Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 (Cth)

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Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation.

Dated 11 February 2016

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Fiona Nash

Minister for Rural Health

Contents

1Name

This is the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016.

2Commencement
  1. (1)

    Each provision of this instrument 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.

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.

Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

16 February 2016

2.

Schedule 1

1 July 2015.

1 July 2015

3.

Schedules 2 and 3

The day after this instrument is registered.

16 February 2016

4.

Schedule 4, Part 1

A single day to be fixed by the Minister by notice in the Gazette.

However, if the provisions do not commence within the period of 6 months beginning on the day after this instrument is registered, they commence on the day after the end of that period.

16 August 2016

5.

Schedule 4, Parts 2 and 3

The day after this instrument is registered.

16 February 2016

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

  1. (2)

    Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3Authority

This instrument is made under the Therapeutic Goods Act 1989.

4Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments relating to charges exemptions

Therapeutic Goods Regulations 1990

1

Regulation 2

Insert:

Class III medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Finance Minister means the Minister who administers the Public Governance, Performance and Accountability Act 2013.

joint replacement medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

2

Subregulation 43AAC(1)

Omit “or (5)”, substitute “, (5), (5A) or (5B)”.

3Paragraph 43AAC(4)(b)

Repeal the paragraph, substitute:

  1. (b)

    either:

    1. (i)

      the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or

    2. (ii)

      before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013,authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and

4

Paragraph 43AAC(5)(b)

Repeal the paragraph, substitute:

  1. (b)

    for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015, either:

    1. (i)

      the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or

    2. (ii)

      before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013,authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and

5

After subregulation 43AAC(5)

Insert:

Inclusion in Register of certain joint replacement medical devices on or after 1 July 2014 and on or before 30 June 2015

  1. (5A)

    The requirements in this subregulation are met if:

    1. (a)

      the therapeutic goods are a joint replacement medical device; and

    2. (b)

      the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and

    3. (c)

      the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and

    4. (d)

      the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and

    5. (e)

      the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and

    6. (f)

      the person’s turnover of the medical device for the 2015‑16 financial year was of low value; and

    7. (g)

      the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.

Inclusion in Register of certain joint replacement medical devices on or before 30 June 2014

  1. (5B)

    The requirements in this subregulation are met if:

    1. (a)

      the therapeutic goods are a joint replacement medical device; and

    2. (b)

      the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and

    3. (c)

      the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and

    4. (d)

      the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and

    5. (e)

      the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and

    6. (f)

      the person’s turnover of the medical device for the 2015‑16 financial year was of low value; and

    7. (g)

      the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.

6

Paragraph 43AAE(2)(c)

Omit “or (5)(d)”, substitute “, (5)(d), (5A)(e) or (5B)(e)”.

Schedule 2Amendments relating to exemptions for IVD medical devices

Therapeutic Goods Regulations 1990

1

Regulation 2

Insert:

Class 1 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class 2 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class 3 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class 4 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

in‑house IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

IVD device means an IVD medical device:

  1. (a)

    that is:

    1. (i)

      a Class 1 IVD medical device; or

    2. (ii)

      a Class 2 IVD medical device; or

    3. (iii)

      a Class 3 IVD medical device; or

    4. (iv)

      a Class 4 IVD medical device; and

  2. (b)

    that is not an in‑house IVD medical device.

IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

2

Paragraph 43AAB(1)(a)

After “43AAF”, insert “or 43AAGE”.

3

Paragraph 43AAB(1)(b)

Omit “or 43AAD”, substitute “, 43AAD, 43AAGB or 43AAGC”.

4

Subdivision 2 of Division 1 of Part 7 (heading)

Repeal the heading, substitute:

Subdivision 2—Exemption from liability to pay certain annual charges—therapeutic goods other than IVD devices

5

Before regulation 43AABA

Insert:

43AAAAApplication

This Subdivision does not apply to IVD devices.

6

Regulation 43AABA

Repeal the regulation, substitute:

43AABAPurpose of this Subdivision

For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.

7

After regulation 43AAG

Insert:

Subdivision 2A—Exemption from liability to pay annual charge—IVD devices

43AAGAPurpose of this Subdivision

For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.

