Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014

No. 4, 2014

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

Contents

1 Short title 1

2 Commencement 2

3 Schedule(s) 2

Schedule 1—Advertising etc. 3

Therapeutic Goods Act 1989 3

Schedule 2—Obtaining information etc. 10

Therapeutic Goods Act 1989 10

Schedule 3—Goods that are not therapeutic goods 14

Therapeutic Goods Act 1989 14

Schedule 4—Restricted representations and prohibited representations 17

Therapeutic Goods Act 1989 17

Schedule 5—Evaluation and registration of therapeutic goods 18

Therapeutic Goods Act 1989 18

Schedule 6—Conditions 23

Therapeutic Goods Act 1989 23

Schedule 7—Presentation 27

Therapeutic Goods Act 1989 27

Schedule 8—Consent to the import, supply or export of goods 28

Therapeutic Goods Act 1989 28

Schedule 9—Review of decisions 29

Therapeutic Goods Act 1989 29

Schedule 10—Kits 30

Therapeutic Goods Act 1989 30

Schedule 11—False or misleading statements 31

Therapeutic Goods Act 1989 31

Schedule 12—Notice of cancellation of registration or listing 33

Therapeutic Goods Act 1989 33

Schedule 13—Publication etc. 34

Therapeutic Goods Act 1989 34

Schedule 14—Auditing applications 38

Therapeutic Goods Act 1989 38

Schedule 15—Failure to comply with requirements to provide information etc. 39

Therapeutic Goods Act 1989 39

Schedule 16—Other amendments 41

Therapeutic Goods Act 1989 41

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

[Assented to 28 February 2014]

The Parliament of Australia enacts:
1 Short title

This Act may be cited as the Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014.
2 Commencement

This Act commences on the day this Act receives the Royal Assent.
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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.
Advertising etc.

Therapeutic Goods Act 1989

 1 Paragraph 25(1)(f)

Omit “, or any requirements relating to advertising applicable under Part 5-1 or under the regulations”.

 2 After paragraph 25(1)(f)

Insert:

are complied with in relation to the goods; and

 fa

whether:

 i

the applicable provisions of the Therapeutic Goods Advertising Code; and

 ii

the other requirements (if any) relating to advertising applicable under Part 5-1 or the regulations;

 3 Paragraph 26(1)(f)

Omit “or to a requirement relating to advertising applicable under Part 5-1 or under the regulations”.

 4 After paragraph 26(1)(f)

Insert:

 fa

either of the following has not been complied with in relation to the goods:

 i

an applicable provision of the Therapeutic Goods Advertising Code;

 ii

any other requirement relating to advertising applicable under Part 5-1 or the regulations; or

 5 Paragraph 26A(2)(d)

Omit “and to every requirement (if any) relating to advertising applicable under Part 5-1 or under the regulations”.

 6 After paragraph 26A(2)(d)

Insert:

 da

both of the following are complied with in relation to the medicine:

 i

the applicable provisions of the Therapeutic Goods Advertising Code;

 ii

the other requirements (if any) relating to advertising applicable under Part 5-1 or under the regulations; and

 7 Paragraph 30(1A)(c)

Omit “the requirements”, substitute “an applicable provision of the Therapeutic Goods Advertising Code or any other requirement”.

 8 Paragraph 30(2)(ba)

After “(d),”, insert “(da),”.

 9 Paragraph 30(2)(e)

Omit “or to a requirement relating to advertising applicable to the goods under Part 5-1 or under the regulations”.

 10 After paragraph 30(2)(e)

Insert:

 ea

either of the following has not been complied with in relation to the goods:

 i

an applicable provision of the Therapeutic Goods Advertising Code;

 ii

any other requirement relating to advertising applicable under Part 5-1 or the regulations; or

 11 After paragraph 31(1)(ga)

Insert:

 gb

the conformity of the goods to a standard applicable to the goods;

 12 Paragraph 31(1)(h)

Repeal the paragraph, substitute:

 h

whether either of the following has not been complied with in relation to the goods:

 i

an applicable provision of the Therapeutic Goods Advertising Code;

 ii

any other requirement relating to advertising applicable under Part 5-1 or the regulations;

 13 Paragraph 31(2)(g)

Omit “, or to a requirement relating to advertising applicable to the goods under Part 5-1 or under the regulations”.

