THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 3) BILL 2009

i Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

B09BM255.v08.docx 5/11/2009 9:09 AM

Contents

1 Short

title

...........................................................................................

2 Commencement

.................................................................................

3 Schedule(s)

........................................................................................

Schedule 1--Biologicals

Therapeutic Goods Act 1989

Schedule 2--Immunity from civil actions

102

Therapeutic Goods Act 1989

102

Schedule 3--Recall of therapeutic goods

105

Therapeutic Goods Act 1989

105

Schedule 4--Information gathering

106

Therapeutic Goods Act 1989

106

Schedule 5--Unpaid annual charges

108

Therapeutic Goods Act 1989

108

Schedule 6--Other amendments

109

Therapeutic Goods Act 1989

109

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 1

A Bill for an Act to amend the Therapeutic Goods

Act 1989, and for related purposes

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the Therapeutic Goods Amendment (2009

Measures No. 3) Act 2009.

2 Commencement

(1) Each provision of this Act specified in column 1 of the table

commences, or is taken to have commenced, in accordance with

column 2 of the table. Any other statement in column 2 has effect

according to its terms.

2 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

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 this Act receives the Royal Assent.

2. Schedule 1

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not

commence within the period of 12 months

beginning on the day this Act receives the

Royal Assent, they commence on the day

after the end of that period.

However, if the Therapeutic Goods

(Charges) Amendment Act 2009 does not

receive the Royal Assent before the end of

that period, the provision(s) do not

commence at all.

3. Schedules 2 to

The day after this Act receives the Royal

Assent.

Note:

This table relates only to the provisions of this Act as originally

passed by both Houses of the Parliament and assented to. It will not be

expanded to deal with provisions inserted in this Act after assent.

(2) Column 3 of the table contains additional information that is not

part of this Act. Information in this column may be added to or

edited in any published version of this Act.

3 Schedule(s)

Each Act that is specified in a Schedule to this Act is amended or

repealed as set out in the applicable items in the Schedule

concerned, and any other item in a Schedule to this Act has effect

according to its terms.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 3

Schedule 1--Biologicals

Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

biological has the meaning given by section 32A.

2 Subsection 3(1)

Insert:

biological number of a biological means:

(a) the number assigned to the biological under subsection

32DB(2), 32DF(2) or 32DN(5); or

(b) if, in accordance with regulations made for the purposes of

paragraph 9A(4)(ca), a different number is assigned to the

biological--that different number.

3 Subsection 3(1)

Insert:

Class 1 biological means a biological included in a class of

biologicals that is:

(a) a class prescribed by the regulations for the purposes of

section 32AA; and

(b) a class referred to in those regulations as Class 1 biologicals.

4 Subsection 3(1) (definition of included in the Register)

Repeal the definition, substitute:

included in the Register:

(a) in relation to a biological--means included in the Register

under Part 3-2A; and

(b) in relation to a medical device to which Chapter 4 applies--

means included in the Register under Chapter 4.

Note:

Section 41BJ deals with the application of Chapter 4 to medical

devices.

Schedule 1 Biologicals

4 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

5 Subsection 3(1) (paragraph (a) of the definition of medicine)

After "goods", insert "(other than biologicals)".

6 Subsection 3(1) (definition of therapeutic device)

After "means therapeutic goods", insert "(other than biologicals)".

7 Subsection 3(1) (definition of therapeutic goods)

After "and includes", insert "biologicals,".

8 After paragraph 6AAE(6)(b)

Insert:

(ba) in the part of the Register for biologicals included under

Part 3-2A; or

9 Paragraph 7B(1)(b)

Omit "or are exempt goods in relation to Part 3-2", substitute ", are

exempt goods in relation to Part 3-2, are included in the Register under

Part 3-2A or are exempt under subsection 32CA(2) or section 32CB".

10 After paragraph 9(1)(a)

Insert:

(aa) the evaluation of a biological, other than a Class 1 biological,

for inclusion in the Register under Part 3-2A; or

11 Subsection 9A(3)

Omit "3 parts", substitute "4 parts".

12 After paragraph 9A(3)(b)

Insert:

(ba) a part for biologicals included in the Register under

Part 3-2A; and

13 Paragraph 9A(4)(b)

Repeal the paragraph, substitute:

(b) the ways in which goods that are included in one part of the

transferred, to another part of the Register; and

14 After paragraph 9A(4)(c)

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 5

Insert:

(ca) the ways in which a biological that has been assigned a

number under subsection 32DB(2), 32DF(2) or 32DN(5) may

be assigned a different number (which may be any

combination of numbers and either or both of letters and

symbols); and

15 After subsection 9D(3)

Insert:

(3A)

If:

(a) the person in relation to whom a biological is included in the

included in the entry in the Register that relates to the

biological; and

(b) the Secretary is satisfied that the variation requested does not

indicate any reduction in the quality, safety or efficacy of the

biological for the purposes for which it is to be used;

the Secretary may vary the entry in accordance with the request.

(3B)

If:

(a) a particular biological ceases to be a biological because of a

determination under subsection 32A(3); and

(b) the biological is included in the Register under Part 3-2A;

the Secretary must move the entry relating to the biological from

the part of the Register for biologicals to whichever other part of

the Register is applicable.

16 Subsection 9D(4)

Omit "the part for goods to be known as registered goods or to the part

for goods to be known as listed goods (whichever is applicable)",

substitute "whichever other part of the Register is applicable".

17 After subsection 14(5)

Insert:

(5A) Subsection (1), (2) or (4) does not apply if:

(a) the therapeutic goods are a biological; and

Schedule 1 Biologicals

6 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(b) the person imports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Note:

A defendant bears an evidential burden in relation to the matter in

subsection (5A): see subsection 13.3(3) of the Criminal Code.

Note:

The heading to subsection 14(5) is replaced by the heading "Exceptions".

18 After subsection 14(9)

Insert:

Exception

(9A) Subsection (6), (7) or (9) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person supplies the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Note:

A defendant bears an evidential burden in relation to the matter in

subsection (9A): see subsection 13.3(3) of the Criminal Code.

19 After subsection 14(13)

Insert:

Exception

(13A) Subsection (10), (11) or (13) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person exports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Note:

A defendant bears an evidential burden in relation to the matter in

subsection (13A): see subsection 13.3(3) of the Criminal Code.

20 After subsection 14A(1)

Insert:

Exception

(1A) Subsection (1) does not apply if:

(a) the therapeutic goods are a biological; and

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 7

(b) the person imports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

21 After subsection 14A(2)

Insert:

Exception

(2A) Subsection (2) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person supplies the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

22 After subsection 14A(3)

Insert:

Exception

(3A) Subsection (3) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person exports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

23 At the end of Part 3-1

Add:

15AB Conditions relating to exceptional release of biologicals

(1) Regulations made for the purposes of paragraphs 14(9A)(b) and

14A(2A)(b) may also prescribe conditions that apply in relation to

the supply of a biological that occurs after the circumstances

prescribed for the purposes of those paragraphs have occurred.

(2) The conditions prescribed by those regulations must apply only to

the person supplying the biological.

(3) A person commits an offence if:

(a) the person does an act or omits to do an act; and

Schedule 1 Biologicals

8 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(b) the act or omission results in the breach of any of the

conditions referred to in subsection (1).

Penalty for contravention of this subsection: 60 penalty units.

24 After section 15A

Insert:

15B Application of this Part to a biological

(1) Subject to this section, this Part does not apply to a biological on

and after the commencement of this section.

Biologicals currently included in the Register

(2) If, immediately before the commencement of this section,

therapeutic goods that are a biological were registered goods or

listed goods, this Part continues to apply to the biological on and

after that commencement until the time the biological is included

in the Register under Part 3-2A.

Note:

Section 32DN deals with including the biological under Part 3-2A.

Pending applications

(3)

If:

(a) before the commencement of this section, an application was

made under this Part for the registration or listing of

therapeutic goods that are a biological; and

(b) immediately before that commencement, the application was

not finally determined; and

commencement;

this Part continues to apply to the biological on and after that

commencement until the earliest of the following:

(d) the time the biological is included in the Register under

Part 3-2A;

(e) if the application is unsuccessful when it is finally

determined--the time the application is finally determined;

(f) the time the application is withdrawn;

(g) the time the application lapses.

Note:

Section 32DN deals with including the biological under Part 3-2A.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 9

(4) For the purposes of this section, an application is finally

determined when the application, and any applications for review

or appeals arising out of it, have been finally determined or

otherwise disposed of.

Transitional

(5) This Part applies to a biological on and after the commencement of

this section in relation to things done, or omitted to be done, in

relation to the biological before the commencement of this section.

(6) If this Part continues to apply to a biological during a period

described in subsection (2) or (3), then this Part also applies to the

biological after the end of that period in relation to things done, or

omitted to be done, in relation to the biological during that period.

25 After Part 3-2

Insert:

Part 3-2A--Biologicals

Division 1--Preliminary

32 What this Part is about

This Part regulates biologicals. It does this by providing a process

for including biologicals in the Register and providing for

enforcement through criminal offences and civil penalties.

This Part provides for the following administrative processes:

(a)

exempting biologicals from the requirement to be

included in the Register;

(b)

making the inclusion of biologicals in the Register

subject to conditions;

(c)

suspending or cancelling entries of biologicals

from the Register;

Schedule 1 Biologicals

10 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(d)

requiring public notification of problems with

biologicals, and recovery of biologicals;

(e)

obtaining information or documents about

biologicals.

32A Meaning of biological

(1) Subject to subsection (3), a biological is a thing that:

(a)

either:

(i) comprises, contains or is derived from human cells or

human tissues; or

(ii) is specified under subsection (2); and

(b) is represented in any way to be, or is, whether because of the

way in which it is presented or for any other reason, likely to

be taken to be:

(i) for use in the treatment or prevention of a disease,

ailment, defect or injury affecting persons; or

(ii) for use in making a medical diagnosis of the condition

of a person; or

(iii) for use in influencing, inhibiting or modifying a

physiological process in persons; or

(iv) for use in testing the susceptibility of persons to a

disease or ailment; or

(v) for use in the replacement or modification of parts of the

anatomy in persons.

(2) The Secretary may, by legislative instrument, specify things for the

purposes of subparagraph (1)(a)(ii).

Note:

For specification by class, see subsection 13(3) of the Legislative

Instruments Act 2003.

(3) The Secretary may, by legislative instrument, determine that a

specified thing is not a biological for the purposes of this Act.

Note:

For specification by class, see subsection 13(3) of the Legislative

Instruments Act 2003.

32AA Biological classes

The regulations may prescribe different classes of biologicals.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 11

Note 1:

The regulations may prescribe the circumstances in which a biological

included in a class of biologicals is separate and distinct from other

biologicals: see section 32AB.

Note 2:

The Secretary may approve different application forms for different

classes of biologicals: see section 32DD.

32AB When biologicals are separate and distinct from other

biologicals

(1) The regulations may prescribe the circumstances in which a

biological included in a specified class of biologicals is separate

and distinct from other biologicals.

(2) The regulations may make different provision in relation to

different classes of biologicals that are prescribed by the

regulations for the purposes of section 32AA.

Note:

The Secretary may cancel the entry of a biological from the Register if

the biological has changed so that it has become separate and distinct

from the biological as so included: see subsection 32GC(1).

Division 2--Main criminal offences and civil penalties

32B What this Division is about

This Division contains criminal offences and civil penalties

relating to the import, export, manufacture, supply and use of

biologicals.

32BA Criminal offences for importing a biological

(1) A person commits an offence if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

Schedule 1 Biologicals

12 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person;

and

(c)

either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person;

and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 13

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the importation.

Note:

A defendant bears a legal burden in relation to the matter in

subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Schedule 1 Biologicals

14 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Note:

A defendant bears an evidential burden in relation to the matters in

subsection (6): see subsection 13.3(3) of the Criminal Code.

32BB Criminal offences for exporting a biological

(1) A person commits an offence if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological; and

(c)

either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 15

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological; and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the exportation.

Note:

A defendant bears a legal burden in relation to the matter in

subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

Schedule 1 Biologicals

16 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Note:

A defendant bears an evidential burden in relation to the matters in

subsection (6): see subsection 13.3(3) of the Criminal Code.

32BC Criminal offences for manufacturing a biological

(1) A person commits an offence if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB; and

(c)

either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 17

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB; and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the manufacture.

Note:

A defendant bears a legal burden in relation to the matter in

subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

Schedule 1 Biologicals

18 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Note:

A defendant bears an evidential burden in relation to the matters in

subsection (6): see subsection 13.3(3) of the Criminal Code.

32BD Criminal offences for supplying a biological

(1) A person commits an offence if:

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological; and

(c)

either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 19

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological; and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

Schedule 1 Biologicals

20 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the supply.

Note:

A defendant bears a legal burden in relation to the matter in

subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Note:

A defendant bears an evidential burden in relation to the matters in

subsection (6): see subsection 13.3(3) of the Criminal Code.

32BE Notice required to adduce evidence in support of exception to

offences

(1)

If:

(a) a defendant is committed for trial for an offence against

subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(1); or

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Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 21

(b) an offence against subsection 32BA(1), 32BB(1), 32BC(1) or

32BD(1) is to be heard and determined by a court of

summary jurisdiction;

the committing magistrate or the court must:

(d) cause a copy of this section to be given to the defendant.

