Announcement dates
25 and 31 March 2022
Links to announcement
https://www.legislation.gov.au/Details/F2022L00400
https://www.legislation.gov.au/Details/F2022C00361
Problem being addressed
The Therapeutic Goods Order No. 90 Standard for human albumin (18/10/2011) and Therapeutic Goods (Exempting monographs of pharmacopoeias) Determination No. 1 of 2011 were due to sunset on 1 April 2022.
Proposal
The Department of Health certified that Therapeutic Goods Order No. 90 Standard for human albumin (18/10/2011) (“TGO 90”) and Therapeutic Goods (Exempting monographs of pharmacopoeias) Determination No. 1 of 2011 (‘the Determination”) were working efficiently and effectively.
The Department of Health decided to remake TGO 90 as the Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022. The Department of Health decided to repeal the Determination and include its content in the Therapeutic Goods (Exempt Monographs) Determination 2021.
The Therapeutic Goods Act 1989 (Cth) and associated Regulations and Orders such as the above two legislative instruments set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods. TGO 90 required that albumin (derived from plasma) from humans comply with the monograph for human albumin in the European Pharmacopoeia or British Pharmacopoeia. The Determination set out specific monographs of the United States Pharmacopeia-National Formulary that were not accepted as standards.
The Department of Health, after consultation with peak industry stakeholders and selected medicine sponsors, remade the above instruments without significant amendments and certified that they were operating efficiently and effectively. A Regulation Impact Statement is not required.
Assessed RIS outcome
Sunsetting instruments