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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, June 2014

27 June 2014

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This consultation closed on 11 July 2014

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 delegates' 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 delegates, the reasons for those decisions, and invites further submissions from the applicant and parties who made valid submissions in response to the original invitations for submissions (published on 20 February for AgVet and delegate-initiated scheduling applications at Consultation: Invitation for public comment - ACCS, ACMS and joint ACCS/ACMS meetings, March 2014). Edited versions of these submissions are 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, 11 July 2014.

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 and Poisons Scheduling Secretariat (MDP88)
PO Box 9848
CANBERRA ACT 2601
email: SMP@health.gov.au
Facsimile: 02 6289 2650

The closing date for further submissions is 11 July 2014.

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