Commonwealth Coat of Arms of Australia

 

National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 1) Regulations 2020

I, General the Honourable David Hurley AC DSC (Retd), GovernorGeneral of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 11 June 2020

David Hurley

GovernorGeneral

By His Excellencys Command

Greg Hunt

Minister for Health

 

 

 

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009

1  Name

  This instrument is the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 1) Regulations 2020.

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 July 2020.

1 July 2020

Note: This table relates only to the provisions of this instrument as originally made.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 National Health Act 1953.

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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

 

National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009

1  Subregulation 1A.1(1)

Omit On or after 1 July 2020, a, substitute A.

2  Subregulation 1A.1(2)

Omit $300,440, substitute $180,960.

3  Subregulation 1A.2(3)

Omit $178,550, substitute $103,270.

4  Subregulation 1A.2(6)

Omit “21day period”, substitute “period of 15 business days”.

5  Subregulation 1A.4(1)

Omit 21 days, substitute 15 business days.

6  Subregulations 1A.5(2) and 1A.10(1)

Omit 14 days, substitute 10 business days.

7  Paragraph 1A.11(2)(a)

Omit “15th day”, substitute “11th business day”.

8  Regulation 2.1A (paragraph beginning “If the person’s application”)

Omit “and is in the major or minor evaluation category, the person will need to have given the Department prior notice at least 28 days”, substitute “the person will need to have given the Department prior notice at least 20 business days”.

9  Subregulation 2.2(1) (table item 4)

Omit “$10,880”, substitute “$11,280”.

10  Regulation 2.15 (heading)

Omit major or minor applications to the Committee, substitute most applications.

11  Subregulation 2.15(1)

Omit or 2, substitute , 2 or 4.

12  Paragraph 2.15(1)(b)

Omit “28 days”, substitute “20 business days”.

13  Paragraph 2.15(5)(c)

Repeal the paragraph, substitute:

 (c) be sent to:

 (i) the office of the Department administering the Committee; or

 (ii) if the prior notice is of an application for the Minister to exercise a power mentioned in item 3.1 of Schedule 1—the office of the Department administering applications about that item.

14  Subregulation 2.17(1) (heading)

Omit proposed major or minor applications for the Committee, substitute prior notices of applications.

15  Subregulation 2.17(1)

Omit 14 days, substitute 10 business days.

16  Subregulation 2.17(2)

Omit “21 days”, substitute “15 business days”.

17  Subregulation 2.18(2)

Omit 14 days, substitute 10 business days.

18  Paragraph 2.18(3)(c)

Omit 14 days, substitute 10 business days.

19  Regulation 3.1 (paragraph beginning “The person”)

Omit “7 days”, substitute “5 business days”.

20  Subregulation 3.2(1)

After under, insert subsection 85(2), (2A) or (3), paragraph 85(7)(b) or.

21  Paragraph 3.10(1)(b)

Omit 7 days, substitute 5 business days.

22  Subregulation 3.10(1) (note 2)

Omit 42 days, substitute 30 business days.

23  Subregulation 3.10(4)

Omit 7 days, substitute 5 business days.

24  Paragraph 3.11(1)(d)

Omit 42 days, substitute 30 business days.

25  Subregulation 3.12(1)

Omit 14 days, substitute 10 business days.

26  Subregulation 3.12(2)

Omit 21 days, substitute 15 business days.

27  Subregulation 3.13(2)

Omit 14 days, substitute 10 business days.

28  Paragraph 3.13(3)(c)

Omit 14 days, substitute 10 business days.

29  Subregulations 3A.3(1) and 3A.4(2)

Omit 14 days, substitute 10 business days.

30  Subregulation 4.1(4)

Omit 28 days, substitute 20 business days.

31  Subregulation 6.1(1)

Omit 14 days, substitute 10 business days.

32  Subparagraph 6.2(2)(a)(i)

Omit 14 days, substitute 10 business days.

33  Subregulations 6.2(3), (4) and (5)

Omit 14 days, substitute 10 business days.

34  Regulation 6.4

Omit 28 days, substitute 20 business days.

35  Before regulation 7.1

Insert:

Division 1Application of these Regulations as originally made

36  Before regulation 7.2

Insert:

Division 2Application and transitional provisions relating to 2019 amendments

37  In the appropriate position in Part 7

Insert:

Division 3Application and transitional provisions relating to amendments commencing on 1 July 2020

7.3  Application of amendments of regulation 2.15

  The amendments of regulation 2.15 made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to proposed applications whose submission due day is after 28 July 2020.