43AAGBExemption from liability to pay annual charge—2017‑18 financial year

Inclusion of IVD device in Register commencing in 2017‑18 financial year

  1. (1)

    A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:

    1. (a)

      the inclusion of the device in the Register commenced in the 2017‑18 financial year; and

    2. (b)

      the person’s turnover of the device for the 2017‑18 financial year is of low value; and

    3. (c)

      the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.

Inclusion of IVD device in Register on or before 30 June 2017

  1. (2)

    A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:

    1. (a)

      the inclusion of the device in the Register commenced on or before 30 June 2017; and

    2. (b)

      the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and

    3. (c)

      the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and

    4. (d)

      the person’s turnover of the device for the 2017‑18 financial year was of low value; and

    5. (e)

      the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.

    Note 1: See regulation 43AAA for the meaning of turnover and when turnover is of low value.

    Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

    Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.

    Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.

    Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.

43AAGCExemption from liability to pay annual charge—financial years commencing on or after 1 July 2018

A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:

  1. (a)

    either:

    1. (i)

      the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or

    2. (ii)

      the inclusion in the Register of the device commenced in the current financial year;

  2. (b)

    the person’s turnover of the device for the current financial year is of low value;

  3. (c)

    the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.

Note 1: See regulation 43AAA for the meaning of turnover and when turnover is of low value.

Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.

Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.

Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.

43AAGDExemption from liability to pay annual charge—late notice that turnover was of low value

  1. (1)

    This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.

  2. (2)

    The person may, on or before 15 September in the next financial year, give the Secretary, in writing:

    1. (a)

      a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and

    2. (b)

      a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and

    3. (c)

      if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).

    Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

  3. (3)

    The documents given under subregulation (2) must be accompanied by the fee payable.

  4. (4)

    The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:

    1. (a)

      the notice referred to in paragraph (2)(a); and

    2. (b)

      the declaration referred to in paragraph (2)(b); and

    3. (c)

      if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and

    4. (d)

      the fee referred to in subregulation (3).

  5. (5)

    If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.

  6. (6)

    If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:

    1. (a)

      states that the person is liable to pay the charge for the relevant financial year; and

    2. (b)

      states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:

      1. (i)

        the person did not give the documents to the Secretary by the required date;

      2. (ii)

        one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);

      3. (iii)

        the documents were not accompanied by the correct fee; and

    3. (c)

      specifies the date on which the charge for the relevant financial year becomes payable.

43AAGEPerson may notify Secretary that turnover of IVD device for financial year will not be of low value

  1. (1)

    This regulation applies in relation to the following:

    1. (a)

      an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;

    2. (b)

      an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.

  2. (2)

    If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.

  3. (3)

    As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.

    Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).

43AAGFSecretary may notify person that annual charge is payable if turnover is not of low value

IVD device entered in Register at any time in 2017‑18 financial year

  1. (1)

    If:

    1. (a)

      an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and

    2. (b)

      the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and

    3. (c)

      the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and

    4. (d)

      the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;

the Secretary must give the person a written notice in accordance with subregulation (2).

  1. (2)

    A notice given to a person under subregulation (1) must:

    1. (a)

      state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:

      1. (i)

        for the 2017‑18 financial year; or

      2. (ii)

        for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and

    2. (b)

      specify the date on which the relevant charge, or charges, become payable.

IVD device entered in Register at any time in financial year commencing on or after 1 July 2018

  1. (3)

    If:

    1. (a)

      an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and

    2. (b)

      the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and

    3. (c)

      the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and

    4. (d)

      the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;

the Secretary must give the person a written notice in accordance with subregulation (4).

  1. (4)

    A notice given to a person under subregulation (3) must:

    1. (a)

      state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:

      1. (i)

        for the relevant financial year; or

      2. (ii)

        for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and

    2. (b)

      specify the date on which the relevant charge, or charges, become payable.

Subdivision 2B—Waiver of certain annual charges

43AAGGPurpose of Subdivision

For section 44A of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.

Schedule 3Amendments relating to medical devices

Therapeutic Goods (Medical Devices) Regulations 2002

1

Subregulation 1.4(2)

Repeal the subregulation, substitute:

  1. (2)

    This regulation does not apply to an IVD medical device.

2

Subregulation 5.3(1)

After “subject to subregulation (2)”, insert “or (2A)”.

