Remaking sunsetting instrument without significant amendments – Department of Health
On 21 March 2019, the Department of Health (the Department) remade the Therapeutic Good Order No. 78 (the Order) without significant amendment.
The remade Order, Therapeutic Goods (Standard for tablets, capsules and pills) Order 101, reflects changes made to the Therapeutic Goods Act 1989 since commencement of TGO 78 in 2009. It offers sponsors a choice to stay with existing requirements or to use requirements set out in an applicable monograph in the British Pharmacopeia (BP), the European Pharmacopoeia (EP) or the United States Pharmacopeia - National Formulary (USP).