Federal Register of Legislation - Australian Government

Primary content

Regulations as made
These regulations amend the Therapeutic Goods Regulations 1990 to extend the fee-free period under which sponsors of low risk medicines that were listed in the Australian Register of Therapeutic Goods on 6 March 2018 may apply without charge to re-list their medicines in accordance with those reforms.
Administered by: Health
Exempt from sunsetting by the Legislation (Exemptions and Other Matters) Regulation 2015 s12 item 63AA
Registered 25 Sep 2019
Tabling HistoryDate
Tabled HR14-Oct-2019
Tabled Senate14-Oct-2019
To be repealed 06 Dec 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019

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

Dated 19 September 2019

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for 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 instrument is the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019.

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

The day after this instrument is registered.

26 September 2019

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  Paragraph 43A(4)(d)

Omit “within the period of 18 months beginning on 6 March 2018”, substitute “before the end of 5 March 2021”.

2  In the appropriate position in Part 9

Insert:

Division 11Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019

68  Application and transitional provisions

             (1)  The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.

             (2)  If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:

                     (a)  made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and

                     (b)  paid the fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 in relation to the application;

the Secretary must, on behalf of the Commonwealth, refund to the person an amount equal to the fee paid.