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NDPSC record of reasons, 48th meeting, 10-12 October 2006

National Drugs and Poisons Schedule Committee

The Record of the Reasons contains the basis of scheduling decisions and other outcomes arising from the meeting. Please note that the Record of the Reasons includes extracts from the NDPSC minutes which have been edited to remove confidential information.

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NDPSC Record of reasons, Meeting 48 (pdf,641kb)*

Contents

Glossary
  • 1.7 Procedural matters
    • 1.7.1 Operations/policies of the Committee
      • 1.7.1.1 Draft template for scheduling/rescheduling and electronic lodgement of submissions
      • 1.7.1.2 Confidential information and release of information in the record of reasons for medicines
      • 1.7.1.3 Derivative definition and usage
  • 1.8 NDPSC working party
    • 1.8.1 Trans-Tasman Harmonisation Working Party (TTHWP)
      • 1.8.1.1 Unharmonised medicines in the AUSNZ scheduling database
      • 1.8.1.2 New medicines in New Zealand (MCC meeting 34 & 35): Adrafinil, Exenatibe, Sitagliptin Phosphate, Sorafenib Tosylate, Telbivudine, Varenicline Tartrate
2. Proposed changes/additions to Parts 1 to 3 and Part 5 of the Standard for the Uniform Scheduling of Drugs and Poisons
  • 2.1 SUSDP, Part 1
  • 2.2 SUSDP, Part 2
  • 2.3 SUSDP, Part 3
    • 2.3.1 Item deleted
    • 2.3.2 Storage statements for Schedule 2 & Schedule 3 medicines
  • 2.4 SUSDP, Part 5
Agricultural/Veterinary, Industrial and Domestic Chemicals
3. Matters arising from the minutes of the previous meeting
  • 3.1 Sulfentrazone
  • 3.2 Indoxacarb
4. Other outstanding matters from previous meetings
  • 4.1 Potassium azeloyl diglycinate
  • 4.2 N-oleyl-1, 3-Diaminopropane and N-coco-1, 3-Diaminopropane
Proposed changes/additions to the Standard for the Uniform Scheduling of Drugs and Poisons
  • 5.1 SUSDP, Part 4
  • 5.2 SUSDP, Part 5
    • 5.2.1 Item deleted

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6. Matters referred by the Australian Pesticides and Veterinary Medicines Authority
  • 6.1 Ibafloxacin
  • 6.2 Pradofloxacin
  • 6.3 Clothiandin
  • 6.4 Acibenzolar-S-Methyl
  • 6.5 GHRH injectable plasmid
  • 6.6 Cefovecin
  • 6.7 Paraquat
  • 6.8 Dichlorprop-P
  • 6.9 Profoxydim
  • 6.10 2,4-Dichlorophenoxyacetic acid (2,4-D)
7. Matters referred by Office of Chemical Safety
  • 7.1 Methyl methacrylate and ethyl methacrylate
  • 7.2 Basic orange 31
8. Other matters for consideration
9. Information items (Ag/Vet, Industrial & Domestic Chemicals
Pharmaceuticals
10. Matters arising from the minutes of the previous meeting
  • 10.1 Mometasone

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11. Other outstanding matters from previous meetings
  • 11.1 Fluorides
  • 11.2 Potassium chloride
  • 11.3 Sumatriptan
12. Proposed changes/additions to the Standard for the Uniform Scheduling of Drugs and Poisons
  • 12.1 SUSDP, Part 4
    • 12.1.1 Diltiazem
    • 12.1.2 Butoconazole
    • 12.1.3 Alclometasone
    • 12.1.4 Nicotinic acid
    • 12.1.5 Fixed dose combination opiate analgesics
    • 12.1.6 Prochlorperazine
  • 12.2 SUSDP, Part 5
13. Matters referred by the Australian Drug Evaluation Committee
  • 13.1 New substances (not seen before by NDPSC)
    • 13.1.1 Deferasirox
    • 13.1.2 Duloxetine
    • 13.1.3 Tigecycline
    • 13.1.4 Tipranavir
  • 13.2 For information (substances already scheduled)

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14. Other matters for consideration
  • 14.1 Item deleted
15. Matters referred by the Medicines Evaluation Committee (MEC)
16. Matters referred by the Medicines Classification Committee (MCC) of New Zealand
  • 16.1 Sedating antihistamines
    • 16.1.1 Day-night packs containing sedating antihistamines - Brompheniramine, Chlorpheniramine, Dexchlorpheniramine, Diphenhydramine, Doxylamine, Pheniramine, Promethazine, Trimeprazine, Triprolidine
    • 16.1.2 Sedating antihistamines in children under 2 years of age
  • 16.2 Oseltamivir
  • 16.3 Hydrocortisone 0.5% in combination with a local anaesthetic
  • 16.4 Paracetamol 665mg tablets
  • 16.5 Tranexamic acid
17. Minutes of the Adverse Drug Reactions Advisory Committee
  • 17.1 Item deleted
18. Minutes of the Medical Device Evaluation Committee (MDEC)
19. Information items (pharmaceuticals)
  • 19.1-19.3 Items deleted
  • 19.4 Diclofenac
  • 19.5 Orlistat
  • 19.6 Item deleted
20. Item deleted
21. Amendments to the SUSDP
  • 21.1 Editorial changes & errata
    • 21.1.1 Editorial changes & errata arising from SUSDP 21 Amendment 1: (Azelastine, Brompheniramine, Chlorpheniramine, Dexchlorpheniramine, Diphenhydramine, Diphenylpyraline, Doxylamine, Promethazine, Triprolidine)

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