Regulation Impact Statement Updates

Official website for publishing regulatory impact analysis information for regulatory decisions announced by the Australian Government, COAG and COAG Councils.

Therapeutic Goods Order No. 98 – Microbiological Standards for Medicines 2018

Aust Gov
10th October 2018

Remaking of sunsetting instrument without significant amendments – Therapeutic Goods Administration

On 1 October 2018, the Therapeutic Goods Administration (TGA) remade the Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines, which were due to sunset on 1 October 2018, as the Therapeutic Goods Order No. 98 – Microbiological Standards for Medicines 2018 (TGO 98), with only minor amendments.

TGO 98 specifies the minimum microbiological requirements that a medicine must comply with throughout its shelf life.

Consistent with government best practice regulation requirements for sunsetting instruments, the TGA, after consultation, assessed the order as operating effectively and efficiently. Therefore, a Regulation Impact Statement was not required for the remaking this instrument without significant amendments.

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