 14 After paragraph 31(2)(g)

Insert:

 gaa

whether either of the following has not been complied with in relation to the goods:

 i

an applicable provision of the Therapeutic Goods Advertising Code;

 ii

any other requirement relating to advertising applicable under Part 5-1 or the regulations;

 15 Paragraph 32DA(3)(d)

Repeal the paragraph, substitute:

 d

both of the following are complied with in relation to the biological:

 i

the applicable provisions of the Therapeutic Goods Advertising Code;

 ii

the other requirements (if any) relating to advertising applicable under Part 5-1 or under the regulations; and

 16 Paragraph 32DE(1)(d)

Repeal the paragraph, substitute:

are complied with in relation to the biological; and

 d

whether:

 i

the applicable provisions of the Therapeutic Goods Advertising Code; and

 ii

the other requirements (if any) relating to advertising applicable under Part 5-1 or the regulations;

 17 Paragraph 32GA(1)(j)

Omit “the requirements”, substitute “an applicable provision of the Therapeutic Goods Advertising Code or any other requirement”.

 18 Paragraph 32GC(1)(g)

Repeal the paragraph, substitute:

 g

either of the following has not been complied with in relation to the biological:

 i

an applicable provision of the Therapeutic Goods Advertising Code;

 ii

any other requirement relating to advertising applicable under Part 5-1 or under the regulations.

 19 Paragraph 32JA(1)(m)

Repeal the paragraph, substitute:

 m

whether either of the following has not been complied with in relation to the biological:

 i

an applicable provision of the Therapeutic Goods Advertising Code;

 ii

any other requirement relating to advertising applicable under Part 5-1 or under the regulations;

 20 Paragraph 41FD(h)

Repeal the paragraph, substitute:

 h

both of the following are complied with in relation to devices of that kind:

 i

the applicable provisions of the Therapeutic Goods Advertising Code;

 ii

the other requirements (if any) relating to advertising applicable under Part 5-1 or under the regulations; and

 21 Paragraph 41GL(h)

Omit “the requirements”, substitute “an applicable provision of the Therapeutic Goods Advertising Code or any other requirement”.

 22 Paragraph 41JA(1)(h)

Repeal the paragraph, substitute:

 h

whether either of the following has not been complied with in relation to the devices:

 i

an applicable provision of the Therapeutic Goods Advertising Code;

 ii

any other requirement relating to advertising applicable under Part 5-1 or under the regulations;

 23 Application—medicines etc.

Evaluation and registration

Listing of therapeutic goods

Listing of certain medicines

Cancellation of registration or listing

Obtaining information etc.

 1

(1) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications for the registration of therapeutic goods made on or after the commencement of this item.section 25 of the

2

(2) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications for the listing of therapeutic goods made on or after the commencement of this item.section 26 of the

3

(3) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications for the listing of medicines made on or after the commencement of this item.section 26A of the

4

(4) The amendment of subsection 30(1A) of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under that subsection on or after the commencement of this item, whether the breach to which the notice relates occurs before or after that commencement.

 5

(5) The amendments of subsection 30(2) of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to cancellations under that subsection of which a person is informed under subsection 30(3) of that Act on or after the commencement of this item, whether the circumstances that give rise to the cancellation occur before or after that commencement.

 6

(6) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under that section on or after the commencement of this item, whether:section 31 of the

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.

 24 Application—biologicals

Class 1 biologicals

Biologicals other than Class 1 biologicals

Cancellation of biologicals from the Register

Obtaining information etc.

 1

(1) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to applications for the inclusion of a Class 1 biological in the Register made on or after the commencement of this item.section 32DA of the

2

(2) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to applications for the inclusion of a biological other than a Class 1 biological in the Register made on or after the commencement of this item.section 32DE of the

3

(3) The amendment of subsection 32GA(1) of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under that subsection on or after the commencement of this item, whether the breach to which the notice relates occurs before or after that commencement.

 4

(4) The amendment of subsection 32GC(1) of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to cancellations under that subsection of which a person is informed under subsection 32GC(2) of that Act on or after the commencement of this item, whether the circumstances that give rise to the cancellation occur before or after that commencement.

 5

(5) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under that section on or after the commencement of this item, whether:section 32JA of the

a

if the notice is given to an applicant for the inclusion of a biological in the Register—the application is made before or after that commencement; or

 b

if the notice is given to a person in relation to whom a biological is or was included in the Register—the biological is included in the Register before or after that commencement.

 25 Application—medical devices

Including medical devices in the Register

Cancellation of entries from the Register

Obtaining information etc.

 1

(1) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to applications for a kind of medical device to be included in the Register made on or after the commencement of this item.section 41FD of the

2

(2) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under that section on or after the commencement of this item, whether the breach to which the notice relates occurs before or after that commencement.section 41GL of the

3

(3) The amendment of subsection 41JA(1) of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under that subsection on or after the commencement of this item, whether:

 a

if the notice is given to an applicant for a conformity assessment certificate or for the inclusion of a kind of medical device in the Register—the application is made before or after that commencement; or

 b

if the notice is given to a person who holds or held a conformity assessment certificate—the conformity assessment certificate was issued before or after that commencement; or

 c

if the notice is given to a person in relation to whom a kind of medical device is or was included in the Register—the kind of medical device is included in the Register before or after that commencement.

