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Invitation for public comment - ACMS and ACCS meetings, October 2011
Regulation 42ZCZK, Therapeutic Goods Regulations 1990
This consultation opened on 10 August 2011 and closed on 7 September 2011.
Meeting of the Advisory Committee on Chemicals Scheduling - 18 October 2011; and Meeting of the Advisory Committee on Medicines Scheduling - 19 October 2011.
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 comment. Public 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.
Public submissions that simply reserve the right to comment on a scheduling proposal or are made after the closing date need not be considered by the advisory committee.
Public submissions must also include the name of the person making the submission and a postal or email (preferred) contact address.
Please note that all public 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.
Persons making public submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF) via the email address provided below. Accordingly, public submissions, preferably in electronic format, should be made to:
GPO Box 9848
CANBERRA ACT 2601
Facsimile: 02 6289 2650
The closing date for submissions is 7 September 2011.
The relevant expert advisory committee(s) will consider all valid public submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will then make an interim decision. This interim decision is expected to be published at Reasons for scheduling delegate's interim decisions & invitations for further comment on 21 December 2011 and will be open for further submissions from the applicant and persons who made a submission in response to the original invitation received on or before the closing date for public submissions. For more information on the scheduling processes please see the SPF.
The current Poisons Standard comprises the Standard for the Uniform Scheduling of Medicines and Poisons No. 1 (SUSMP 1) and SUSMP 1 Amendment 1, 2 and 3. These can be accessed at The Poisons Standard (the SUSMP). Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au or on 02 6289 1359 during business hours.
1. Advisory Committee on Chemicals Scheduling (ACCS)
1.1 Ametoctradin - seeking advice on a proposal to create a new Appendix B entry. Advice is also sought on alternatively including ametoctradin in Schedule 5.
1.2 Deltamethrin - seeking advice on a proposal to reschedule deltamethrin, when impregnated in plastic resin strip material containing 4 per cent or less of deltamethrin, from Schedule 7 to Schedule 5.
1.3 Dicamba - seeking advice regarding the appropriateness of the current scheduling of dicamba. In particular, whether the current 20 per cent cut-off from Schedule 6 to Schedule 5 could be increased; including, but not limited to, advice on a proposed increase of this cut-off to 50 per cent.
1.4 Fluxapyroxad - seeking advice on a proposal to include in Schedule 5. Advice is also sought on whether a Schedule 6 entry may be more appropriate for fluxapyroxad.
1.5 Indaziflam - seeking advice on a proposal to include indaziflam in Schedule 6.
1.6 Prosulfuron - seeking advice on a proposal to include prosulfuron in Schedule 6 with a possible cut-off to Schedule 5 for preparations containing 5 per cent or less of prosulfuron.
2. Advisory Committee on Medicines Scheduling (ACMS)
2.1 Adrenaline - seeking advice on a proposal to list adrenaline in Appendix H.
2.2 Azelastine - seeking advice on a proposal to reschedule azelastine from Schedule 3 to Schedule 2 when supplied in topical eye preparations containing 0.05 per cent or less of azelastine.
2.3 Diclofenac - seeking advice on a proposal to exempt from scheduling topical preparations containing diclofenac, other than those indicated for the treatment of solar keratosis. Advice is also being sought on two alternative approaches to this possible exemption from scheduling:
- limiting this possible exemption to preparations containing 4 per cent or less of diclofenac, other than those for the treatment of solar keratosis; or
- an exemption for topical preparations containing 2 per cent or less diclofenac and including in Schedule 2 topical preparations containing more than 2 per cent, up to 4 per cent diclofenac, when not indicated for the treatment of solar keratosis.
2.4 Famciclovir - seeking advice on a proposal to reschedule 1500 mg or less of famciclovir from Schedule 4 to Schedule 3 when in oral preparations for the single dose treatment of herpes labialis (cold sores) in immunocompetent patients.
2.5 Follistatin - seeking advice on inclusion of follistatin in Schedule 4 or 8. Advice is also sought on the possible inclusion of a group entry for follistatin-related proteins in the same schedule.
2.6 Fingolimod - consideration of inclusion of fingolimod in Appendix L with a requirement for labelling with warning statement 76 "Do not become pregnant during use or within (Insert number of months as per approved Product Information ) months of stopping treatment."
2.7 3,4-Methylenedioxypyrovalerone (MDPV) - seeking advice on a proposal to include 3,4-methylenedioxypyrovalerone in Schedule 9 with a cross-reference from the common name MDPV to 3,4-methylenedioxypyrovalerone.
2.8 Piper methysticum (kava) - seeking advice on a proposal to allow access when used in accordance with the traditional use patterns of the Pacific Island region. Consideration may include exempting Piper methysticum from scheduling controls when in aqueous preparations for human non-therapeutic use (i.e. for recreational use).
The delegate is particularly seeking jurisdictional views in this matter and advice on alternate jurisdictional controls separate from scheduling which could be applied to appropriately control access and use of these kava preparations.
2.9 Synthetic cannabinoids - the delegate is seeking advice on the appropriate scheduling of the following synthetic cannabinoids and classes of synthetic cannabinoids, in particular inclusion in Schedule 8 or 9 with the possibility of cut-offs to unscheduled for lower concentrations:
The delegate is seeking advice on the potential unintended regulatory impact of this type of decision. The delegate is also seeking advice on alternate wording of the schedule entry to possibly refer to:
- 'synthetic agonists of cannabinoid receptors or synthetic cannabinomimetics'; and/or
- 'substances intended to have a substantially similar pharmacological effect to tetrahydrocannabinols'.
2.10 Schedule 8 labelling requirements - seeking advice on a proposal to amend Part 2, subparagraph 7.(1)(a)(iv) of the SUSMP to allow an appropriate designation under the New Zealand Misuse of Drugs Regulation 1977 next to the signal word on the signal word line. This possible amendment may allow some common packaging to be used for Schedule 8 products between Australia and New Zealand.
Advice is also sought on potential harmonisation of other SUSMP Schedule 8 general labelling requirements between Australia and New Zealand.