EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information Specification 2009 Revocation Specification 2015
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy/performance and timely availability of therapeutic goods that are used in or exported from Australia. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, is responsible for administering the Act.
Section 61 of the Act lists a number of persons or organisations, such as the World Health Organisation and state and territory authorities that have functions relating to therapeutic goods, to which the Secretary of the Department of Health can release specified kinds of therapeutic goods information. Section 61 also allows the Minister for Health to make a legislative instrument setting out other circumstances in which the Secretary can release therapeutic goods information to the public under that section. The power to make a legislative instrument also includes the power to revoke the legislative instrument.
The Therapeutic Goods Information Specification 2009 Revocation Specification 2015 (the Specification) is made by a delegate of the Minister under subsection 61(5D) of the Act and revokes the Therapeutic Goods Information Specification 2009 (the 2009 Specification). It will be replaced by the Therapeutic Goods Information Specification 2015.
The Specification commenced on the day after the Therapeutic Goods Information Specification 2015 was registered on the Federal Register of Legislative Instruments.
BACKGROUND
Amendments to section 61 of the Act made in 2009, including the introduction of subsections 61(5C) and (5D), facilitate a more extensive release of therapeutic goods information by the Secretary. These amendments supported the making of the 2009 Specification which allows the Secretary to release to the public a range of information, primarily relating to registered therapeutic goods.
The purpose of the Specification is to revoke the 2009 Specification so that it can be replaced with the Therapeutic Goods Information Specification 2015, principally in order to update a number of references to the names of expert committees established by the Therapeutic Goods Regulations 1990 and to update references to provisions of the Act which have changed since 2009.
CONSULTATION
The nature of the Specification is such that consultation was not considered to be necessary as the 2009 Specification will be replaced by Therapeutic Goods Information Specification 2015 which makes only changes of a minor nature to the 2009 Specification.
The Specification is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights for a legislative instrument that does not raise any human rights issues
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods Information Specification 2015
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 Legislative Instrument
The Therapeutic Goods Information Specification 2009 Revocation Specification 2015 is made under subsection 61(5D) of the Therapeutic Goods Act 1989 (the Act) by a delegate of the Minister for Health. It revokes the Therapeutic Goods Information Specification 2009.
Human rights implications
As this instrument does not include any measures other than revoking the 2009 Specification (which is to be replaced by the Therapeutic Goods Information Specification 2015), it 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.
Professor John Skerritt, delegate of the Minister for Health