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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, May 2013

23 May 2013

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This consultation closed on 6 June 2013.

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

A delegate of the Secretary to the Department of Health and Ageing hereby gives notice of delegates' interim decisions under subsection 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations).

This notice provides the interim decisions of delegates, the reasons for those decisions and invites further submissions from the applicant and parties who made a valid submission in response to the original invitation for submissions (published on 29 November 2012 and 7 February 2013 for general scheduling applications and for Agvet and delegate-initiated scheduling applications respectively at Invitation for public comment - ACMS and ACCS meetings, March 2013 and Invitation for public comment - ACCS meeting, March 2013. 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 (6 June 2013).

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 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 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 6 June 2013.

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