Background to the revised arrangements and cost recovery

15 April 2011

Background to the revised medicines and poisons scheduling arrangements

In October 2008 the Council of Australian Governments (COAG) endorsed the scheduling-related recommendations from the Productivity Commission Research Report: Chemicals and Plastics Regulation.

This report supported scheduling reforms that had previously been recommended by the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the 'Galbally Review').

Since 2008 the Department of Health and Ageing, in collaboration with the National Coordinating Committee on Therapeutic Goods (NCCTG), has been consulting on changes to the framework to give effect to the revised scheduling arrangements. The NCCTG is a subcommittee of the Australian Health Ministers' Advisory Council (AHMAC) and is the body responsible for scheduling policy in Australia. It comprises representatives from the Australian, state and territory governments and the New Zealand government. The Therapeutic Goods Administration (TGA) provides the Secretariat for the NCCTG.

The NCCTG is the author of the Scheduling Policy Framework which is a guidance document that decision-makers within the Department must have regard to when making scheduling decisions. This document also provides guidance for applicants about the scheduling process including public consultation, classification systems and information requirements.

Legislation to amend the Therapeutic Goods Act 1989 (the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009) received Royal Assent on 29 September 2009. Changes to the Therapeutic Goods Regulations 1990 to underpin these legislative changes, were in place by 1 July 2010.

Cost recovery arrangements

The AHMC agreed that 100% cost recovery should be implemented as part of the arrangements for the scheduling of medicines and poisons.

A draft Cost Recovery Impact Statement (CRIS) was released for public consultation between January and March 2010. This document was developed to identify:

  • all relevant costs involved with the new scheduling arrangements,
  • calculation of the expected recoveries from each industry sector, and
  • calculation of proposed application fees for each sector based on estimated work input to applications for scheduling.

Cost recovery arrangements are being examined in light of comments received on the draft CRIS. Cost recovery arrangements for both medicines and poisons will commence together, once these arrangements have been finalised.

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