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Consultation: Invitation for public comment - ACMS meeting, July 2015

Public consultation on the proposed amendments to the Poisons Standard (Medicines)

10 June 2015

This consultation closed on 9 July 2015.

Invitation to comment

The TGA is seeking comments from interested parties on the following 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
2-Hydroxyethyl Methacrylate Noting the Chemical Delegate's interim decision to create a new Schedule 5 entry - 2-HYDROXYETHYL METHACRYLATE except when in nail preparations labelled "Avoid contact with skin", should therapeutic and/or dental use of this substance be exempt or have a cut-off of strength? If a cut-off of strength is to be applied, is the proposed implementation date of 1 February 2016 appropriate for therapeutic and/or dental use?
Levocetirizine

Although Levocetirizine is covered by the entry for Cetirizine it is proposed to include specific entries for Levocetirizine in Schedule 2, Schedule 4 and Appendix K in the Poisons Standard.

Consideration should include:

  • whether all levocetirizine preparations for oral use should be in Schedule 2; or
  • whether levocetirizine should be exempt from scheduling in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when: (a) in a primary pack containing not more than 5 days' supply; and (b) labelled with a recommended daily dose not exceeding 5 mg of levocetirizine (i.e. consistent with the scheduling exemption for cetirizine).
Proton Pump Inhibitors (PPIs)

To create new Appendix H entries for the following Schedule 3 proton pump inhibitors:

  • lansoprazole;
  • omeprazole;
  • pantoprazole; and
  • rabeprazole.

Timetable

Document released for consultation on Thursday, 11 June 2015.

Interested parties should respond by close of business Thursday, 9 July 2015.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

This consultation is inviting public submissions under subsection 42ZCZK/42ZCZL 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 above 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.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the Poisons Standard (Medicines) or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the amendment/s. If you do not support the amendment/s, you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the TGA Internet website: feedback on submissions will be provided through the TGA Internet site: Public submissions on scheduling matters

Scheduling decisions made by the medicines delegate following consideration of submissions from interested parties, along with advice from the Advisory Committee on Medicines Scheduling (ACMS) will be published on the TGA website as interim decisions.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the cover sheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to medicines.scheduling@tga.gov.au.