Consultation: Draft regulations to implement the revised scheduling framework
This consultation closed on 16 March 2010.
29 January 2010
Purpose of this consultation
The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. This is aimed at minimising the risks of poisoning from, and the misuse and abuse of, scheduled substances.
On Tuesday 29 September 2009, the Governor-General Ms Quentin Bryce AC, gave Royal Assent to the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009: Act No. 96 of 2009.
This Act, which covers new arrangements for the scheduling of medicines and chemicals, comes into effect on 1 July 2010 and can be viewed on the ComLaw website.
Consultation on the Scheduling Policy Framework (SPF) and the Poisons Standard were conducted 11 April – 29 May 2009. In line with the Government's commitment to conduct further consultation on the details of the arrangements related to implementation of the new framework, the draft regulations are provided for public comment.
Together with the SPF, amending regulations will provide support to the provisions within the amending Act No. 96, and in doing so provide guidance to applicants, committees and decision-makers within the new framework.
Consultation documents
Making a submission
Submissions should include the name of your organisation (or your name if the submission is made as an individual) contact details for the submission, including email address where available and an indication of the industry sector(s) (therapeutic, agricultural and veterinary, or other chemicals) of which you or your organisation are a part or represent.
Submissions should be delivered to TGA by 5pm on Tuesday 16 March 2010.
Due to time constraints to meet the commencement date for the new framework, extensions for submissions will not be granted and late submissions will not be considered.
A list of names of all parties making submissions will be published on the TGA website.
All submissions will be published on the TGA's website. For submissions made by individuals, all personal details will be removed where possible from your submission before it is published.
Confidential material contained within submissions should be clearly marked. Reasons for a claim to confidentiality must be included. Where possible, confidential material will be removed from material published on the TGA's website.
Enquiries
Enquiries should be directed via email to schedulingconsultation@tga.gov.au, or to 02 6232 8560.
Background
These new scheduling arrangements reflect the recommendations from the Galbally Review (2001)1 and the model approved by Australian Health Ministers Council in 2006. They also take into account the scheduling-related recommendations arising from the 2008 Productivity Commission Research Report on Chemicals and Plastics Regulation2, which have been accepted by Council of Australian Government. Government policy is that the costs associated with these new scheduling arrangements will be fully recovered from industry.
- Rhonda Galbally 2001; National Competition Review of Drugs Poisons & Controlled Substance Legislation
- Productivity Commission July 2008; Productivity Commission Research Report: Chemicals and Plastic Regulation