Consultation on the Scheduling Policy Framework and Standard for the Uniform Scheduling of Medicines and Poisons
11 August 2009
This consultation opened on 17 April 2009 and closed on 29 May 2009.
Background
The proposed Scheduling Policy Framework and proposed Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) have been developed by the National Co-ordinating Committee on Therapeutic Goods (NCCTG) (as the committee which oversees scheduling policy) comprising representatives from the Australian, state and territory governments and the New Zealand government. The Scheduling Policy Framework is intended to replace the current National Drugs and Poisons Schedule Committee (NDPSC) Interim Guidelines and the SUSMP is intended to replace the current Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).
The proposed SUSMP is substantially based on the current SUSDP, updated to reflect contemporary practise and to implement recommendations of the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the 'Galbally Review').
The Government introduced the 'Therapeutic Goods Amendment (2009 Measures No. 2 ) Bill 2009' during the Winter 2009 Parliamentary sitting. Schedule 1 of the Bill includes amendments to the Therapeutic Goods Act 1989 that will underpin the new scheduling arrangements, which are expected to commence in July 2010.
Enquiries
Enquiries should be directed via email to schedulingconsultation@tga.gov.au, or to 02 6232 8186.
Consultation documents
- Proposed Scheduling Policy Framework (pdf,237kb)
- Proposed Standard for the Uniform Scheduling of Medicines and Poisons (pdf,168kb)
In addition, the following accompanying resource documents are also available:
- Flowchart (pdf,71kb) depicting new arrangements for the scheduling of medicines and poisons
- Table highlighting changes (pdf,35kb) made to the Standard for the Uniform Scheduling of Drugs and Poisons to bring about the new Standard for the Uniform Scheduling of Medicines and Poisons
Public submissions on the proposed Scheduling Policy Framework (SPF) and the Standard Uniform Scheduling of Medicines and Poisons (SUSMP) were invited during 17 April 2009 and 29 May 2009.
The SPF and SUSMP are key components of the new arrangements for the scheduling of medicines and poisons, endorsed by the Australian Health Ministers' Conference. An overview of the proposed scheduling and rescheduling processes is depicted in the flowchart above.
A table highlighting changes made to the SUSDP to bring about the new SUSMP has been prepared to assist interested parties in cross referencing the scheduling requirements and to understand the reasons for amendments.