(2) A defendant must not, without leave of the court, adduce evidence

in support of the exception under subsection 32BA(6), 32BB(6),

32BC(6) or 32BD(6) unless the defendant gives notice of

particulars of the exception:

(a) if paragraph (1)(a) applies--more than 21 days before the

trial begins; or

(b) if paragraph (1)(b) applies--more than 21 days before the

hearing of the offence begins.

(3) A defendant must not, without leave of the court, call any other

person to give evidence in support of the exception unless:

(a) the notice under subsection (2) includes the name and address

of the person or, if the name and address is not known to the

defendant at the time the defendant gives the notice, any

information in the defendant's possession that might be of

material assistance in finding the person; and

(b) if the name or the address is not included in the notice--the

court is satisfied that the defendant before giving the notice

took, and after giving the notice continued to take, all

reasonable steps to ascertain the name or address; and

defendant subsequently ascertains the name or address or

receives information that might be of material assistance in

finding the person--the defendant immediately gives notice

of the name, address or other information, as the case may

be; and

(d) if the defendant is told by or on behalf of the prosecutor that

the person has not been found by the name, or at the address,

given by the defendant:

(i) the defendant immediately gives notice of any

information in the defendant's possession that might be

of material assistance in finding the person; and

Schedule 1 Biologicals

22 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(ii) if the defendant later receives any such information--

the defendant immediately gives notice of the

information.

(4) A notice purporting to be given under this section on behalf of the

defendant by the defendant's legal practitioner is, unless the

contrary is proved, taken as having been given with the authority of

the defendant.

(5) Any evidence tendered to disprove that the exception applies may,

subject to direction by the court, be given before or after evidence

is given in support of the exception.

(6) A notice under this section must be given in writing to the Director

of Public Prosecutions. A notice is taken as having been given if it

is:

(a) delivered to or left at an office of the Office of the Director of

Public Prosecutions; or

(b) sent by certified mail addressed to the Director of Public

Prosecutions at an office of the Office of the Director of

Public Prosecutions.

(7) In this section:

Director of Public Prosecutions means a person holding office as,

or acting as, the Director of Public Prosecutions under the Director

of Public Prosecutions Act 1983.

32BF Civil penalties for importing, exporting, manufacturing or

supplying a biological

Importing a biological for use in humans

(1) A person contravenes this subsection if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 23

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

Exporting a biological for use in humans

(2) A person contravenes this subsection if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

Manufacturing a biological for use in humans

(3) A person contravenes this subsection if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

Schedule 1 Biologicals

24 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

Supplying a biological for use in humans

(4) A person contravenes this subsection if:

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

Exception if person was not the sponsor of the biological

(5) Subsection (1), (2), (3) or (4) does not apply if the person proves

that he or she was not the sponsor of the biological at the time of

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 25

the importation, exportation, manufacture or supply, as the case

may be.

Civil penalty relating to the supply of biologicals included in the

Register

(6) A person contravenes this subsection if:

(a) a biological is included in the Register in relation to the

person; and

(b) the biological is of a kind prescribed by the regulations for

the purposes of this paragraph; and

(d) the biological number of the biological is not set out on the

label of the biological in the prescribed manner.

Maximum civil penalty:

(a) for an individual--200 penalty units; and

(b) for a body corporate--2,000 penalty units.

32BG Criminal offence and civil penalty relating to a failure to

notify the Secretary about manufacturing

Criminal offence

(1) A person commits an offence if:

(a)

the

person:

(i) imports a biological into Australia for use in humans; or

(ii) exports a biological from Australia for use in humans;

(iii) manufactures a biological in Australia for use in

humans; or

(iv) supplies a biological in Australia for use in humans; and

(b) the person is the sponsor of the biological; and

relation to the biological and the biological is not exempt

under subsection 32CA(2); and

(d) the person has not, at or before the time of the importation,

exportation, manufacture or supply, properly notified to the

Secretary either or both of the following:

(i) the manufacturer of the biological;

Schedule 1 Biologicals

26 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(ii) the premises used in the manufacture of the biological.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Civil penalty

(2) A person contravenes this subsection if:

(a)

the

person:

(i) imports a biological into Australia for use in humans; or

(ii) exports a biological from Australia for use in humans;

(iii) manufactures a biological in Australia for use in

humans; or

(iv) supplies a biological in Australia for use in humans; and

(b) the person is the sponsor of the biological; and

relation to the biological and the biological is not exempt

under subsection 32CA(2); and

(d) the person has not, at or before the time of the importation,

exportation, manufacture or supply, properly notified to the

Secretary either or both of the following:

(i) the manufacturer of the biological;

(ii) the premises used in the manufacture of the biological.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

Definition

(3) For the purposes of this section:

(a) a manufacturer is properly notified to the Secretary if:

(i) the manufacturer was nominated, as a manufacturer of

the biological, in an application for inclusion of the

biological in the Register; or

(ii) the Secretary was subsequently informed in writing that

the manufacturer is a manufacturer of the biological;

and

(b)

premises

are

properly notified to the Secretary if:

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 27

(i) the premises were nominated, as premises used in the

manufacture of the biological, in an application for

inclusion of the biological in the Register; or

(ii) the Secretary was subsequently informed in writing that

the premises are used in the manufacture of the

biological.

32BH Criminal offence relating to wholesale supply

A person commits an offence if:

(a) the person supplies a biological in Australia for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological; and

ultimate consumer of the biological.

Penalty: 120 penalty units.

32BI Criminal offence for using a biological not included in the

Register

(1) A person commits an offence if:

(a) the person uses a biological; and

(b) the biological is used:

(i) in the treatment of another person; or

Schedule 1 Biologicals

28 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(ii) solely for experimental purposes in humans; and

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CO(1) or (2);

(v) the person uses the biological in accordance with an

approval under subsection 32CK(1);

(vi) the person uses the biological in accordance with a

condition applicable under regulations made for the

purposes of section 32CL;

(vii) the person uses the biological in accordance with an

authority under subsection 32CM(1); and

(d)

either:

(i) if the person used the biological in the treatment of that

other person--the use of the biological has resulted in,

or will result in, harm or injury to that other person; or

(ii) if the person used the biological solely for experimental

purposes in humans--the use of the biological has

resulted in, or will result in, harm or injury to any of

those humans.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

(a) the person uses a biological; and

(b) the biological is used:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans; and

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 29

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CO(1) or (2);

(v) the person uses the biological in accordance with an

approval under subsection 32CK(1);

(vi) the person uses the biological in accordance with a

condition applicable under regulations made for the

purposes of section 32CL;

(vii) the person uses the biological in accordance with an

authority under subsection 32CM(1); and

(d)

either:

(i) if the person used the biological in the treatment of

another person--the use of the biological is likely to

result in harm or injury to that other person; or

(ii) if the person used the biological solely for experimental

purposes in humans--the use of the biological is likely

to result in harm or injury to any of those humans.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person uses a biological; and

(b) the biological is used:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans; and

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CO(1) or (2);

(v) the person uses the biological in accordance with an

approval under subsection 32CK(1);

Schedule 1 Biologicals

30 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(vi) the person uses the biological in accordance with a

condition applicable under regulations made for the

purposes of section 32CL;

(vii) the person uses the biological in accordance with an

authority under subsection 32CM(1).

Penalty for contravention of this subsection: 500 penalty units.

32BJ General criminal offences relating to this Part

Including incorrect biological number on containers etc.

(1) A person commits an offence if:

(a) the person sets out or causes to be set out, on a container or

package that contains a biological or on a label of a

biological, a number that purports to be the biological

number of the biological; and

(b) the number is not that biological number.

Penalty: 60 penalty units.

(2) For the purposes of subsection (1), number includes any

combination of one or more of the following:

(a)

numbers;

(b)

letters;

(c)

symbols.

Advertising biological for an indication

(3) A person commits an offence if:

(a) the person, by any means, advertises a biological for an

indication; and

(b) the biological is included in the Register; and

inclusion.

Penalty: 60 penalty units.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 31

Arranging supply of biological not included in Register

(4) A person commits an offence if:

(a) the person claims, by any means, that the person or another

person can arrange the supply of a biological; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological.

Penalty for contravention of this subsection: 60 penalty units.

32BK Civil penalty for making misrepresentations about biologicals

(1) A person contravenes this section if:

(a) the person makes a representation of a kind referred to in

subsection (2); and

(b) the representation is false or misleading.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

(2) Subsection (1) applies to the following representations:

(a) representations that a biological is included in the Register;

(b) representations that a person is exempt under subsection

32CA(1) in relation to a biological or that a biological is

exempt under subsection 32CA(2);

Schedule 1 Biologicals

32 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

section 32CB;

(d) representations that a biological is the subject of an approval

under subsection 32CK(1);

(e) representations that a biological is the subject of an authority

under subsection 32CM(1);

(f) representations that a biological is the subject of an approval

under subsection 32CO(1) or (2).

Division 3--Exemptions

Subdivision A--Preliminary

32C What this Division is about

There are 4 kinds of exemptions in relation to biologicals:

(a)

exemptions of biologicals under the regulations;

and

(b)

exemptions of biologicals to deal with

emergencies; and

(c)

exemptions of biologicals for special and

experimental uses; and

(d)

exemptions of biologicals where substitutes are

unavailable.

Subdivision B--Exempting biologicals under the regulations

32CA Exempt biologicals

(1) The regulations may exempt specified persons from the operation

of Division 4 in relation to specified biologicals.

Note:

For specification by class, see subsection 13(3) of the Legislative

Instruments Act 2003.

(2) The regulations may exempt specified biologicals from the

operation of Division 4.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 33

Note:

For specification by class, see subsection 13(3) of the Legislative

Instruments Act 2003.

(3) An exemption under this section may be subject to conditions that

are prescribed in the regulations.

(4) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of a condition of an

exemption under this section.

Penalty: 60 penalty units.

(5) If the regulations revoke an exemption, the revocation takes effect

on the day specified in the regulations. The day must not be earlier

than 28 days after the day on which the regulations revoking the

exemption take effect.

Subdivision C--Exempting biologicals to deal with emergencies

32CB Minister may make exemptions

(1) The Minister may, by writing, exempt specified biologicals from

the operation of Division 4.

Note 1:

For specification by class, see subsection 46(3) of the Acts

Interpretation Act 1901.

Note 2:

There are criminal offences and a civil penalty relating to biologicals

exempt under this section not conforming to standards etc.: see

section 32CJ.

(2) The Minister may make an exemption under subsection (1) only if

the Minister is satisfied that, in the national interest, the exemption

should be made so that:

(a) the biologicals may be stockpiled as quickly as possible in

order to create a preparedness to deal with a potential threat

to public health that may be caused by a possible future

emergency; or

(b) the biologicals can be made available urgently in Australia in

order to deal with an actual threat to public health caused by

an emergency that has occurred.

Period of exemption

(3) An exemption under subsection (1) comes into force:

Schedule 1 Biologicals

34 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(a) on the day the exemption is made; or

(b) on a later day specified in the exemption.

(4) An exemption under subsection (1) remains in force for the period

specified in the exemption, unless revoked earlier.

Note:

Section 32CD deals with variation and revocation of the exemption.

Effect of inclusion of biological in the Register

(5) An exemption under subsection (1) ceases to have effect in relation

to a particular biological when that biological becomes included in

the Register under Division 4.

Exemption not a legislative instrument

(6) An exemption under subsection (1) is not a legislative instrument.

32CC Conditions of exemptions

An exemption under section 32CB is subject to conditions

specified in the exemption about any of the following:

(a) the quantity of biologicals that are exempt;

(b) the source of those biologicals;

manufacture or supply those biologicals;

(d) the supply of those biologicals (including the persons or class

of persons to whom biologicals may be supplied for use and

the circumstances under which a stockpile of biologicals may

be supplied for use);

(e) the storage and security of those biologicals;

(f) the keeping and disclosure of, and access to, records about

those biologicals;

(g) the disposal of those biologicals;

(h) the manner in which any of those biologicals is to be dealt

with if a condition of the exemption is breached;

(i) any other matters that the Minister thinks appropriate.

Whether or not biologicals are exempt under section 32CB is not

affected by whether or not there is a breach of a condition under

this section in relation to those biologicals.

Note 1:

There are criminal offences and civil penalties related to the breach of

a condition of an exemption: see sections 32CH and 32CI.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 35

Note 2:

Section 32CD deals with variation and revocation of the conditions.

32CD Variation or revocation of exemption

Variation of exemption

(1) The Minister may, by writing, vary an exemption made under

section 32CB by removing specified biologicals from the

exemption.

Note:

For specification by class, see subsection 46(3) of the Acts

Interpretation Act 1901.

Revocation of exemption

(2) The Minister may, by writing, revoke an exemption made under

section 32CB.

Variation or revocation of conditions

(3) The Minister may, by writing:

(a) vary the conditions of an exemption made under

section 32CB (including by imposing new conditions); or

(b) revoke the conditions of an exemption made under

section 32CB.

