THERAPEUTIC GOODS AMENDMENT (2016 MEASURES NO. 1) BILL 2016

2016

The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Therapeutic Goods Amendment (2016

Measures No. 1) Bill 2016

No. , 2016

(Health and Aged Care)

A Bill for an Act to amend the Therapeutic Goods

Act 1989, and for related purposes

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Contents

Short title ........................................................................................... 1

Commencement ................................................................................. 1

Schedules ........................................................................................... 2

Schedule 1--Variation of entries in Register

Therapeutic Goods Act 1989

Schedule 2--Conformity assessment of medical devices

Therapeutic Goods Act 1989

Schedule 3--Exemptions

A New Tax System (Goods and Services Tax) Act 1999

Therapeutic Goods Act 1989

Schedule 4--Committees

Therapeutic Goods Act 1989

Schedule 5--Permissible ingredients

Therapeutic Goods Act 1989

Schedule 6--Approval of therapeutic goods, biologicals and

medical devices

Therapeutic Goods Act 1989

Schedule 7--Time limits

Therapeutic Goods Act 1989

Schedule 8--Record-keeping etc.

Therapeutic Goods Act 1989

Schedule 9--Applications for variations of entries in Register

Therapeutic Goods Act 1989

Schedule 10--Public notification and recalls

Therapeutic Goods Act 1989

Schedule 11--Obtaining information etc.

Therapeutic Goods Act 1989

Schedule 12--Miscellaneous amendments

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

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 is the Therapeutic Goods Amendment (2016 Measures

No. 1) Act 2016.

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.

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. Sections 1 to 3

and anything in

this Act not

elsewhere covered

by this table

The day this Act receives the Royal Assent.

2. Schedule 1

A single day to be fixed by Proclamation.

However, if the provisions do not commence

within the period of 6 months beginning on

the day this Act receives the Royal Assent,

they commence on the day after the end of

that period.

3. Schedules 2 to

The day after this Act receives the Royal

Assent.

4. Schedule 9

A single day to be fixed by Proclamation.

However, if the provisions do not commence

within the period of 6 months beginning on

the day this Act receives the Royal Assent,

they commence on the day after the end of

that period.

5. Schedules 10

to 12

The day after this Act receives the Royal

Assent.

Note:

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

enacted. It will not be amended to deal with any later amendments of

this Act.

(2) Any information in column 3 of the table is not part of this Act.

Information may be inserted in this column, or information in it

may be edited, in any published version of this Act.

3 Schedules

Legislation 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.

Variation of entries in Register Schedule 1

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Schedule 1--Variation of entries in Register

Therapeutic Goods Act 1989

1 Before subsection 9D(3)

Insert:

(2C) If:

(a) the person in relation to whom therapeutic goods are

registered or listed has requested the Secretary to vary the

entry in the Register that relates to the goods; and

(b) the variation is of a kind specified in the regulations; and

satisfied;

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

2 After paragraph 9D(3)(b)

Insert:

(ba) subsection (2C) does not apply to the request; and

3 Before subsection 9D(3A)

Insert:

(3AC) If:

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

(b) the variation is of a kind specified in the regulations; and

satisfied;

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

4 After paragraph 9D(3A)(aa)

Insert:

(ab) subsection (3AC) does not apply to the request; and

5 Before subsection 9D(3D)

Insert:

Schedule 1 Variation of entries in Register

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(3CB) If:

(a) the person in relation to whom a kind of medical device is

included in the Register has requested the Secretary to vary

the entry in the Register that relates to the kind of medical

device; and

(b) the variation is of a kind specified in the regulations; and

satisfied;

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

6 After paragraph 9D(3D)(b)

Insert:

(ba) subsection (3CB) does not apply to the request; and

Conformity assessment of medical devices Schedule 2

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Schedule 2--Conformity assessment of

medical devices

Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

Australian conformity assessment body means an Australian

corporation that is the subject of a conformity assessment body

determination made under the regulations.

Australian corporation means a corporation that is registered

under Part 2A.2 of the Corporations Act 2001.

2 Subsection 3(1) (paragraph (a) of the definition of

authorised person)

After "this Act", insert "or the regulations".

3 Subsection 3(1)

Insert:

certification-related activities, when used in relation to an

Australian conformity assessment body, means activities that

consist of, or relate to, the issue of certificates as mentioned in

section 41FIA.

conformity assessment body determination has the meaning given

by section 41EWA.

4 After Part 4-4

Insert:

Schedule 2 Conformity assessment of medical devices

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

Part 4-4A--Australian conformity assessment

bodies

41EWA Conformity assessment body determinations

(1) The regulations may make provision for and in relation to

empowering the Secretary to make conformity assessment body

determinations.

(2) A conformity assessment body determination is a determination

that a specified Australian corporation is an Australian conformity

assessment body for the purposes of this Act.

(3) The regulations may make provision for and in relation to the

following matters:

(a) applications for conformity assessment body determinations;

(b) the approval by the Secretary of a form for such an

application;

(d) the application fee for such an application;

(e) the lapsing of such an application;

(f) the assessment by the Secretary of whether a conformity

assessment body determination should be made in response

to such an application;

(g) the assessment fee for such an assessment;

(h) the duration of conformity assessment body determinations.

(4) A conformity assessment body determination:

(a) may be of general application; or

(b) may be limited to either or both of the following:

(i) one or more specified kinds of medical devices;

(ii) one or more specified kinds of conformity assessment

procedures.

(5) The regulations may provide that a conformity assessment body

determination is subject to:

(a) the conditions prescribed by the regulations; and

(b) such other conditions (if any) as are specified in the

determination.

Conformity assessment of medical devices Schedule 2

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(6) The following are examples of conditions that may be prescribed:

(a) a condition that the body will allow an authorised person:

(i) to enter, at any reasonable time, premises used by the

body to carry on certification-related activities; and

(ii) while on those premises, to inspect those premises and

anything on those premises that concerns

certification-related activities carried on by the body;

and

(iii) while on those premises, to make any still or moving

image or any recording of those premises or anything on

those premises that concerns certification-related

activities carried on by the body; and

(iv) while on those premises, to inspect, and make copies of,

any documents that concern certification-related

activities carried on by the body;

(b) a condition that the body will, if requested to do so by the

Secretary, give the Secretary information, or produce to the

Secretary documents, that concern certification-related

activities carried on by the body.

(7) The regulations may make provision for and in relation to

empowering the Secretary to revoke or vary a conformity

assessment body determination.

(8) Subsections (3) to (7) do not limit subsection (1).

(9) The express references in this section to the Secretary do not, by

implication, prevent the regulations from empowering the

Secretary to delegate any or all of the Secretary's functions or

powers under regulations made for the purposes of this section.

(10) If a conformity assessment body determination is in force under the

regulations, the determination must be published on the

Department's website.

(11) A conformity assessment body determination made under the

regulations is not a legislative instrument.

(12) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not

apply to the specification of an Australian corporation in a

conformity assessment body determination.

Schedule 2 Conformity assessment of medical devices

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

Note:

Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with

specification by class.

5 After section 41FI

Insert:

41FIA Certificates issued by Australian conformity assessment

bodies

(1) If:

(a) a section 41FC application is made for a kind of medical

device to be included in the Register; and

(b) the application has been selected for audit; and

conformity assessment body to the effect that the body is

satisfied that devices of that kind comply with the essential

principles; and

(d) the certificate was issued under a contract between the person

and the body; and

(e) the certificate has been given to the Secretary;

then, in auditing the application, the Secretary may have regard to

the certificate.

