to prevent the commission of an offence or the
15
contravention of a civil penalty provision
16
(1) For the purposes of section 54B, in determining whether an
17
executive officer of a body corporate failed to take all reasonable
18
steps to prevent the commission of the offence or the contravention
19
of a civil penalty provision, a court is to have regard to:
20
(a) what action (if any) the officer took towards ensuring that the
21
body's employees, agents and contractors have a reasonable
22
knowledge and understanding of the requirements to comply
23
with this Act and the regulations, in so far as those
24
requirements affect the employees, agents or contractors
25
concerned; and
26
(b) what action (if any) the officer took when he or she became
27
aware that the body was committing an offence against, or
28
otherwise contravening, this Act or the regulations.
29
(2) This section does not, by implication, limit the generality of
30
section 54B.
31
(3) In this section, executive officer has the same meaning as in
32
section 54B.
33
146 Subsections 55(1), (2), (3) and (4)
34
Amendments Schedule 1
Therapeutic Goods Amendment Bill 2005 No. , 2005 101
After "this Act,", insert "or for a contravention of a civil penalty
1
provision,".
2
147 Paragraph 56A(1)(a)
3
After "section 18", insert "or 18A".
4
148 Subsection 56A(3)
5
After "this Act", insert "or a contravention of a civil penalty provision".
6
149 Subsection 56A(4)
7
Repeal the subsection, substitute:
8
(4) In proceedings for:
9
(a) an offence against section 14 or 41MA; or
10
(b) the contravention of section 14A or 41MAA (civil penalty
11
provisions);
12
a certificate by the Secretary to the effect that:
13
(c) the Secretary did not consent to the importation, supply or
14
exportation that is the subject of the proceedings; or
15
(d) the Secretary consented to that importation, supply or
16
exportation subject to conditions specified in the certificate;
17
is prima facie evidence of the matters specified in the certificate.
18
150 Subsection 56A(5)
19
After "this Act", insert "or a contravention of a civil penalty provision".
20
151 Subsection 60(1) (paragraph (b) of the definition of initial
21
decision)
22
After "section 14", insert "or 14A".
23
152 Subsection 60(1) (paragraph (k) of the definition of initial
24
decision)
25
After "section 41MA", insert "or 41MAA".
26
153 Subsection 61(3A)
27
After "31A,", insert "31AA,".
28
154 After paragraph 61(4A)(b)
29
Insert:
30
Schedule 1 Amendments
102 Therapeutic Goods Amendment Bill 2005 No. , 2005
or (ba) the head of an international organisation that has a function
1
relating to therapeutic goods, health or law enforcement;
2
155 At the end of subsection 61(4A)
3
Add:
4
; (g) information relating to an offence committed against this
5
Act, or alleged to have been committed against this Act,
6
involving therapeutic goods;
7
(h) information relating to the contravention of a civil penalty
8
provision, or the alleged contravention of a civil penalty
9
provision, involving therapeutic goods;
10
(i) a breach of a requirement of this Act or the regulations.
11
156 After subsection 61(4A)
12
Insert:
13
(4B) The release of therapeutic goods information mentioned in
14
paragraphs (4A)(g), (h) and (i) is not taken, for the purposes of
15
paragraph 1(d) of Information Privacy Principle 11 in section 14 of
16
the Privacy Act 1988, to be authorised by law.
17
157 After subsection 61(5)
18
Insert:
19
(5A) The Secretary may release to the public therapeutic goods
20
information relating to any decision or action taken under this Act
21
or the regulations.
22
(5B) The release of therapeutic goods information under
23
subsection (5A) is not taken, for the purposes of paragraph 1(d) of
24
Information Privacy Principle 11 in section 14 of the Privacy Act
25
1988, to be authorised by law.
26
Therapeutic Goods Amendment (Medical Devices) Act 2002
27
158 Item 12 of Schedule 2
28
Repeal the item, substitute:
29
12 Paragraphs 19D(3)(a) and (4)(a)
30
Omit "(other than listed goods that are therapeutic devices)".
31