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

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

1 April 2015

The closing date for submissions is 7 May 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.


Document released for consultation on Thursday, 2 April 2015.

Interested parties should respond by close of business Thursday, 7 May 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 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.

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

To delete the Schedule 3 entry for codeine, and reschedule the current Schedule 3 codeine entry to Schedule 4 due to potential issues of morbidity, toxicity and dependence.

Consideration may be given as to whether all current Schedule 3 preparations should be rescheduled to Schedule 4, or whether any rescheduling to Schedule 4 should only apply to combination analgesic products containing codeine.

Consideration may be given as to whether the Schedule 2 entry for codeine should also be amended.

Esomeprazole To amend the scheduling of esomeprazole to include oral preparations containing 20 mg or less of esomeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.
Hydrocortisone and hydrocortisone acetate (excluding other salts and derivatives)

To amend the scheduling of hydrocortisone and hydrocortisone acetate to include preparations for dermal human therapeutic use containing 1% or less of hydrocortisone when combined with an antifungal substance (and no other therapeutically active substance) in Schedule 2 under the following conditions:

  • In packs containing 15 g or less; and
  • For the treatment of tinea and other fungal skin infections; and
  • Not labelled for the treatment of children under 12 years.
Naloxone To amend the scheduling of naloxone to include single use prefilled syringe preparations for injection containing 400 micrograms/mL of naloxone or less in Schedule 3
Orlistat To amend the scheduling of orlistat from Schedule 3 to Schedule 2 for oral preparations for weight-control purposes containing 120mg or less or orlistat per dosage unit.

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.

How to respond

All submissions should be accompanied by a TGA submission cover sheet. Submissions must include full personal or organizational contact details (including address, telephone number and email).

Electronic submissions are preferred and should be emailed to Please include 'Proposed Amendments to the Poisons Standard (Medicines)' in the subject line of the email.

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.


Any questions relating to submissions should be directed by email to