(2) If:

(a) a section 41FC application is made for a kind of medical

device to be included in the Register; and

(b) the application has been selected for audit; and

conformity assessment body to the effect that the body is

satisfied that an appropriate conformity assessment procedure

has been applied to devices of that kind; and

(d) the certificate was issued under a contract between the person

and the body; and

(e) the certificate has been given to the Secretary;

then, in auditing the application, the Secretary may have regard to

the certificate.

(3) If a conformity assessment body determination that relates to an

Australian conformity assessment body is limited to one or more

specified kinds of medical devices, subsection (1) does not apply to

Conformity assessment of medical devices Schedule 2

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

a certificate issued by the body unless the certificate relates to one

of those kinds of medical devices.

(4) If a conformity assessment body determination that relates to an

Australian conformity assessment body is limited to one or more

specified kinds of conformity assessment procedures,

subsection (2) does not apply to a certificate issued by the body

unless the certificate relates to one of those kinds of conformity

assessment procedures.

(5) This section does not, by implication, limit the matters to which the

Secretary may have regard.

Schedule 3 Exemptions

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Schedule 3--Exemptions

A New Tax System (Goods and Services Tax) Act 1999

1 After paragraph 38-50(6)(b)

Insert:

(ba) the supply of the drug or medicinal preparation is authorised

by rules under subsection 19(7A) of that Act; or

Therapeutic Goods Act 1989

2 Subsection 3(1)

Insert:

health practitioner means a person who, under a law of a State or

internal Territory, is registered or licensed to practice in any of the

following health professions:

(a) Aboriginal and Torres Strait Islander health practice;

(b) dental (not including the professions of dental therapist,

dental hygienist, dental prosthetist or oral health therapist);

(d) medical radiation practice;

(e) nursing;

(f) midwifery;

(g) occupational therapy;

(h) optometry;

(i) pharmacy;

(j) physiotherapy;

(k) podiatry;

(l) psychology.

3 Section 19 (heading)

Repeal the heading, substitute:

Exemptions Schedule 3

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

19 Exemptions for certain uses

4 After subsection 19(7)

Insert:

(7A) The Minister may, by legislative instrument, make rules

authorising any health practitioner who is included in a specified

class of health practitioners to supply:

(a) specified therapeutic goods for use in the treatment of

humans; or

(b) a specified class of such goods;

to the class or classes of recipients specified in those rules, so long

as:

rules; and

(d) the conditions (if any) specified in those rules are satisfied.

(7B) In making rules under subsection (7A), the Minister must comply

with:

(a) such requirements (if any) as are prescribed by the

regulations; and

(b) such restrictions (if any) as are prescribed by the regulations;

and

(7C) If:

(a) a person is authorised, by subsection (7A) rules, to supply

therapeutic goods; and

(b) the person supplies those goods in accordance with those

rules;

the person must:

(d) do so within 28 days after the supply.

(7D) A notification under subsection (7C) must:

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

the Secretary; and

(b) contain such information as is prescribed by the regulations.

Schedule 3 Exemptions

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

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(7E) An approval of a form may require or permit information 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.

(7F) A person commits an offence if:

(a) the person is subject to a requirement under subsection (7C);

and

(b) the person omits to do an act; and

Penalty: 10 penalty units.

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

Note:

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

(7H) In recommending to the Governor-General that regulations should

be made for the purposes of paragraph (7D)(b), the Minister must

have regard to the principle that information should only be

prescribed for the purposes of that paragraph if the information is

reasonably required for the responsible scrutiny by the Secretary of

the operation of the scheme embodied in subsection (7A).

5 After subsection 21A(11)

Insert:

(11A) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 19(7A) rules; and

(i) therapeutic goods specified in those rules; or

(ii) therapeutic goods included in a class of therapeutic

goods specified in those rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules; and

Exemptions Schedule 3

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(e) either:

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

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

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

because:

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

(ii) the supply is not in the circumstances specified in those

rules; or

(iii) the supply is not in accordance with the conditions

specified in those rules.

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

(11B) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 19(7A) rules; and

(i) therapeutic goods specified in those rules; or

(ii) therapeutic goods included in a class of therapeutic

goods specified in those rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules; and

(e) the use of the goods, if goods were used, would be likely to

result in harm or injury to any person; and

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

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

(ii) the supply is not in the circumstances specified in those

rules; or

(iii) the supply is not in accordance with the conditions

specified in those rules.

Penalty: 2,000 penalty units.

Schedule 3 Exemptions

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(11C) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 19(7A) rules; and

(i) therapeutic goods specified in those rules; or

(ii) therapeutic goods included in a class of therapeutic

goods specified in those rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules.

Penalty: 500 penalty units.

6 After subsection 31B(3)

Insert:

Authority under subsection 19(7A) rules

(3A) If a person is authorised, by subsection 19(7A) rules, to supply

therapeutic goods, the Secretary may give the person a written

notice requiring the person to give the Secretary specified

information or documents relating to one or more of the following:

(a) the supply of the goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to goods of that kind.

7 Subsections 31B(4) and (5)

Omit "or (3)", substitute ", (3) or (3A)".

8 Subparagraphs 32BD(1)(b)(v), (2)(b)(v) and (4)(b)(v)

Omit "that is held", substitute "or (7A) that covers the supply of the

biological".

Exemptions Schedule 3

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

9 Subparagraph 32BF(4)(b)(v)

Omit "that is held", substitute "or (7A) that covers the supply of the

biological".

10 Subdivision D of Division 3 of Part 3-2A (heading)

Repeal the heading, substitute:

Subdivision D--Exempting biologicals for certain uses

11 Section 32CM (heading)

Repeal the heading, substitute:

32CM Exemptions for health practitioners

12 After subsection 32CM(7)

Insert:

(7A) The Minister may, by legislative instrument, make rules

authorising any health practitioner who is included in a specified

class of health practitioners to supply a specified biological, for use

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

specified in those rules, so long as:

(a) the biological is supplied in the circumstances specified in

those rules; and

(b) the conditions (if any) specified in those rules are satisfied.

(7B) In making rules under subsection (7A), the Minister must comply

with:

(a) such requirements (if any) as are prescribed by the

regulations; and

(b) such restrictions (if any) as are prescribed by the regulations;

and

(7C) If:

(a) a person is authorised, by subsection (7A) rules, to supply a

biological; and

(b) the person supplies the biological in accordance with those

rules;

the person must:

Schedule 3 Exemptions

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(d) do so within 28 days after the supply.

(7D) A notification under subsection (7C) must:

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

the Secretary; and

(b) contain such information as is prescribed by the regulations.

(7E) An approval of a form may require or permit information 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.

(7F) A person commits an offence if:

(a) the person is subject to a requirement under subsection (7C);

and

(b) the person omits to do an act; and

Penalty: 10 penalty units.

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

Note:

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

(7H) In recommending to the Governor-General that regulations should

be made for the purposes of paragraph (7D)(b), the Minister must

have regard to the principle that information should only be

prescribed for the purposes of that paragraph if the information is

reasonably required for the responsible scrutiny by the Secretary of

the operation of the scheme embodied in subsection (7A).

13 Section 32CN (heading)

Repeal the heading, substitute:

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

health practitioner

14 Subsection 32CN(4) (penalty)

Omit "for contravention of this subsection".

Exemptions Schedule 3

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

15 At the end of section 32CN

Add:

(5) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 32CM(7A) rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules; and

(e) 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

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

because:

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

(ii) the supply is not in the circumstances specified in those

rules; or

(iii) the supply is not in accordance with the conditions

specified in those rules.

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

(6) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 32CM(7A) rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

Schedule 3 Exemptions

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(iii) the supply is not in accordance with the conditions

specified in those rules; and

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

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

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

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

(ii) the supply is not in the circumstances specified in those

rules; or

(iii) the supply is not in accordance with the conditions

specified in those rules.

