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Invitation for public comment - ACMS and ACCS meetings, June 2011

Regulation 42ZCZK, Therapeutic Goods Regulations 1990

13 April 2011

This consultation opened on 13 April 2011 and closed on 13 May 2011.

Meeting of the Advisory Committee on Chemicals Scheduling - 21 June 2011; and Meeting of the Advisory Committee on Medicines Scheduling - 22 June 2011.

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 an expert advisory committee.

Accordingly, the following scheduling proposals are open for public comment. Public 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.

Public submissions that simply reserve the right to comment on a scheduling proposal or are made after the closing date need not be considered by the advisory committee.

Public submissions must also include the name of the person making the submission and a postal or email (preferred) contact address.

Please note that all public 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.

Persons making public submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF) via the email address provided below. Accordingly, public submissions, preferably in electronic format, should be made to:

The Secretary
Scheduling Secretariat
GPO Box 9848
CANBERRA ACT 2601

Email: SMP@health.gov.au

Facsimile: 02 6289 2500

The closing date for submissions is 13 May 2011.

The relevant expert advisory committee(s) will consider all valid public submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will then make an interim decision. This interim decision will be made public as soon as practicable and will be open for further submissions from the applicant and persons who made a submission in response to the original invitation received on or before the closing date for public submissions. For more information on the scheduling processes please see the SPF.

The current Poisons Standard comprises the Standard for the Uniform Scheduling of Medicines and Poisons No. 1 (SUSMP 1) and SUSMP 1 Amendment 1. These can be accessed at www.comlaw.gov.au. Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au or on 02 6289 1359 during business hours.

Proposed amendments referred by the delegate for scheduling advice

1. Advisory Committee on Chemicals Scheduling (ACCS)

1.1 Mesotrione - proposal to include in Schedule 6.

1.2 Saflufenacil - proposal to reschedule from Schedule 7 to Schedule 6. The delegate is also seeking advice on potential cut-offs from Schedule 6 to Schedule 5, including the possibility of a 70 per cent cut-off limited to water dispersible granule formulations.

1.3 Pyroxasulfone - proposal to include in Schedule 7. The delegate is also seeking advice on potential cut-offs from Schedule 7 to Schedule 6, including the possibility of an 85 per cent cut-off limited to pre-emergence herbicide use.

1.4 Naphthalene - proposal to increase the current restrictions through scheduling on domestic use of naphthalene, including (but not necessarily limited to) mothballs, blocks, discs, pellets or flakes. The delegate is particularly seeking advice on:

  • Expanding the container requirements for domestic use of camphor and naphthalene under SUSMP Part 2, Labels and Containers, paragraphs 28 and 29 to apply to flake forms of naphthalene.
  • Rescheduling some, or all, forms of naphthalene for domestic use from Schedule 6 to Schedule 7 or Appendix C. This consideration may include the potential for a low concentration cut-off. Particular consideration is likely to be given to further restricting loose or flaked forms of naphthalene.
  • In addition to domestic pesticidal use (mothballs etc), information on other domestic uses is particularly being sought to help define potential regulatory impact from increasing current restrictions.

2. Advisory Committee on Medicines Scheduling (ACMS)

2.1 Cough and Cold preparations:

  • Following consideration of advice from a number of expert sources including the Advisory Committee on Medicines Schedules (ACMS), the delegate refers the following revised proposal regarding cough and cold preparations to the ACMS for further advice:
  • Cough and cold preparations - proposal to schedule five substances used in currently unscheduled cough and cold preparations to Schedule 2. The delegate proposes that this rescheduling apply to the following substances for use in cough and cold products only where it will not result in less restrictive scheduling:
    • Carbetapentane (pentoxyverine)
    • Guaiphenesin (guaifenesin)
    • Ipecacuanha (cephaelis acuminata and cephaelis ipecacuanha)
    • Phenylephrine
    • Senega
  • The TGA proposes to address the use of cough and cold medicines by different age groups separately through product registration and labelling processes.
  • Additional information for stakeholders on the TGA review of cough and cold medicines is available at Labelling and packaging of cough and cold medicines - proposed changes to requirements.

2.2 Loperamide - proposal to reschedule loperamide in packs of eight dosage units or less, up to a maximum of one days' supply, from Schedule 2 to unscheduled.

2.3 Nicotine - proposal to amend the Schedule 4 entry to exempt from scheduling, when used for human therapeutic use as an aid in withdrawal from tobacco smoking:

  • nicotine oromucosal film; and
  • nicotine inhalation cartridges for oromucosal use.

These proposed exemptions are similar to the exemptions for nicotine in chewing gums, lozenges, and preparations for sublingual, transdermal or oromucosal spray use when used as an aid in withdrawal from tobacco smoking.

ACMS advice is also sought on potentially expanding the nicotine exemption to include all oromucosal uses.

2.4 Orphenadrine - proposal to reschedule orphenadrine from Schedule 4 to Schedule 3 when combined with paracetamol with certain conditions. These conditions could include:

  • limited orphenadrine content per dosage unit, such as 35 mg or less;
  • a limited pack size, such as 24 dosage units or less; and/or
  • a restricted indication, such as when used for the relief of pain associated with skeletal muscle spasm in adults and children over 12 years of age.

2.5 Rabeprazole - proposal to create a new entry for rabeprazole 10 mg or less in Appendix H.

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