When variation or revocation takes effect

(4) A variation or revocation under this section takes effect:

(a) if the Minister states in the variation or revocation that the

variation or revocation is necessary to prevent imminent risk

of death, serious illness or serious injury--on the day the

variation or revocation is made; or

(b) in any other case--on a later day specified in the variation or

revocation (which must not be earlier than 28 days after the

day the variation or revocation is made).

32CE Informing persons of exemption etc.

If the Minister makes an exemption under section 32CB, the

Minister must take reasonable steps to give a copy of the following

to each person covered by paragraph 32CC(c):

(a)

the

exemption;

Schedule 1 Biologicals

36 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(b) any variation or revocation of the exemption under

section 32CD.

32CF Notification and tabling

Notification

(1) The Secretary must cause a notice setting out particulars of the

following:

(a) an exemption made under section 32CB because of

paragraph 32CB(2)(b);

(b) a variation or revocation under section 32CD, to the extent

that the variation or revocation relates to an exemption made

under section 32CB because of paragraph 32CB(2)(b);

to be published in the Gazette within 7 days after the day on which

the exemption, variation or revocation is made. However, the

exemption, variation or revocation is not invalid merely because of

a failure to comply with this subsection.

Tabling

(2) The Minister must cause a document setting out particulars of the

following:

(a) an exemption made under section 32CB because of

paragraph 32CB(2)(b);

(b) a variation or revocation under section 32CD, to the extent

that the variation or revocation relates to an exemption made

under section 32CB because of paragraph 32CB(2)(b);

to be tabled in each House of the Parliament within 5 sitting days

of that House after the day on which the exemption, variation or

revocation is made. However, the exemption, variation or

revocation is not invalid merely because of a failure to comply

with this subsection.

32CG Disposal of unused biologicals

(1) This section applies to a biological if:

(a) an exemption under section 32CB in relation to that

biological ceases to have effect otherwise than because that

biological becomes included in the Register under

Division 4; and

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 37

(b) that biological has not been used before the exemption so

ceases to have effect.

(2) The Secretary may arrange for the disposal of the biological in

accordance with the regulations.

(3) Regulations made for the purposes of subsection (2) may set out

the methods by which the biological is to be stored, supplied,

destroyed, exported or otherwise disposed of.

(4) A method set out in the regulations under subsection (3) must not

enable or permit any benefit to be conferred on a person (including

the Commonwealth) other than the owner of the biological.

32CH Criminal offences for breaching a condition of an exemption

(1) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption; and

(d) the act or omission is likely to cause a serious risk to public

health.

Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.

(2) Strict liability applies to paragraph (1)(b).

Note:

For strict liability, see section 6.1 of the Criminal Code.

(3) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption.

Penalty: Imprisonment for 4 years or 240 penalty units, or both.

(4) Strict liability applies to paragraph (3)(b).

Note:

For strict liability, see section 6.1 of the Criminal Code.

Schedule 1 Biologicals

38 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(5) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption.

Penalty: 60 penalty units.

(6) An offence against subsection (5) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

32CI Civil penalty for breaching a condition of an exemption

A person contravenes this section if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

32CJ Criminal offences and civil penalty for biologicals not

conforming to standards etc.

(1) This section applies if:

(a) a biological is exempt under section 32CB; and

(b) a person supplies a batch of the biologicals; and

batch:

(i) do not conform to a standard applicable to the

biologicals; or

(ii) are otherwise not fit to be used for their intended

purposes.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 39

(2) The Secretary may, by written notice given to the person, require

the person to take steps to recover the biologicals included in that

batch (except any of those biologicals that cannot be recovered

because they have been administered to, or applied in the treatment

of, a person).

(3) The notice may specify one or more of the following requirements:

(a) the steps to be taken to recover the biologicals;

(b) the manner in which the steps are to be taken;

(4) The Secretary must, as soon as practicable after giving the notice,

cause particulars of it to be published in the Gazette.

Notice is not a legislative instrument

(5) A notice given under subsection (2) is not a legislative instrument.

Offences

(6) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

(d)

either:

(i) the use of any of the biologicals has resulted in, or will

result in, harm or injury to any person; or

(ii) the use of any of the biologicals, if any of the

biologicals were used, would result in harm or injury to

any person; and

(e) the harm or injury has resulted, will result, or would result,

because the person failed to comply with that requirement.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

(7) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

Schedule 1 Biologicals

40 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(d) the use of any of the biologicals, if any of the biologicals

were used, would be likely to result in harm or injury to any

person; and

(e) the harm or injury would be likely to result because the

person failed to comply with that requirement.

Penalty: 2,000 penalty units.

(8) An offence against subsection (7) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(9) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

Penalty: 60 penalty units.

(10) An offence against subsection (9) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

Civil penalty

(11) A person contravenes this subsection if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 41

Subdivision D--Exempting biologicals for special and

experimental uses

32CK Approvals for importing, exporting or supplying a biological

for special and experimental uses

(1) The Secretary may, by notice in writing, grant an approval to a

person for one or more of the following:

(a) the importation into Australia of a specified biological;

(b) the exportation from Australia of a specified biological;

that is:

(d) for use in the treatment of another person; or

(e) for use solely for experimental purposes in humans.

(2) Subsection (1) does not apply if the biological is included in the

relation to the biological or the biological is exempt under

subsection 32CA(2).

Application for approval

(3) An application for an approval for use of the kind referred to in

paragraph (1)(d) must:

(a) be made to the Secretary; and

(b) be accompanied by such information relating to the

biological the subject of the application as is required by the

Secretary.

(4) An application for an approval for use of the kind referred to in

paragraph (1)(e) must:

(a) be made to the Secretary; and

(b) be made in writing; and

biological the subject of the application as is required by the

Secretary; and

(d) be accompanied by the prescribed evaluation fee.

Secretary's decision

(5) If an application for an approval is made, the Secretary must:

Schedule 1 Biologicals

42 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(a) after having considered the application; and

(b) in the case of an application for an approval for use of the

kind referred to in paragraph (1)(e)--after having evaluated

the information submitted with the application;

notify the applicant of the decision on the application as soon as

practicable after making the decision and, in the case of a decision

not to grant the approval, of the reasons for the decision.

Conditions

(6) The Secretary may grant an approval under subsection (1) subject

to any conditions that are specified in the notice of approval.

(7) Those conditions may include a condition relating to the charges

that may be made for the biological to which the approval relates.

This subsection does not limit subsection (6).

(8) An approval under subsection (1) for use of the kind referred to in

paragraph (1)(e) is subject to the conditions (if any) specified in the

regulations. Those conditions (if any) are in addition to any

conditions imposed under subsection (6).

(9) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of a condition of an

approval under subsection (1).

Penalty: 60 penalty units.

Approval not a legislative instrument

(10) An approval under subsection (1) is not a legislative instrument.

32CL Conditions of use of biological for experimental purposes in

humans

(1) The use by a person (the experimenter) for experimental purposes

in humans of a biological that is the subject of an approval:

(a) that is held by another person under subsection 32CK(1); and

(b) that covers the importation into Australia, or the supply in

Australia, of the biological for use solely for experimental

purposes in humans;

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 43

is subject to the conditions (if any) specified in the regulations

relating to one or more of the following:

purposes;

(d) the principles to be followed in the use of the biological for

those purposes;

(e) the monitoring of the use, and the results of the use, of the

biological for those purposes;

(f) the circumstances in which the experimenter must cease the

use of the biological for those purposes.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of a condition

applicable under regulations made for the purposes of this

section.

Penalty for contravention of this subsection: 60 penalty units.

32CM Exemptions for medical practitioners

(1) The Secretary may, in writing, authorise a specified medical

practitioner to supply a specified biological, for use in the

treatment of humans, to the class or classes of recipients specified

in the authority.

Note:

Section 32CN contains criminal offences relating to the giving an

authority to a medical practitioner.

(2) The Secretary may give an authority under subsection (1) subject

to any conditions that are specified in the authority.

(3) The Secretary may impose conditions (or further conditions) on an

authority given to a person under subsection (1) by giving to the

person written notice of the conditions (or further conditions).

(4) An authority under subsection (1) may only be given:

(a) to a medical practitioner included in a class of medical

practitioners prescribed by the regulations for the purposes of

this paragraph; or

(b) to a medical practitioner who has the approval of an ethics

committee to supply the specified biological.

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44 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Paragraph (b) does not apply in the exceptional circumstances (if

any) prescribed by the regulations for the purposes of this

subsection.

(5) An authority under subsection (1) may only be given in relation to

a class or classes of recipients prescribed by the regulations for the

purposes of this subsection.

(6) The regulations may prescribe the circumstances in which a

biological may be supplied under an authority under subsection (1).

(7) An authority under subsection (1) is not a legislative instrument.

(8) In this section:

medical practitioner means a person who is registered, in a State

or internal Territory, as a medical practitioner.

32CN Criminal offences relating to the giving of an authority to a

medical practitioner

(1) A person commits an offence if:

(a) the Secretary has authorised, under subsection 32CM(1), the

person to supply a biological; and

(b) the person supplies the biological; and

(i) the supply is not in accordance with the authority;

(ii) the supply is not in accordance with the conditions to

which the authority is subject;

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6); and

(d)

either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 45

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6).

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

(a) the Secretary has authorised, under subsection 32CM(1), the

person to supply a biological; and

(b) the person supplies the biological; and

(i) the supply is not in accordance with the authority;

(ii) the supply is not in accordance with the conditions to

which the authority is subject;

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6); and

(d) the use of the biological, if the biological were used, would

be likely to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6).

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the Secretary has authorised, under subsection 32CM(1), the

person to supply a biological; and

(b) the person supplies the biological; and

(i) the supply is not in accordance with the authority;

(ii) the supply is not in accordance with the conditions to

which the authority is subject;

Schedule 1 Biologicals

46 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6).

Penalty for contravention of this subsection: 500 penalty units.

Subdivision E--Exempting biologicals where substitutes are

unavailable etc.

32CO Approvals where substitutes for biologicals are unavailable

etc.

(1) The Secretary may, by notice in writing, grant an approval to a

person for:

(a) the importation into Australia of a specified biological; or

(b) the importation into Australia of a specified biological and

the supply in Australia of that biological;

if the Secretary is satisfied that:

substitute for the biological are unavailable or are in short

supply; and

(d)

either:

(i) the biological that is the subject of the application for

approval is registered or approved for general marketing

in at least one foreign country specified by the Secretary

under subsection (5); or

(ii) an application that complies with section 32DA or

32DD has been made for inclusion of the biological in

the Register; and

(e) the biological is of a kind specified by the Secretary in a

determination under subsection (6); and

(f) the approval is necessary in the interests of public health.

(2) The Secretary may, by notice in writing, grant an approval to a

person for:

(a) the importation into Australia of a specified biological; or

(b) the importation into Australia of a specified biological and

the supply in Australia of that biological;

if the Secretary is satisfied that:

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 47

(d) an application that complies with section 32DA or 32DD has

been made for inclusion of the biological in the Register; and

(e) the biological is of a kind specified by the Secretary in a

determination under subsection (6); and

(f) the approval is necessary in the interests of public health.

Application for approval

(3) An application for an approval must:

(a) be made to the Secretary; and

(b) be accompanied by such information relating to the

biological as is required by the Secretary.

Secretary's decision

(4) If an application for an approval is made, the Secretary must, after

having considered the application, notify the applicant of the

decision on the application as soon as practicable after making the

decision and, in the case of a decision not to grant the approval, of

the reasons for the decision.

Determinations

(5) The Secretary may, by legislative instrument, make a

determination specifying foreign countries for the purposes of

subparagraph (1)(d)(i).

(6) The Secretary may, by legislative instrument, make a

determination specifying the kinds of biologicals that can be the

subject of an approval under this section.

Conditions

(7) The Secretary may grant an approval subject to any conditions that

are specified in the notice of approval.

(8) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of a condition of an

approval under subsection (1) or (2).

Penalty: 60 penalty units.

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48 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Period of approval

(9) The Secretary may grant an approval for such period as is specified

in the notice of approval.

When approval lapses

(10) The approval lapses if:

(a) the period specified in the notice of approval expires; or

(b) a decision has been made on an application that has been

made for inclusion of the biological in the Register.

(11) The approval lapses if:

(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f),

or paragraph (2)(c), (d), (e) or (f), as the case requires, no

longer applies in relation to the biological, or that a condition

of the approval has been contravened; and

(b) the Secretary has given to the person to whom the approval

was granted a notice stating that the Secretary is so satisfied.

(12) The lapsing of the approval on the expiry of the period specified in

the notice of approval does not prevent another approval being

granted under this section in relation to the biological before that

lapsing. The other approval may be expressed to take effect on the

expiry of that period.

Approval not a legislative instrument

(13) An approval under subsection (1) or (2) is not a legislative

instrument.

Division 4--Including biologicals in the Register

Subdivision A--Preliminary

32D What this Division is about

A Class 1 biological can be included in the Register if a proper

application is made and the applicant certifies various matters.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 49

A biological other than a Class 1 biological can be included in the

satisfied the biological is suitable for inclusion following an

evaluation of the biological.

Subdivision B--Class 1 biologicals

32DA Application for inclusion in the Register

(1) A person may make an application to the Secretary to include a

Class 1 biological in the Register.

