Federal Register of Legislation - Australian Government

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SLI 2015 No. 214 Regulations as made
This regulation amends the Therapeutic Goods Regulations 1990 to revise the basis on which application and evaluation fees for over the counter medicines are determined.
Administered by: Health
Registered 01 Dec 2015
Tabling HistoryDate
Tabled HR02-Dec-2015
Tabled Senate03-Dec-2015
Date of repeal 02 Jan 2016
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003
Table of contents.

 

Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015

 

Select Legislative Instrument No. 214, 2015

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 26 November 2015

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Fiona Nash

Minister for Rural Health

  

  


Contents

1............ Name................................................................................................... 1

2............ Commencement................................................................................... 1

3............ Authority............................................................................................. 1

4............ Schedules............................................................................................ 1

Schedule 1—Amendments                                                                                                2

Therapeutic Goods Regulations 1990                                                                     2

 


1  Name

                   This is the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015.

2  Commencement

             (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.  The whole of this instrument

1 January 2016.

1 January 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Note:          This table relates only to the provisions of this instrument as originally made.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.

             (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.

3  Authority

                   This instrument is made under the Therapeutic Goods Act 1989.

4  Schedules

                   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

  

Therapeutic Goods Regulations 1990

1  Regulation 2

Insert:

C1 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C1 (section 23) application has the meaning given by Part 1 of Schedule 9.

C2 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C2 (section 23) application has the meaning given by Part 1 of Schedule 9.

C3 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C3 (section 23) application has the meaning given by Part 1 of Schedule 9.

C4 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C4 (section 23) application has the meaning given by Part 1 of Schedule 9.

N1 application has the meaning given by Part 1 of Schedule 9.

N2 application has the meaning given by Part 1 of Schedule 9.

N3 application has the meaning given by Part 1 of Schedule 9.

N4 application has the meaning given by Part 1 of Schedule 9.

N5 application has the meaning given by Part 1 of Schedule 9.

2  After regulation 10A

Insert:

10AA  Prescribed requests for variations of entries in Register

                   A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:

                     (a)  the definition of C1 (section 9D) application;

                     (b)  the definition of C2 (section 9D) application;

                     (c)  the definition of C3 (section 9D) application;

                     (d)  the definition of C4 (section 9D) application.

3  Paragraph 43(1)(a)

After “Part 2”, insert “or 3”.

4  Subregulation 43(2)

After “item 9”, insert “in Part 2”.

5  Subregulations 43A(1) and (2)

After “item 2 or 3”, insert “in Part 2”.

6  Paragraph 43AA(a)

After “payable under”, insert “Part 2 of”.

7  Subregulation 43AB(1)

After “item 9AB”, insert “in Part 2”.

8  After regulation 43AB

Insert:

43AC  Refund of fees where no evaluation undertaken—registered OTC medicines

             (1)  This regulation applies if:

                     (a)  a person makes an application of a kind mentioned in item 6 of the table in Part 3 of Schedule 9; and

                     (b)  the person has paid the application fee required under that item in respect of the application; and

                     (c)  an evaluation of documentation in respect of the application is not undertaken.

             (2)  The Secretary must refund to the person the following amount:

                     (a)  for a C2 (section 9D) application—$3 780;

                     (b)  for a C3 (section 9D) application—$6 330;

                     (c)  for a C4 (section 9D) application—$8 270.

9  Paragraph 45(8)(e)

After “item 6 in”, insert “Part 2 of”.

10  Paragraph 45(10)(e)

After “item 7 in”, insert “Part 2 of”.

11  Subregulation 45AA(1)

Omit “Schedule 9”, substitute “Part 2 of Schedule 9 or”.

12  At the end of Part 9

Add:

Division 3Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015

50  Application

                   The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.

13  Schedule 5A (table item 3, paragraph (b) of column 3)

After “item 14 or 14A”, insert “in Part 2”.

14  Part 1 of Schedule 9 (heading)

Repeal the heading, substitute:

Part 1Interpretation

15  Subclause 1(1) of Part 1 of Schedule 9

Insert:

C1 (section 9D) application means a request made under subsection 9D(1), (2) or (3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C1 (section 9D) application.

C1 (section 23) application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in the manner approved by the Secretary under paragraph 23(1)(a) of the Act for a C1 (section 23) application.

C2 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C2 (section 9D) application.

C2 (section 23) application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in the manner approved by the Secretary under paragraph 23(1)(a) of the Act for a C2 (section 23) application.

