Federal Register of Legislation - Australian Government

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Proclamations/Commencement of Act as made
This Proclamation provides for the commencement of the Therapeutic Goods Amendment Act (No. 2) 2006.
Administered by: Health
Registered 31 Mar 2006
Tabling HistoryDate
Tabled HR09-May-2006
Tabled Senate09-May-2006
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

EXPLANATORY STATEMENT

 

 

Subject:       Therapeutic Goods Amendment Act (No. 2) 2006 - Proclamation

 

                   Proclamation        

 

Item 2 of subsection 2(1) of the Therapeutic Goods Amendment Act (No. 2) 2006 (the Act) provides that Schedule 1 to that Act commences on a day to be fixed by Proclamation. Item 2 also provides that if any of the provisions in Schedule 1 do not commence within the period of 6 months beginning on the day on which the Act receives Royal Assent, they commence on the first day after the end of that period. The Act received Royal Assent on 1 March 2006.

 

The purpose of the Proclamation is to fix 3 April 2006 as the day on which Schedule 1 to the Act commences. Schedule 1 contains the amendments to the Therapeutic Goods Act 1989 (the TG Act) to restrict patent certification requirements under subsection 26B(1) of the TG Act. A certificate in relation to patents is currently required to be provided by all applicants seeking to include therapeutic goods (with the exception of therapeutic and medical devices) in the Australian Register of Therapeutic Goods (ARTG), on or after 1 January 2005.

 

The amendments provided under Schedule 1 will:

 

  • restrict the patent certification requirement under the TG Act to only those applicants who have to submit safety or efficacy data of the goods as part of the process of applying for inclusion of their product in the ARTG, and who rely on safety or efficacy data previously submitted to the Therapeutic Goods Administration by another person in relation to an approved product, as part of the process of applying for approval of that product; and
  • require that applicants for the registration or listing of goods either notify the Secretary that the patent certification requirements under subsection 26B(1) do not apply or provide a certificate required under subsection 26B(1) in relation to patents.

 

The delayed commencement date of the provisions under Schedule 1 was sought to allow for the update and implementation of changes to the Electronic Listing Facility (ELF) for the listing of medicines in the ARTG under section 26A of the TG Act.  The required notifications by applicants in relation to patent certification requirements must be made through the ELF system which is the form to be approved by the Secretary. The amendments are expected to save the complementary healthcare industry the significant cost attributed to patent searches.

 

Consultation in relation to the commencement date of Schedule 1 to the Act was undertaken in preparation of the Act.  Further consultation was undertaken with the Complementary Healthcare Council of Australia, the complementary health care industry body in relation to the changes required to the ELF system.

 

The Proclamation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.