Consultation: Proposed amendments to the Poisons Standard (Codeine)

Scheduling medicines

10 December 2015

This consultation closed on Friday, 29 January 2016.

Invitation to comment

In view of the submissions made following the interim decision to-up schedule products containing codeine and in view of the subsequent announcement to defer a final decision, the TGA is sought further advice/submissions from interested parties on the options listed below. Any information gathered through this process will be referred by the delegate to the Advisory Committee on Medicines Scheduling (ACMS) in March 2016 for advice. The provision of the following options does not preclude the delegate from considering alternatives to these or the original application made in February 2015.

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS), March 2016
Substance Proposal
Codeine

Schedule 2 (cough and cold medicine preparations):

  1. Proposal to amend the Schedule 2 entry to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction; OR
  2. Proposal to up-schedule the Schedule 2 entry to Schedule 3 and reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction; OR
  3. Retain the interim decision to up-schedule to Schedule 4.

Schedule 3 (including, but not limited to codeine containing analgesics):

  1. Proposal to amend the Schedule 3 entry to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction; OR
  2. Retain the interim decision to up-schedule to Schedule 4.

Timetable

Document released for consultation on Friday, 11 December 2015.

Interested parties should respond by close of business Friday, 29 January 2016.

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 coversheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the TGA Internet website. Feedback on submissions will be provided at: 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 coversheet).
  • 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.