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Invitation for public comment - ACMS and joint ACMS/ACCS meetings, February 2011

Regulation 42ZCZK, Therapeutic Goods Regulations 1990

15 December 2010

This consultation opened on 15 December 2010 and closed on 19 January 2011.

Meeting of the Advisory Committee on Chemicals Scheduling - 22 February 2011; Meeting of the Advisory Committee on Medicines Scheduling - 23 February 2011; and Joint Meeting of the Advisory Committees on Medicines & Chemicals Scheduling - 28 February 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 Poisons Standard contained in this notice will be referred for scheduling advice to an expert advisory committee.

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 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. The SPF is accessible at Scheduling policy framework.

Persons making public submissions were strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred).

The closing date for submissions was Wednesday 19 January 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 will be made public as soon as practicable and will be open for further public comment from persons who made a submission in response to the original invitation and received on or before the closing date for public submission. If no submissions are received to the original invitation, then the interim decision may be considered final.

For more information on the scheduling processes please see the Scheduling Policy Framework. The current Poisons Standard comprises the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) and can be accessed at www.comlaw.gov.au.

Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au or phone 02 6289 2584 during business hours.

Proposed amendments referred by the delegate for scheduling advice

  1. Advisory Committee on Medicines Scheduling (ACMS)
    • 1.1 Asenapine - proposal to include in Appendix K.
    • 1.2 Chloramphenicol - consideration of amending the Schedule 3 entry to restrict chloramphenicol for ophthalmic use only in the treatment of bacterial conjunctivitis.
    • 1.3 Paracetamol + ibuprofen combination - consideration for a higher schedule. Currently in Schedule 2.
    • 1.4 Rupatadine - proposal to include in Appendix K.
    • 1.5 Tafluprost - proposal to include in Appendices D and L.
    • 1.6 Tapentadol - proposal to include in Appendices D and K.
    • 1.7 Tolvaptan - proposal to include in Appendices D and L.
  2. Advisory Committee on Chemicals Scheduling (ACCS)
    • 2.1 Cefquinome - proposal to include cefquinome in Schedule 4.
    • 2.2 Derquantel - proposal to include derquantel in Schedule 6 with a cut-off to Schedule 5 for preparations containing 1 per cent or less of derquantel.
    • 2.3 Diethylhexyl phthalate (DEHP) - proposal to schedule DEHP, including consideration of:
        • a parent entry in Schedule 6 or 7;
        • prohibition of cosmetic use through listing in Appendix C.
  3. The delegate is also seeking advice on potential cut-offs and exemptions, including possibly restricting the use in toys and childcare articles to less than 0.05 per cent.
  4. 2.4 Emodepside - proposal to amend the Schedule 5 entry for emodepside by extending the current capture of preparations containing 2.5 per cent or less of emodepside for external treatment of animals to also capture preparations containing 2.5 per cent or less of emodepside for oral treatment of animals.
  5. 2.5 Flumioxazin - proposal to amend the Schedule 7 entry for flumioxazin to allow a cut-off to Schedule 6 for preparations in water soluble bags when individually packed in sealed sachets.
  6. 2.6 Mavacoxib - proposal to include in Schedule 4.
  7. 2.7 Metofluthrin - proposal to include metofluthrin in Schedule 6.
  8. 2.8 Proquinazid - proposal to include in Schedule 6.
  9. Joint meeting of the Advisory Committees on Medicines and Chemicals Scheduling (ACMS and ACCS)
    • 3.1 Methylsulfonylmethane - consideration of inclusion of methylsulfonylmethane in Schedule 4 for human therapeutic use in concentrations greater than 1500 mg per dosage unit. This consideration may also include methylsulfonylmethane for non-human use, mirroring the scheduling of dimethyl sulfoxide.
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