 Obtaining information etc.

Therapeutic Goods Act 1989

 1 Paragraph 30(1C)(b)

Omit “the medicine should have been listed”, substitute “any of the certifications by the person under subsection 26A(2) or (2A) in relation to the medicine are incorrect”.

 2 Section 31 (at the end of the heading)

Add “or documents”.

 3 Paragraphs 31(5A)(a) to (c)

Repeal the paragraphs, substitute:

 a

the person is given a notice under this section in relation to therapeutic goods; and

 b

the person gives information or a document in compliance or purported compliance with the notice; and

 c

the information or document is false or misleading in a material particular; and

 4 Subparagraphs 31(5A)(d)(i) and (ii)

Omit “medicine” (wherever occurring), substitute “therapeutic goods”.

 5 Paragraphs 31(5B)(a) to (c)

Repeal the paragraphs, substitute:

 a

the person is given a notice under this section in relation to therapeutic goods; and

 b

the person gives information or a document in compliance or purported compliance with the notice; and

 c

the information or document is false or misleading in a material particular; and

 6 Paragraph 31(5B)(d)

Omit “medicine” (wherever occurring), substitute “therapeutic goods”.

 7 Subsection 31(6)

Repeal the subsection (not including the penalty), substitute:

 6

A person who is given a notice under this section in relation to therapeutic goods must not, in compliance or purported compliance with the notice, give information or a document that is false or misleading in a material particular.

 8 Section 31AAA (heading)

Omit “in relation to medicines listed under section 26A”, substitute “or documents in relation to therapeutic goods”.

 9 Paragraphs 31AAA(a) and (b)

Repeal the paragraphs, substitute:

 a

the person is given a notice under section 31 in relation to therapeutic goods; and

 b

the person gives information or a document in compliance or purported compliance with the notice; and

 10 Paragraph 31AAA(c)

After “information”, insert “or document”.

 11 Paragraph 32GB(1)(b)

Omit “the biological should have been included in the Register”, substitute “any of the certifications by the person under subsection 32DA(3) in relation to the biological are incorrect”.

 12 Paragraph 32JB(1)(a)

Repeal the paragraph, substitute:

 a

the person is given a notice under section 32JA; and

 aa

the person is covered by paragraph 32JA(1)(b) or (c); and

 13 Paragraph 41GM(1)(b)

Omit “the kind of device should have been included in the Register”, substitute “any of the certifications by the person under section 41FD in relation to the kind of device are incorrect”.

 14 Section 41JA (at the end of the heading)

Add “or documents”.

 15 Paragraph 41JB(3)(a)

Repeal the paragraph, substitute:

 a

the person is given a notice under section 41JA; and

 aa

the person is covered by paragraph 41JA(1)(b), (ba), (d) or (da); and

 16 Application of amendments

Information or documents about medicines etc.

Information or documents about biologicals

Information or documents about medical devices

 1

(1) The amendments of sections 30, 31 and 31AAA of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 31 of that Act on or 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.

 2

(2) The amendments of sections 32GB and 32JB of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 32JA of that Act on or after the commencement of this item, whether:

 a

if the notice is given to an applicant for the inclusion of a biological in the Register—the application is made before or after that commencement; or

 b

if the notice is given to a person in relation to whom a biological is or was included in the Register—the biological is included in the Register before or after that commencement.

 3

(3) The amendments of sections 41GM, 41JA and 41JB of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 41JA of that Act on or after the commencement of this item, whether:

 a

if the notice is given to an applicant for a conformity assessment certificate or for the inclusion of a kind of medical device in the Register—the application is made before or after that commencement; or

 b

if the notice is given to a person who holds or held a conformity assessment certificate—the conformity assessment certificate was issued before or after that commencement; or

 c

if the notice is given to a person in relation to whom a kind of medical device is or was included in the Register—the kind of medical device is included in the Register before or after that commencement.

 Goods that are not therapeutic goods

Therapeutic Goods Act 1989

 1 Subsection 3(1) (at the end of the definition of therapeutic goods)

Add:

; or (g) goods covered by a determination under subsection 7AA(1) (excluded goods); or

 h

goods covered by a determination under subsection 7AA(2) (excluded goods), if the goods are used, advertised, or presented for supply in the way specified in the determination.

 2 After section 7

Insert:

 7AA Excluded goods 1

The Minister may, by legislative instrument, determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7) are excluded goods for the purposes of this Act.

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

 2

The Minister may, by legislative instrument, determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7), when used, advertised, or presented for supply in a way specified in the determination, are excluded goods for the purposes of this Act.

