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Consultation: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only)

25 February 2019

This consultation closed on 1 April 2019.

The TGA sought comments from interested parties on the proposed criteria, accompanying guidance and plans for monitoring of the supply of Schedule 3 (S3) Pharmacist only - Appendix M substances.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Monday, 25 February 2019.

Interested parties should respond by close of business Monday, 1 April 2019.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

This public consultation paper outlines a proposed framework for the use of Appendix M of the Poisons Standard. Appendix M is intended to include substances that have formerly been scheduled as Schedule 4 (S4) and have required a prescription by a medical practitioner, but if rescheduled to S3 could be dispensed by a pharmacist with specific controls in place that help to ensure appropriate use. It is not intended that Appendix M controls would be routinely required for medicines that are rescheduled from S4 to S3; however, the addition of Appendix M controls might facilitate downscheduling of S4 substances in circumstances where doubt might otherwise exist as to the public health benefit of doing so.

Advice is sought on the feasibility, practicality and reasonableness of this framework from a wide range of stakeholders.

Background

In January 2018, a revised Scheduling Policy Framework (SPF) was published and came into force, including provision for Appendix M. Appendix M appears in the Poisons Standard from February 2019 with the heading "additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist". However, to date, there has been no explicit guidance for applicants on what additional controls might be applied under Appendix M. Consideration of these and other issues has been part of the brief of an ad hoc working group formed in January 2018 to continue work on outstanding scheduling issues. This group comprises representatives from the states and territories, the medicines and chemical scheduling advisory committees, industry groups and professionals from the medicine, pharmacy and chemicals sectors, as well as consumer representatives.

The working group has met three times to date - 9 February, 6 March and 11 December 2018. While discussion on the structure and use of Appendix M has progressed, at the last meeting it was agreed that further public consultation on this matter was warranted.

Content of submissions

Submissions may address any, or all, of the questions posed in the consultation paper.

Enquiries

Any questions relating to submissions should be directed to the Transparency, Reforms and Evaluation Support Section by email to tgaregreforms@health.gov.au or by telephone to the information line 1800 020 653.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

A final framework for Appendix M will be developed based on feedback received and agreed with key stakeholders. Guidance for applicants will be updated accordingly on the TGA website and any identified changes to process implemented by mid 2019.

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)
    • seek feedback about how the consultation was undertaken.
  • 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.
  • More information on consultations and privacy is included in the submission form and on our website.