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.