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Regulation impact statement: Codeine re-scheduling

Version 1.1, December 2016

20 December 2016

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Abbreviation Meaning
ACMS Advisory Committee for Medicines Scheduling
ACSOM Advisory Committee on the Safety of Medicines
ARGPM Australian Regulatory Guidelines for Prescription Medicines
AHMAC Australian Health Ministers' Advisory Council
AMA Australian Medical Association
API Active Pharmaceutical Ingredient(s)
ARTG Australian Register of Therapeutic Goods
ASMI Australian Self Medication Industry
AusPAR Australian Public Assessment Report
BAU business as usual
CACC combination analgesic containing codeine
CATAG Council of Australian Therapeutic Advisory Groups
CCA codeine-containing analgesics
CMI Consumer Medicines Information
DHC dihydrocodeine
EMA European Medicines Agency
FDA Food and Drug Administration (USA)
GMP Good Manufacturing Practice
GI gastrointestinal
GP general practitioner
MBS Medicare Benefits Schedule
MHRA Medicines and Healthcare products Regulatory Agency (UK)
NDPSC National Drugs and Poisons Schedule Committee
OBPR Office of Best Practice Regulation
OTC over the counter
PBS Pharmaceutical Benefits Scheme
PGA The Pharmacy Guild of Australia
PI Product Information
PIL Patient Information Leaflet
PSA Pharmaceutical Society of Australia
QALY quality adjusted life year
RACGP Royal Australian College of General Practitioners
RACP Royal Australian College of Physicians
RASML Required Advisory Statements for Medicine Labels
RBE Regulatory Burden Estimate
RBM Regulatory Burden Measure
RIS Regulation Impact Statement
RTM real-time monitoring
SHPA Society of Hospital Pharmacists of Australia
SmPC Summary of product characteristics
SPF Scheduling Policy Framework
SUSMP Standard for the Uniform Scheduling of Medicines and Poisons;
Poisons Standard
TGA Therapeutic Goods Administration
WHO World Health Organization

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