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

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Scheduling medicines and poisons

1 October 2015

This consultation closes on 15 October 2015

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 subsection 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 2 April 2015 and 11 June 2015 for general scheduling applications and for delegate-initiated scheduling application respectively at Consultation: Invitation for public comment - ACMS meeting, July 2015 and Consultation: Invitation for public comment - ACMS meeting, July 2015). 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. As per subsection 42ZCZP of the Regulations, further submissions in relation to the interim decision are to be made within 10 business days after the publication of the notice and therefore, must be received by the closing date 15 October 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, 2015), issued by the National Coordinating Committee on Therapeutic Goods.

How to make a submission

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 15 October 2015.

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