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National Drugs and Poisons Schedule Committee

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National Drugs and Poisons Schedule Committee National Drugs and Poisons Schedule Committee Record of Reasons 47th Meeting 20-22 June 2006 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 47 – June 2006 i TABLE OF CONTENTS GLOSSARY................................................................................................................................................ IV 1.7 PROCEDURAL MATTERS................................................................................................................1 1.7.1 OPERATIONS/POLICIES OF THE COMMITTEE ..................................................................................1 1.7.1.1 Draft Template for Scheduling/Rescheduling .............................................................................. 1 1.7.1.2 Procedural and Governance Issues............................................................................................... 2 1.7.1.3 Outcomes from the May 2006 NCCTG Meeting ......................................................................... 4 1.7.1.3.1 Sponsor Access to Evaluation Reports ................................................................................... 4 1.7.1.3.2 Release of Information in the Record of Reasons................................................................... 6 1.7.1.3.3 A Policy for the Harmonisation of Schedule 4 Medicines .................................................... 10 1.7.1.3.4 [Item Deleted]....................................................................................................................... 11 1.8 NDPSC WORKING PARTIES ........................................................................................................12 1.8.1 Minutes of the TTHWP February 2006 Meeting (Meeting 15)..............................................12 1.8.1.1 Nomenclature of Recombinant Medicines ................................................................................. 12 1.8.1.2 Unharmonised Medicines in the AusNZ Scheduling Database.................................................. 14 TABLE 1 –Harmonisation Recommendations to NDPSC.................................................................... 16 Proposals based on least restrictive scheduling and nomenclature or wording issues ..................... 16 Other harmonisation proposals........................................................................................................ 39 Proposals based on the policy for OTC and Prescription medicines and policy for naming botanicals......................................................................................................................................... 48 TABLE 2 – Harmonisation Recommendations to MCC....................................................................... 54 Proposals based on the least restrictive scheduling and nomenclature or wording issues ............... 54 Proposals based on the policy for OTC and Prescription medicines and policy for naming botanicals......................................................................................................................................... 85 TABLE 3 – Deferred Items .................................................................................................................. 98 TABLE 4 – Substances Remaining Unharmonised At This Time...................................................... 117 1.8.2 Globally Harmonised System (GHS) for Classification and Labelling of Chemicals..........122 1.9 PROPOSED ROUTINE CHANGES TO THE SUSDP ........................................................................123 2. PROPOSED CHANGES/ADDITIONS TO PARTS 1 TO 3 AND PART 5 OF THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS...........................123 2.1 SUSDP, PART 1 ........................................................................................................................123 2.2 SUSDP, PART 2 ........................................................................................................................123 2.2.1 Storage Statements for Schedule 5 and 6 Products .............................................................123 2.3 SUSDP, PART 3 ........................................................................................................................130 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS....................131 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ)..................................131 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS.................................131 4.1 LYE WATER ..............................................................................................................................131 4.2 N-OLEYL-1,3-DIAMINOPROPANE..............................................................................................134 4.3 AMINES USED AS CURING AGENTS FOR EPOXY RESINS ............................................................139 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.........................................................................................143 5.1 SUSDP, PART 4 ........................................................................................................................143 5.1.1 Potassium Azeloyl Diglycinate, Azelaic Acid and the Definition of Derivative...................143 5.1.2 Eyelash and Eyebrow Tints (Phenylenediamines and Toluenediamine)..............................148 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 47 – June 2006 ii 5.2 SUSDP, PART 5 ........................................................................................................................154 5.2.1 [Item Deleted]......................................................................................................................154 6. MATTERS REFERRED BY THE AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY. ...................................................................................................................154 6.1 CYDIA POMONELLA GRANULOSIS VIRUS ..................................................................................154 6.2 SULFURYL FLUORIDE ................................................................................................................155 6.3 PROSULFOCARB ........................................................................................................................156 6.4 TRENBOLONE ACETATE/OESTRADIOL/TYLOSIN TARTRATE......................................................157 6.5 ACETYL ISOVALERYLTYLOSIN TARTRATE ................................................................................158 6.6 ACETAMIPRID............................................................................................................................159 6.7 METFLUMAZONE/AMITRAZ.......................................................................................................160 6.8 TULATHROMYCIN......................................................................................................................160 6.9 INDOXACARB ............................................................................................................................161 6.10 SULFENTRAZONE.......................................................................................................................163 7. MATTERS REFERRED BY OFFICE OF CHEMICAL SAFETY (OCS) ................................163 8. OTHER MATTERS FOR CONSIDERATION ............................................................................163 8.1 PAINT FOR CHILDREN’S PLAY EQUIPMENT AND THE DEFINITION OF TOY.................................163 9. INFORMATION ITEMS (AG/VET, INDUSTRIAL & DOMESTIC CHEMICALS)..............164 9.1 NAPHTHALENE ..........................................................................................................................164 PHARMACEUTICALS............................................................................................................................167 10. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (POST- MEETING SUBMISSIONS UNDER 42ZCZ)........................................................................................167 10.1 POTASSIUM CHLORIDE ..............................................................................................................167 10.2 ORLISTAT..................................................................................................................................171 10.3 IBUPROFEN................................................................................................................................174 10.4 KETOTIFEN................................................................................................................................176 11. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ............................178 11.1 FRACTIONATED PLASMA PRODUCTS .........................................................................................178 11.2 OCTOCOG ALFA ........................................................................................................................181 11.3 HUMAN PLASMA-DERIVED PROTEIN C .....................................................................................182 11.4 CETIRIZINE................................................................................................................................183 11.5 ACONITUM SPP..........................................................................................................................187
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