 3

Before making a determination under this section, the Minister must have regard to the following matters:

 a

whether it is likely that the specified goods, if not regulated under this Act, might harm the health of members of the public;

 b

whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by this Act to regulate the specified goods;

 c

whether the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory scheme.

 4

The Minister may have regard to any other matter he or she considers relevant.

 3 At the end of paragraph 8(1)(b)

Add “or”.

 4 After paragraph 8(1)(b)

Insert:

 c

goods in relation to which the Minister is considering making a determination under section 7AA (excluded goods);

 5 At the end of Chapter 2

Add:

 9F Removal of entries from Register 1

This section applies if:

 a

there is an entry on the Register in relation to goods; and

 b

the Secretary is satisfied that the goods are not therapeutic goods.

 2

The Secretary may, by written notice given to the person in relation to whom the goods are entered on the Register, remove the entry of the goods from the Register.

 3

Before removing the entry, the Secretary must:

 a

inform the person in writing that the Secretary proposes the removal and set out the reasons for it; and

 b

invite the person to make written submissions to the Secretary in relation to the proposed removal within the period specified in the notice (being not less than 20 working days after the day the notice is given).

 4

The Secretary must not give the person a notice under subsection (2) until the Secretary has had regard to any submissions the person makes under paragraph (3)(b).

 5

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

 6

If the Secretary removes an entry of goods from the Register under this section, the removal has effect on the day specified in the notice under subsection (2) in relation to the goods, being a day not earlier than 20 working days after the day on which the notice is given to the person.

 7

(7) If the Secretary removes an entry of goods from the Register under this section, the Secretary must, as soon as practicable after the removal, cause to be published in the Gazette, or on the Department’s website, a notice setting out particulars of the removal.

 6 After paragraph 56A(1)(h)

Insert:

 ha

there was no determination under section 7AA which applied to particular goods; or

 7 Subsection 60(1) (paragraph (ab) of the definition of initial decision)

Omit “9C or 9D”, substitute “9C, 9D or 9F”.

 8 Application—removal of entries from Register

Section 9F of the Therapeutic Goods Act 1989, as inserted by this Schedule, applies in relation to goods entered on the Register before or after the commencement of this item.

 Restricted representations and prohibited representations

Therapeutic Goods Act 1989

 1 Paragraph 42DL(1)(a)

After “goods”, insert “, the use of which has not been permitted under subsection 42DK(2)”.

 2 Before paragraph 42DL(2)(a)

Insert:

 aa

that the use of a prohibited representation, as referred to in paragraph (1)(a), has not been permitted under subsection 42DK(2);

 3 Paragraph 42DL(3)(a)

After “(1)(a)”, insert “, (c)”.

 4 Application of amendments

The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to advertisements published or broadcast on or after the commencement of this item.section 42DL of the

Evaluation and registration of therapeutic goods

Therapeutic Goods Act 1989

 1 Paragraph 19A(8)(b)

Omit “section 25”, substitute “subsection 25(3)”.

 2 Subsection 24D(3)

Omit “notified under subsection 25(4) of the Secretary’s decision on the evaluation”, substitute “notified of the Secretary’s decision under subsection 25(3) in relation to the goods”.

 3 Section 25 (heading)

Omit “and registration”.

 4 Subsections 25(3), (4) and (5)

Repeal the subsections, substitute:

Note: See also sections 25AA (approved product information for medicine), 25AB (registration of therapeutic goods) and 25AC (notice of decision not to register therapeutic goods).

 3

After an evaluation under this section of goods has been completed, the Secretary must decide:

 a

to register the goods; or

 b

not to register the goods.

 5 Subsection 25AA(1)

Repeal the subsection, substitute:

Note: Subsection (4) deals with variation of the product information.

 1

The Secretary must approve product information in relation to therapeutic goods if:

 a

the Secretary decides, under subsection 25(3), to register the goods; and

 b

the goods are:

 i

restricted medicine; or

 ii

medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph 25(1)(da)(ii).

 1A

However, the Secretary must not approve product information in relation to therapeutic goods under subsection (1) unless the Secretary is satisfied that the product information reflects the basis on which the Secretary decided under subsection 25(3) to register the goods.

 6 Paragraphs 25AA(2)(b) and (3)(b)

After “subsection 25(4)”, insert “(as in force on that day)”.

 7 Paragraph 25AA(3)(c)

Omit “under subparagraph 25(4)(d)(ii)”.

 8 After subsection 25AA(4)

Insert:

 4A

Without limiting subsection (4), a variation to the product information is not appropriate unless:

 a

if subparagraph (4)(b)(i) applies—the product information, as varied, reflects the basis on which the Secretary decided under section 9D to vary the entry in the Register in relation to the medicine; or

 b

if subparagraph (4)(b)(ii) applies—the product information, as varied, reflects the basis on which the Secretary decided under section 28 to change the conditions to which the inclusion of the medicine is subject.

