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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