3

After subregulation 5.3(2)

Insert:

  1. (2A)

    Subregulation (1) does not apply to an application for a medical device that is covered by clause 5.8 of Schedule 2 or clause 1.8 of Schedule 2A.

4

Subregulation 7.3(2)

Omit “National Manager of the Therapeutic Goods Administration”, substitute “Secretary”.

5

At the end of regulation 8.1A

Add:

  1. ; (j)

    matters relating to:

    1. (i)

      any malfunction or deterioration in the characteristics or performance of the devices; or

    2. (ii)

      any inadequacy in the design, manufacture, labelling, instructions for use or advertising materials of the devices; or

    3. (iii)

      any use in accordance with, or contrary to, the use intended by the manufacturer of the devices;

that has led to any complaint or problem in relation to the devices, no matter how minor;

  1. (k)

    matters of the kind mentioned in subsection 41MP(2) of the Act;

  2. (l)

    whether the devices comply with conditions to which the inclusion of the devices in the Register is subject;

  3. (m)

    matters relating to the formulation of ingredients that constitute the devices.

6

Subregulation 10.3(1)

After “must”, insert “, within 2 months after the medical device is first manufactured in Australia,”.

7

Subregulation 10.3(2)

After “must”, insert “, within 2 months after the medical device is first imported into Australia,”.

8

Regulation 10.5

Omit all the words after “Regulations”, substitute “to an officer of the Department”.

9

After regulation 10.6

Insert:

10.6ADelegation of Secretary’s powers under section 41HD of the Act

The following positions are prescribed for the purposes of paragraph 57(9)(b) of the Act:

  1. (a)

    First Assistant Secretary, Medicines Regulation Division;

  2. (b)

    First Assistant Secretary, Medical Devices and Product Quality Division;

  3. (c)

    Principal Medical Adviser, Regulatory Services Group.

10

Subregulation 10.7(2)

Omit all the words after “regulation”, substitute “to an officer of the Department”.

11

At the end of Part 11

Add:

Division 11.4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016

11.27Application

  1. (1)

    The amendments made by items 1, 12 and 13 of Schedule 3 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to medical devices included in the Register on or after the day that Schedule commences if the application for inclusion in the Register was made on or after that day.

12

Paragraph 10(3)(a) of Schedule 1

After “measurement”, insert “or be compared to at least one point of reference indicated in Australian legal units of measurement”.

13

Paragraph 10(3)(b) of Schedule 1

After “approved”, insert “in writing”.

  1. 14

    Dictionary (at the end of the definition of intended purpose)

Add:

  1. ; or (d)

    any technical documentation describing the mechanism of action of the device.

Schedule 4Other amendmentsPart 1Sponsor transfers

Therapeutic Goods Regulations 1990

1

Regulation 10A

Repeal the regulation.

2

After regulation 10AA

Insert:

10ABChange of person in whose name goods are listed or registered

Application

  1. (1)

    This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.

Death of person

  1. (2)

    If the relevant person dies, the legal personal representative (the notifying person) of the dead person:

    1. (a)

      is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person

  1. (3)

    If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:

    1. (a)

      is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate

  1. (4)

    If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:

    1. (a)

      is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business

  1. (5)

    If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:

    1. (a)

      is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

    2. (b)

      must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.

Secretary may request further information

  1. (6)

    If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.

Secretary must amend the Register and provide new certificate

  1. (7)

    If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:

    1. (a)

      amend the Register accordingly; and

    2. (b)

      as soon as practicable after amending the Register:

      1. (i)

        inform the person of the amendment; and

      2. (ii)

        make available to the person a certificate of registration or listing.

10ACChange of name of person

Application

  1. (1)

    This regulation applies in relation to a person in relation to whom therapeutic goods are registered or listed.

Change of name of person

  1. (2)

    If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.

Secretary may request further information

  1. (3)

    The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.

Secretary must amend the Register and provide new certificate

  1. (4)

    If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:

    1. (a)

      amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and

    2. (b)

      as soon as practicable after entering the new name:

      1. (i)

        inform the person that the new name has been entered in the Register; and

      2. (ii)

        make available to the person a new certificate of registration or listing.

3

Regulation 10F

Repeal the regulation, substitute:

10FChange of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act

Application

  1. (1)

    This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.

