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Part A - Final decisions on matters referred to an expert advisory committee (November 2017)
1. Advisory Committee on Medicines Scheduling (ACMS #22)
1.9 Clotrimazole
Delegate's final decision
Final decision:
The delegate's final decision is to not to amend the Schedule 3 entry of clotrimazole.
Implementation date: N/A
Reasons:
The delegate notes the public submission on the interim decision. However, as no new evidence has been received to alter the interim decision for clotrimazole, the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision.
Public submissions on the interim decision
One (1) submission was received that opposed the delegate's interim decision.
The main points opposed are:
- The Schedule and Appendix entries for clotrimazole should be amended as proposed by the applicant. If not, the delegate will miss an opportunity to improve access to clotrimazole for the safe and effective treatment of thrush by women.
- Clotrimazole is available OTC without mandatory pharmacist intervention in more than 70 other countries and is available as a general sale item in the US and the UK. The delegate will also miss the opportunity to bring the Australian scheduling of clotrimazole into alignment with comparable overseas markets.
Interim decision
The interim decision for clotrimazole was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 1.9. Clotrimazole.
Scheduling proposal
The pre-meeting scheduling proposal for clotrimazole was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.