This consultation closed on 29 September 2016

Notice under subsection 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations)

A delegate of the Secretary to the Department of Health hereby gives notice of delegates' interim decisions for amending the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsection 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations). This notice also provides the reasons for each decision and the date of effect (the implementation date) of the decision.

The delegates' interim decisions and reasons relate to:

scheduling proposals initially referred to the July 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#18);

scheduling proposals initially referred to the July 2016 Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (ACCS-ACMS#13); and

scheduling proposals initially referred to the July 2016 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#17).

Pre-meeting public notices

Pre-meeting public notices inviting submissions on the scheduling proposals referred to the expert advisory committees were published on 7 April 2016 (Medicines) and 26 May 2016 (Chemicals) on the TGA website at: Public notice about scheduling.

Redacted versions of public submissions received in response to the requests for public comment will be published on or after the date of this notice on the TGA website at Public submissions on scheduling matters.

Interim decisions

This notice provides the interim decisions of the delegates and the reasons for those decisions and invites further submissions from the applicant and parties who made valid submissions in response to the original invitations for submissions (published on 7 April 2016 and 26 May 2016 at Scheduling advisory committees: invitations for public comment).

Further submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date, 29 September 2016.

Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate.

Please note that all valid submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submissions to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015), issued by the Australian Health Ministers' Advisory Council (AHMAC). The SPF is accessible at: AHMAC - Scheduling policy framework for medicines and chemicals.

Persons making submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred) via the email address provided below. Submissions, preferably in electronic format, should be made to:

Chemicals.Scheduling@tga.gov.au for items referred to the Advisory Committee on Chemicals Scheduling; and Medicines.Scheduling@tga.gov.au for items referred to the Advisory Committee on Medicines Scheduling.

The closing date for further submissions is 29 September 2016.

Privacy and your personal information

Your personal information is protected by law, including the Privacy Act 1988. It is collected by the Australian Government Department of Health for the purposes of identifying the person making a submission as part of the public invitation process, and contacting that person about their submission, for example to seek clarification of issues raised in the submissions.

The consequences of not providing your personal information may result in the Department being unable to communicate with you about your submission.

The Department is unlikely to disclose your personal information it has collected as part of the public comment process to any other Department, body or person or to overseas recipients.

More information about the Department's management of personal information is contained in the Department's privacy policy. The Department's privacy policy contains information such as how you may access the personal information the Department holds about you, how you can seek correction of it, and how you may complain about a breach of the Australian Privacy Principles.

The Department's privacy policy is available on the Department of Health website.

Alternatively, you may contact the Department by telephone on 02 6289 1555 or freecall 1800 020 103, or by using the online enquiries form.

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