Guidelines for the National Drugs and Poisons Schedule Committee
This document describes the Guidelines for the National Drugs and Poisons Schedule Committee including:
- Guidelines for committee procedures
- Guidelines for application and information requirements
- Guidelines for classification of medicines and poisons
- Guidelines for public consultation
- Guidelines for use of confidential information
Guidelines for the National Drugs and Poisons Schedule Committee (pdf,232kb)
Amendment schedule
October 2009
In October 2009 Chapter 2 of the NDPSC Guidelines was modified to reflect the decision of the October 2009 NDPSC meeting to no longer allow two cut-offs for public scheduling applications. There is now only the 20 week cut-off, with the applicant entitled to comment on any evaluation of their application prior to NDPSC consideration.
February 2008
In February 2008 Chapter 2 of the NDPSC Guidelines was modified to confirm that where an applicant who copies and submits a reference to the NDPSC for the purposes of making a scheduling/rescheduling application does any act comprised in the copyright of the work under the Copyright Act 1968 (Copyright Act), those acts are taken to be authorised by the Commonwealth under section 183 of the Copyright Act.
January 2007
In January 2007 Chapter 2 of the NDPSC Guidelines were modified to reflect the new option to provide scheduling/rescheduling applications in electronic format, preferably using the NDPSC scheduling/rescheduling template.
June 2006
In June 2006 the NDPSC Guidelines were modified to reflect the provision of NDPSC evaluation reports to sponsors for comment prior to an NDPSC Meeting, excepting ag/vet chemicals where there is an existing APVMA process.
June 2004
In June 2004 the Guidelines were further modified to update the URL links to reflect TGA's move from the Department of Health and Ageing's website to its own website.
March 2003
In March 2003 the original 1997 Guidelines were modified:
- to remove references inconsistent with the Therapeutic Goods Act 1989 (TG Act) or the Therapeutic Goods Regulations 1990;
- to update references to names of the Department, NRA and other organisations;
- to revise the introduction to reflect the TG Act and Regulations; and
- to replace the term drug where appropriate with medicine.
Chapter 2 has been retained in its entirety for operational reasons. The delivery address and number of submission copies to be provided to the NDPSC Secretariat has been updated.
Chapter 3 regarding classification of medicines and poisons and notified as an applicable guideline by NCCTG has been retained unchanged except for the above dot points.
Remaining chapters have been replaced with a reference to the TG Act/Regulations or are under review as appropriate.