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Scheduling delegate's interim decisions and invitation for further comment: ACMS, February 2015

4 February 2015

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Notice under subsections 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations)

A delegate of the Secretary to the Department of Health hereby gives notice of delegate's interim decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsections 42ZCZP the Therapeutic Goods Regulations 1990 (the Regulations). This notice also provides the reasons for each decision and the date of effect of the decision.

This notice provides the interim decisions of the delegate, the reasons for those decisions and invites further submissions for the applicant and parties who made valid submissions in response to the original invitations for submissions (published on 14 August 2014 and 17 November 2014 for general scheduling applications and delegate-initiated scheduling applications respectively at Consultation: Invitation for public comment - ACMS and joint ACCS/ACMS meetings, November 2014 and Consultation: Invitation for public comment - Out-of-session ACMS meeting, November 2014. Edited versions of these submissions will be made available at Public submissions on scheduling matters.

Further 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 19 February 2015.

Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate.

Please note that all valid submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submissions 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 for Medicines and Chemicals (SPF, 2010), issued by the National Coordinating Committee on Therapeutic Goods. The SPF is accessible at NCCTG scheduling policy framework.

Persons making submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred) via the email address provided below. Submissions, preferably in electronic format, should be made to Medicines.Scheduling@tga.gov.au for items referred to the Advisory Committee on Medicines Scheduling.

The closing date for further submissions is 19 February 2015.

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