(2) An application must:

(a) be made in accordance with a form that is approved, in

writing, by the Secretary; and

(b) be accompanied by a statement certifying the matters

mentioned in subsection (3); and

form; and

(d) be accompanied by the prescribed application fee.

(3) The applicant must certify that:

(a) the biological is a Class 1 biological; and

(b) the biological is safe for the purposes for which it is to be

used; and

to it; and

(d) the biological complies with every requirement (if any)

relating to advertising applicable under Part 5-1 or under the

regulations; and

(e) the biological complies with all prescribed quality or safety

criteria that are applicable to it; and

(f) the biological does not contain substances that are prohibited

imports for the purposes of the Customs Act 1901.

(4) An approval of a form may require or permit an application to be

given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

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50 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

32DB Inclusion of Class 1 biological in the Register

(1) If an application is made in accordance with section 32DA for a

Class 1 biological to be included in the Register in relation to a

person, the Secretary must include the biological in the Register in

relation to the person.

Biological number

(2) If the Secretary includes the biological in the Register, the

Secretary must assign a unique number to the biological. The

number assigned may be any combination of numbers and either or

both of letters and symbols.

Note:

The number assigned is the biological number of the biological.

Certificate

(3) As soon as practicable after the biological has been included in the

the inclusion of the biological in the Register.

(4) The certificate must:

(a) specify the biological number of the biological; and

(b) specify the day on which the inclusion of the biological in the

Duration of inclusion in the Register

(5) The biological remains included in the Register in relation to the

person until the Secretary cancels the entry of the biological from

the Register under this Part.

Note:

The biological is taken not to be included in the Register while it is

suspended: see section 32FD.

32DC Refusal to include Class 1 biological in the Register

If:

(a) an application is made under subsection 32DA(1) to include a

Class 1 biological in the Register; and

(b) the Secretary refuses the application;

the Secretary must, as soon as practicable after the refusal, give the

person notice of the refusal and of the reasons for the refusal.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 51

Subdivision C--Biologicals other than Class 1 biologicals

32DD Application for inclusion in the Register

(1) A person may make an application to the Secretary to include a

biological, other than a Class 1 biological, in the Register.

(2) An application is not effective unless:

(a) the application is made in accordance with a form that is

approved, in writing, by the Secretary and that relates to that

biological; and

(b) the application is accompanied by any documents that the

form requires; and

specified in the form; and

(d) if the Secretary so requires--the applicant has delivered to

that office a reasonable number of samples of the biological;

and

(e) the application is accompanied by the prescribed application

fee.

Note:

An evaluation fee is also payable: see sections 32DI to 32DM.

(3) The Secretary may approve different forms for different classes of

biologicals that are prescribed by the regulations for the purposes

of section 32AA.

(4) An approval of a form may require or permit an application to be

given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32DE Evaluation of biologicals

(1) If an application is made in accordance with section 32DD for a

biological to be included in the Register in relation to a person, the

Secretary must evaluate the biological for inclusion in the Register,

having regard to:

(a) whether the quality, safety and efficacy of the biological for

the purposes for which it is to be used have been

satisfactorily established; and

(b) whether the presentation of the biological is acceptable; and

Schedule 1 Biologicals

52 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

it; and

(d) whether the biological complies with every requirement (if

any) relating to advertising applicable under Part 5-1 or under

the regulations; and

(e) if a step in the manufacture of the biological has been carried

out outside Australia and the biological is not exempt from

the operation of Part 3-3--whether the manufacturing and

quality control procedures used in the step are acceptable;

and

(f) if a step in the manufacture of the biological has been carried

out in Australia, the biological is not exempt from the

operation of Part 3-3 and the person is not exempt from the

operation of that Part in relation to that step--whether that

step has been carried out in accordance with that Part; and

(g) whether the biological contains substances that are prohibited

imports for the purposes of the Customs Act 1901; and

(h) whether all of the manufacturers of the biological are

nominated as manufacturers of the biological in the

application; and

(i) such other matters (if any) as the Secretary considers

relevant.

(2) For the purposes of paragraph (1)(e), subsections 25(2), (2E), (2F)

and (2G) apply in a way corresponding to the way in which they

apply for the purposes of paragraph 25(1)(g).

32DF Inclusion of biological in the Register

(1)

If:

(a) an application is made in accordance with section 32DD for a

biological to be included in the Register in relation to a

person; and

(b) the Secretary decides that it is appropriate to include the

biological in the Register after an evaluation under

section 32DE; and

and payable by the person remains unpaid;

the Secretary must include the biological in the Register in relation

to the person.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 53

Biological number

(2) If the Secretary includes the biological in the Register, the

Secretary must assign a unique number to the biological. The

number assigned may be any combination of numbers and either or

both of letters and symbols.

Note:

The number assigned is the biological number of the biological.

Certificate

(3) As soon as practicable after the biological has been included in the

the inclusion of the biological in the Register.

(4) The certificate must:

(a) specify the biological number of the biological; and

(b) specify the day on which the inclusion of the biological in the

Duration of inclusion in the Register

(5) The biological remains included in the Register in relation to the

person until the Secretary cancels the entry of the biological from

the Register under this Part.

Note:

The biological is taken not to be included in the Register while it is

suspended: see section 32FD.

32DG Refusal to include biological in the Register

If:

(a) an application is made under subsection 32DD(1) to include a

biological in the Register; and

(b) the Secretary refuses the application;

the Secretary must, as soon as practicable after the refusal, give the

person notice of the refusal and of the reasons for the refusal.

32DH Lapsing of application

(1) An application under subsection 32DD(1) for inclusion of a

biological in the Register lapses if:

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54 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(a) any part of the evaluation fee payable in respect of the

biological remains unpaid at the end of the period of 42 days

after the day on which the part became due and payable; or

(b) information given to the Secretary by, or on behalf of, the

applicant in connection with the application, including

information given for the purpose of a requirement under

section 32JA, is false or misleading in a material particular;

section 32JA to give information consisting of patient data in

relation to the biological.

(2) In this section:

patient data, in relation to a biological, means information, derived

from clinical trials, relating to individuals before, during and after

the administration of the biological to those individuals, including,

but not limited to, demographic, biochemical and haematological

information.

32DI Evaluation fee

(1) If an application is made in accordance with section 32DD for a

biological to be included in the Register, an evaluation fee

specified in, or determined in accordance with, the regulations is

payable by the applicant in respect of the evaluation of the

biological for inclusion in the Register.

(2) The Secretary must notify the applicant in writing of the amount of

the evaluation fee.

32DJ When evaluation fee due for payment

(1) Subject to sections 32DK and 32DM, an evaluation fee payable by

an applicant is due and payable on the day on which the applicant

is notified of the amount of the evaluation fee.

(2) The evaluation fee is payable in the manner prescribed by the

regulations.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 55

32DK Payment of evaluation fee by instalments

(1) The regulations may provide for the payment of an evaluation fee

to be made by such instalments and at such times as are ascertained

in accordance with the regulations, and the evaluation fee is due

and payable accordingly.

(2) Regulations made for the purposes of subsection (1) may provide

that a person is not allowed to pay an evaluation fee by instalments if

any part of an instalment of that or any other evaluation fee payable

by the person was unpaid immediately after the time when it became

due for payment.

(3)

If:

(a) the regulations make provision as mentioned in

subsection (2); and

(b) an instalment of an evaluation fee under section 32DI was

unpaid immediately after the time when it became due for

payment;

the balance of the evaluation fee becomes due and payable

immediately.

(4) Subsection (2) does not limit subsection (1).

32DL Recovery of evaluation fee

An evaluation fee may be recovered by the Commonwealth as a

debt due to the Commonwealth.

32DM Reduction of evaluation fee where evaluation not completed

within prescribed period

(1) Nothing in section 32DI, 32DJ or 32DK requires the applicant to

pay more than

of the evaluation fee before the completion of the

evaluation if a period is prescribed under paragraph 63(2)(daa) for

completing the evaluation.

(2) The Secretary must notify the applicant in writing of the day the

evaluation is completed.

(3) If the evaluation is not completed within that period, the evaluation

fee is

of the fee that, apart from this subsection, would have

been the evaluation fee.

Schedule 1 Biologicals

56 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(4)

If:

(a) the evaluation is completed within that period; and

(b) part of the evaluation fee under section 32DI is unpaid when

the evaluation is completed;

that part becomes due and payable on the completion of the

evaluation.

(5) For the purposes of this section, if a copy of the evaluation report,

or a summary of that report, is given to either or both of the

following:

(a)

the

applicant;

(b) a committee established under the regulations to advise the

Secretary on applications to include biologicals in the

prescribed under paragraph 63(2)(daa);

then the evaluation is taken to be completed immediately before

the first copy or summary is so given.

Note:

This subsection has the effect that if the applicant withdraws the

application after being given a copy of the evaluation report, or a

summary of that report, before the end of that period, the full

evaluation fee is due and payable by the applicant.

(6) A notification under subsection (2) is not a legislative instrument.

Subdivision D--Transitional provisions for existing biologicals

32DN Transitional provisions for existing biologicals

Biologicals currently included in the Register

(1) If, immediately before the commencement of this section,

therapeutic goods that are a biological were included in relation to

a person:

(a) in the part of the Register for goods known as registered

goods; or

(b) in the part of the Register for goods known as listed goods; or

then, as soon as practicable after the commencement of this

section, the Secretary must:

(d) by writing, cancel the inclusion of the goods in that part; and

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 57

(e) include the biological in the Register under this Part in

relation to the person; and

(f) vary the Register as a result of that cancellation and

inclusion.

Pending applications

(2)

If:

(a) before the commencement of this section, an application was

made for the registration or listing of therapeutic goods that

are a biological or for the inclusion of such goods in the

(b) immediately before that commencement, the application was

not finally determined; and

before or after that commencement; and

(d) the application is successful when it is finally determined;

and

(e) the goods are included:

(i) in the part of the Register for goods known as registered

goods; or

(ii) in the part of the Register for goods known as listed

goods; or

(iii) in the part of the Register for medical devices included

in the Register under Chapter 4;

then, as soon as practicable after that inclusion, the Secretary must:

(f) by writing, cancel the inclusion of the goods in that part; and

(g) include the biological in the Register under this Part in

relation to the person; and

(h) vary the Register as a result of that cancellation and

inclusion.

(3) For the purposes of this section, an application is finally

determined when the application, and any applications for review

or appeals arising out of it, have been finally determined or

otherwise disposed of.

Notice of decisions

(4) The Secretary must give the person written notice of the

cancellation and inclusion under subsection (1) or (2).

Schedule 1 Biologicals

58 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Biological number

(5) If the Secretary includes the biological in the Register under

subsection (1) or (2), the Secretary must assign a unique number to

the biological. The number assigned may be any combination of

numbers and either or both of letters and symbols.

Note:

The number assigned is the biological number of the biological.

Certificate

(6) As soon as practicable after the biological has been included in the

certificate of the inclusion of the biological in the Register.

(7) The certificate must:

(a) specify the biological number of the biological; and

(b) specify the day on which the inclusion of the biological in the

Duration of inclusion in the Register

(8) The biological remains included in the Register in relation to the

person until the Secretary cancels the entry of the biological from

the Register under this Part.

Note:

The biological is taken not to be included in the Register while it is

suspended: see section 32FD.

Annual charge

(9) If, during a financial year, the Secretary includes a biological in the

Therapeutic Goods (Charges) Act 1989 does not apply in relation

to the biological for that financial year.

No review of decisions

(10) A decision under this section is taken not to be an initial decision

for the purposes of section 60.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 59

Subdivision E--Criminal offences and civil penalties

32DO Criminal offences for false statements in applications for

including biologicals in the Register

(1) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in, or in connection with, an

application for inclusion of a biological in the Register; and

and

(d)

either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in, or in connection with, an

application for inclusion of a biological in the Register; and

and

(d) the use of the biological, if the biological were used, would

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in, or in connection with, an

application for inclusion of a biological in the Register; and

Schedule 1 Biologicals

60 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Penalty for contravention of this subsection: Imprisonment for 12

months or 1,000 penalty units, or both.

32DP Civil penalty for false statements in applications for including

biologicals in the Register

A person contravenes this section if the person in, or in connection

with, an application for inclusion of a biological in the Register,

makes a statement that is false or misleading in a material

particular.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

32DQ Criminal offence and civil penalty for failing to notify adverse

effects etc. of biological while it is included in the Register

Criminal offence

(1) A person commits an offence if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person knows that particular information is information

of a kind to which subsection (3) applies; and

within the period specified in the regulations (whether or not

the person has already given to the Secretary other

information relating to the same matter).

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Civil penalty

(2) A person contravenes this subsection if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person knows that particular information is information

of a kind to which subsection (3) applies; and

within the period specified in the regulations (whether or not

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 61

the person has already given to the Secretary other

information relating to the same matter).

Maximum civil penalty:

(a) for an individual--3,000 penalty units; and

(b) for a body corporate--30,000 penalty units.

Relevant information

(3) This subsection applies to information of the following kinds:

(a) information that contradicts information already given by the

person under this Act in relation to the biological (including

information given about the quality, safety or efficacy of the

biological);

(b) information that indicates that the use of the biological in

accordance with the recommendations for its use may have

an unintended harmful effect;

accordance with the recommendations for its use, may not be

as effective as the application for inclusion of the biological

in the Register or information already given by the person

under this Act suggests.

