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Consultation: Invitation for public comment - Out-of-session ACMS meeting, November 2014

20 October 2014

This consultation closed on 17 November 2014.

Notice inviting public submissions under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations)

The delegate of the Secretary of the Department of Health 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 committees.

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 making submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred) via the email address provided below.

Email: medicines.scheduling@tga.gov.au for items referred to the Advisory Committee on Medicines Scheduling.

The closing date for submissions is 17 November 2014.

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 for Medicines and Poisons (SPF, 2010), issued by the National Coordinating Committee on Therapeutic Goods. The SPF is accessible at NCCTG scheduling policy framework.

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 05 February 2015. 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 (also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Medicine scheduling queries can be directed to the Medicines Scheduling Secretariat at medicines.scheduling@tga.gov.au and chemical scheduling queries can be directed to the Chemicals Scheduling Secretariat at chemicals.scheduling@health.gov.au.

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 Proposal
Cannabidiol To create a new Schedule 4 entry for cannabidiol for therapeutic use with consideration of an Appendix D listing