Penalty: 2,000 penalty units.

(7) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 32CM(7A) rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules.

Penalty for contravention of this subsection: 500 penalty units.

16 After subsection 32JG(3)

Insert:

Authority under subsection 32CM(7A) rules

(3A) If a person is authorised, by subsection 32CM(7A) rules, to supply

a biological, the Secretary may give the person a written notice

requiring the person to give 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;

Exemptions Schedule 3

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(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.

17 Subsection 32JG(4)

Omit "or (3)", substitute ", (3) or (3A)".

18 Section 41H

Omit "particular medical practitioners", substitute "health

practitioners".

19 Section 41HC (heading)

Repeal the heading, substitute:

41HC Exemptions for health practitioners

20 Subsection 41HC(2)

After "An authority", insert "under subsection (1)".

21 Subsection 41HC(3)

Omit "a person's authority", substitute "the authority given to a person

under subsection (1)".

22 Subsection 41HC(4)

After "authority", insert "under subsection (1)".

23 At the end of subsection 41HC(5)

Add "under subsection (1)".

24 After subsection 41HC(5)

Insert:

(6) The Minister may, by legislative instrument, make rules

authorising any health practitioner who is included in a specified

class of health practitioners to supply a specified kind of medical

device, for use in the treatment of humans, to the class or classes of

recipients specified in those rules, so long as:

Schedule 3 Exemptions

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(a) that kind of medical device is supplied in the circumstances

specified in those rules; and

(b) the conditions (if any) specified in those rules are satisfied.

(6A) In making rules under subsection (6), the Minister must comply

with:

(a) such requirements (if any) as are prescribed by the

regulations; and

(b) such restrictions (if any) as are prescribed by the regulations;

and

(6B) If:

(a) a person is authorised, by subsection (6) rules, to supply a

specified kind of medical device; and

(b) the person supplies a medical device of that kind in

accordance with those rules;

the person must:

(d) do so within 28 days after the supply.

(6C) A notification under subsection (6B) must:

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

the Secretary; and

(b) contain such information as is prescribed by the regulations.

(6D) An approval of a form may require or permit information 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.

(6E) A person commits an offence if:

(a) the person is subject to a requirement under subsection (6B);

and

(b) the person omits to do an act; and

Penalty: 10 penalty units.

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

Note:

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

Exemptions Schedule 3

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(6G) In recommending to the Governor-General that regulations should

be made for the purposes of paragraph (6C)(b), the Minister must

have regard to the principle that information should only be

prescribed for the purposes of that paragraph if the information is

reasonably required for the responsible scrutiny by the Secretary of

the operation of the scheme embodied in subsection (6).

25 Section 41JF (heading)

Repeal the heading, substitute:

41JF Secretary may require information relating to health

practitioner authorisations

26 Subsection 41JF(1)

Omit "section 41HC", substitute "subsection 41HC(1)".

27 After subsection 41JF(1)

Insert:

(1A) If a person is authorised, by subsection 41HC(6) rules, to supply a

specified kind of medical device, the Secretary may give the

person a written notice requiring the person to give the Secretary

specified information or documents relating to one or more of the

following:

(a) the supply of devices of that kind;

(b) the handling of devices of that kind;

(d) the results of the supply of devices of that kind;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to devices of that kind.

28 Subsection 41JF(2)

Omit "The notice", substitute "A notice under subsection (1) or (1A)".

29 Subsection 41JF(3)

Omit "The notice", substitute "A notice under subsection (1) or (1A)".

30 Paragraphs 41MO(1)(a), (2)(a) and (4)(a)

Omit "section 41HC", substitute "subsection 41HC(1)".

Schedule 3 Exemptions

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

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31 After subsection 41MO(4)

Insert:

(4A) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 41HC(6) rules; and

those rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules; and

(e) either:

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

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

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

because:

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

(ii) the supply is not in the circumstances specified in those

rules; or

(iii) the supply is not in accordance with the conditions

specified in those rules.

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

(4B) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 41HC(6) rules; and

those rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

Exemptions Schedule 3

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules; and

(e) the use of the device, if the device were used, would be likely

to result in harm or injury to any person; and

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

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

(ii) the supply is not in the circumstances specified in those

rules; or

(iii) the supply is not in accordance with the conditions

specified in those rules.

Penalty: 2,000 penalty units.

(4C) A person commits an offence if:

(a) the person is a health practitioner; and

(b) the person is included in a class of health practitioners

specified in subsection 41HC(6) rules; and

those rules; and

(d) any of the following applies:

(i) the supply is not in accordance with those rules;

(ii) the supply is not in the circumstances specified in those

rules;

(iii) the supply is not in accordance with the conditions

specified in those rules.

Penalty: 500 penalty units.

32 Section 53A (after table item 8)

Insert:

subsection 21A(11A)

subsection 21A(11C)

33 Section 53A (after table item 13F)

Insert:

13FA

subsection 32CN(5)

subsection 32CN(7)

Schedule 3 Exemptions

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

34 Section 53A (after table item 32)

Insert:

32A

subsection 41MO(4A)

subsection 41MO(4C)

35 Paragraph 56A(1)(b)

After "approval", insert "under subsection 19(1)".

36 Paragraph 56A(1)(b)

Omit "section 19", substitute "subsection 19(5)".

37 Paragraph 56A(1)(ba)

Omit "41HC", substitute "subsection 41HC(1)".

Schedule 5 Permissible ingredients

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

Schedule 5--Permissible ingredients

Therapeutic Goods Act 1989

1 Section 26BD

Repeal the section.

2 Before section 26C

Insert:

26BE Variation of section 26BB determination--application by

person

(1) A person may apply to the Secretary for a recommendation that the

Minister vary a section 26BB determination.

(2) An application under subsection (1) must:

(a) be made in accordance with a form approved, in writing, by

the Secretary; and

(b) set out the recommendation sought; and

form; and

(d) be accompanied by the prescribed application fee (if any).

Decision by Secretary whether to make recommendation

(3) If:

(a) an application is made under subsection (1); and

(b) any applicable prescribed evaluation fee has been paid;

the Secretary must carry out an evaluation of whether to make the

recommendation.

(4) After carrying out the evaluation, the Secretary must:

(a) make the recommendation; or

(b) refuse to make the recommendation.

(5) In deciding whether to make the recommendation, the Secretary

must have regard to:

(a) the quality and safety of the ingredients concerned; and

Permissible ingredients Schedule 5

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

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

relevant.

Minister may vary determination

(6) If the Secretary makes a recommendation under paragraph (4)(a),

the Minister must:

(a) by legislative instrument, vary the section 26BB

determination; or

(b) refuse to vary the section 26BB determination.

(7) In making a decision under subsection (6), the Minister must have

regard to:

(a) the recommendation made under paragraph (4)(a); and

(b) such other matters (if any) as the Minister considers relevant.

Further information

(8) The Secretary may, by written notice given to a person who has

made an application under subsection (1), require the person to:

(a) give the Secretary such further information in connection

with the application as is specified in the notice; and

(b) do so within such reasonable time as is specified in the

notice.

Applications or information may be given electronically

(9) An approval of a form mentioned in paragraph (2)(a), or a notice

mentioned in subsection (8), may require or permit an application

or information 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.

3 After subsection 60(2A)

Insert:

(2B) If the Secretary decides, under paragraph 26BE(4)(b), to refuse to

make a recommendation, a person is not entitled to request the

Minister to reconsider the decision unless the person made an

application under subsection 26BE(1) for the recommendation.

