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

26 April 2012

This consultation closed on 25 May 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 25 May 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 5 September 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 Reasons for referral
Penflufen Proposal to include penflufen in Schedule 6 with a possible lower scheduling for preparations containing 24 per cent or less of penflufen. The delegate has requested advice from the ACCS in regards to commercial-in-confidence data supplied in support of this proposal.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS)
Substance Scheduling proposal Reasons for referral
Ibuprofen and phenylephrine Proposal to reschedule ibuprofen from Schedule 2 to unscheduled when in divided preparations each containing 200 mg (or less) of ibuprofen in fixed dose combination with 5 mg (or less) of phenylephrine, in packs containing not more than 25 tablets. This consideration includes, but it is not limited to, restricting the entry for the treatment of adults and children aged 12 years of age and over. The delegate has requested advice from the ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6).
Omeprazole Proposal to amend the current Schedule 3 omeprazole entry to increase the maximum allowed pack size from 14 to 28 dosage unit. The delegate has requested advice from the ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6).
Vibrio cholera and enterotoxigenic Escherichia coli vaccine Proposal to down-schedule cholera vaccine from Schedule 4 to Schedule 3 to harmonise with New Zealand. This consideration includes a new specific entry for both vibrio cholera vaccine and for enterotoxigenic Escherichia coli vaccine in Schedule 3. The delegate has requested advice from the ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6).
Cetirizine Proposal to reschedule from Schedule 2 to unscheduled to harmonise with New Zealand. This consideration includes divided forms of cetirizine for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose in packs containing 5 days supply for the treatment of seasonal allergic rhinitis. The delegate has requested advice from the ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6).
1,3-dimethylamylamine (DMAA) Proposal to include DMAA in Schedule 9. The delegate has requested advice from the ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6).
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 Reasons for referral
Hydrogen peroxide and Carbamide peroxide Proposal to scheduling all teeth whitening products containing hydrogen peroxide and carbamide peroxide to Schedule 4. The delegates have requested advice from the ACCS and ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6). As this proposal involves rescheduling from a chemical schedule to a therapeutic good schedule, as well as exemptions, a joint meeting is appropriate.
Tylosin Proposal to reschedule tylosin from Schedule 5 to Schedule 4. The delegates have requested advice from the ACCS and ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6). As this proposal involves rescheduling from a chemical schedule to a therapeutic good schedule, a joint meeting is appropriate.
Tranexamic acid Proposal to amend the Schedule 4 tranexamic acid entry to exclude cosmetic topical use of tranexamic acid and/or its derivatives from scheduling, in particular cetyl tranexamate hydrochloride at up to 3 per cent. The delegates have requested advice from the ACCS and ACMS in regards to this rescheduling proposal under section 5.2 of the SPF (page 6).

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