C3 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C3 (section 9D) application.

C3 (section 23) application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in the manner approved by the Secretary under paragraph 23(1)(a) of the Act for a C3 (section 23) application.

C4 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C4 (section 9D) application.

C4 (section 23) application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in the manner approved by the Secretary under paragraph 23(1)(a) of the Act for a C3 (section 23) application.

N1 application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in a manner approved by the Secretary under paragraph 23(1)(a) of the Act for an N1 application.

N2 application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in a manner approved by the Secretary under paragraph 23(1)(a) of the Act for an N2 application.

N3 application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in a manner approved by the Secretary under paragraph 23(1)(a) of the Act for an N3 application.

N4 application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in a manner approved by the Secretary under paragraph 23(1)(a) of the Act for an N4 application.

N5 application means an application made under subsection 23(1) of the Act to register an OTC medicine that is made in a manner approved by the Secretary under paragraph 23(1)(a) of the Act for an N5 application.

16  At the end of Part 1 of Schedule 9

Add:

2  Part 2 fees do not apply in relation to applications and evaluations covered by Part 3

                   The fees prescribed in Part 2 do not apply in relation to applications and evaluations covered by Part 3.

17  Part 2 of Schedule 9 (heading)

Repeal the heading, substitute:

Part 2Table of fees other than for applications and evaluations covered by Part 3

18  Part 2 of Schedule 9 (before the table)

Insert:

3  Table of fees

                   The following table sets out particular fees other than fees for applications and evaluations covered by Part 3.

19  Part 2 of Schedule 9 (table item 9D, column 2)

After “item 4 or 5”, insert “, or in Part 3 of this Schedule,”.

20  At the end of Schedule 9

Add:

Part 3Table of particular application and evaluation fees in relation to certain OTC medicines

  

4  Table of application and evaluation fees

                   The following table sets out particular application and evaluation fees in relation to OTC medicines that are, or are to be, registered goods.

 

 

Application and evaluation fees

 

Column 1
Item

Column 2
Matter

Column 3
Fee $

1

Application fee under paragraph 23(2)(a) of the Act:

 

 

(a) for an N1 application

1 530

 

(b) for an N2 application

1 530

 

(c) for an N3 application

2 450

 

(d) for an N4 application

3 575

 

(e) for an N5 application

5 310

 

(f) for a C1 (section 23) application

1 530

 

(g) for a C2 (section 23) application

1 530

 

(h) for a C3 (section 23) application

1 530

 

(i) for a C4 (section 23) application

2 450

2

Evaluation fee under subsection 24(1) of the Act:

 

 

(a) for an N1 application

3 780

 

(b) for an N2 application

5 360

 

(c) for an N3 application

8 270

 

(d) for an N4 application

13 700

 

(e) for an N5 application

20 300

 

(f) for a C2 (section 23) application

3 780

 

(g) for a C3 (section 23) application

6 330

 

(h) for a C4 (section 23) application

8 270

3

If, at the time a person submits an application of a kind mentioned in paragraph (a), (b), (c), (d) or (e) of item 1:

 

 

(a) the person also submits an additional application or applications of the same kind; and

 

 

(b) each application relates to goods that contain the same therapeutically active ingredient; and

 

 

(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made;

 

 

the application fee under paragraph 23(2)(a) of the Act for each additional application is:

 

 

(d) for an additional N1 application

765

 

(e) for an additional N2 application

765

 

(f) for an additional N3 application

1 225

 

(g) for an additional N4 application

1 225

 

(h) for an additional N5 application

1 225

4

If, at the time a person submits an application of a kind mentioned in paragraph (c), (d) or (e) of item 2:

 

 

(a) the person also submits an additional application or applications of the same kind; and

 

 

(b) each application relates to goods that contain the same therapeutically active ingredient; and

 

 

(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made;

 

 

the evaluation fee under subsection 24(1) of the Act for each additional application is:

 

 

(d) for an additional N3 application

4 185

 

(e) for an additional N4 application

4 185

 

(f) for an additional N5 application

4 185

5

Application fee under paragraph 9D(7)(f) of the Act for a C1 (section 9D) application

1 530

6

Application fee under paragraph 9D(7)(f) of the Act:

 

 

(a) for a C2 (section 9D) application

5 310

 

(b) for a C3 (section 9D) application

7 860

 

(c) for a C4 (section 9D) application

10 720