Schedule 5 Permissible ingredients

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

4 Transitional provisions

(1)

If:

(a) an application was made under subsection 26BD(1) of the

Therapeutic Goods Act 1989 before the commencement of

this item; and

(b) no decision was made on the application before that

commencement;

then, despite the repeal of section 26BD of the Therapeutic Goods Act

1989 by this Schedule, that section continues to apply, in relation to:

(d) a variation of a determination in response to the application;

as if that repeal had not happened.

(2)

The repeal of section 26BD of the Therapeutic Goods Act 1989 by this

Schedule does not affect the continuity of a variation made under that

section before the commencement of this item.

Approval of therapeutic goods, biologicals and medical devices Schedule 6

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Schedule 6--Approval of therapeutic goods,

biologicals and medical devices

Therapeutic Goods Act 1989

1 After section 25

Insert:

25AAA Therapeutic goods (priority applicant) determinations

(1) The regulations may make provision for and in relation to

empowering the Secretary to make therapeutic goods (priority

applicant) determinations.

(2) A therapeutic goods (priority applicant) determination is a

determination that, for the purposes of this Act, a specified person

is a priority applicant in relation to any section 23 application that

may be made by the person for the registration of therapeutic

goods specified in the determination.

(3) The regulations may make provision for and in relation to the

following matters:

(a) applications for therapeutic goods (priority applicant)

determinations;

(b) the approval by the Secretary of a form for such an

application;

(d) the application fee for such an application.

(4) The regulations may make provision for and in relation to the

following matters:

(a) empowering the Secretary to revoke a therapeutic goods

(priority applicant) determination;

(b) the consequences of the revocation of a therapeutic goods

(priority applicant) determination.

(5) Subsections (3) and (4) do not limit subsection (1).

(6) A period prescribed under paragraph 63(2)(da) for the evaluation

of therapeutic goods covered by a section 23 application for which

Schedule 6 Approval of therapeutic goods, biologicals and medical devices

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

the applicant is a priority applicant may be shorter than the period

prescribed under that paragraph for the evaluation of therapeutic

goods covered by a section 23 application for which the applicant

is not a priority applicant.

(7) The regulations may provide that, if:

(a) a person is a priority applicant in relation to a section 23

application made by the person; and

(b) a decision is made on the application;

a statement setting out the decision may be published on the

Department's website.

(8) The express references in this section to the Secretary do not, by

implication, prevent the regulations from empowering the

Secretary to delegate any or all of the Secretary's functions or

powers under regulations made for the purposes of this section.

(9) If a therapeutic goods (priority applicant) determination is in force

under the regulations, the determination may be published on the

Department's website.

(10) A therapeutic goods (priority applicant) determination made under

the regulations is not a legislative instrument.

(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not

apply to the specification of a person in a therapeutic goods

(priority applicant) determination.

Note:

Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with

specification by class.

2 After section 32DE

Insert:

32DEA Biologicals (priority applicant) determinations

(1) The regulations may make provision for and in relation to

empowering the Secretary to make biologicals (priority applicant)

determinations.

(2) A biologicals (priority applicant) determination is a determination

that, for the purposes of this Act, a specified person is a priority

applicant in relation to any section 32DD application that may be

Approval of therapeutic goods, biologicals and medical devices Schedule 6

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

made by the person for the inclusion in the Register of a biological

specified in the determination.

(3) The regulations may make provision for and in relation to the

following matters:

(a) applications for biologicals (priority applicant)

determinations;

(b) the approval by the Secretary of a form for such an

application;

(d) the application fee for such an application.

(4) The regulations may make provision for and in relation to the

following matters:

(a) empowering the Secretary to revoke a biologicals (priority

applicant) determination;

(b) the consequences of the revocation of a biologicals (priority

applicant) determination.

(5) Subsections (3) and (4) do not limit subsection (1).

(6) A period prescribed under paragraph 63(2)(daa) for the evaluation

of a biological covered by a section 32DD application for which

the applicant is a priority applicant may be shorter than the period

prescribed under that paragraph for the evaluation of a biological

covered by a section 32DD application for which the applicant is

not a priority applicant.

(7) The regulations may provide that, if:

(a) a person is a priority applicant in relation to a section 32DD

application made by the person; and

(b) a decision is made on the application;

a statement setting out the decision may be published on the

Department's website.

(8) The express references in this section to the Secretary do not, by

implication, prevent the regulations from empowering the

Secretary to delegate any or all of the Secretary's functions or

powers under regulations made for the purposes of this section.

Schedule 6 Approval of therapeutic goods, biologicals and medical devices

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(9) If a biologicals (priority applicant) determination is in force under

the regulations, the determination may be published on the

Department's website.

(10) A biologicals (priority applicant) determination made under the

regulations is not a legislative instrument.

(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not

apply to the specification of a person in a biologicals (priority

applicant) determination.

Note:

Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with

specification by class.

3 After section 41EC

Insert:

41ECA Conformity assessment (priority applicant) determinations

(1) The regulations may make provision for and in relation to

empowering the Secretary to make conformity assessment (priority

applicant) determinations.

(2) A conformity assessment (priority applicant) determination is a

determination that, for the purposes of this Act, a specified person

is a priority applicant in relation to any section 41EB application

that may be made by the person for a conformity assessment

certificate in relation to medical devices of a kind specified in the

determination.

(3) The regulations may make provision for and in relation to the

following matters:

(a) applications for conformity assessment (priority applicant)

determinations;

(b) the approval by the Secretary of a form for such an

application;

(d) the application fee for such an application.

(4) The regulations may make provision for and in relation to the

following matters:

(a) empowering the Secretary to revoke a conformity assessment

(priority applicant) determination;

Approval of therapeutic goods, biologicals and medical devices Schedule 6

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(b) the consequences of the revocation of a conformity

assessment (priority applicant) determination.

(5) Subsections (3) and (4) do not limit subsection (1).

(6) The regulations may make provision for and in relation to the

priority to be given by the Secretary to consideration of a

section 41EB application where the applicant is a priority

applicant.

(7) The regulations may provide that, if:

(a) a person is a priority applicant in relation to a section 41EB

application made by the person; and

(b) a decision is made on the application;

a statement setting out the decision may be published on the

Department's website.

(8) The express references in this section to the Secretary do not, by

implication, prevent the regulations from empowering the

Secretary to delegate any or all of the Secretary's functions or

powers under regulations made for the purposes of this section.

(9) If a conformity assessment (priority applicant) determination is in

force under the regulations, the determination may be published on

the Department's website.

(10) A conformity assessment (priority applicant) determination made

under the regulations is not a legislative instrument.

(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not

apply to the specification of a person in a conformity assessment

(priority applicant) determination.

Note:

Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with

specification by class.

4 Before section 41FL

Insert:

41FKA Medical devices (priority applicant) determinations

(1) The regulations may make provision for and in relation to

empowering the Secretary to make medical devices (priority

applicant) determinations.

Schedule 6 Approval of therapeutic goods, biologicals and medical devices

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(2) A medical devices (priority applicant) determination is a

determination that, for the purposes of this Act, a specified person

is a priority applicant in relation to any section 41FC application

that may be made by the person for the inclusion in the Register of

a medical device of a kind specified in the determination.

(3) The regulations may make provision for and in relation to the

following matters:

(a) applications for medical devices (priority applicant)

determinations;

(b) the approval by the Secretary of a form for such an

application;

(d) the application fee for such an application.

(4) The regulations may make provision for and in relation to the

following matters:

(a) empowering the Secretary to revoke a medical devices

(priority applicant) determination;

(b) the consequences of the revocation of a medical devices

(priority applicant) determination.

(5) Subsections (3) and (4) do not limit subsection (1).