 9 After section 25AA

Insert:

 25AB Registration of therapeutic goods etc.

Therapeutic devices

the Secretary must:

Therapeutic goods that are not therapeutic devices

the Secretary must, in accordance with subsection (3), notify the applicant in writing of the decision within 28 days of making the decision.

Date registration commences

 1

If:

 a

an application is made in accordance with section 23 for the registration of therapeutic goods in relation to a person; and

 b

the Secretary decides under subsection 25(3) to register the goods; and

 c

the goods are therapeutic devices;

 d

notify the applicant in writing of the decision within 28 days of making the decision; and

 e

include the goods in the Register; and

 f

give the applicant a certificate of registration.

 2

If:

 a

an application is made in accordance with section 23 for the registration of therapeutic goods in relation to a person; and

 b

the Secretary decides under subsection 25(3) to register the goods; and

 c

the goods are not therapeutic devices;

 3

The notice must:

 a

set out the decision under subsection 25(3) to register the goods; and

 b

if the goods are restricted medicine or medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph 25(1)(da)(ii)—set out the product information approved under subsection 25AA(1) for the medicine; and

 c

inform the applicant that the goods will not be included in the Register unless and until the applicant gives the Secretary:

 i

the certificate required under subsection 26B(1); or

 ii

a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application.

 4

If the applicant gives the Secretary the certificate referred to in subparagraph (3)(c)(i) or the notice referred to in subparagraph (3)(c)(ii), the Secretary must:

 a

include the goods in the Register; and

 b

give the applicant a certificate of registration.

 5

To avoid doubt, if the applicant gives the Secretary the certificate referred to in subparagraph (3)(c)(i) or the notice referred to in subparagraph (3)(c)(ii), the Secretary must include the goods in the Register under paragraph (4)(a) without inquiring into the correctness of the certificate or the notice.

 6

The registration of therapeutic goods commences on the day specified in the certificate of registration.

 25AC Notice of decision not to register therapeutic goods

If:

the Secretary must notify the applicant in writing of the decision, and the reasons for the decision, within 28 days of making the decision.

 a

an application is made in accordance with section 23 for the registration of therapeutic goods in relation to a person; and

 b

the Secretary decides under subsection 25(3) not to register the goods;

 10 Section 26BA

Omit “25(4)” substitute “25AB(3)”.

 11 Application of amendments

Evaluation of therapeutic goods

Approved product information

Registration of therapeutic goods

 1

(1) The amendments of sections 19A, 24D and 25 of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to evaluations under section 25 of that Act completed on or after the commencement of this item.

 2

(2) The amendments of Therapeutic Goods Act 1989 made by this Schedule (other than the amendment made by item 8) apply in relation to therapeutic goods the evaluation of which under section 25 of that Act is completed on or after the commencement of this item.section 25AA of the

3

(3) Subsection 25AA(4A) of the Therapeutic Goods Act 1989, as inserted by this Schedule, applies in relation to variations to product information made on or after the commencement of this item.

 4

(4) Sections 25AB and 25AC of the Therapeutic Goods Act 1989, as inserted by this Schedule, apply in relation to therapeutic goods the evaluation of which under section 25 of that Act is completed on or after the commencement of this item.

 12 Saving of approved forms

A form that has been approved for the purposes of subparagraph 25(4)(d)(i) of the Therapeutic Goods Act 1989 immediately before this item commences is taken, after that time, to have been approved for the purposes of subparagraph 25AB(3)(c)(ii) of that Act (as inserted by this Schedule).

 Conditions

Therapeutic Goods Act 1989

 1 After paragraph 28(4)(a)

Insert:

 aa

in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or

 ab

in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or

 2 After subsection 28(4)

Insert:

 4A

For the purposes of paragraphs (4)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

 3 After paragraph 32EE(3)(a)

Insert:

 aa

in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or

 ab

in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or

 4 After subsection 32EE(3)

Insert:

 3A

For the purposes of paragraphs (3)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

 5 Subsection 40(3)

Omit “imposition or variation”, substitute “imposition, variation or removal”.

 6 Paragraph 40(3)(b)

Repeal the paragraph, substitute:

 b

in any other case—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day.

 7 After subsection 40(3)

Insert:

 3A

For the purposes of paragraph (3)(b), the earlier day must not be earlier than the day the notice is given to the person.

 8 Subsection 41EL(2)

Omit “imposition or variation”, substitute “imposition, variation or removal”.

