Consultation: Proposed Schedule 3 Substances to Be Added to Appendix H of the Poisons Standard

This consultation closes on 9 July 2018. On this page: Invitation to comment | Consultation documents | Reference documents |Timetable | About the consultation | Content of submissions | How to submit | Enquiries | What will happen | Privacy information Invitation to comment The TGA is seeking comments from interested parties on the proposed...

This consultation closes on 9 July 2018.

On this page: Invitation to comment | Consultation documents | Reference documents |Timetable | About the consultation | Content of submissions | How to submit | Enquiries | What will happen | Privacy information

Invitation to comment

The TGA is seeking 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 documents

How to access a pdf or Word document

Reference documents

(for reference only; not for consultation or comments)

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 'What will happen').

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.

Content of submissions

Submissions may provide comment on any, or all, of the substances proposed to be added to Appendix H or other identified issues.

How to submit

Complete the online consultation submission form to upload your submission in either pdf or word format.

Alternatively, hardcopy submissions with a printed coversheet may be mailed to:

Regulatory Reforms Team
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Enquiries

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

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 considered by the Scheduling Delegate. Outcomes of this review, including additions to Appendix H, will be summarised on this webpage.

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.
Source: www.tga.gov.au