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Adoption of GHS and Scheduling of Medicines and Poisons

28 April 2009

The Department of Health and Ageing is currently seeking comments on documents relating to the Globally Harmonised System for Classification and Labeling of Chemicals (the GHS) and on changes to the arrangements for scheduling of medicines and poisons.

Comments should be directed to the relevant unit in the Department of Health and Ageing, and not to the APVMA.

Globally Harmonised System of Classification and Labeling of Chemicals

The Office of Chemical Safety and Environmental Health (OCSEH) is seeking public comment on a Discussion Paper which outlines possible options for the adoption of the Globally Harmonised System of Classification and Labeling of Chemicals (GHS) within the system of public health regulation of domestic and consumer chemicals, including pesticides.

The discussion paper explores the options and possible implications that might arise from the adoption of the GHS in respect to domestic and consumer chemicals (including pesticides) within the Australian regulatory framework for the uniform scheduling of drugs and poisons. The discussion paper also provides a comparative analysis of the health hazard criteria used in the current system of poisons scheduling for domestic and consumer chemicals in Australia with those proposed in the Globally Harmonised System of Classification and Labeling of Chemicals (GHS). The paper outlines the options for possibly adopting the GHS, the likely costs and benefits of those options and a technical assessment of the similarities and differences between current poisons scheduling criteria and GHS criteria which may have a bearing on the scope of any future proposal to implement the GHS.

The discussion paper (external site), including the contact details for comments are available from the OCSEH website.

New arrangements for the scheduling of medicines and poisons

The new arrangements for the scheduling of medicines and poisons implement recommendations of the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the Galbally Review). The new arrangements were initially developed for implementation under the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) and have since been refined to apply in Australia only. These new scheduling arrangements also implement the scheduling-related recommendations of the Productivity Commission Research Report Chemicals and Plastics Regulation (July 2008).

Under the new arrangements, the National Drugs and Poisons Schedule Committee (NDPSC) will be disbanded and replaced with two separate committees, one responsible for medicines (the Medicines Scheduling Expert Advisory Committee) and the other responsible for agricultural, veterinary, domestic and other chemicals (the Chemicals Scheduling Expert Advisory Committee). The Scheduling Policy Framework will replace the current NDPSC Guidelines. The new arrangements will be underpinned by the Therapeutic Goods Act 1989 and by associated regulations. The draft Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) will replace the current Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and includes the implementation of several Galbally Review recommendations.

The consultation documents (external site), including the contact details for comments are now available on the TGA website.

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