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Scheduling delegates' final decisions: NCEs, May 2018
Scheduling medicines and poisons
New Chemical Entities - medicines for human therapeutic use
Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include rufinamide in Schedule 4, Appendix K and Appendix L as follows:
Schedule 4 - New Entry
Appendix K - New Entry
Appendix L, Part 2 - New Entry
Warning statement/s: 62 (Do not use if pregnant), 76 (Do not become pregnant during use or within (Insert number of months as per approved Product Information) month(s) of stopping treatment), 77 (WARNING - May cause birth defects)
Implementation date: 1 June 2018
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- Rufinamide is a new chemical entity with no clinical experience in Australia.
- the purposes for which a substance is to be used and the extent of use of a substance
- Rufinamide is an anti-epileptic drug to be used widely.
- the toxicity of a substance
- Satisfactory with pregnancy warning.
- the dosage, formulation, labelling, packaging and presentation of a substance
- Pregnancy label added.
The delegate of the Secretary proposed to amend the Poisons Standard with respect to rufinamide.
Rufinamide is not specifically scheduled and is not captured by any entry in the Poisons Standard.
The delegate considered the following in regards to this scheduling:
- Advice on the place in therapy of this medicine;
- Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.