Tag Archives: Life Sciences

ILN Today Post

Life Sciences Update

‘Talk the talk, walk the walk’: warranty requirements under Australian Consumer Law

By Jessica Kinny and Wendy Blacker of Gadens Lawyers, Sydney

On 16 November 2010 the final Australian Consumer Law (ACL) regulations were published.  One of the key provisions of the ACL is section 54, which is a statutory guarantee of acceptable quality of a good or service enforceable against the suppliers and manufacturers of that good or service.  read more

 

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ILN Today Post

Gadens Lawyers – Life Sciences Update

Section 60A Therapeutic Goods Act 1989 (Cth):  the ‘new’/‘old’ paradox solved?

By Jessica Kinny and Wendy Blacker of Gadens Lawyers, Sydney

A sponsor must apply to the Therapeutic Goods Administration (TGA) for a therapeutic good to be entered on the Australian Register of Therapeutic Goods before that good can be lawfully supplied in Australia.  When an application for the registration of a good is refused by the TGA, the sponsor can seek to have that decision reconsidered by the Minister for Health and Ageing (Minister) under s 60 of the Therapeutic Goods Act 1989 (Cth) (the Act).  If the Minister upholds the decision to refuse registration, the sponsor can then seek a review on the merits[1] by the Administrative Appeals Tribunal (Tribunal).  read more

 

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ILN Today Post

Gadens Lawyers – Life Sciences Update

A more transparent Therapeutic Goods Administration?

By Jessica Kinny and Wendy Blacker of Gadens Lawyers, Sydney

On 20 July 2011 the Australian Government released a report that could be the catalyst for greater transparency in the operation and regulation of the therapeutic goods industry.

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