Scheduling delegate's final decision: codeine, December 2016
Scheduling medicines and poisons
The date and reasons for the final scheduling decision relating to Codeine have not changed. Corrections have been made in this update to rectify a publishing error.
20 December 2016
(Codeine - ACMS meetings - July/August 2015 and March 2016)
Notice under subsections 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations)
The delegate of the Secretary to the Department of Health hereby give notice of delegate's final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsection 42ZCZS the Therapeutic Goods Regulations 1990 (the Regulations). This notice also provides the reasons for the decision and the date of effect (implementation date) of the decision.
The delegate's final decision and reasons relate to the scheduling of codeine considered by:
- the July/August 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#15); and
- the March 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#17).
Scheduling proposals referred to the expert advisory committees
Pre-meeting public notice
July/August 2015 ACMS#15
On 1 April 2015, under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations), the delegate published a pre-meeting public notice on the TGA website which specified the proposed amendments to the current Poisons Standard and invited public comment. The proposed amendments referred to the ACMS by the medicines scheduling delegate for codeine were:
- To delete the Schedule 3 entry for codeine, and re-schedule 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 re-scheduled to Schedule 4, or whether any re-scheduling 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.
The pre-meeting consultation period was open for public comment for 20 business days and closed on 7 May 2015.
In accordance with subsection 42ZCZL of the Regulations redacted versions of public submissions received in response this invitation were published on 15 December 2015 at: Public submissions on scheduling matters.
July/August 2015 ACMS#15
On 1 October 2015, in accordance with subsection 42ZCZN of the Regulations, the delegate made an interim decision on an application and under subsection 42ZCZP of the Regulations, the delegate's interim decision and the reasons for the decision was published on TGA website. Further submissions were also invited from the applicants and parties who made valid pre-meeting submissions. The inivitation to make submissions was open for 10 business days and closed on 15 October 2015.
Redacted versions of public submissions received in response these invitations were published on 15 December 2015 at: Public submissions on scheduling matters.
Additional consultation period
In order to give due consideration to the submissions received in the interim decision public consultation period and to seek further advice from the ACMS at its March 2016 meeting, the medicines scheduling delegate on 18 November 2015 deferred a final decision on the proposed codeine re-scheduling.
The TGA then sought further advice and public comment on several options for codeine re-scheduling via an additional consultation period that was open from 10 December 2015 through 29 January 2016.
Edited versions of valid public submissions received in response to the additional consultation period were published on 20 December 2016 at Public submissions on scheduling matters.
In accordance with subsection 42ZCZR of the Regulations, the delegate having made an interim decision on an application, has made a final decision confirming the interim decision after consideration of all submissions.
Publishing of the amendments to the Poisons Standard
The amendments to the Schedules, Appendices or other parts of the Poisons Standard are published electronically on ComLaw as amendments to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on ComLaw, is available at SUSMP.