Federal Register of Legislation - Australian Government

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Regulations as made
This instrument amends the Competition and Consumer Regulations 2010 by repealing and substituting regulation 92AA to prescribe a process that complementary medicines have undergone in Australia, authorised by a licence, to be substantially transformed for the purposes of paragraph 255(2)(c) of the Australian Consumer Law.
Administered by: Treasury
Registered 11 Dec 2020
Table of contents.

Commonwealth Coat of Arms of Australia

 

Competition and Consumer Amendment (Australian Consumer Law—Country of Origin Representations) Regulations 2020

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 10 December 2020

David Hurley

Governor‑General

By His Excellency’s Command

Karen Andrews

Minister for Industry, Science and Technology

 

 

 

  

  


Contents

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

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

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

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

Schedule 1—Amendments                                                                                                                          2

Competition and Consumer Regulations 2010                                                                                2

 


1  Name

                   This instrument is the Competition and Consumer Amendment (Australian Consumer Law—Country of Origin Representations) 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

The day after this instrument is registered.

12 December 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 section 139G of the Competition and Consumer Act 2010.

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

  

Competition and Consumer Regulations 2010

1  Regulation 92AA

Repeal the regulation, substitute:

92AA  Process substantially transforming medicines in Australia

             (1)  For the purposes of paragraph 255(2)(c) of the Australian Consumer Law, this regulation prescribes a process that medicines have undergone in Australia to be substantially transformed in Australia.

             (2)  This regulation applies to medicines that are complementary medicines (within the meaning of the Therapeutic Goods Regulations 1990) and are either:

                     (a)  listed goods; or

                     (b)  registered goods.

             (3)  The process is the carrying out of the last step (except one covered by subregulation (4)) in the manufacture of the dosage form of medicines that:

                     (a)  occurs at premises in Australia; and

                     (b)  is authorised by a licence to occur in relation to those medicines at those premises.

             (4)  This subregulation covers the following steps:

                     (a)  covering of the dosage form of medicines in containers;

                     (b)  packaging of the dosage form of medicines;

                     (c)  labelling of the dosage form of medicines;

                     (d)  storage of the dosage form of medicines (whether in packaging or not);

                     (e)  testing of the dosage form of medicines;

                      (f)  release for supply of the dosage form of medicines.

             (5)  A term (except “process”) used in this regulation and the Therapeutic Goods Act 1989 has the same meaning in this regulation as it has in that Act.

Note:          Terms whose meaning is affected include “containers”, “dosage form”, “labelling”, “licence”, “listed goods”, “manufacture”, “medicines”, “packaging”, “premises”, “registered goods”, “release for supply”, “storage” and “testing”.