Federal Register of Legislation - Australian Government

Primary content

Specifications as made
This instrument specifies under subsection 61(5D) of the Therapeutic Goods Act 1989 (the Act) the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act. The Specification has the effect of permitting the Secretary to release to the public therapeutic goods information in relation to recall actions being information kept by the TGA in its System for Australian Recall Actions database as set out in Schedule 1 to the Specification.
Administered by: Health
Registered 13 Mar 2013
Tabling HistoryDate
Tabled HR14-Mar-2013
Tabled Senate14-Mar-2013

STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

 

Text Box: Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods Information (System for Australian Recall Actions) Specification 2013
This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Therapeutic Goods Information (System for Australian Recall Actions) 2013 (the Specification) is made by the Minister for Health under subsection 61(5D) of the Therapeutic Goods Act 1989 (the Act).  It has the effect of permitting the Secretary of the Department of Health and Ageing to release to the public specified kinds of information relating to Australian recall actions being information kept by the Therapeutic Goods Administration in its System for Australian Recall Actions database.  
Recall action is described in the Specification as action taken by a person to resolve a problem with therapeutic goods supplied in the Australian market that have, or may potentially have, deficiencies relating to safety, quality, efficacy or presentation.  The kinds of information that will be released include, for example, the name and a description of the goods, the person undertaking the recall and its date of commencement, the nature of the recall action (e.g., permanent removal of the goods from the Australian market), recall instructions and relevant contact information for obtaining more information about the goods.
Human rights implications
This legislative instrument does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.

Dr John Skerritt, delegate of the Minister for Health
 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Therapeutic Goods (Listing) Notice 2012 (No. 4) -                                  Calcified Lithothamnion tophiforme

 

This legislative instrument is compatible with the human rights and freedoms recognised or d   eclared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the Bill/Legislative Instrument

Therapeutic Goods (Listing) Notice 2012 (No. 4) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act). The Listing Notice has the effect of requiring that therapeutic goods that contain ‘Calcified Lithothamnion tophiforme’ as a therapeutically active ingredient, and that are presented as oral preparations, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods. The Listing Notice commences on the day after it is registered on the Federal Register of Legislative Instruments (FRLI). Once the Listing Notice commences, applications can be made for the listing on the Register of new therapeutic goods that contain ingredients/substances of the kind set out in the notice.

Human rights implications

This legislative instrument does not engage any of the applicable rights or freedoms.

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

 

Dr John Skerritt, delegate of the Minister for Health