32DR Criminal offences and civil penalties for failing to notify

adverse effects etc. of biological where application

withdrawn or lapses

(1) If an application for inclusion of a biological in the Register is

withdrawn or lapses, the Secretary may, within 14 days after the

application is withdrawn or lapses, give the applicant written notice

requiring the applicant:

(a) to inform the Secretary in writing whether the applicant is

aware of any information of a kind to which subsection (2)

applies; and

(b) if the applicant is aware of such information, to give the

information to the Secretary in writing.

(2) This subsection applies to information of the following kinds:

(a) information that contradicts information already given by the

person under this Act in relation to the biological (including

Schedule 1 Biologicals

62 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

information given about the quality, safety or efficacy of the

biological);

(b) information that indicates that the use of the biological in

accordance with the recommendations for its use may have

an unintended harmful effect;

accordance with the recommendations for its use, may not be

as effective as the application for inclusion of the biological

in the Register or information already given by the person

under this Act suggests.

Offences

(3) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (1); and

(b) the person fails to comply with the notice within 30 days

after the notice is given to the person.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

(4) A person commits an offence if:

(a) the person gives information in purported compliance with a

notice under subsection (1); and

(b) the information is false or misleading in a material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Civil penalties

(5) A person contravenes this subsection if:

(a) the Secretary gives a notice to the person under

subsection (1); and

(b) the person fails to comply with the notice within 30 days

after the notice is given to the person.

Maximum civil penalty:

(a) for an individual--3,000 penalty units; and

(b) for a body corporate--30,000 penalty units.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 63

(6) A person contravenes this subsection if:

(a) the person gives information in purported compliance with a

notice under subsection (1); and

(b) the information is false or misleading in a material particular.

Maximum civil penalty:

(a) for an individual--3,000 penalty units; and

(b) for a body corporate--30,000 penalty units.

Subdivision F--Advice from Gene Technology Regulator

32DS Consultation with Gene Technology Regulator

(1) This section applies to an application for inclusion of a biological

in the Register if the biological is, or contains, a GM product or a

genetically modified organism.

(2) Subject to subsection (5), the Secretary must give written notice to

the Gene Technology Regulator:

(a) stating that the application has been made; and

(b) requesting the Gene Technology Regulator to give advice

about the application.

(3) If the Secretary gives the Gene Technology Regulator a notice

under subsection (2), the Gene Technology Regulator may give

written advice to the Secretary about the application.

(4) The advice is to be given within the period specified in the notice.

(5) If an advice from the Gene Technology Regulator is in force under

section 32DT in relation to a class of biologicals, the Secretary is

not required to notify the Gene Technology Regulator under this

section in relation to an application for inclusion in the Register of

a biological belonging to that class.

(6) A notice under subsection (2) is not a legislative instrument.

32DT Secretary may seek advice about classes of GM products or

genetically modified organisms

(1) The Secretary may request advice from the Gene Technology

Regulator in relation to:

Schedule 1 Biologicals

64 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(a) biologicals that consist of, or that contain, a GM product

belonging to a class of GM products specified in the request;

(b) biologicals that consist of, or that contain, genetically

modified organisms belonging to a class of genetically

modified organisms specified in the request.

(2) A request for advice under subsection (1) must specify the matters

to which the advice is to relate.

(3) If the Secretary requests advice from the Gene Technology

Regulator under subsection (1), the Gene Technology Regulator

may provide written advice in relation to the matters specified in

the request.

(4) If the Gene Technology Regulator gives advice to the Secretary

under subsection (3), the advice remains in force until it is

withdrawn by the Gene Technology Regulator by written notice

given to the Secretary.

32DU Secretary to take advice into account

If the Secretary receives advice from the Gene Technology

Regulator:

(a) in response to a notice under section 32DS within the period

specified in the notice; or

(b)

under

section

32DT;

the Secretary must:

decision on the application to which the notice relates, or on

an application to which the advice under section 32DT

relates, as the case requires; and

(d) inform the Gene Technology Regulator of the decision on the

application.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 65

Division 5--Conditions

32E What this Division is about

Inclusions of biologicals in the Register are subject to certain

automatic conditions. The Minister and the Secretary may impose

further conditions.

32EA Conditions applying automatically

Entry and inspection powers

(1) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will:

(a) allow an authorised person:

(i) to enter, at any reasonable time, any premises (including

premises outside Australia) at which that person or any

other person deals with the biological; and

(ii) while on those premises, to inspect those premises and

any biological on those premises and to examine, take

measurements of, conduct tests on or take samples of

any biological on those premises or any thing on those

premises that relates to any biological; and

(iii) while on those premises, to make any still or moving

image or any recording of those premises or any thing

on those premises; and

(b) if requested to do so by an authorised person, produce to the

person such documents relating to the biological included in

the Register as the person requires and allow the person to

copy the documents.

(2) An authorised person is not authorised to enter premises as

mentioned in subsection (1) unless the person has shown his or her

identity card issued under section 52 if required by the occupier of

the premises. For the purposes of this subsection, occupier, in

relation to premises, includes a person present at the premises who

is in apparent control of the premises.

Schedule 1 Biologicals

66 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Delivery of samples

(3) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will deliver a reasonable number of

samples of the biological if the Secretary so requests:

(a) within the period, of not less than 14 days after the day the

request is made, specified in the request; and

(b) in accordance with any other requirements specified in the

request.

Manufacturing

(4) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will:

(a) if a manufacturer who was not nominated as a manufacturer

of the biological in the application for inclusion of the

biological in the Register is to become a manufacturer of a

step in the manufacture of the biological--inform the

Secretary in writing of that fact and of the name and address

of that manufacturer before that manufacturer begins to carry

out that step; and

(b) if premises that were not nominated in the application as

premises to be used in the manufacture of the biological are

to become premises used in a step in the manufacture of the

biological--inform the Secretary in writing of that fact and of

the name and address of the new premises before the

premises are first so used.

(5) The inclusion of a biological, other than a Class 1 biological, in the

(a) each step in the manufacture of the biological that is carried

out in Australia is carried out by a person who is the holder

of a licence to carry out that step or who is exempt from the

operation of Part 3-3 in relation to that step; and

(b) each step in the manufacture of the biological that is carried

out outside Australia is the subject of a certification in force

under subsection 32EB(2).

(6) Subsection (5) does not apply if the biological is exempt from the

operation of Part 3-3.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 67

(7) Paragraph (5)(b) does not apply in relation to a step that was the

subject of the evaluation under section 32DE. This subsection

ceases to apply in relation to that step if either or both of the

following occur:

(a) that step begins to be carried out at premises that are different

from the premises in respect of which that evaluation was

conducted;

(b) that step begins to be carried out by a manufacturer that is

different from the manufacturer in respect of which that

evaluation was conducted.

Expiry date

(8) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will not supply a batch of the biological in

Australia, or export a batch of the biological from Australia, after

the expiry date for the biological.

Advertising

(9) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will not, by any means, advertise the

biological for an indication other than an indication accepted in

relation to that inclusion.

32EB Certification of manufacturing steps outside Australia

(1) The person in relation to whom a biological, other than a Class 1

biological, is included in the Register may apply to the Secretary

for a certification under this section of a step in the manufacture of

the biological that is to be carried out outside Australia.

(2) If an application is made to the Secretary under this section, the

Secretary may, by writing, certify that the manufacturing and

quality control procedures used in that step are acceptable. The

Secretary must give the person written notice of the certification.

(3) In deciding whether to give the certification, subsections 25(2),

(2E), (2F) and (2G) apply in a way corresponding to the way in

which they apply for the purposes of paragraph 25(1)(g).

Schedule 1 Biologicals

68 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

32EC Imposition of conditions by legislative instrument

(1) The inclusion of a biological in the Register is subject to the

conditions set out in a determination under subsection (2).

(2) The Minister may, by legislative instrument, make a determination

setting out conditions for the purposes of subsection (1), being

conditions that relate to:

(a) the manufacture of the biological; or

(b) the custody, use, supply, disposal or destruction of the

biological; or

(d) matters dealt with in, or matters additional to matters dealt

with in, standards applicable to the biological; or

(e) such other matters relating to the biological as the Minister

thinks appropriate.

(3) Without limiting subsection (2), different conditions may be

specified for different classes of biologicals.

32ED Imposition of conditions at time biological included in the

Register

(1) If the Secretary includes a biological in the Register in relation to a

person, the Secretary may, by notice in writing given to the person,

impose conditions on the inclusion of the biological in the

(2) A notice under subsection (1) is not a legislative instrument.

32EE Imposition or variation or removal of conditions after

biological included in the Register

(1) The Secretary may, by notice in writing given to the person in

relation to whom a biological is included in the Register, impose

new conditions on the inclusion or vary or remove conditions

imposed under section 32ED or this subsection.

(2) The Secretary's power under subsection (1) may be exercised at

the request of the person concerned or on the Secretary's own

initiative. A request must be accompanied by the prescribed fee.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 69

(3) The imposition or variation or removal of a condition under

subsection (1) takes effect:

(a) if the notice states that the action is necessary to prevent

imminent risk of death, serious illness or serious injury--on

the day on which the notice is given to the person; or

(b) in any other case--on a later day specified in the notice,

being a day not earlier than 28 days after the notice is given

to the person.

(4) A notice under subsection (1) is not a legislative instrument.

32EF Criminal offences for breach of condition

(1) A person commits an offence if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register; and

(d) the act or omission has resulted in, or will result in, harm or

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register; and

(d) the act or omission is likely to result in harm or injury to any

person.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

Schedule 1 Biologicals

70 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register.

Penalty for contravention of this subsection: Imprisonment for 12

months or 1,000 penalty units, or both.

32EG Civil penalty for breach of condition

A person contravenes this section if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

Division 6--Suspension from the Register

32F What this Division is about

The Secretary may suspend biologicals from the Register in certain

circumstances. A biological that is suspended is taken not to be

included in the Register for most purposes.

32FA Suspension of biological from the Register

(1) The Secretary may, by written notice given to a person in relation

to whom a biological is included in the Register, suspend the

biological from the Register if:

(a) the Secretary is satisfied that:

(i)

there

is a potential risk of death, serious illness or

serious injury if the biological continues to be included

in the Register; and

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 71

(ii) it is likely that the person will, within the period of the

suspension, be able to take the action necessary to

ensure that the biological would not cause a potential

risk of death, serious illness or serious injury if the

biological were to continue to be included in the

(b) the Secretary is satisfied that it is likely that there are grounds

for cancelling the entry of the biological from the Register

under Division 7 (other than because of paragraph

32GA(1)(a) or (d)).

Notice of proposed suspension in some cases

(2) However, before suspending a biological from the Register

because it is likely that there are grounds for cancelling the entry of

the biological from the Register under section 32GC, the Secretary

must:

(a) inform the person by written notice that the Secretary

proposes the suspension and set out the reasons for it; and

(b) invite the person to make written submissions to the

Secretary in relation to the proposed suspension within the

period specified in the notice (being not less than 28 days

after the day the notice is given).

(3) The Secretary must not make a decision relating to the proposed

suspension until the Secretary has had regard to any submissions

the person makes under paragraph (2)(b).

Period of suspension

(4) A notice under subsection (1) must specify the period of the

suspension (which must not exceed 6 months).

Note:

Section 32FB deals with when the suspension takes effect and

extensions of the suspension.

Publication in Gazette

(5) As soon as practicable after giving a notice under subsection (1),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the suspension.

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72 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Notice not a legislative instrument

(6) A notice under subsection (1) is not a legislative instrument.

32FB When suspension takes effect etc.

(1) A suspension under section 32FA takes effect:

(a) if the notice under subsection 32FA(1) states that the

suspension is necessary to prevent a potential risk of death,

serious illness or serious injury--on the day on which the

notice is given to the person; or

(b) in any other case--on a later day specified in the notice,

being a day not earlier than 28 days after the notice is given

to the person.

(2) The suspension has effect until:

(a) the Secretary revokes it under section 32FC; or

(b) the end of:

(i) the period specified under subsection 32FA(4); or

(ii) if the period is extended under subsection (3) of this

section--the period as so extended.

Extension of suspension

(3) The Secretary may, by written notice given to the person, extend

the period specified under subsection 32FA(4) by a further

specified period not exceeding 6 months.

Publication in Gazette

(4) As soon as practicable after giving a notice under subsection (3),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the extension.

Notice not a legislative instrument

(5) A notice under subsection (3) is not a legislative instrument.

32FC Revocation of suspension

(1) The Secretary must revoke a suspension under section 32FA, by

written notice given to the person in relation to whom the

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 73

biological is included in the Register, if the Secretary is satisfied

that:

(a) the ground on which the biological was suspended from the

(b) there are no other grounds for suspending the biological from

the Register.

(2) The Secretary's power to revoke the suspension may be exercised:

(a) if the person in relation to whom the biological is included in

the Register applies in writing to the Secretary; or

(b) on the Secretary's own initiative.

Publication in Gazette

(3) As soon as practicable after giving a notice under subsection (1),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the revocation.

