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Revised: 1 September 2017

Medicines Classification Committee - General Principles of Trans-Tasman Scheduling Harmonisation

The following general principles were recommended by the Working Party on the Trans-Tasman Harmonisation of the Schedules between Australia and New Zealand and accepted by the National Drugs and Poisons Schedule Committee and the Medicines Classification Committee.

  1. For both countries there should be:
    • equivalent scheduling for drugs and poisons
    • equivalent general exemptions from scheduling
    • a common set of definitions and scheduling criteria and guidelines
    • consistent interpretation of scheduling criteria
    • common nomenclature for drugs and poisons
    • within the schedules, common descriptions for generic drug and poison classes or any other general classification
    • harmonisation of labelling and packaging harmonisation of safety directions, warning statements and first-aid instructions.
  2. Where differences in scheduling of a drug or poison currently exist between New Zealand and Australia, the following principles should apply:
    • the classification should be reassessed using the common set of definitions and scheduling criteria with a view to achieving a common outcome
    • the underlying principle is to harmonise on the less restrictive schedule while giving due consideration to public health and safety issues and/or specific jurisdictional needs.
  3. The process of harmonisation of drug and poisons scheduling should recognise the wider regulatory requirements of other agencies and any complexities should not be exacerbated by harmonisation of schedules.

Both countries should be encouraged to adopt nomenclature for medicines based on their International Non-proprietary Names.

New Zealand should accept into part 1 of the First Schedule to the Medicines Regulations 1984 and amendments, any medicines which are listed as prescription medicines in the Australian Schedule but which are not scheduled in New Zealand and are not deemed to be general sale medicines in New Zealand. Australia should adopt into Schedule 4 all medicines which are prescription medicines in New Zealand, but which are not scheduled in Australia.

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