 9 After paragraph 41EL(2)(a)

Insert:

 aa

in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

 ab

in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

 10 At the end of section 41EL

Add:

 3

For the purposes of paragraphs (2)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

 11 Subsection 41FP(2)

Omit “imposition or variation”, substitute “imposition, variation or removal”.

 12 After paragraph 41FP(2)(a)

Insert:

 aa

in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

 ab

in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

 13 At the end of section 41FP

Add:

 3

For the purposes of paragraphs (2)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

 14 Application of amendments

Conditions relating to medicines etc.

Conditions relating to biologicals

Conditions relating to licences

Conditions relating to medical devices

 1

(1) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under subsection 28(3) of that Act on or after the commencement of this item.section 28 of the

2

(2) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under that section on or after the commencement of this item.section 32EE of the

3

(3) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under subsection 40(2) of that Act on or after the commencement of this item.section 40 of the

4

(4) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under that section on or after the commencement of this item.section 41EL of the

5

(5) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under that section on or after the commencement of this item.section 41FP of the

Presentation

Therapeutic Goods Act 1989

 1 After paragraph 30(2)(a)

Insert:

 aa

it appears to the Secretary that the presentation of the goods:

 i

in the case of registered goods—is not acceptable; or

 ii

in the case of listed goods—is unacceptable; or

 2 Subsection 30EA(1) (cell at table item 5A, column headed “Circumstance relating to therapeutic goods”)

Repeal the cell, substitute:

 3 Paragraph 32GC(1)(a)

Omit “unacceptable” (second occurring), substitute “not acceptable”.

 4 Subsection 32HA(1) (table item 9)

Omit “unacceptable” (second occurring), substitute “not acceptable”.

 5 Application of amendments

The amendments made by this Schedule apply in relation to therapeutic goods included in the Register before or after the commencement of this item.

 Consent to the import, supply or export of goods

Therapeutic Goods Act 1989

 1 Subsection 60(1) (paragraph (b) of the definition of initial decision)

After “grant”, insert “, or imposing conditions on a grant of,”.

 2 Application of amendment

The amendment made by this Schedule applies in relation to conditions imposed on or after the commencement of this item.

 Review of decisions

Therapeutic Goods Act 1989

 1 After subsection 60(3B)

Insert:

 3C

(3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision then the substituted decision:

 a

is taken to be a decision of the Secretary (except for the purpose of any review of the substituted decision); and

 b

has effect, or is taken to have had effect, on and from the date determined by the Minister.

 2 Application of amendment

The amendment made by this Schedule applies in relation to decisions revoked by the Minister on or after the commencement of this item.

 Kits

Therapeutic Goods Act 1989

 1 Subsection 7B(1)

Repeal the subsection, substitute:

 1

If a package contains one or more goods, the package and each of the goods in the package together constitute a kit for the purposes of this Act if:

 a

the package and each of the goods are for use as a unit; and

 b

the package and the goods do not constitute a composite pack or a system or procedure pack; and

 c

at least one of the goods is therapeutic goods; and

 d

each item of the therapeutic goods consists of goods that are:

 i

registered or listed; or

 ii

exempt goods in relation to Part 3-2; or

 iii

included in the Register under Part 3-2A; or

 iv

exempt under subsection 32CA(2) or section 32CB.

 2 Application of amendment

The amendment made by this Schedule applies in relation to applications for listing of therapeutic goods made on or after the commencement of this item.

 False or misleading statements

Therapeutic Goods Act 1989

 1 Before Chapter 3

Insert:

 9G Criminal offences for false statements in requests for variation of entries in 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 a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods; and

 c

the statement is false or misleading in a material particular; and

 d

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.

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.

Penalty: 2,000 penalty units.

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

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

 2

A person commits an offence if:

 a

the person makes a statement; and

 b

the statement is made in or in connection with a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods; and

 c

the statement is false or misleading in a material particular; and

 d

the use of the goods, if the goods were used, would be likely to result in harm or injury to any person.

 3

Subsection (2) is an offence of strict liability.

 4

A person commits an offence if:

 a

the person makes a statement; and

 b

the statement is made in or in connection with a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods; and

 c

the statement is false or misleading in a material particular.

 9H Civil penalty for false statements in requests for variation of entries in Register

A person contravenes this section if the person in or in connection with a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods, 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.

 2 Section 53A (before table item 1)

Insert:

 3 Application of amendments

Sections 9G and 9H of the Therapeutic Goods Act 1989, as inserted by this Schedule, apply in relation to requests under section 9D of that Act made on or after the commencement of this item.

 Notice of cancellation of registration or listing

Therapeutic Goods Act 1989

 1 Paragraph 30(5)(b)

Repeal the paragraph, substitute:

 b

in any other case—on the day specified in the notice, which must be at least 20 working days after the notice is given to the person.