(6) The regulations may make provision for and in relation to the

priority to be given by the Secretary to consideration of a

section 41FC application where the applicant is a priority

applicant.

(7) The regulations may provide that, if:

(a) a person is a priority applicant in relation to a section 41FC

application made by the person; and

(b) a decision is made on the application;

a statement setting out the decision may be published on the

Department's website.

(8) The express references in this section to the Secretary do not, by

implication, prevent the regulations from empowering the

Secretary to delegate any or all of the Secretary's functions or

powers under regulations made for the purposes of this section.

Approval of therapeutic goods, biologicals and medical devices Schedule 6

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(9) If a medical devices (priority applicant) determination is in force

under the regulations, the determination may be published on the

Department's website.

(10) A medical devices (priority applicant) determination made under

the regulations is not a legislative instrument.

(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not

apply to the specification of a person in a medical devices (priority

applicant) determination.

Note:

Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with

specification by class.

Schedule 7 Time limits

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

Schedule 7--Time limits

Therapeutic Goods Act 1989

1 After paragraph 63(2)(dd)

Insert:

(de) provide for the periods within which the performance of

specified functions conferred on the Secretary by this Act is

to be completed; and

(df) provide for the periods within which specified decisions

under this Act are to be made by the Secretary; and

Record-keeping etc. Schedule 8

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Schedule 8--Record-keeping etc.

Therapeutic Goods Act 1989

1 At the end of subparagraph 28(5)(a)(i)

Add ", complies with record-keeping requirements covered by

paragraph (c) or (ca), or keeps documents that relate to the subject

goods".

2 At the end of paragraph 28(5)(a)

Add:

(iv) while on those premises, to inspect, and make copies of,

any records kept in compliance with paragraph (c) or

(ca); and

(v) while on those premises, to inspect, and make copies of,

any documents that relate to the subject goods; and

3 After paragraph 28(5)(c)

Insert:

(ca) comply, in relation to the subject goods, with any

record-keeping requirements that are prescribed; and

4 Paragraph 28(5)(d)

Omit "such record", substitute "record kept in compliance with

paragraph (c) or (ca)".

5 Paragraph 46A(4)(a)

Omit all the words from and including "being" to and including "goods;

and", substitute:

being premises connected with:

(iv) the importation, export, manufacture or supply of

therapeutic goods; or

(v) the keeping of documents relating to the importation,

export, manufacture or supply of therapeutic goods; or

(vi) the keeping of records in compliance with

paragraph 28(5)(c) or (ca); and

Schedule 9 Applications for variations of entries in Register

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

Schedule 9--Applications for variations of

entries in Register

Therapeutic Goods Act 1989

1 At the end of subsection 9D(7)

Add:

; and (g) the request is accompanied by information that is:

(i) of a kind determined under subsection (8); and

(ii) in a form approved, in writing, by the Secretary.

2 At the end of section 9D

Add:

(8) The Secretary may, by legislative instrument, determine a kind of

information for the purposes of subparagraph (7)(g)(i).

Note:

See also subsection 33(3A) of the Acts Interpretation Act 1901.

3 Application of amendments

The amendments of section 9D of the Therapeutic Goods Act 1989

made by this Schedule apply in relation to requests made after the

commencement of this item.

Public notification and recalls Schedule 10

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Schedule 10--Public notification and recalls

Therapeutic Goods Act 1989

1 Division 2A of Part 3-2 (heading)

Repeal the heading, substitute:

Division 2A--Public notification, and recall, of therapeutic

goods

2 Section 30EA (heading)

Repeal the heading, substitute:

30EA Public notification, and recall, of therapeutic goods

3 Subsection 30EA(1) (table items 1, 2, 3 and 4, column

headed

"Circumstance relating to therapeutic goods")

After "but", insert "the Secretary is satisfied that".

4 Subsection 30EA(1) (table item 5, column headed

"Circumstance relating to therapeutic goods")

Omit ", 19D(1) or 42E(1) or section 42EA", substitute "or 19D(1)".

5 Subsection 30EA(1) (at the end of the table)

Add:

The goods are counterfeit (within

the meaning of section 42E)

The person supplying the goods

6 Paragraph 30EA(2)(a)

Omit "recover", substitute "recall".

7 After paragraph 30EA(2)(b)

Insert:

(ba) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, of specified information, or of information of a

specified kind, relating to either or both of the following:

Schedule 10 Public notification and recalls

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

(i) therapeutic goods;

(ii) the circumstances referred to in paragraph (1)(a) in

relation to therapeutic goods;

8 At the end of subsection 30EA(2)

Add:

; (d) to notify the Secretary, in the specified manner and within

such reasonable period as is specified, of specified

information, or of information of a specified kind, relating to

the persons to whom therapeutic goods have been supplied.

9 Subsection 30EA(4)

Omit "recover", substitute "recall".

10 Subsection 30EA(4)

Omit "recovered", substitute "recalled".

11 At the end of Division 2A of Part 3-2

Add:

30EE Saving of other laws

This Division is not intended to exclude or limit the operation of

any other law of the Commonwealth or any law of a State or

Territory.

12 Subsection 30F(2)

Omit "recover", substitute "recall".

13 Subsection 30F(2)

Omit "recovered", substitute "recalled".

14 Paragraph 30F(3)(a)

Omit "recover", substitute "recall".

15 At the end of section 30F

Add:

Public notification and recalls Schedule 10

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Saving of other laws

(7) This section is not intended to exclude or limit the operation of any

other law of the Commonwealth or any law of a State or Territory.

16 Section 32

Omit "recovery", substitute "recall".

17 Subsection 32CJ(2)

Omit "recover", substitute "recall".

18 Subsection 32CJ(2)

Omit "recovered", substitute "recalled".

19 Paragraph 32CJ(3)(a)

Omit "recover", substitute "recall".

20 At the end of section 32CJ

Add:

Saving of other laws

(12) This section is not intended to exclude or limit the operation of any

other law of the Commonwealth or any law of a State or Territory.

21 Division 8 of Part 3-2A (heading)

Repeal the heading, substitute:

Division 8--Public notification, and recall, of biologicals

22 Section 32H

Omit "recover", substitute "recall".

23 Section 32HA (heading)

Repeal the heading, substitute:

Schedule 10 Public notification and recalls

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

32HA Public notification, and recall, of biologicals

24 Subsection 32HA(1) (table item 1, column headed

"Circumstance relating to biological")

After "but", insert "the Secretary is satisfied that".

25 Subsection 32HA(1) (table item 2, column headed

"Circumstance relating to biological")

After "but", insert "the Secretary is satisfied that".

26 Subsection 32HA(1) (table item 3, column headed

"Circumstance relating to biological")

After "but", insert "the Secretary is satisfied that".

27 Subsection 32HA(1) (table item 4, column headed

"Circumstance relating to biological")

After "but", insert "the Secretary is satisfied that".

28 Subsection 32HA(1) (table item 7, column headed

"Circumstance relating to biological")

Omit "supplied in contravention of subsection 42E(1) or section 42EA",

substitute "counterfeit goods (within the meaning of section 42E)".

29 Subsection 32HA(1) (table item 8, column headed

"Circumstance relating to biological")

After "but", insert "the Secretary is satisfied that".

30 Paragraph 32HA(2)(a)

Omit "recover", substitute "recall".

31 After paragraph 32HA(2)(b)

Insert:

(ba) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, of specified information, or of information of a

specified kind, relating to either or both of the following:

(i) the biological;

(ii) the circumstances referred to in paragraph (1)(a);

Public notification and recalls Schedule 10

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

32 At the end of subsection 32HA(2)

Add:

; (d) to notify the Secretary, in the specified manner and within

such reasonable period as is specified, of specified

information, or of information of a specified kind, relating to

the persons to whom the biological has been supplied.

