Notice inviting public submissions under Regulation 42ZCZK of the Therapeutic Goods Regulations 1990
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 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 19 December 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 29 May 2014. 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.
Proposed amendments to the poisons standard referred by the delegate for scheduling advice
| Substance | Proposal |
|---|---|
| Naproxen | Proposal to amend the Schedule 2 entry for Naproxen to include a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when not labelled for the treatment of children under 12 years of age. |
| Sodium oxybate | Proposal to include sodium oxybate for human therapeutic use in Schedule 8 an in Appendix D Item 1. |