Notice of refusal to revoke suspension

(4) If the Secretary decides, after an application is made under

paragraph (2)(a), not to revoke the suspension, the Secretary must:

(a) notify the applicant in writing of his or her decision; and

(b) state in the notice the reasons for the decision.

Notice not a legislative instrument

(5) A notice under subsection (1) is not a legislative instrument.

32FD Effect of suspension

(1) If a biological is suspended from the Register under section 32FA,

the biological is taken, for the purposes of this Act (other than

section 32DQ, Division 5, sections 32FB and 32FC and

Divisions 7 and 9), not to be included in the Register while the

suspension has effect.

Note:

Dealing in a biological that is not included in the Register may be a

criminal offence or may contravene a civil penalty provision: see

Division 2.

(2) While the suspension has effect, the Secretary's power under

Division 7 to cancel the entry of the biological from the Register is

not affected.

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74 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Division 7--Cancellation from the Register

32G What this Division is about

The Secretary may cancel inclusions of biologicals in the Register

in certain circumstances.

32GA Immediate cancellation of biological from the Register in

various circumstances

(1) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) the Secretary is satisfied that there would be an imminent risk

of death, serious illness or serious injury if the biological

continued to be included in the Register; or

(b) the biological ceases to be a biological or the biological

becomes covered by an order under section 7 declaring goods

not to be therapeutic goods; or

the biological or the biological is exempt under subsection

32CA(2); or

(d) the person requests in writing the cancellation of the entry of

the biological from the Register; or

(e) the biological contains substances that are prohibited imports

for the purposes of the Customs Act 1901; or

(f) the Secretary is satisfied that a statement made in, or in

connection with, the application for including the biological

in the Register was false or misleading in a material

particular; or

(g) the annual charge payable under the Therapeutic Goods

(Charges) Act 1989 in respect of the inclusion of the

biological in the Register is not paid within 28 days after it

becomes payable; or

(h) the person has failed to comply with a condition mentioned

in subsection 32EA(1) or (3); or

(i) both of the following apply:

(i) under the regulations, an authority constituted by or

under the regulations gives a direction to, or makes a

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 75

requirement of, the person in relation to an

advertisement of the biological to ensure that

advertising complies with the Therapeutic Goods

Advertising Code;

(ii) the person does not comply with the direction or

requirement; or

(j) there is a breach, involving the biological, of the

requirements relating to advertising applicable under Part 5-1

or under the regulations.

(2) A notice under subsection (1) is not a legislative instrument.

32GB Immediate cancellation of biological from the Register after

failure to comply with information gathering notice

(1) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) the Secretary gives to the person a notice under section 32JA

requiring the person to give to the Secretary information, or

to produce to the Secretary documents, relating to the

biological; and

(b) the notice under section 32JA is given for the purposes of

ascertaining whether the biological should have been

included in the Register; and

within a further 14 days after the end of the period specified

in that notice.

(2) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) the Secretary gives to the person a notice under section 32JA

requiring the person to give to the Secretary information, or

to produce to the Secretary documents, relating to whether

the biological is being:

(i) supplied in Australia; or

(ii) imported into Australia; or

(iii) exported from Australia; and

(b)

either:

Schedule 1 Biologicals

76 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(i) the information or documents given are to the effect that

the biological is not being supplied in Australia,

imported into Australia or exported from Australia; or

(ii) the person fails to comply with the notice under

section 32JA within a further 14 days after the end of

the period specified in that notice.

(3) A notice under subsection (1) or (2) is not a legislative instrument.

32GC Cancellation of biological from the Register after notice of

proposed cancellation

(1) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) it appears to the Secretary that the quality, safety or efficacy

of the biological is unacceptable or that the presentation of

the biological is unacceptable; or

(b) the biological has changed so that it has become separate and

distinct from the biological as so included; or

Note:

Section 32AB deals with when a biological is separate and

distinct from other biologicals.

inclusion of the biological is subject (except a condition

mentioned in subsection 32EA(1) or (3)); or

(d) the Secretary gives to the person a notice under section 32JA:

(i) that requires the person to give to the Secretary

information, or to produce to the Secretary documents,

relating to the biological; and

(ii) in respect of which section 32GB does not apply;

and the person fails to comply with that notice within a

further 14 days after the end of the period specified in that

notice; or

(e) the person contravenes subsection 32DQ(1) or (2) in relation

to the biological; or

(f) the biological does not conform to a standard applicable to it;

(g) the biological does not comply with a requirement relating to

advertising applicable to it under Part 5-1 or under the

regulations.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 77

(2) However, before cancelling the entry of the biological from the

(a) inform the person in writing that the Secretary proposes the

cancellation and set out the reasons for it; and

(b) invite the person to make written submissions to the

Secretary in relation to the proposed cancellation within the

period specified in the notice (being not less than 28 days

after the day the notice is given).

(3) The Secretary must not make a decision relating to the proposed

cancellation until the Secretary has had regard to any submissions

the person makes under paragraph (2)(b).

(4) A notice under subsection (1) is not a legislative instrument.

32GD Revocation of cancellation of biological upon request

(1)

If:

(a) the Secretary cancels the entry of a biological from the

paragraph 32GA(1)(d); and

(b) before the end of the period of 90 days beginning on the day

the biological ceased to be included in the Register, the

person requests, in writing, the Secretary to revoke the

cancellation; and

the Secretary may, by notice in writing given to the person, revoke

the cancellation.

(2) If the cancellation is revoked, the cancellation is taken never to

have occurred.

32GE Publication of cancellation of entry from Register

The Secretary must cause to be published in the Gazette, as soon as

practicable after cancelling an entry of a biological from the

32GF Date of effect of cancellation of entries from Register

If the Secretary cancels an entry of a biological from the Register,

the cancellation has effect on the day on which the notice of

Schedule 1 Biologicals

78 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

cancellation is given to the person in relation to whom the

biological was included in the Register.

Division 8--Public notification and recovery of biologicals

32H What this Division is about

The Secretary may require a person to recover biologicals, or to

inform the public about biologicals, that do not comply with

requirements or cannot lawfully be supplied. There are criminal

offences and a civil penalty for breaching such a requirement.

32HA Public notification and recovery of biologicals

(1) The Secretary may, by notice in writing, impose requirements,

relating to a biological, on a person if:

(a) any of the circumstances referred to in the 2nd column of an

item in the following table occur in relation to the biological;

and

(b) the person is referred to in the 3rd column of that item.

Circumstances in which requirements may be imposed

Item

Circumstance relating to biological Person

subject

requirements

It is supplied while it is included in the

standard applicable to it

The person in relation to

whom it is included in the

It is a biological, other than a Class 1

biological, and it is supplied while it is included

in the Register, but the manufacturing

principles have not been observed in its

manufacture

The person in relation to

whom it is included in the

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 79

Circumstances in which requirements may be imposed

Item

Circumstance relating to biological Person

subject

requirements

It is supplied while:

(a) the person is exempt under subsection

32CA(1) in relation to the biological or the

biological is exempt under subsection

32CA(2); or

(b) it is exempt under section 32CB; or

subsection 32CK(1); or

(d) it is the subject of an authority under

subsection 32CM(1); or

(e) it is the subject of an approval under

subsection 32CO(1) or (2);

but it does not conform with a standard

applicable to it

The person supplying it

It is a biological, other than a Class 1

biological, and it is supplied while:

(a) the person is exempt under subsection

32CA(1) in relation to the biological or the

biological is exempt under subsection

32CA(2); or

(b) it is exempt under section 32CB; or

subsection 32CK(1); or

(d) it is the subject of an authority under

subsection 32CM(1); or

(e) it is the subject of an approval under

subsection 32CO(1) or (2);

but the manufacturing principles have not been

observed in its manufacture

The person supplying it

Schedule 1 Biologicals

80 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Circumstances in which requirements may be imposed

Item

Circumstance relating to biological Person

subject

requirements

It is supplied while:

(a) it is not included in the Register; and

(b) the person is not exempt under subsection

32CA(1) in relation to the biological and the

biological is not exempt under subsection

32CA(2); and

(d) it is not the subject of an approval under

subsection 32CK(1); and

(e) it is not the subject of an authority under

subsection 32CM(1); and

(f) it is not the subject of an approval under

subsection 32CO(1) or (2)

The person supplying it

It is supplied while it is exempt under

section 32CB, and the Secretary is satisfied that

it is not fit to be used for its intended purpose

The person supplying it

It is supplied in contravention of subsection

42E(1) or section 42EA

The person supplying it

It is a biological, other than a Class 1

biological, and it is supplied while it is included

in the Register, but there is a breach of the

condition set out in subsection 32EA(5)

The person in relation to

whom it is included in the

It appears to the Secretary that the quality,

safety or efficacy of the biological is

unacceptable or that the presentation of the

biological is unacceptable

The person in relation to

whom the biological is

included in the Register

It has been suspended from the Register

The person in relation to

whom it is included in the

Its entry has been cancelled from the Register

The person in relation to

whom it is included in the

(2) The requirements may be one or more of the following:

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 81

(a) to take specified steps, in the specified manner and within

such reasonable period as is specified, to recover the

biological that has been supplied;

(b) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, that the circumstances referred to in

paragraph (1)(a) have occurred in relation to the biological;

reasonable period as is specified, specified information, or

information of a specified kind, relating to the manufacture

or supply of the biological.

(3) If the circumstances referred to in paragraph (1)(a) apply only to a

batch of the biological, the Secretary may limit the imposition of

the requirements to that batch.

(4) A requirement to recover a biological under this section does not

apply to a biological that cannot be recovered because it has been

administered to, or applied in the treatment of, a person.

(5) A notice under subsection (1) is not a legislative instrument.

32HB Publication of requirements

The Secretary must cause to be published in the Gazette, as soon as

practicable after imposing a requirement under section 32HA, a

notice setting out particulars of the requirement.

32HC Criminal offences for non-compliance with requirements

(1) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA; and

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (4) instead:

see section 53A.

(2) A person commits an offence if:

Schedule 1 Biologicals

82 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA; and

person.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA.

Penalty for contravention of this subsection: Imprisonment for 12

months or 1,000 penalty units, or both.

32HD Civil penalty for non-compliance with requirements

A person contravenes this section if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

32HE Powers of suspension and cancellation unaffected

Imposition of a requirement under section 32HA does not affect

the Secretary's power to suspend a biological, or cancel the entry

of a biological, from the Register under this Part.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 83

Division 9--Obtaining information or documents

Subdivision A--Preliminary

32J What this Division is about

The Secretary may by written notice seek information or

documents relating to:

�

applications for inclusion of biologicals in the Register; or

�

biologicals included in the Register; or

�

the supply of, and other matters relating to, biologicals

covered by exemptions under Division 3.

There are criminal offences for failing to comply with a notice and

for giving false or misleading information or documents and civil

penalties for giving false or misleading information or documents.

Subdivision B--Obtaining information or documents for

biologicals included or proposed to be included in the

Register

32JA Secretary may require information or documents

(1) The Secretary may, by written notice given to a person:

(a) who is an applicant for the inclusion of a biological in the

(b) in relation to whom a biological is included in the Register;

previous 5 years, included in the Register;

require the person to give to the Secretary information, or to

produce to the Secretary documents, that are relevant to one or

more of the following:

(d) the formulation of the biological;

(e) the composition of the biological;

(f) the design specifications of the biological;

Schedule 1 Biologicals

84 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(g) the quality of the biological;

(h) the method and place of manufacture or preparation of the

biological and the procedures employed to ensure that proper

standards are maintained in the manufacture and handling of

the biological;

(i) the presentation of the biological;

(j) the safety and efficacy of the biological for the purposes for

which it is to be used;

(k) whether the biological conforms with a standard applicable to

it;

(l) whether the biological complies with conditions (if any) on

the inclusion of the biological in the Register;

(m) whether the biological complies with every requirement (if

any) relating to advertising applicable under Part 5-1 or under

the regulations;

(n) if the biological is included in the Register in relation to the

person--whether the biological is being:

(i) supplied in Australia; or

(ii) imported into Australia; or

(iii) exported from Australia;

(o) the regulatory history of the biological in another country;

(p) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

(2) The person must give the information, or produce the documents,

to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

Note:

Section 32JB contains criminal offences for failing to comply with the

notice and for giving false or misleading information or documents

and section 32JC contains a civil penalty for giving false or

misleading information or documents.

(3) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 85

(4) If a notice is given under subsection (1) to a person covered by

paragraph (1)(c), then paragraphs (1)(d) to (p) (to the extent to

which they are relevant) apply in relation to that part of the period

of 5 years before the notice was given during which the biological

was included in the Register.

32JB Criminal offences for failing to comply with a notice etc.

(1) A person commits an offence if:

(a) the person is given a notice under section 32JA; and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

Note:

Failure to comply with the notice might also lead to suspension or

cancellation of the entry of a biological in the Register (see

Divisions 6 and 7).

(2) A person commits an offence if:

(a) the person is given a notice under section 32JA in relation to

a biological; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular; and

(d)

either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note:

A jury may acquit a person of an offence against this subsection and

may convict the person of an offence against subsection (5) instead:

see section 53A.

(3) A person commits an offence if:

(a) the person is given a notice under section 32JA in relation to

a biological; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular; and

Schedule 1 Biologicals

86 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(d) the use of the biological, if the biological were used, would

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

(4) An offence against subsection (3) is an offence of strict liability.

