Consultation: Proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard

This consultation closed on 9 July 2018.

The TGA sought comments from interested parties on the proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard to allow them to be advertised direct to consumers.

On this page: Consultation documents | Reference documents |Timetable | About the consultation | Submissions | Enquiries | Outcomes | Privacy information

Consultation documents

How to access a pdf or Word document

• Consultation paper: Substances proposed to be added to Appendix H of the Poisons Standard (pdf,161kb)
• Consultation paper: Substances proposed to be added to Appendix H of the Poisons Standard (docx,89kb)

Reference documents

(for reference only; not for consultation or comments)

• Appendix 1 - Guidelines for advertising medicines containing Schedule 3 substances (pdf,166kb)
• Appendix 1 - Guidelines for advertising medicines containing Schedule 3 substances (docx,93kb)

Timetable

Documents released for consultation on Monday, 4 June 2018.

Interested parties should respond by close of business Monday, 9 July 2018.

Feedback will be released following consideration of submissions. (see 'Outcomes').

About the consultation

This consultation is the culmination of input from stakeholders at meetings held in February TGA presentation: Scheduling working group meeting one, 9 February 2018 and March of 2018 TGA presentation: Medicines scheduling and scheduling policy ad hoc working group meeting two, 6 March 2018 and follows consultations held in 2017 conducted as part of the review of the Scheduling Policy Framework (SPF) and Schedule 3 advertising in response to Recommendations 11 and 12 of the Medicines and Medical Device Review (MMDR).

As part of the SPF review, it was agreed that advertising of medicines containing Schedule 3 substances should be permitted unless there was reason not to. In order for these medicines to be lawfully advertised, they need to be included in Appendix H of the Poisons Standard.

The purpose of this consultation is to provide an opportunity for consumers, healthcare professionals and industry to comment on the Schedule 3 substances proposed to be added to Appendix H of the Poisons Standard, also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUMSP). Once added to Appendix H, medicines containing these substances will be able to be advertised direct to consumers.

Submissions

• Submissions received: Consultation: Proposed Schedule 3 substances proposed to be added to Appendix H of the Poisons Standard

Enquiries

Any questions relating to submissions should be directed to the Regulatory Reforms Team by email to tgaregreforms@health.gov.au

Outcomes

• Outcomes of the consultation to add substances to Appendix H of the Poisons Standard

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.