Draft Standard for the Uniform Scheduling of Medicines and Poisons and Draft Scheduling Policy Framework
13 June 2007
Please note: This consultation closed on 25 July 2007.
Written submissions are invited on the following consultation documents:
Draft Standard for the Uniform Scheduling of Medicines and Poisons (pdf,581kb)
Draft Scheduling Policy Framework (pdf,450kb)
In addition the following accompanying resource document is also available:
Table of changes from SUSDP to SUSMP (pdf,82kb)
Background
The draft Standard for the Uniform Scheduling of Medicines and Poisons (Scheduling Standard) has been developed by the National Co-ordinating Committee on Therapeutic Goods (NCCTG) (as the Committee which provides recommendations on the administrative and regulatory controls for therapeutic goods) comprising representatives from Australia, New Zealand, and Australian State and Territory governments. The Scheduling Standard is substantially based on the current Australian Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) which contains a significant number of medicines, the scheduling of which has been harmonised with New Zealand.
The scheduling harmonisation process being undertaken by Australia and New Zealand will continue up to the commencement of the joint regulatory scheme and the Scheduling Standard, when released, will include all of the new and previously harmonised schedule entries.
While the Scheduling Standard is in hard copy for the purposes of consultation, it has been established in the draft Australia New Zealand Therapeutic Products Regulatory Scheme (Administration and Interpretation) Rule 2006 as an electronic register that will be made available for inspection on the Australia New Zealand Therapeutic Products Authority (ANZTPA) website. The Scheduling Standard will come into effect at the commencement of the joint regulatory scheme.
The Scheduling Standard will include a record of ANZTPA's decisions relating to the scheduling of medicines which will apply in Australia and New Zealand. New Zealand has proposed only to recognise recommendations for scheduling of substances for human therapeutic use included in Schedules 2, 3 and 4 of the Scheduling Standard (the remaining schedules and appendices of the Scheduling Standard will not be adopted in New Zealand). Decisions relating to the scheduling of poisons will apply in Australia only. New poisons scheduling legislation is under development which implements the poisons scheduling model agreed by the Australian Health Ministers' Conference in November 2006 (out of session). The model included the Department of Health and Ageing as the decision-maker for matters relating to the scheduling of poisons in Australia.
Scheduling decisions for medicines and poisons will take the form of entries in the Scheduling Standard. These entries will be a scheduling recommendation to New Zealand and to the Australian States and Territories and will be given effect by Australian State and Territory and New Zealand legislation.
A table comparing the SUSDP provisions with their comparable entries in the new draft Scheduling Standard has been prepared to assist stakeholders in cross referencing the scheduling requirements and to understand the reasons for amendments.
At the commencement of the joint regulatory scheme the draft Scheduling Policy Framework is intended to replace the Australian National Drugs and Poisons Schedule Committee (NDPSC) Guidelines and the requirements and criteria used by New Zealand's Medicines Classification Committee. The Scheduling Policy Framework will be maintained by the Medicines and Chemicals Scheduling Committees and overseen by the NCCTG.
An earlier draft of the Scheduling Policy Framework was released for stakeholder consultation, along with the scheduling model for medicines and poisons in July 2005. Stakeholder comments on the earlier draft have been taken into account in the development of the latest draft.
URL: http://www.anztpa.org/consult/dr-scheduling.htm