Consultation: Invitation for public comment - ACMS and joint ACCS/ACMS meetings, November 2014

14 August 2014

This consultation closed on 11 September 2014.

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 11 September 2014.

Email: Medicines.Scheduling@tga.gov.au

The Secretary
Communications and Secretariat
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

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 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 5 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)). Queries regarding medicine scheduling can be directed to the Medicine Scheduling Secretariat at Medicine.Scheduling@tga.gov.au. Chemical scheduling related queries can be directed to the Chemical scheduling Secretariat at chemicalscheduling@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 joint committee of the Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
Gamma Butyrolactone Proposal to consider whether a separate entry for gamma butyrolactone is required in either Appendix C or Schedule 9 to restrict its use in cosmetics or other types of products.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the ACMS.
Substance Proposal
Benzydamine Proposal to exempt from scheduling benzydamine in preparations for topical use containing 3 mg or less of benzydamine in divided oral preparations and 3 mg/ml or less in undivided oral preparations in a pack of 50 ml or less.
Naproxen Proposal to amend the Schedule 2 naproxen entry to exclude naproxen in a dosage form of 200 mg or less of naproxen per dosage unit in packs of 12 or less dosage units with a maximum recommended daily dose of not more than 600 mg of naproxen, and when not labelled for the treatment of children 12 years of age or less.
Naproxen Proposal to include naproxen in Appendix H.
Pantoprozole A new Schedule 2 entry for pantoprazole when supplied in oral preparations containing 20mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days of supply.
Paracetamol in combination with Caffeine Proposal to exempt paracetamol when compounded with caffeine, in a powder or granule product containing 1000mg or less of paracetamol and in tablets or capsules containing 500mg or less of paracetamol when paracetamol is the only therapeutic active constituent and when supplied in primary packs of not more than 20 tablets/caplets or 10 sachets of powders/granules.
Paracetamol in combination with Ibuprofen Proposal to include paracetamol when combined with ibuprofen in Appendix H.
Paracetamol in combination with Phenylephrine

Proposal to include the following in Schedule 3:

  • 500 mg of paracetamol when combined with more than 2.5 mg phenylephrine per tablet or capsule or caplet
  • Individually wrapped powders or sachets of granules containing paracetamol 1000 mg and more than 5 mg phenylephrine per dose

Proposal to include in the following in Schedule 2:

  • 500 mg of paracetamol when combined with 2.5 mg phenylephrine or less per tablet or capsule or caplet in packs containing more than 20 tablets or capsules or caplets per pack
  • Individually wrapped powders or sachets of granules containing paracetamol 1000 mg and 5 mg phenylephrine or less per dose in packs containing more than 10 such powders or sachets

Proposal to exempt from scheduling the following:

  • 500 mg of paracetamol when combined with 2.5 mg phenylephrine or less per tablet or capsule or caplet in packs containing 20 or less tablets or capsules or caplets per pack
  • Individually wrapped powders or sachets of granules containing paracetamol 1000 mg and 5 mg phenylephrine or less per dose in packs containing 10 or less such powders or sachets.