 2 Application of amendment

The amendment of subsection 30(5) of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to cancellations of which a person is informed under subsection 30(3) of that Act on or after the commencement of this item, whether the circumstances that give rise to the cancellation occur before or after that commencement.

 Publication etc.

Therapeutic Goods Act 1989

 1 Subsection 9A(6)

Omit “the Gazette notice”, substitute “the notice”.

 2 After section 30A

Insert:

 30B Publication of cancellation of registration or listing

If the Secretary cancels the registration or listing of therapeutic goods under Gazette, or on the Department’s website, a notice setting out particulars of the cancellation.section 30, the Secretary must, as soon as practicable after the cancellation, cause to be published in the

3 Subsection 60(2)

Repeal the subsection, substitute:

request the Minister to reconsider the decision.

 2

A person whose interests are affected by an initial decision may, by notice in writing given to the Minister:

 a

if this Act requires the person to be given notice in writing of the decision, or of particulars of the decision—within 90 days after the notice is given to the person; or

 b

otherwise—within 90 days after the earlier of:

 i

(i) notice of the decision, or of particulars of the decision, being published in the Gazette or on the Department’s website; and

 ii

the decision first coming to the person’s notice;

 4 Amendments of listed provisions—publication

Omit “in the Gazette” and substitute “in the Gazette or on the Department’s website” in the following provisions:

 a

(a) subsection 3(1) (paragraph (b) of the definition of listable goods);

 b

(b) subsection 3(1) (definition of therapeutic device);

 c

subsections 3(3), 3A(2), 3B(2), 7(1) and (3), 9A(5), 13(5), 14(14), 14A(4), 29D(5), 29E(4) and 29F(3);

 d

section 30EB;

 e

subsections 32FA(5), 32FB(4) and 32FC(3);

 f

sections 32GE and 32HB;

 g

subsections 38(4), 41(6), 41BD(2A), (3) and (4);

 h

paragraphs 41CC(2)(f) and 41DD(2)(d);

 i

section 41EV;

 j

subsections 41GA(4) and 41GC(4);

 k

paragraph 41GD(3)(b);

 l

subsection 41GF(3);

 m

paragraph 41GH(2)(b);

 n

sections 41GP and 41KB;

 o

subsections 42V(4) and 54(4).

 5 Amendments of listed provisions—publication

Omit “in Gazette” in the following provisions:

 a

subsection 29D(5) (heading);

 b

subsection 29E(4) (heading);

 c

subsection 29F(3) (heading);

 d

subsection 32FA(5) (heading);

 e

subsection 32FB(4) (heading);

 f

subsection 32FC(3) (heading);

 g

subsection 38(4) (heading).

 6 Application—publication 1

(1) The amendments of sections 3A and 3B of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to declarations made on or after the commencement of this item.

 2

(2) The amendments of sections 14 and 14A of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to decisions to give consent made on or after the commencement of this item.

 3

(3) The amendments of sections 29D, 29E, 29F, 32FA, 32FB, 32FC of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given on or after the commencement of this item.

 4

(4) Section 30B of the Therapeutic Goods Act 1989, as inserted by this Schedule, applies in relation to cancellations occurring on or after the commencement of this item.

 5

(5) The amendments of sections 30EB, 32HB, 41KB and 42V of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item.

 6

(6) The amendments of sections 32GE and 41GP of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to entries cancelled on or after the commencement of this item.

 7

(7) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to licences granted on or after the commencement of this item.section 38 of the

8

(8) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to licences revoked or suspended on or after the commencement of this item.section 41 of the

9

(9) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to conformity assessment certificates revoked or varied on or after the commencement of this item.section 41EV of the

10

(10) The amendments of sections 41GA and 41GF of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to suspensions occurring on or after the commencement of this item.

 11

(11) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to extensions given on or after the commencement of this item.section 41GC of the

12

(12) The amendments of sections 41GD and 41GH of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to suspensions revoked on or after the commencement of this item.

 13

(13) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to goods forfeited on or after the commencement of this item.section 54 of the

7 Application—review of decisions

The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to initial decisions made on or after the commencement of this item.section 60 of the

Auditing applications

Therapeutic Goods Act 1989

 1 Subsection 41FH(2)

Repeal the subsection, substitute:

 2

If an application is selected for auditing:

 a

(a) the Secretary must give the applicant a written notice (the selection notice) that:

 i

informs the applicant of the selection; and

 ii

requires the applicant to provide, within the period specified in the notice, information that the Secretary is satisfied is relevant to the audit; and

 b

the application must be dealt with under this Subdivision and not under Subdivision B.

 3

The selection notice must be given within:

 a

20 working days after the application is made; or

 b

if the regulations prescribe a longer period for that kind of application—that longer period.