Death of person

  1. (2)

    If the relevant person dies, the legal personal representative (the notifying person) of the dead person:

    1. (a)

      is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person

  1. (3)

    If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:

    1. (a)

      is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate

  1. (4)

    If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:

    1. (a)

      is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business

  1. (5)

    If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:

    1. (a)

      is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and

    2. (b)

      must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.

Secretary may request further information

  1. (6)

    If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.

Secretary must amend the Register and provide new certificate

  1. (7)

    If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:

    1. (a)

      amend the Register accordingly; and

    2. (b)

      as soon as practicable after amending the Register:

      1. (i)

        inform the person of the amendment; and

      2. (ii)

        make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.

10FAChange of name of person

Application

  1. (1)

    This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.

Change of name of person

  1. (2)

    If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.

Secretary may request further information

  1. (3)

    The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.

Secretary must amend the Register and provide new certificate

  1. (4)

    If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:

    1. (a)

      amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

    2. (b)

      as soon as practicable after entering the new name:

      1. (i)

        inform the person that the new name has been entered in the Register; and

      2. (ii)

        make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.

4

Regulation 10H

Repeal the regulation, substitute:

10HChange of person for whom a biological is included in the Register under Part 3‑2A of the Act

Application

  1. (1)

    This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.

Death of person

  1. (2)

    If the relevant person dies, the legal personal representative (the notifying person) of the dead person:

    1. (a)

      is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person

  1. (3)

    If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:

    1. (a)

      is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate

  1. (4)

    If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:

    1. (a)

      is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business

  1. (5)

    If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:

    1. (a)

      is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

    2. (b)

      must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.

Secretary may request further information

  1. (6)

    If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.

Secretary must amend the Register and provide new certificate

  1. (7)

    If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:

    1. (a)

      amend the Register accordingly; and

    2. (b)

      as soon as practicable after amending the Register:

      1. (i)

        inform the person of the amendment; and

      2. (ii)

        make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.

10HAChange of name of person

Application

  1. (1)

    This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.

Change of name of person

  1. (2)

    If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.

Secretary may request further information

  1. (3)

    The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.

Secretary must amend the Register and provide new certificate

  1. (4)

    If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:

    1. (a)

      amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

    2. (b)

      as soon as practicable after entering the new name:

      1. (i)

        inform the person that the new name has been entered in the Register; and

      2. (ii)

        make available to the person a new certificate of the inclusion of the biological in the Register under that Part.

  1. 5

    Subregulation 48(1) (paragraphs (c), (d) and (da) of the definition of initial decision)

Repeal the paragraphs.

Part 2References to National Manager etc.

Therapeutic Goods Regulations 1990

  1. 6

    Regulation 2 (definition of Required Advisory Statements for Medicine Labels)

Repeal the definition, substitute:

Required Advisory Statements for Medicine Labelsmeans the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.

7

Subregulation 5Q(1)

Omit all the words after “5N”, substitute “to an officer of the Department”.

8

Paragraph 7(1)(a)

Omit “12(1A)”, substitute “12(2)”.

9

Subregulation 12AB(2)

Omit “National Manager, Therapeutic Goods Administration”, substitute “Secretary”.

10

Subregulation 42(2)

Omit “National Manager of the Therapeutic Goods Administration”, substitute “Secretary”.

11

Subregulation 46A(1)

Repeal the subregulation, substitute:

  1. (1)

    For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.

12

Paragraphs 46A(2)(a) and (b)

Repeal the paragraphs, substitute:

  1. (a)

    First Assistant Secretary, Medicines Regulation Division;

  2. (b)

    First Assistant Secretary, Medical Devices and Product Quality Division;

  1. (c)

    Principal Medical Adviser, Regulatory Services Group.

13

Subregulation 47(1)

Omit all the words after “Regulations”, substitute “to an officer of the Department”.

14

Subregulation 47(1A)

Omit all the words after “be given”, substitute “only to the First Assistant Secretary of, or an Assistant Secretary in, a Division in the Department that is responsible for the administration of therapeutic goods”.

15

Subregulation 48(1A)

Omit all the words after “regulation”, substitute “to an officer of the Department”.