33 Subsection 32HA(4)

Omit "recover", substitute "recall".

34 Subsection 32HA(4)

Omit "recovered", substitute "recalled".

35 At the end of Division 8 of Part 3-2A

Add:

32HF Saving of other laws

This Division is not intended to exclude or limit the operation of

any other law of the Commonwealth or any law of a State or

Territory.

36 Paragraph 41BB(f)

Omit "recovery", substitute "recall".

37 Section 41GR (paragraph (b) of note 2)

Omit "recovery", substitute "recall".

38 Part 4-9 (heading)

Repeal the heading, substitute:

Part 4-9--Public notification, and recall, of medical

devices

39 Section 41K

Omit "recover", substitute "recall".

Schedule 10 Public notification and recalls

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

40 Section 41KA (heading)

Repeal the heading, substitute:

41KA Public notification, and recall, of medical devices

41 Subsection 41KA(1) (table item 1, column headed

"Circumstance relating to a kind of medical device")

After "but", insert "the Secretary is satisfied that".

42 Subsection 41KA(1) (table item 2, column headed

"Circumstance relating to a kind of medical device")

After "but", insert "the Secretary is satisfied that".

43 Subsection 41KA(1) (table item 3, column headed

"Circumstance relating to a kind of medical device")

After "but", insert "the Secretary is satisfied that".

44 Subsection 41KA(1) (table item 4, column headed

"Circumstance relating to a kind of medical device")

After "but", insert "the Secretary is satisfied that".

45 Subsection 41KA(1) (at the end of the table)

Add:

It is counterfeit goods (within the

meaning of section 42E)

The person supplying the kind of

medical device

46 Subsection 41KA(2)

Omit "one or both", substitute "one or more".

47 Paragraph 41KA(2)(a)

Omit "recover", substitute "recall".

48 At the end of subsection 41KA(2)

Add:

; (c) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, of specified information, or of information of a

specified kind, relating to either or both of the following:

Public notification and recalls Schedule 10

No. , 2016

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(i) medical devices of that kind;

(ii) the circumstances referred to in paragraph (1)(a);

(d) to publish, in the specified manner and within such

reasonable period as is specified, specified information, or

information of a specified kind, relating to the manufacture

or distribution of medical devices of that kind;

(e) to notify the Secretary, in the specified manner and within

such reasonable period as is specified, of specified

information, or of information of a specified kind, relating to

the persons to whom medical devices of that kind have been

supplied.

49 Subsection 41KA(4)

Omit "recover", substitute "recall".

50 Subsection 41KA(4)

Omit "recovered", substitute "recalled".

51 At the end of Part 4-9

Add:

41KE Saving of other laws

This Part is not intended to exclude or limit the operation of any

other law of the Commonwealth or any law of a State or Territory.

52 Paragraph 41MP(2)(b)

Omit "recover", substitute "recall".

53 Paragraph 41MPA(2)(b)

Omit "recover", substitute "recall".

54 Section 42V (heading)

Repeal the heading, substitute:

Schedule 10 Public notification and recalls

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

No. , 2016

42V Recall of therapeutic goods because of actual or potential

tampering

55 Paragraph 42V(2)(a)

Omit "recover", substitute "recall".

56 Subsection 42V(3)

Omit "recovered", substitute "recalled".

57 Section 42VA (heading)

Repeal the heading, substitute:

42VA Civil penalty relating to the recall of therapeutic goods

because of actual or potential tampering

58 Section 42VB (heading)

Repeal the heading, substitute:

42VB Relief from liability for contraventions relating to the recall of

therapeutic goods because of actual or potential

tampering

59 Section 42W (heading)

Repeal the heading, substitute:

42W Supply etc. of therapeutic goods that are subject to recall

requirements

60 Subparagraphs 42W(1)(b)(i) and (2)(b)(i)

Omit "recover", substitute "recall".

61 Paragraph 61(4A)(da)

Omit "recovery", substitute "recall".

62 After paragraph 61(4A)(da)

Insert:

(db) action taken by the Secretary under section 32HA (about

notification and recall of biologicals);

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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

(dc) action taken by the Secretary under section 41KA (about

notification and recall of medical devices);

63 Application of amendments

Therapeutic goods

(1)

The amendments of section 30EA of the Therapeutic Goods Act 1989

made by this Schedule apply in relation to requirements imposed after

the commencement of this item.

(2)

The amendments of sections 30F and 32CJ of the Therapeutic Goods

Act 1989 made by this Schedule apply in relation to notices given after

the commencement of this item.

Biologicals

(3)

The amendments of section 32HA of the Therapeutic Goods Act 1989

made by this Schedule apply in relation to requirements imposed after

the commencement of this item.

Medical devices

(4)

The amendments of section 41KA of the Therapeutic Goods Act 1989

made by this Schedule apply in relation to requirements imposed after

the commencement of this item.

(5)

The amendments of sections 41MP and 41MPA of the Therapeutic

Goods Act 1989 made by this Schedule apply in relation to steps taken

after the commencement of this item.

Product tampering

(6)

The amendments of sections 42V, 42VA, 42VB and 42W of the

Therapeutic Goods Act 1989 made by this Schedule apply in relation to

requirements imposed after the commencement of this item.

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Schedule 11--Obtaining information etc.

Therapeutic Goods Act 1989

1 Paragraph 31(2)(fa)

Omit "the matters covered by a certification by the person under

paragraph 26A(2)(j)", substitute "any of the matters covered by a

certification by the person under subsection 26A(2) or (2A)".

2 Application of amendments

The amendment of section 31 of the Therapeutic Goods Act 1989 made

by this Schedule applies in relation to notices given under section 31 of

that Act after the commencement of this item, whether:

(a) if the notice is given to an applicant for the registration or

listing of therapeutic goods--the application is made before

or after that commencement; or

(b) if the notice is given to a person in relation to whom

therapeutic goods are or were registered or listed--the goods

are registered or listed before or after that commencement.

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Schedule 12--Miscellaneous amendments

Therapeutic Goods Act 1989

1 Subsection 3(1) (definition of National Manager of the

Therapeutic Goods Administration)

Repeal the definition.

2 After subsection 19A(1)

Insert:

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

person for the importation into Australia, or the supply in

Australia, of specified therapeutic goods if the Secretary is satisfied

that:

(a) registered goods that could act as a substitute for the goods

are unavailable or are in short supply; and

(b) either:

(i) the goods that are the subject of the application are not

registered or approved for general marketing in any of

the foreign countries specified by the Secretary in a

determination under subsection (3); or

(ii) the goods that are the subject of the application are

registered or approved for general marketing in at least

one foreign country specified by the Secretary in a

determination under subsection (3), but are not readily

available for importation into, and supply in, Australia;

and

a foreign country; and

(d) the manufacturing and quality control procedures used in the

manufacture of the goods are acceptable; and

(e) the goods are of a kind:

(i) included in Schedule 10 of the Therapeutic Goods

Regulations; or

(ii) specified by the Secretary in a determination under

subsection (4); and

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

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3 Subsection 19A(3)

Omit "this section", substitute "subsection (1)".

4 Paragraph 19A(9)(a)

After "(d)," (first occurring), insert "paragraph (1A)(a), (b), (c), (d), (e)

or (f),".

5 At the end of section 19A

Add:

(11) An approval under subsection (1), (1A) or (2) is not a legislative

instrument.

6 At the end of subsection 30(1)

Add:

; or (g) the Secretary is satisfied that a statement made in, or in

connection with, the application for registration or listing of

the goods was false or misleading in a material particular; or

(h) the annual registration or listing charge is not paid within 28

days after it becomes payable.

