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Consultation: Regulatory options for appropriate access and safety controls for alkyl nitrites

Seeking public feedback

30 November 2018

This consultation closes on 15 January 2019

Invitation to comment

The TGA is seeking comments from interested parties on a discussion paper outlining different approaches to access and safety controls for alkyl nitrites in order to inform a decision on how best to control potential risks to public health and safety.

Options for access range from general (unrestricted) sale, through to access in pharmacies, pharmacist only access, prescription only access or prohibited substance status. It may be appropriate for access controls to vary for between members of the alkyl nitrite family of substances. We are interested in hearing your views.

Consultation documents

How to access a pdf or Word document


Document released for consultation on Friday 30 November 2018.

Interested parties should respond by close of business Tuesday 15 January 2019.

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

About the consultation

Information about the reason for and purpose of the consultation is available at: Further public consultation on appropriate access and safety controls (Poisons Standard schedule) for alkyl nitrites.


Background information is available at: Further public consultation on appropriate access and safety controls (Poisons Standard schedule) for alkyl nitrites.

Content of submissions

You are invited to comment on possible options for the future scheduling of alkyl nitrites.

Submissions can be provided along with any supporting evidence against all, or any, of the options provided in the consultation paper.

You may also wish to comment on whether it would be appropriate for scheduling to vary for individual members of the alkyl nitrite family of substances.

In addition, submissions might include:

  • What you see as the likely benefits or drawbacks of the options presented.
  • An assessment of how any changes to the way that alkyl nitrites are regulated will impact on you.

How to submit

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

Consultation submission form

Director, Scheduling Project Management
Regulatory Engagement and Planning Branch
Regulatory Practice and Support Division
Therapeutic Goods Administration
PO Box 100

How to access a Word document


Any questions relating to submissions should be directed to the Director, Scheduling Project Management by email to or by telephone to 02 6221 6903.

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.

The TGA also proposes to hold public meetings in Sydney and Melbourne at the end of January or early February 2019 to facilitate further stakeholder input into the discussion about possible approaches to access and safety controls for alkyl nitrites. Further details will be advised in December 2018.

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.