Remaking of Sunsetting Instrument without significant amendments – Department of Health
On 23 September 2021, the Department of Health remade without significant amendments the Restricted Medicine Specification 2011, which was due to sunset on 1 October 2021. The newly made Therapeutic Goods (Restricted Medicines) Specification 2021 will sunset on 1 October 2031.
The Specification specifies medicines or classes of medicines for the purpose of the definition of ‘restricted medicine’ in subsection 3(1) of the Therapeutic Goods Act 1989, for which a Product Information document is required to be submitted to the Therapeutic Goods Administration as part of an application for registration.
Consistent with Government’s best practice regulation requirements for sunsetting instruments, the Department of Health has, after consultation with stakeholders, assessed the instrument as operating effectively and efficiently. Therefore, a Regulation Impact Statement is not required for remaking this instrument.