The closing date for submissions is 11 December 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. 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 submissions is 11 December 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 http://www.tga.gov.au/publication/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 4 June 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 |
|---|---|
| Aciclovir | Proposal to reschedule aciclovir in muco-adhesive tablets containing 50 mg in a pack of two tablets or less from Schedule 4 to Schedule 2. |
Oestradiol Desogestrel Ethinylestradiol Norethisterone Levonorgestrel Cyproterone Gestodene Drospirenone Mestranol Medroxyprogesterone Oestrogens Progestogens | To create new Schedule 3 entries for these substances when indicated for oral contraception. The applicant has proposed potential conditions of:
Limit of 3-6 months' supply in one transaction |
| Diphenoxylate | Proposal to down schedule diphenoxylate 2.5mg or less in packs of 8 or less dosage units, when combined with a quantity of atropine sulphate equivalent to at least 1 per cent of the dose of diphenoxylate from Schedule 3 to Schedule2. To remove diphenoxylate from Appendix H. |
| Esomeprazole | Proposal to create a new entry in Appendix H for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease (GORD), in packs containing not more than 14 days supply. |
| Hydrocortisone compounded with Aciclovir | Proposal to amend the Schedule 3 entry for hydrocortisone 1 per cent (1%w/w) when compounded with aciclovir 5% (5% w/w) or less in primary packs of not more than 2 g for dermal use in adults and adolescents (12 years of age and older). To include aciclovir in Appendix H. |
| Ranitidine | Proposal to exempt ranitidine from Schedule 2 when in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 7 dosage units. |