Remaking of Sunsetting Instrument without significant amendments – Department of Health
On 31 March 2020, the Department of Health remade with minor amendments the Therapeutic Goods (Multi-Site Manufacturing Licences) Guidelines 2010, which were due to sunset on 1 April 2020. The newly made Therapeutic Goods (Guidelines for Multi-Site Licenses) Instrument 2020 will sunset on 1 April 2030.
The instrument provides for guidelines to set out the circumstances in which a licence, issued under Part 3-3 of the Therapeutic Goods Act 1989 to manufacture therapeutic goods to which that Part applies (for example manufacturers of medicines and biologicals), may cover two or more manufacturing sites.
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.