7 Subparagraph 30(2)(ea)(ii)

Omit "regulations; or", substitute "regulations.".

8 Paragraph 30(2)(f)

Repeal the paragraph.

9 After section 30A

Insert:

30AA Revocation of cancellation of registration or listing--payment

of annual registration or listing charge

(1) If:

(a) the Secretary cancels the registration or listing of therapeutic

goods because the annual registration or listing charge was

not paid within 28 days after it became payable (see

paragraph 30(1)(h)); and

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(b) before the end of the period of 90 days beginning on the day

the goods ceased to be registered or listed, the person

requests, in writing, the Secretary to revoke the cancellation;

and

(d) the request is accompanied by the prescribed application fee;

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.

10 At the end of subsection 30F(4)

Add "or on the Department's website".

11 After section 31B

Insert:

31BA Secretary may require information about therapeutic goods

approved under section 19A

(1) The Secretary may give to a person who is granted an approval

under subsection 19A(1), (1A) or (2) in relation to specified

therapeutic goods 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 goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations.

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 specified in the notice (which must not be

less than 14 days after the day the notice is given); and

(b) in the form specified in the notice.

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(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.

12 Section 31C (heading)

Repeal the heading, substitute:

31C Criminal offence for failing to give information or documents

sought under section 31A, 31AA, 31B or 31BA

13 Paragraph 31C(a)

Omit "or 31B", substitute ", 31B or 31BA".

14 Subsection 31D(1)

Omit "or 31B", substitute ", 31B or 31BA".

15 Paragraph 31E(1)(c)

Omit "or 31B", substitute ", 31B or 31BA".

16 Subsection 31F(1)

Omit "or 31B", substitute ", 31B or 31BA".

17 Subparagraphs 32BA(1)(b)(v), (2)(b)(v) and (4)(b)(v)

After "32CO(1)", insert ", (1A)".

18 Subparagraphs 32BD(1)(b)(vi), (2)(b)(vi) and (4)(b)(vi)

After "32CO(1)", insert ", (1A)".

19 Subparagraphs 32BF(1)(b)(v) and (4)(b)(vi)

After "32CO(1)", insert ", (1A)".

20 Subparagraph 32BH(b)(vi)

After "32CO(1)", insert ", (1A)".

21 Subparagraphs 32BI(1)(c)(iv), (2)(c)(iv) and (4)(c)(iv)

After "32CO(1)", insert ", (1A)".

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22 Subparagraph 32BJ(4)(b)(vi)

After "32CO(1)", insert ", (1A)".

23 Paragraph 32BK(2)(f)

After "32CO(1)", insert ", (1A)".

24 At the end of subsection 32CJ(4)

Add "or on the Department's website".

25 After subsection 32CO(1)

Insert:

(1A) 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 not registered or approved for general

marketing in any of the foreign countries specified by

the Secretary under subsection (5); or

(ii) 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), but is not readily available for

importation into, and supply in, Australia; and

(e) the biological is registered or approved for general marketing

in a foreign country; and

(f) the manufacturing and quality control procedures used in the

manufacture of the biological are acceptable; and

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

determination under subsection (6); and

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

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26 Paragraph 32CO(8)(b)

After "(1)", insert ", (1A)".

27 Paragraph 32CO(11)(a)

After "(f)," (first occurring), insert "paragraph (1A)(c), (d), (e), (f), (g)

or (h),".

28 Subsection 32CO(13)

After "(1)", insert ", (1A)".

29 After section 32GD

Insert:

32GDA Revocation of cancellation of biological upon request--

payment of annual charge

(1) If:

(a) the Secretary cancels the entry of a biological from the

Therapeutic Goods (Charges) Act 1989 in respect of the

inclusion of the biological in the Register was not paid within

28 days after it becomes payable; 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

(Charges) Act 1989 in respect of the inclusion of the

biological in the Register has been paid; and

(d) the request is accompanied by the prescribed application fee;

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.

30 Subsection 32HA(1) (table item 3, column headed

"Circumstance relating to biological", paragraph (e))

After "32CO(1)", insert ", (1A)".

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31 Subsection 32HA(1) (table item 4, column headed

"Circumstance relating to biological", paragraph (e))

After "32CO(1)", insert ", (1A)".

32 Subsection 32HA(1) (table item 5, column headed

"Circumstance relating to biological", paragraph (f))

After "32CO(1)", insert ", (1A)".

33 Subsection 32JH(1)

After "32CO(1)", insert ", (1A)".

34 After section 41AA

Insert:

41AB Secretary may require information or documents

(1) If:

(a) a person is the holder of a licence; and

(b) the person has carried out, or is carrying out, one or more

steps in the manufacture of therapeutic goods;

the Secretary may, by written notice given to the person, require

the person to:

documents, relating to one or more of the following:

(i) the therapeutic goods;

(ii) if the therapeutic goods consist of a mixture of

ingredients--those ingredients;

(iii) if the therapeutic goods consist of a mixture of

ingredients--the suppliers of those ingredients;

(iv) if the therapeutic goods consist of a combination of

component parts--those component parts;

(v) if the therapeutic goods consist of a combination of

component parts--the suppliers of those component

parts;

(vi) the containers or packages used, or proposed to be used,

to contain the therapeutic goods;

(vii) the batch numbers of the therapeutic goods;

(viii) the expiry dates of the therapeutic goods;

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(ix) the distribution of the therapeutic goods;

(x) the conformity of the therapeutic goods to a standard

applicable to the goods;

(xi) the step or steps that the person has carried out, or is

carrying out, in the manufacture of the therapeutic

goods;

(xii) the premises used to carry out one or more steps in the

manufacture of the therapeutic goods;

(xiii) the observance of the manufacturing principles;

(xiv) the names, qualifications and experience of individuals

who have control of any of the steps that have been

carried out, or are being carried out, in the manufacture

of the therapeutic goods;

(xv) the measures for quality assurance and quality control

employed in the taking of any of the steps that have

been carried out, or are being carried out, in the

manufacture of the therapeutic goods;

(xvi) compliance with the conditions of the licence;

(xvii) whether there are grounds for revoking or suspending

the licence;

(xviii) any other matter that is prescribed by the regulations

and that relates to the manufacture of the therapeutic

goods; and

(d) do so:

(i) within such reasonable time as is specified in the notice;

and

(ii) in such form as is specified in the notice.

(2) The time specified in the notice must not be shorter than 14 days

after the notice is given.

(3) The rule in subsection (2) does not apply if the Secretary is

satisfied that, because of circumstances of urgency, the time

specified in the notice should be shorter than 14 days after the

notice is given.

(4) An approval of a 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

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

41AC Criminal offence for contravening a requirement in a notice

under section 41AB

A person commits an offence if:

(a) the person has been given a notice under section 41AB; and

(b) the person omits to do an act; and

Penalty: 400 penalty units.

41AD False or misleading information--offence

(1) A person commits an offence if:

(a) the person is given a notice under section 41AB; and

(b) the person gives information to the Secretary in compliance,

or purported compliance, with the notice; and

(i) is false or misleading; or

(ii) omits any matter or thing without which the information

is misleading.

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

both.

(2) Subsection (1) does not apply as a result of subparagraph (1)(c)(i)

if the information is not false or misleading in a material particular.

Note:

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

subsection (2).

(3) Subsection (1) does not apply as a result of subparagraph (1)(c)(ii)

if the information did not omit any matter or thing without which

the information is misleading in a material particular.

Note:

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

subsection (3).

