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Supplementary invitation for public comment - ACMS meeting, February 2011

Regulation 42ZCZK, Therapeutic Goods Regulations 1990

16 December 2010

This consultation opened on 16 December 2010 and closed on 21 January 2011.

Meeting of the Advisory Committee on Medicines Scheduling - 23 February 2011

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

Further to the notice published on 15 December 2010, 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 also be referred for scheduling advice to the Advisory Committee on Medicines Scheduling (ACMS).

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 Friday 21 January 2011. Please note this differs from the closing date for matters included in the previous notice published on 15 December 2010.

The ACMS 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. Additional items referred to the February 2011 meeting of the ACMS (other items were previously referred to the February 2011 meeting of the ACMS as detailed in the public notice published on 15 December 2010)
    • 1.1 Pantoprazole - proposal to create a new entry for pantoprazole in Appendix H.
    • 1.2 Ibuprofen - proposal to amend part (a) of the current Schedule 2 ibuprofen entry to increase the Schedule 2 limit on liquid preparations to at least 8 g or less (currently is 4 g or less).
    • 1.3 Fexofenadine - proposal to amend the current Schedule 2 fexofenadine entry to exempt oral fexofenadine for the short-term symptomatic relief of seasonal allergic rhinitis from the requirements of scheduling.
      • This consideration may include limiting the exemption to:
        • small pack sizes (10 dosage units or less);
        • packs containing not more than 5 days supply at the maximum dose recommended on the label;
        • for the treatment of adults and children aged 12 years of age and over; and
        • a maximum daily dose of 120 mg.
      • Consideration may also include whether the exemption from scheduling should be limited to products labelled to the effect of "This product should not be used when pregnant or when breastfeeding except when advised by your Doctor or Pharmacist. Do not use with other antihistamines."

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