 4

Subparagraph (2)(a)(ii) does not limit section 41JA (Secretary may require information).

 2 Paragraph 41FK(a)

Repeal the paragraph, substitute:

 a

the applicant fails to comply with a notice under section 41FH within 10 working days after the end of the period specified in the notice; or

 3 Application of amendments

The amendments of sections 41FH and 41FK of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications made on or after the commencement of this item.

 Failure to comply with requirements to provide information etc.

Therapeutic Goods Act 1989

 1 After paragraph 30(2)(c)

Insert:

 caa

all of the following subparagraphs apply:

 i

the Secretary gives the person a notice under section 31 that requires the person to give to the Secretary information, or to produce to the Secretary documents, relating to the goods;

 ii

subsection (1C) of this section does not apply to the notice;

 iii

the person fails to comply with that notice within a further 14 days after the end of the period specified in that notice; or

 2 After subsection 32JB(1)

Insert:

Note: A defendant bears an evidential burden in relation to the matter in subsection (1A): see subsection 13.3(3) of the Criminal Code.

 1A

Subsection (1) does not apply if the person has a reasonable excuse.

 3 After subsection 41JB(3)

Insert:

Note: A defendant bears an evidential burden in relation to the matter in subsection (3A): see subsection 13.3(3) of the Criminal Code.

 3A

Subsection (3) does not apply if the person has a reasonable excuse.

 4 Application of amendments 1

(1) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under section 31 of that Act on or after the commencement of this item, whether the goods in relation to which the notice is given are registered or listed before or after that commencement.section 30 of the

2

(2) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under section 32JA of that Act on or after the commencement of this item.section 32JB of the

3

(3) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given under section 41JA of that Act on or after the commencement of this item.section 41JB of the

Other amendments

Therapeutic Goods Act 1989

 1 After section 41

Insert:

 41AAAA Withdrawal of revocation of licence upon request 1

If:

 a

the Secretary revokes a licence because of the request of a person made under paragraph 41(1)(d); and

 b

before the end of the period of 90 days beginning on the day the licence was revoked, the person requests, in writing, the Secretary to withdraw the revocation; and

 c

the request is accompanied by the prescribed application fee (if any);

the Secretary may, by notice in writing given to the person, withdraw the revocation.

 2

If the revocation is withdrawn, the revocation is taken never to have occurred.

 2 Section 41ES

Before “The Secretary”, insert “(1)”.

 3 At the end of section 41ES

Add:

the Secretary may, by notice in writing given to the manufacturer, withdraw the revocation.

 2

If:

 a

the Secretary revokes a certificate under subsection (1); and

 b

before the end of the period of 90 days beginning on the day the certificate was revoked, the manufacturer requests, in writing, the Secretary to withdraw the revocation; and

 c

the request is accompanied by the prescribed application fee (if any);

 3

If the revocation is withdrawn, the revocation is taken never to have occurred.

 4 After section 41GL

Insert:

 41GLA Revocation of cancellation of entries upon request 1

If:

 a

the Secretary cancels the entry of a kind of medical device because of the request of a person made under paragraph 41GL(d); 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 requests, in writing, the Secretary to revoke the cancellation; and

 c

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.

 5 After subsection 60(5)

Insert:

the Secretary must, as soon as practicable after the revocation, cause to be published in the Gazette, or on the Department’s website, a notice setting out particulars of the revocation.

the Secretary must, as soon as practicable after the substituted decision is made, cause to be published in the Gazette, or on the Department’s website, a notice setting out particulars of the substituted decision.

 5A

If:

 a

(a) the initial decision is one the particulars of which are required to be published in the Gazette or on the Department’s website; and

 b

the Minister revokes the initial decision;

 5B

If:

 a

(a) the initial decision is one the particulars of which are required to be published in the Gazette or on the Department’s website; and

 b

(b) the Minister revokes the initial decision and makes a decision (the substituted decision) in substitution for the initial decision;

 6 Application of amendments 1

(1) Section 41AAAA of the Therapeutic Goods Act 1989, as inserted by this Schedule, applies in relation to revocations under section 41 of that Act occurring on or after the commencement of this item.

 2

(2) The amendments of Therapeutic Goods Act 1989 made by this Schedule apply in relation to revocations under that section of that Act occurring on or after the commencement of this item.section 41ES of the

3

(3) Section 41GLA of the Therapeutic Goods Act 1989, as inserted by this Schedule, applies in relation to cancellations under section 41GL of that Act occurring on or after the commencement of this item.

 4

(4) The amendment of Therapeutic Goods Act 1989 made by this Schedule applies in relation to requests for reconsideration made on or after the commencement of this item.section 60 of the

[Minister’s second reading speech made in—

House of Representatives on 12 December 2013

Senate on 12 February 2014]

(236/13)