Federal Register of Legislation - Australian Government

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Proclamations/Commencement of Act as made
This Proclamation provides for the commencement of Schedule 2, Schedule 5 and Part 2 of Schedule 7 of the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009.
Administered by: Health
Registered 16 Dec 2009
Tabling HistoryDate
Tabled HR02-Feb-2010
Tabled Senate02-Feb-2010
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

EXPLANATORY STATEMENT

 

 

Therapeutic Goods Amendment (2009 Measures No.1) Act 2009

 

Proclamation

 

Subsection 2(1) of the Therapeutic Goods Amendment (2009 Measures No.1) Act 2009 (the Act) provides that Schedules 2, 5 and Part 2 of Schedule 7 to the Act commence on a single day to be fixed by Proclamation.  Items 3, 6 and 9 of subsection 2(1) of the Act provide that if any of the provisions of Schedule 2, 5 or Part 2 of Schedule 7 do not commence within the period of six months beginning on the day the Act receives the Royal Assent, they commence on the first day after the end of that period.  The Act received the Royal Assent on 28 August 2009.

 

The purpose of the Proclamation is to fix the commencement dates for specified Schedules to the Act.  The Proclamation fixes 25 February 2010 as the day on which Schedule 2 to the Act commences; 8 February 2010 as the day on which Schedule 5 to the Act commences; and 25 January 2010 as the day on which Part 2 of Schedule 7 to the Act commences.

 

Schedule 2 of the Act amends Part 3-3 of the Therapeutic Goods Act 1989 (the TG Act) to modify and clarify a number of matters relating to the granting and the varying of manufacturing licences.  In particular, it provides that manufacturing licenses are to be issued on a per site/location basis unless allowed for in the guidelines determined by the Secretary to the Department of Health and Ageing.  Schedule 2 also sets out provisions for the transfer of licences, where the ownership of a manufacturing operation changes and provisions to allow for variations to matters authorised in manufacturing licences, such as the manufacturing sites. 

 

Currently the TG Act authorises the setting out of a list of permitted ingredients and prohibited ingredients to be included in listable medicines under the Therapeutic Goods Regulations 1990.  However, many permitted ingredients for listable medicines before the TG Act came into force are not specifically identified in the Regulations.  A medicine can be a listed medicine if it contains an ingredient that is present in a therapeutic good that has already been granted a marketing approval.  Schedule 5 to the Act enables the Minister for Health and Ageing (the Minister) to make a determination, by legislative instrument, specifying permitted or prohibited ingredients of a listable medicine under the TG Act.  The specific listing of these ingredients, including permitted concentrations or amounts of these ingredients, provides clarity and transparency of these requirements.  Stakeholders can therefore refer to these legislative instruments for information on whether the specified ingredients or components are permitted to be included in listable medicines, and whether these are subject to certain limitations.

 

Part 2 of Schedule 7 to the Act provides for a number of amendments covering various subject matters.  These amendments include changes to the current system of imposing conditions on registration or listing of therapeutic goods included in the Register, enhancing scrutiny of Australian and overseas manufacture of listed medicines and authorising the Secretary to request information relating to the safety, efficacy and other specified matters about kinds of medical devices.  Part 2 of Schedule 7 also authorises the Minister to make a code relating to advertisements about therapeutic goods.

 

The Schedules of the Act covered by this Proclamation require the making of legislative instruments, implementation of changes to the current Information Technology systems, and the setting up of the necessary administrative arrangements required by these amendments.  The commencement dates take into consideration the earliest possible dates that these arrangements and requirements can be put in place. 

 

The amendments set out in the Schedules to the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 incorporate a number of overdue regulatory reforms which were to be implemented as part of the legislation covering the proposed Australia New Zealand Therapeutic Products Agency (ANZTPA), and were subject to extensive industry consultation in that context.  The ANZTPA was postponed in July 2007 as a result of the New Zealand Government’s decision not to proceed with their enabling legislation due to insufficient parliamentary support.  Further consultation occurred in late July – early August 2008 following the Australian Government’s decision to pursue reforms to the Australian therapeutic goods regulatory framework.  The industry strongly supported progress in these areas, especially as some changes were delayed for several years in anticipation of the ANZTPA legislation. 

 

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