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Invitation for public comment - ACMS and ACCS meetings, March 2013

29 November 2012

This consultation closed on  17 January 2013.

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

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 be referred for scheduling advice to relevant expert advisory committees1.

Accordingly, the following scheduling proposals are open for public submissions. 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.

Persons wishing to make a submission are strongly encouraged to submit them in electronic format (Word or unsecured PDF) to the email address provided below by 17 January 2013.

Email: SMP@health.gov.au

The Secretary
Scheduling Secretariat
GPO Box 9848
CANBERRA ACT 2601

Facsimile: 02 6289 2650

Public submissions received after the closing date may or may not be considered by the advisory committee(s).

Public submissions must include the name of the person making the submission and preferably an email or postal address.

Please note that the 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 relevant expert advisory committee(s) will then consider all valid submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will make an interim scheduling decision. This interim decision is expected to be published on 23 May 2013. The applicant and persons who made a submission in response to the original invitation received on or before the closing date will be invited to comment on the delegates' interim decision.

The current Poisons Standard is available at The Poisons Standard (the SUSMP). Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au.


Footnote

  1. Notice inviting public submissions for the agriculture and veterinary chemicals and delegate initiated scheduling applications will be published on 7 February 2013 with the public comments due on 7 March 2013.

Proposed amendments to the poisons standard referred by the delegate for scheduling advice

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS)
Substance/s Scheduling proposal
Benzodiazepines Proposal to reschedule benzodiazepines from Schedule 4 to Schedule 8.
Diclofenac Proposal to exempt from scheduling for diclofenac when presented as a 140 mg or less diclofenac transdermal drug delivery system.
Hydrocortisone and hydrocortisone acetate Proposal to reschedule preparations containing 1 per cent or less hydrocortisone and hydrocortisone acetate when combined with antifungal substances for dermal use from Schedule 3 to Schedule 2.
Nabiximols

Proposal to reschedule nabiximols from Paragraph 3 of the Appendix D to Paragraph 1 of the Appendix D.

Oseltamivir Proposal to reschedule oseltamivir for the treatment and prevention of influenza type A and type B from Schedule 4 to Schedule 3.
Lisdexamfetamine Proposal to include lisdexamfetamine in Schedule 8.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the joint meeting of the Advisory Committee on Chemicals Scheduling (ACCS) & the Advisory Committee on Medicines Scheduling (ACMS).
Substance/s Scheduling proposal
Adrenaline, bupivacaine and lignocaine Proposal to reschedule a veterinary preparation containing adrenaline, bupivacaine and lignocaine from Schedule 4 to Schedule 6.
Tylosin Proposal to reschedule tylosin from Schedule 5 to Schedule 4.

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Content last updated: Thursday, 29 November 2012

Content last reviewed: Thursday, 29 November 2012

Web page last updated: Thursday, 24 January 2013

URL: http://www.tga.gov.au/newsroom/consult-scheduling-acmcs-1303.htm