Note:

For strict liability, see section 6.1 of the Criminal Code.

(5) A person commits an offence if:

(a) the person is given a notice under section 32JA; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Penalty for contravention of this subsection: Imprisonment for 12

months or 1,000 penalty units, or both.

32JC Civil penalty for giving false or misleading information or

document in compliance with a notice

A person contravenes this section if:

(a) the person is given a notice under section 32JA; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

32JD Self-incrimination

(1) A person is not excused from giving information or producing a

document under section 32JA on the ground that the information or

the production of the document might tend to incriminate the

person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given or the document produced; and

(b) giving the information or producing the document; and

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 87

indirect consequence of giving the information or producing

the document;

are not admissible in evidence against the individual:

(d) in criminal proceedings, except proceedings for an offence

against subsection 32JB(1), (2), (3) or (5); or

(e) in civil proceedings, except proceedings under section 42Y

for a contravention of section 32JC.

Subdivision C--Obtaining information or documents for

biologicals covered by exemptions

32JE Secretary may require information etc. about biologicals

exempt under the regulations

(1) If a person is exempt under subsection 32CA(1) in relation to a

biological, the Secretary may give the person a written notice

requiring the person to give to the Secretary specified information,

or to produce to the Secretary specified documents, relating to one

or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

(2) If a biological is exempt under subsection 32CA(2), the Secretary

may give the sponsor of the biological a written notice requiring

the sponsor to give to the Secretary specified information, or to

produce to the Secretary specified documents, relating to one or

more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Schedule 1 Biologicals

88 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Compliance

(3) A person given a notice under subsection (1) or (2) must give the

information, or produce the documents, to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

Note:

Section 32JI contains criminal offences for failing to comply with the

notice and for giving false or misleading information or documents

and section 32JJ contains a civil penalty for giving false or misleading

information or documents.

(4) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JF Secretary may require information etc. about biologicals

exempt to deal with emergencies

(1) This section applies to a person who is required to comply with a

condition of an exemption of a biological under section 32CB.

(2) The Secretary may, by written notice given to the person, require

the person to give to the Secretary specified information, or to

produce to the Secretary specified documents, relating to one or

more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

(3) The person must give the information, or produce the documents,

to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 89

Note:

Section 32JI contains criminal offences for failing to comply with the

notice and for giving false or misleading information or documents

and section 32JJ contains a civil penalty for giving false or misleading

information or documents.

(4) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JG Secretary may require information etc. about biologicals

exempt for special and experimental uses

Approval under subsection 32CK(1)

(1) The Secretary may give to a person who is granted an approval

under subsection 32CK(1) in relation to a biological a written

notice requiring the person to give to the Secretary specified

information, or to produce to the Secretary specified documents,

relating to one or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Approval under subsection 32CK(1)--use by another person

(2) The Secretary may give to a person (the experimenter) using a

biological that is the subject of an approval:

(a) that is held by another person under subsection 32CK(1); and

(b) that covers the importation into Australia, or the supply in

Australia, of the biological for use solely for experimental

purposes in humans;

a written notice requiring the experimenter to give to the Secretary

specified information, or to produce to the Secretary specified

documents, relating to either or both of the following:

Schedule 1 Biologicals

90 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(d) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Authority under subsection 32CM(1)

(3) The Secretary may give to a person who is granted an authority

under subsection 32CM(1) in relation to a biological a written

notice requiring the person to give to the Secretary specified

information, or to produce to the Secretary specified documents,

relating to one or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Compliance

(4) A person given a notice under subsection (1), (2) or (3) must give

the information, or produce the documents, to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

Note:

Section 32JI contains criminal offences for failing to comply with the

notice and for giving false or misleading information or documents

and section 32JJ contains a civil penalty for giving false or misleading

information or documents.

(5) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JH Secretary may require information etc. about biologicals

exempt where substitutes are unavailable etc.

(1) The Secretary may give to a person who is granted an approval

under subsection 32CO(1) or (2) in relation to a biological a

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 91

written notice requiring the person to give to the Secretary

specified information, or to produce to the Secretary specified

documents, relating to one or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Compliance

(2) A person given a notice under subsection (1) must give the

information, or produce the documents, to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

Note:

Section 32JI contains criminal offences for failing to comply with the

notice and for giving false or misleading information or documents

and section 32JJ contains a civil penalty for giving false or misleading

information or documents.

(3) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JI Criminal offences for failing to comply with a notice etc.

(1) A person commits an offence if:

(a) the person is given a notice under section 32JE, 32JF, 32JG

or 32JH; and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

(2) A person commits an offence if:

(a) the person is given a notice under section 32JE, 32JF, 32JG

or 32JH; and

Schedule 1 Biologicals

92 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Penalty for contravention of this subsection: Imprisonment for 12

months or 1,000 penalty units, or both.

32JJ Civil penalty for giving false or misleading information or

document in compliance with a notice

A person contravenes this section if:

(a) the person is given a notice under section 32JE, 32JF, 32JG

or 32JH; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Maximum civil penalty:

(a) for an individual--5,000 penalty units; and

(b) for a body corporate--50,000 penalty units.

32JK Self-incrimination

(1) A person is not excused from giving information or producing a

document under section 32JE, 32JF, 32JG or 32JH on the ground

that the information or the production of the document might tend

to incriminate the person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given or the document produced; and

(b) giving the information or producing the document; and

indirect consequence of giving the information or producing

the document;

are not admissible in evidence against the individual:

(d) in criminal proceedings, except proceedings for an offence

against subsection 32JI(1) or (2); or

(e) in civil proceedings, except proceedings under section 42Y

for a contravention of section 32JJ.

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 93

Subdivision D--Inspecting, copying and retaining documents

32JL Secretary may inspect and copy documents

The Secretary may inspect a document produced under

section 32JA, 32JE, 32JF, 32JG or 32JH and may make and retain

copies of the whole or a part of the document.

32JM Secretary may retain documents

(1) The Secretary may take possession of a document produced under

section 32JA, 32JE, 32JF, 32JG or 32JH, and retain it for as long

as is reasonably necessary.

(2) The person otherwise entitled to possession of the document is

entitled to be supplied, as soon as practicable, with a copy certified

by the Secretary to be a true copy.

(3) The certified copy must be received in all courts and tribunals as

evidence as if it were the original.

(4) Until a certified copy is supplied, the Secretary must provide the

person otherwise entitled to possession of the document, or a

person authorised by that person, reasonable access to the

document for the purposes of inspecting and making copies of the

whole or a part of the document.

26 After section 33A

Insert:

33B Application of this Part to biologicals

This Part does not apply to a Class 1 biological.

27 Paragraphs 35(1)(a), (2)(a) and (4)(a)

After "section 18A", insert "or 32CB".

28 Paragraphs 35(5)(c), (7)(c) and (9)(c)

After "section 18A", insert "or 32CB".

29 Paragraphs 35A(1)(c) and (2)(c)

After "section 18A", insert "or 32CB".

Schedule 1 Biologicals

94 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

30 At the end of section 39

Add:

(3)

If:

(a) the licence covers a biological that is exempt under

section 32CB; and

(b) the biological ceases to be exempt under that section before

the licence is revoked;

the licence ceases to be in force in relation to the biological when

the biological ceases to be exempt under that section.

Note:

An exemption under section 32CB may cease to have effect only in

relation to some of the biologicals covered by the exemption: see

subsections 32CB(5) and 32CD(1).

31 Paragraph 40(4)(a)

Repeal the paragraph, substitute:

(a)

ensure

that:

(i) the goods conform to any standard applicable to the

goods; and

(ii) the holder of the licence observes the manufacturing

principles in carrying out any steps in the manufacture

of the goods under the licence;

unless:

(iii) the goods are a biological and are for supply after the

circumstances prescribed by the regulations for the

purposes of paragraphs 14(9A)(b) and 14A(2A)(b) have

occurred; or

(iv) the goods are a biological and are for export after the

circumstances prescribed by the regulations for the

purposes of paragraphs 14(13A)(b) and 14A(3A)(b)

have occurred; and

32 After paragraph 41(1)(g)

Insert:

(ga) the licence covers a biological that is exempt under

section 32CB and the holder has breached a condition of the

exemption in relation to the biological; or

33 After section 41BJ

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 95

Insert:

41BJA Application of this Chapter to a biological

(1) Subject to this section, this Chapter does not apply to a biological

on and after the commencement of this section.

Biologicals currently included in the Register

(2) If, immediately before the commencement of this section,

therapeutic goods that are a biological were included in the

biological on and after that commencement until the time the

biological is included in the Register under Part 3-2A.

Note:

Section 32DN deals with including the biological under Part 3-2A.

Pending applications

(3)

If:

(a) before the commencement of this section, an application was

made under this Chapter for the inclusion in the Register of

therapeutic goods that are a biological; and

(b) immediately before that commencement, the application was

not finally determined; and

commencement;

this Chapter continues to apply to the biological on and after that

commencement until the earliest of the following:

(d) the time the biological is included in the Register under

Part 3-2A;

(e) if the application is unsuccessful when it is finally

determined--the time the application is finally determined;

(f) the time the application is withdrawn;

(g) the time the application lapses.

Note:

Section 32DN deals with including the biological under Part 3-2A.

(4) For the purposes of this section, an application is finally

determined when the application, and any applications for review

or appeals arising out of it, have been finally determined or

otherwise disposed of.

Schedule 1 Biologicals

96 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Transitional

(5) This Chapter applies to a biological on and after the

commencement of this section in relation to things done, or

omitted to be done, in relation to the biological before the

commencement of this section.

(6) If this Chapter continues to apply to a biological during a period

described in subsection (2) or (3), then this Chapter also applies to

the biological after the end of that period in relation to things done,

or omitted to be done, in relation to the biological during that

period.

34 After paragraph 42DL(1)(f)

Insert:

(fa) that contains a statement referring to a biological, other than

a statement authorised or required by a government or

government authority (including a foreign government or

foreign government authority); or

35 Subsection 42V(7)

Omit "section 30", substitute "section 29D or 30, Division 6 or 7 of

Part 3-2A".

36 After subparagraph 46A(4)(a)(ii)

Insert:

(iiaaa) who is required to comply with a condition of an

exemption of biologicals under section 32CB; or

(iiaab) who has been granted an approval under subsection

32CK(1) or an authority under subsection 32CM(1); or

(iiaac) who has been granted an approval under subsection

32CO(1) or (2); or

37 After paragraph 53(b)

Insert:

(ba) inclusion of a biological in the Register; or

38 Section 53A (after table item 13)

Insert:

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 97

13A

subsection 32BA(1)

subsection 32BA(4)

13B

subsection 32BB(1)

subsection 32BB(4)

13C

subsection 32BC(1)

subsection 32BC(4)

13D

subsection 32BD(1)

subsection 32BD(4)

13E

subsection 32BI(1)

subsection 32BI(4)

13F

subsection 32CN(1)

subsection 32CN(4)

13G subsection

32DO(1) subsection

32DO(4)

13H

subsection 32EF(1)

subsection 32EF(4)

13J

subsection 32HC(1)

subsection 32HC(4)

13K

subsection 32JB(2)

subsection 32JB(5)

39 After paragraph 56A(1)(a)

Insert:

(aaaa) a person was not exempt under subsection 32CA(1) in

relation to a particular biological or there was no exemption

under subsection 32CA(2) in relation to a particular

biological; or

(aaab) there was no exemption in effect under section 32CB in

relation to a particular biological; or

40 After paragraph 56A(1)(b)

Insert:

(baa) there was no approval under subsection 32CK(1) or authority

under subsection 32CM(1) granted to a particular person in

relation to a particular biological; or

41 After paragraph 56A(1)(c)

Insert:

(ca) there was no approval under subsection 32CO(1) or (2)

granted to a particular person in relation to a particular

biological; or

42 After paragraph 56A(1)(e)

Insert:

(eaa) a particular biological was or was not included in the

43 Subsections 57(2) and (3)

Schedule 1 Biologicals

98 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

After "paragraph 19(1)(a)", insert ", 32CK(1)(d)".

44 Paragraph 57(5)(b)

After "paragraph 19(1)(a)", insert ", 32CK(1)(d)".

45 Subsections 57(6) and (7)

After "subsection 19(5)", insert ", 32CM(1)".

46 Subsection 57(8)

After "section 19A", insert "or 32CO".

47 After subsection 57(10)

Insert:

(10A) The power of the Minister under subsection 32CB(1) may be

delegated only to the Secretary.

48 Subsection 59(3)

Repeal the subsection.

49 Subsection 60(1) (after paragraph (c) of the definition of

initial decision)

Insert:

(ca) under Part 3-2A (Biologicals); or

50 Subsection 60A(1)

After "section 25", insert ", 32DF, 32DG".

51 After subsection 60A(6)

Insert:

(6AA)

If:

(a) the matter relates to a decision under section 32DF or 32DG;

and

(b) the Minister or the Tribunal remits the matter; and

Biologicals Schedule 1

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 99

evaluation fee that the appellant would have to pay under

section 32DI on making a new application for inclusion of

the biological in the Register;

the authorised delegate must make a decision whether or not to

include the biological in the Register, taking into account the initial

new information or later new information (or both), as the case

may be, as if a fresh application for inclusion of the biological in

the Register had been made.