41AE False or misleading documents--offence

(1) A person commits an offence if:

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(a) the person produces a document to the Secretary; and

(b) the person does so knowing that the document is false or

misleading; and

compliance, with a notice given under section 41AB.

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

both.

(2) Subsection (1) does not apply if the document is not false or

misleading in a material particular.

Note:

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

subsection (2).

(3) Subsection (1) does not apply to a person who produces a

document if the document is accompanied by a written statement

signed by the person or, in the case of a body corporate, by a

competent officer of the body corporate:

(a) stating that the document is, to the knowledge of the

first-mentioned person, false or misleading in a material

particular; and

(b) setting out, or referring to, the material particular in which

the document is, to the knowledge of the first-mentioned

person, false or misleading.

Note:

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

subsection (3).

41AF False or misleading information or documents--civil penalty

(1) A person contravenes this section if:

(a) the person is given a notice under section 41AB; 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.

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(2) Subsection (1) does not apply to a person who produces a

document if the document is accompanied by a written statement

signed by the person or, in the case of a body corporate, by a

competent officer of the body corporate:

(a) stating that the document is, to the knowledge of the

first-mentioned person, false or misleading in a material

particular; and

(b) setting out, or referring to, the material particular in which

the document is, to the knowledge of the first-mentioned

person, false or misleading.

41AG Self-incrimination

(1) A person is not excused from giving information or a producing a

document under a section 41AB notice on the ground that the

giving of the information or the production of the document would

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; or

(b) the giving of the information or the production of the

document; or

indirect consequence of giving the information or producing

the document;

is not admissible in evidence in:

(d) criminal proceedings against the individual, except

proceedings under, or arising out of, section 41AD or 41AE;

(e) proceedings for a pecuniary penalty order against the

individual for a contravention of a civil penalty provision.

35 After subsection 41FN(5)

Insert:

Conditions prescribed by the regulations

(5A) The inclusion of a kind of medical device in the Register is subject

to such conditions (if any) as are prescribed by the regulations.

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Conditions determined by the Minister

(5B) The inclusion of a kind of medical device in the Register is subject

to such conditions (if any) as are determined under

subsection (5C).

(5C) The Minister may, by legislative instrument, determine one or

more conditions for the purposes of subsection (5B).

36 After section 41GLA

Insert:

41GLB Revocation of cancellation of entries--payment of annual

charge

(1) If:

(a) the Secretary cancels the entry of a kind of medical device

because the annual charge payable by a person under

subsection 4(1B) of the Therapeutic Goods (Charges) Act

1989 in respect of the inclusion of the kind of device in the

becomes payable; and

(b) before the end of the period of 90 days beginning on the day

the kind of device ceased to be included in the Register, the

person in relation to whom the kind of device was included in

the Register requests, in writing, the Secretary to revoke the

cancellation; and

Therapeutic Goods (Charges) Act 1989 in respect of the

inclusion of the kind of device in the Register has been paid;

and

(d) the request is accompanied by the prescribed application fee

(if any);

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.

37 After subsection 41HD(1)

Insert:

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

person for:

(a) the importation into Australia of a specified medical device;

(b) the importation into Australia of a specified medical device

and the supply in Australia of that device;

if the Secretary is satisfied that:

could act as a substitute for the medical device are

unavailable or are in short supply; and

(d) either:

(i) the medical device is not registered or approved for

general marketing in any of the foreign countries

specified in a determination under subsection (5); or

(ii) the medical device is registered or approved for general

marketing in at least one foreign country specified in a

determination under subsection (5), but is not readily

available for importation into, and supply in, Australia;

and

(e) the medical device is registered or approved for general

marketing in a foreign country; and

(f) the manufacturing and quality control procedures used in the

manufacture of the medical device are acceptable; and

(g) the medical device is specified in a determination under

subsection (6); and

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

Note:

For specification by class, see the Acts Interpretation Act 1901 and

subsection 13(3) of the Legislation Act 2003.

38 Paragraph 41HD(10)(a)

After "(f)," (first occurring), insert "paragraph (1A)(c), (d), (e), (f), (g)

or (h),".

39 Subsection 41HD(12)

After "(1)", insert ", (1A)".

40 Subsection 41JFA(1)

After "41HD(1)", insert ", (1A)".

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41 Subsection 41KA(1) (table item 3, column headed

"Circumstance relating to a kind of medical device",

paragraph (d))

After "41HD(1)", insert ", (1A)".

42 Subsection 41KA(1) (table item 4, column headed

"Circumstance relating to a kind of medical device",

paragraph (d))

After "41HD(1)", insert ", (1A)".

43 Subsection 41KA(1) (table item 5, column headed

"Circumstance relating to a kind of medical device",

paragraph (e))

After "41HD(1)", insert ", (1A)".

44 Subparagraphs 41MI(1)(b)(iv), (2)(b)(iv) and (4)(b)(iv)

After "41HD(1)", insert ", (1A)".

45 Subparagraph 41MIB(1)(b)(iv)

After "41HD(1)", insert ", (1A)".

46 Subparagraph 41MK(b)(iv)

After "41HD(1)", insert ", (1A)".

47 Paragraph 41MLA(2)(d)

After "41HD(1)", insert ", (1A)".

48 Subparagraph 41MN(9)(b)(iv)

After "41HD(1)", insert ", (1A)".

49 Paragraphs 42T(1)(c) and (2)(d)

Omit "or the National Manager of the Therapeutic Goods

Administration".

50 Subparagraph 46A(4)(a)(iiaac)

After "32CO(1)", insert ", (1A)".

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51 Subparagraph 46A(4)(a)(iib)

After "41HD(1)", insert ", (1A)".

52 Section 54BA (after table item 27)

Insert:

27A

Subsection 41AD(1)

27B

Subsection 41AE(1)

53 Paragraph 56A(1)(bb)

After "41HD(1)", insert ", (1A)".

54 Paragraph 56A(1)(ca)

After "32CO(1)", insert ", (1A)".

55 Subsections 57(8) and (9)

Repeal the subsections, substitute:

(8) The powers of the Secretary under section 19A or 32CO may be

delegated only to a person who holds, occupies or performs the

duties of a position in the Department prescribed by the

regulations.

(9) The powers of the Secretary under section 41HD may be delegated

only to a person who holds, occupies or performs the duties of a

position in the Department prescribed by the regulations.

56 Subsection 61(3A)

After "31B,", insert "31BA,".

57 Subsection 61(3A)

After "32JH,", insert "41AB,".

58 Transitional provisions

(1)

If:

(a) a determination was made under subsection 19A(3) of the

Therapeutic Goods Act 1989; and

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(b) the determination was in force immediately before the

commencement of this item;

the determination has effect, after the commencement of this item, as if

a reference in the determination to a prerequisite for approval by the

Secretary under that section 19A of that Act were a reference to a

prerequisite for approval by the Secretary under subsection 19A(1) of

that Act.

(2)

If:

(a) regulations were made for the purposes of paragraph 57(8)(b)

of the Therapeutic Goods Act 1989; and

(b) the regulations were in force immediately before the

commencement of this item;

the regulations have effect, after the commencement of this item, as if

they had been made for the purposes of subsection 57(8) of the

Therapeutic Goods Act 1989 as amended by this Act.

(3)

If:

(a) regulations were made for the purposes of paragraph 57(9)(b)

of the Therapeutic Goods Act 1989; and

(b) the regulations were in force immediately before the

commencement of this item;

the regulations have effect, after the commencement of this item, as if

they had been made for the purposes of subsection 57(9) of the

Therapeutic Goods Act 1989 as amended by this Act.

Commonwealth of Australia Bills

THERAPEUTIC GOODS AMENDMENT (2016 MEASURES NO. 1) BILL 2016