Consultation: Proposed amendments to the Poisons Standard - ACMS meeting, March 2016

11 November 2015

This consultation closes on 10 December 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 to the Advisory Committee on Medicines Scheduling (ACMS).

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
KETOPROFEN Proposal to amend the scheduling of ketoprofen to include divided preparations for oral use containing 200 mg or less of ketoprofen per dosage unit in in Schedule 3.
LORATADINE Proposal to increase the pack size of unscheduled loratadine (10 mg or less) divided oral preparations from 5 dosage units to 10 dosage units when used in adults and children 12 years of age and over for the treatment of seasonal allergic rhinitis.
NAPROXEN Proposal to amend the Schedule 2 naproxen entry to exclude naproxen (i.e. make it available for sale outside pharmacy) when containing 200mg or less of naproxen per dosage unit in packs of 12 or less dosage units when not labelled for the treatment of children under 12 years of age.
PARACETAMOL

Proposal to amend the Schedule 2 entry of paracetamol to:

  • restrict the pack size requirements to no more than 100 tablets or capsules per pack and no more than 50 wrapped powders or sachets of granules per pack for domestic supply, and
  • specifically limit bulk pack sizes of paracetamol for supply only to hospital, nursing homes and pharmacies for dispensing purposes.

Timetable

Document released for consultation on Thursday 12 November 2015.

Interested parties should respond by close of business Thursday 10 December 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.

How to respond

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

How to access a Word document

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 coversheet (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 .