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Invitation for public comment - ACMS and ACCS meetings, October 2012

14 August 2012

This consultation closed on 12 September 2012

Notice inviting public submissions under Regulation 42ZCZK of the Therapeutic Goods Regulations 1990

The delegate of the Secretary of the Department of Health and Ageing hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees.

Accordingly, the following scheduling proposals are open for public submissions. Submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date.

Persons wishing to make a submission are strongly encouraged to submit them in electronic format (Word or unsecured PDF) to the email address provided below by 12 September 2012.

Email: SMP@health.gov.au

The Secretary
Scheduling Secretariat
GPO Box 9848
CANBERRA ACT 2601

Facsimile: 02 6289 2650

Public submissions received after the closing date may or may not be considered by the advisory committee(s).

Public submissions must include the name of the person making the submission and preferably an email or postal address.

Please note that the submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework (SPF), issued by the National Coordinating Committee on Therapeutic Goods.

The relevant expert advisory committee(s) will then consider all valid submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will make an interim scheduling decision. This interim decision is expected to be published on 19 December 2012 at Reasons for scheduling delegate's interim decisions and invitations for further comment and will be open for further submissions from only the applicant and persons who made a submission in response to the original invitation received on or before the closing date. For more information on the scheduling process please see the SPF.

The current Poisons Standard is available at The Poisons Standard (the SUSMP). Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au.

Proposed amendments to the poisons standard referred by the delegate for scheduling advice

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS)
Substance Scheduling proposal
Thymol Proposal for a new Schedule 6 entry for thymol.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS)
Substance Scheduling proposal
Chloramphenicol Proposal to reschedule chloramphenicol for ophthalmic use from Schedule 3 to Schedule 4
Diclofenac Proposal to amend the Schedule 2 entry for diclofenac when presented in a transdermal drug delivery system for topical use (containing 140 mg or less).
Mometasone Proposal to reschedule mometasone from Schedule 4 to Schedule 3 in preparations for topical use containing 0.1 percent or less of mometasone in packs containing 30 g or less of the preparation when labelled for the treatment of adults and children 12 years and over.
Ostarine (enobosarm) and Selective Androgen Receptor Modulators Proposal for a new Schedule 4 entry for ostarine (enobosarm) and a new Schedule 4 class entry for Selective Androgen Receptor Modulators (SARM).
Pantoprazole Proposal to amend the Schedule 3 entry for pantoprazole 20 mg to increase the maximum allowable pack size from 14 to 28 dosage units.
Paracetamol when combined with ibuprofen

Proposal to reschedule paracetamol 500 mg when combined with ibuprofen 200 mg from Schedule 3 to Schedule 2 for pack sizes of 12 units or less.

Proposal to also include Schedule 3 paracetamol when combined with ibuprofen in Appendix H.
Retigabine Proposal for a new Schedule 4 entry and Appendix K entry for retigabine.
Teriflunomide Proposal for a new Schedule 4 entry, Appendix L and Appendix F entry for teriflunomide.
Vitamin D

Proposal to a new Schedule 3 entry to allow a weekly dose of Vitamin D up to 175 micrograms (7000IU) per recommended dose.

Proposal to also include Schedule 3 Vitamin D in Appendix H.
3. Proposed amendments referred by the delegate for scheduling advice for consideration by the a joint meeting of the ACCS and ACMS
Substance Scheduling proposal
Hydrogen peroxide and carbamide peroxide

Proposal to exempt teeth whitening products containing 3% or less of hydrogen peroxide and 9% or less of carbamide peroxide from scheduling.

Proposal for teeth whitening products containing between 3% - 6% of hydrogen peroxide and between 9% - 18% of carbamide peroxide to be only legally accessible from a registered health practitioner. Patients to be permitted to use these products 'at home' only after consultation with their registered health practitioner.

Proposal for teeth whitening products containing more than 6% hydrogen peroxide and more than 18% carbamide peroxide be legally accessed by registered health practitioners.

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