16

Part 1 of Schedule 10 (heading)

Repeal the heading, substitute:

Part 1—Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch

  1. 17

    Part 1 of Schedule 10 (table item 14, column 2)

Omit “Office of Medicines Authorisation”, substitute “Prescription Medicines Authorisation Branch”.

18

Part 2 of Schedule 10 (heading)

Repeal the heading, substitute:

Part 2—Evaluation of complementary medicines by the Complementary and OTC Medicines Branch

19

Part 2 of Schedule 10 (table item 3, column 2)

Omit “Office of Complementary Medicines”, substitute “Complementary and OTC Medicines Branch”.

20

Part 3 of Schedule 10 (heading)

Repeal the heading, substitute:

Part 3—Evaluation of non‑prescription and other medicines by the Complementary and OTC Medicines Branch

21

Part 3 of Schedule 10 (table item 5, column 2)

Omit “Office of Medicines Authorisation”, substitute “Complementary and OTC Medicines Branch”.

22

Paragraph 3(1)(l) of Schedule 15

Omit “office of the Therapeutic Goods Administration”, substitute “Department”.

  1. 23

    Subclause 4(4) of Schedule 15 (definition of authorised agent)

Omit “Therapeutic Goods Administration”, substitute “Department”.

Part 3Other amendments

Therapeutic Goods Regulations 1990

24

After subregulation 5M(2)

Insert:

  1. (2A)

    The request may be accompanied by information in support of the request.

25

At the end of subregulation 5M(4)

Add:

  1. ; or (c)

    if the decision is a decision of the Secretary under regulation 5K or 5L—revoke the decision without making a decision in substitution for the Secretary’s decision.

26

After subregulation 5M(4)

Insert:

  1. (4A)

    In making a decision under subregulation (4), the Minister:

    1. (a)

      must take into account any information referred to in subregulation (2A); and

    2. (b)

      must not take into account any other information provided by, or on behalf of, the applicant or approval holder after the making of the request, other than information provided in response to a request from the Minister.

  2. (4B)

    Paragraph (4A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the decision of the Secretary.

  1. 27

    Subregulation 16C(6) (definition of acceptable country)

Omit “Gazette”, substitute “Gazette or on the Department’s website”.

28

Subregulation 16J(5)

Omit “Gazette”, substitute “Gazette or on the Department’s website”.

29

Subregulation 25(2)

Omit “Gazette”, substitute “Gazette or on the Department’s website”.

30

Paragraph 47B(1)(c)

Repeal the paragraph, substitute:

  1. (c)

    a person (a sponsor) to whom any of the following applies:

    1. (i)

      an exemption under section 18, 32CA or 41HA of the Act;

    2. (ii)

      an approval under section 19, 32CK or 41HB of the Act;

    3. (iii)

      an authority under section 19, 32CM or 41HC of the Act.

31

At the end of Part 9

Add:

Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016

51Application

  1. (1)

    The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.

  2. (2)

    The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.

  1. 32

    Part 2 of Schedule 9 (table item 9, column 2, paragraph (b))

Omit “paragraphs 38(1)(c), 41(1)(f) and 58(3)(b) of the Act for”.

33

Part 2 of Schedule 9 (table items 14 and 14A)

Repeal the items, substitute:

14

Fee for notification required under item 3 of Schedule 5A:

(a) of intention to sponsor a clinical trial at a trial site using a specified medicine

335

(b) for each notification of an additional trial site or additional trial sites

335

14A

Fee for notification required under item 3 of Schedule 5A:

(a) of intention to sponsor a clinical trial at a trial site using a specified therapeutic device, if the sponsor of the device notifies the Secretary, in accordance with that item, of one or more bodies or organisations conducting the trial for the sponsor, including the sponsor, if the sponsor is conducting the trial (whether or not the sponsor has previously notified the Secretary of one or more bodies or organisations conducting the trial)

335

(b) for each notification of an additional trial site or additional trial sites

335

34

Part 2 of Schedule 9 (table item 18)

Repeal the item, substitute:

18

Fee for providing advice in relation to a prescription medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit

2 085

35

Part 2 of Schedule 9A (table item 17)

Repeal the item, substitute:

17

Fee for notification required under item 3 of Schedule 5A for a biological to which that Schedule applies:

(a) of intention to sponsor a clinical trial at a trial site using a biological

$320

(b) for each notification of an additional trial site or additional trial sites

$320

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