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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.
- 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)
(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)
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 received: Consultation: Proposed Schedule 3 substances proposed to be added to Appendix H of the Poisons Standard
Any questions relating to submissions should be directed to the Regulatory Reforms Team by email to firstname.lastname@example.org
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