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Consultation submissions: The Scheduling Policy Framework and Advertising of Pharmacist-only medicines (Schedule 3 substances)

5 September 2017

Between 31 March and 28 April 2017, the TGA sought comments from interested parties on the review of the Consultation: Scheduling Policy Framework and reforms to advertising of Pharmacist-only medicines (Schedule 3 substances).

We thank those individuals and organisations for their valuable feedback.

All submissions that were not marked as confidential are now available in PDF format.

Submissions

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A further four submissions were received with claims of confidentiality or privacy that prevent the publication of the submissions and the identities of those individuals providing submissions.

TGA response

Generally, responses were supportive of the proposed reforms, in particular measures that would increase the efficiency and transparency of the scheduling process.

Based on the feedback to this consultation, and with AHMAC and Ministerial endorsement, we plan to proceed with the following reforms to the SPF:

  • Split the SPF into a policy document and a guidance handbook. Chapters 1-3 of the current SPF would form the SPF policy document, with the remainder of the SPF being modified to form a guidance document. The guidance document will also better explain the legislative nature of the Poisons Standard and jurisdictional requirements, incorporate assessment of benefit in conjunction with risk in applications, and improve the usability of the application template.
  • Establish a stakeholder working group to provide advice on ongoing reforms to the Poisons Standard and the SPF.
  • Consider changes to the framework that allow full public consultation on the interim decision and extend the two week consultation period on a case by case basis to four weeks.
  • Create a new Appendix in the Poisons Standard (SUSMP) to enable additional controls or requirements for Schedule 3 substances to be specified, in particular for substances that have been down-scheduled from Schedule 4 (prescription only).

We will not be pursuing the proposals to establish a delegate in the APVMA or to introduce market incentives to encourage down-scheduling applications.

There was also strong support overall for reforming the current arrangements for advertising of Schedule 3 (Pharmacist only) medicines. This work will be progressed as part of the broader advertising reforms.