52 Subsection 60A(7)

After "Part 3-2", insert ", 3-2A".

53 Subsection 60A(8) (after paragraph (a) of the definition of

authorised delegate)

Insert:

(aa) exercising a power to decide whether to include a biological

in the Register; or

54 Subsection 61(3A)

After "31B,", insert "32JE, 32JF, 32JG, 32JH,".

55 After paragraph 61(4)(b)

Insert:

(baa) decisions on the inclusion of biologicals in the Register, or

the suspension or cancellation of the inclusion of biologicals

in the Register; or

56 Subsection 61(10)

After "subsection 25(2E)", insert "(including as that subsection applies

because of subsection 32DE(2) or 32EB(3))".

57 After paragraph 63(2)(da)

Insert:

(daa) provide for the periods within which evaluations under

section 32DE in relation to specified biologicals or specified

classes of biologicals are to be completed; and

58 Application--licences

Schedule 1 Biologicals

100 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

The amendment made by item 31 applies in relation to licences granted

before, on or after the commencement of that item.

59 Transitional--exempt biologicals

(1)

This item applies in relation to a class of biologicals that, immediately

before the commencement of this item, was covered by an exemption of

the kind referred to in paragraph 18(1)(c) of the Therapeutic Goods Act

1989.

(2)

At the commencement of this item, there is taken to be an exemption

(the transitional exemption) in force under subsection 32CA(2) of that

Act covering that class of biologicals.

(3)

Subject to this item, the transitional exemption ceases to be in force at

the end of the period (the transitional period) of 3 years beginning on

the day this item commences.

(4) If:

(a) before the end of the period of 18 months beginning on the

day this item commences, a person makes an application in

accordance with section 32DA or 32DD of that Act to

include in the Register a biological included in that class; and

(b) before the end of the transitional period, the person has not

been notified of the Secretary's decision on the application;

the transitional exemption, in relation to that biological, continues in

force past the end of the transitional period until the person is notified

of the Secretary's decision on the application.

(5) If:

(a) before the end of the transitional period, a person makes an

application in accordance with section 32DA or 32DD of that

Act to include in the Register a biological included in that

class; and

(b) before the end of that period, the person is notified of the

Secretary's decision on the application;

the transitional exemption, in relation to that biological, ceases to be in

force immediately after that notification.

60 Transitional regulations

Schedule 2 Immunity from civil actions

102 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Schedule 2--Immunity from civil actions

Therapeutic Goods Act 1989

1 Subsection 18A(12)

Repeal the subsection (not including the note).

2 Subsection 19(8)

Repeal the subsection.

3 Subsection 25(1)

Omit "the goods are to be evaluated for registration", substitute "the

Secretary must evaluate the goods for registration".

4 Subsection 25(4A)

Repeal the subsection.

5 Subsection 25(6)

Repeal the subsection.

6 Subsection 25A(4)

Repeal the subsection.

7 Subsection 26(1B)

Repeal the subsection.

8 Subsection 26A(1B)

Repeal the subsection.

9 Subsection 41ED(1)

Omit "(1)".

10 Subsection 41ED(2)

Repeal the subsection.

11 Section 41GX

Repeal the section.

Immunity from civil actions Schedule 2

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 103

12 Subsection 41HC(6)

Repeal the subsection.

13 Subsection 61(9)

Repeal the subsection.

14 After section 61

Insert:

61A Immunity from civil actions

(1) No civil action, suit or proceeding lies against:

(a) the Commonwealth; or

(b)

protected

person;

in respect of loss, damage or injury of any kind suffered by another

person as a result of anything done, or omitted to be done, by a

protected person in relation to the performance or purported

performance, or in relation to the exercise or purported exercise, of

a protected person's functions, duties or powers under this Act or

the regulations.

(2) Subsection (1) does not apply to an act or omission in bad faith.

(3) A reference in subsection (1) to anything omitted to be done

includes a reference to a failure to make a decision.

(4) In this section:

protected person means any of the following:

(a)

the

Minister;

(b)

the

Secretary;

subsection 57(1);

(d) a member of a committee established under this Act or the

regulations;

(e) an authorised person in relation to a provision of this Act

(other than this section);

(f) an authorised officer (within the meaning of the regulations);

(g) an authorised person (within the meaning of the regulations);

Schedule 2 Immunity from civil actions

104 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(h) a person assisting a person (a primary person) referred to in

paragraph (a), (b), (c), (d), (e), (f) or (g) in relation to the

performance or purported performance, or in relation to the

exercise or purported exercise, of a primary person's

functions, duties or powers under this Act or the regulations.

15 Application

The amendment made by item 14 applies in relation to anything done or

omitted to be done on or after the commencement of that item.

16 Saving

Despite the repeal of provisions of the Therapeutic Goods Act 1989

made by items 1, 2, 4 to 8 and 10 to 13, those provisions (as in force

immediately before the commencement of those items) continue to

apply on and after that commencement in relation to anything done or

omitted to be done before that commencement.

Recall of therapeutic goods Schedule 3

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 105

Schedule 3--Recall of therapeutic goods

Therapeutic Goods Act 1989

1 Subsection 30EA(1) (after table item 5)

Insert:

5A.

The goods are supplied while they are

registered goods or listed goods, but it appears

to the Secretary that the quality, safety or

efficacy of the goods is unacceptable or that the

presentation of the goods is unacceptable

The person in relation to

whom the goods are

included in the Register

2 Subsection 41KA(1) (after table item 5A)

Insert:

5B.

It is supplied while it is included in the

the quality, safety or performance of medical

devices of that kind is unacceptable

The person in relation to

whom the kind of medical

device is included in the

3 Application

The amendments made by items 1 and 2 apply in relation to therapeutic

goods, and kinds of medical devices, included in the Register before, on

or after the commencement of those items.

Schedule 4 Information gathering

106 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Schedule 4--Information gathering

Therapeutic Goods Act 1989

1 Subsection 31(1)

Omit "person who is an applicant for the registration of therapeutic

goods or in relation to whom therapeutic goods are registered, require

the person to give to the Secretary, within such reasonable time as is

specified in the notice and in such form as is specified in the notice,

information or documents relating to one or more of the following:",

substitute:

person:

(aa) who is an applicant for the registration of therapeutic goods;

(ab) in relation to whom therapeutic goods are registered; or

(ac) in relation to whom therapeutic goods were, at any time

during the previous 5 years, registered;

require the person to give to the Secretary, within such reasonable

time as is specified in the notice and in such form as is specified in

the notice, information or documents relating to one or more of the

following:

2 After subsection 31(1)

Insert:

(1A) If a notice is given under subsection (1) to a person covered by

paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to

which they are relevant) apply in relation to that part of the period

of 5 years before the notice was given during which the therapeutic

goods were registered.

3 Subsection 31(2)

Omit "person who is an applicant for the listing of therapeutic goods or

in relation to whom therapeutic goods are listed, require the person to

give to the Secretary, within such reasonable time as is specified in the

notice, information or documents relating to one or more of the

following:", substitute:

person:

Information gathering Schedule 4

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 107

(aa) who is an applicant for the listing of therapeutic goods; or

(ab) in relation to whom therapeutic goods are listed; or

(ac) in relation to whom therapeutic goods were, at any time

during the previous 5 years, listed;

require the person to give to the Secretary, within such reasonable

time as is specified in the notice and in such form as is specified in

the notice, information or documents relating to one or more of the

following:

4 After subsection 31(2)

Insert:

(2A) If a notice is given under subsection (2) to a person covered by

paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to

which they are relevant) apply in relation to that part of the period

of 5 years before the notice was given during which the therapeutic

goods were listed.

5 Subsection 31(4)

Repeal the subsection, substitute:

(4) A person commits an offence if:

(a) the person is given a notice under this section; and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

6 Application

(1)

The amendments made by items 1 to 5 apply in relation to notices given

on or after the commencement of those items.

(2)

Paragraphs 31(1)(ac) and (2)(ac) of the Therapeutic Goods Act 1989, as

inserted by this Act, apply in relation to the registration or listing of

therapeutic goods occurring before, on or after the commencement of

this item.

Schedule 5 Unpaid annual charges

108 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

Schedule 5--Unpaid annual charges

Therapeutic Goods Act 1989

1 After section 44A

Insert:

44B Recovery of unpaid charges

An amount of an annual registration charge, an annual listing

charge, an annual charge for inclusion in the Register or an annual

licensing charge that remains unpaid at the end of the period of 28

days after the day on which the charge becomes payable may be

recovered by the Commonwealth as a debt due to the

Commonwealth.

Note:

Section 44 sets out the day on which a charge becomes payable.

2 Application

The amendment made by item 1 applies in relation to an annual

registration charge, an annual listing charge, an annual charge for

inclusion in the Register or an annual licensing charge that becomes

payable on or after the day on which that item commences.

Other amendments Schedule 6

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 109

Schedule 6--Other amendments

Therapeutic Goods Act 1989

1 Subsection 3(1) (paragraph (e) of the definition of

therapeutic goods)

Omit "prescribed standard in the Australia New Zealand Food

Standards Code as defined in subsection 3(1) of the Australia New

Zealand Food Authority Act 1991", substitute "standard (within the

meaning of subsection 4(1) of the Food Standards Australia New

Zealand Act 1991)".

2 Subsection 3(1) (paragraph (f) of the definition of

therapeutic goods)

After "goods", insert "(other than goods declared to be therapeutic

goods under an order in force under section 7)".

3 At the end of subsection 28(3A)

Add "A request must be accompanied by the prescribed fee.".

4 Paragraph 42DL(1)(f)

Omit "refers", substitute "contains a statement referring".

5 Paragraph 42DL(1)(f)

Omit "Poisons Standard", substitute "current Poisons Standard, other

than a statement authorised or required by a government or government

authority (including a foreign government or foreign government

authority)".

6 Paragraphs 42DL(2)(c) and (3)(b)

Omit "Poisons Standard", substitute "current Poisons Standard".

7 After paragraph 57(1)(c)

Insert:

or (d) a person seconded to the Department from:

(i) an authority of a State or a Territory that has functions

relating to therapeutic goods, health or law enforcement;

Schedule 6 Other amendments

110 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

(ii) a national regulatory authority of a foreign country that

has national responsibility relating to therapeutic goods,

health or law enforcement; or

(iii) an international organisation that has a function relating

to therapeutic goods, health or law enforcement;

8 Subsection 60A(2)

Omit "new information", substitute "initial new information".

9 Subsection 60A(3)

Omit "new information", substitute "initial new information or later

new information (or both)".

10 Subsection 60A(4)

Repeal the subsection, substitute:

(4)

If:

(a) the appellant applies to the Administrative Appeals Tribunal

for review of the decision on reconsideration and lodges

initial new information in support of that application; and

(b) the appellant does not lodge later new information in support

of that application;

the Tribunal must not remit the matter under subsection (3) if all of

the initial new information is information that the Minister took

into account under paragraph (2)(a) in making the decision on

reconsideration.

11 Paragraph 60A(5)(a)

Omit "new information", substitute "initial new information or later

new information (or both)".

12 Paragraph 60A(5)(c)

Omit "new information", substitute "initial new information".

13 Paragraph 60A(5)(d)

Omit "new information" (wherever occurring), substitute "initial new

information".

14 At the end of subsection 60A(5)

Add:

Other amendments Schedule 6

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009 111

; and (e) must not consider any later new information, except later

new information that indicates that the quality, safety or

efficacy of the therapeutic goods is unacceptable.

15 Subsections 60A(6) and (6A)

Omit "new information", substitute "initial new information or later

new information (or both), as the case may be".

16 Subsection 60A(8) (definition of authorised delegate)

Repeal the definition, substitute:

authorised delegate means a delegate of the Secretary:

(a) exercising a power to decide whether to register therapeutic

goods; or

(b) exercising a power to decide whether to issue a conformity

assessment certificate.

17 Subsection 60A(8)

Insert:

initial new information means information that:

(a) was in existence at the time the decision referred to in

subsection (1) was made; and

(b) was not made available to the Secretary or authorised

delegate for the purpose of making that decision; and

and includes any opinions that are wholly or substantially based on

such information (whether the opinions were formed before or

after that decision was made).

18 Subsection 60A(8)

Insert:

later new information means information that:

(a) was in existence at the time the decision on reconsideration

was made; and

(b) was not made available to the Minister or delegate of the

Minister for the purpose of making that decision; and

Schedule 6 Other amendments

112 Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 No. , 2009

and includes any opinions that are wholly or substantially based on

such information (whether the opinions were formed before or

after that decision was made).

19 Subsection 60A(8) (definition of new information)

Repeal the definition.

20 Application

(1)

The amendment made by item 3 applies in relation to requests made on

or after the commencement of that item.

(2)

The amendments made by items 4 and 5 apply in relation to

advertisements published or broadcast on or after the commencement of

those items.

(3)

The amendments made by items 8 to 15 and 17 to 19 apply in relation

to requests made to the Minister to reconsider decisions, where the

requests are made on or after the commencement of those items

(regardless of whether the decisions were made before, on or after that

commencement).

Commonwealth of Australia Bills

THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 3) BILL 2009