Interim decisions and invitation for further comment on substances referred to the March 2019 ACMS/ACCS meetings

This consultation closed on 4 July 2019.

This web publication constitutes a notice for the purposes of regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (Regulations). In accordance with regulation 42ZCZP, this notice sets out:

• the interim decisions made by a delegate of the Secretary under regulation 42ZCZN in relation to proposed amendments to the current Poisons Standard which were referred to an expert advisory committee under subdivision 3D.2 of the Regulations in March 2019;
• the proposed date of effect of the proposed amendments (in circumstances where the interim decision proposes an amendment to the current Poisons Standard).

In accordance with regulation 42ZCZP, interested persons (including the applicant requesting the amendment) are invited to make submissions to the Secretary in relation to these interim decisions on or before 4 July 2019.

Persons making submissions are strongly encouraged to lodge submissions in an electronic format (word or unsecured PDF preferred) using the public submission coversheet available on the TGA's website. Where possible, submissions should be sent to the email addresses provided below:

• chemicals.scheduling@health.gov.au (for submissions relating to interim decisions made in relation to proposed amendments referred to the Advisory Committee on Chemicals Scheduling); or
• medicines.scheduling@health.gov.au (for submissions relating to interim decisions made in relation to proposed amendments referred to the Advisory Committee on Medicines Scheduling or the Advisory Committee on Medicines and Chemicals Scheduling in joint session).

Please note that in accordance with subregulation 42ZCZQ(4) of the Regulations, the Secretary must publish all relevant submissions received. The Secretary must not, however (pursuant to subregulation 42ZCZQ(5)), publish any information that the Secretary considers to be confidential information.

Contents

1. Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #26, March 2019)
   • 1.1. Interim decision in relation to cetirizine
   • 1.2. Interim decision in relation to glyceryl trinitrate
   • 1.3. Interim decision in relation to isosorbide dinitrate
   • 1.4. Interim decision in relation to mometasone
   • 1.5. Interim decision in relation to paracetamol (modified release)
2. Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #4, March 2019)
   • 2.1. Interim decision in relation to Polymer in Durazane 1500
   • 2.2. Interim decision in relation to N-methyl-2-pyrrolidone
   • 2.3. Interim decision in relation to MCPB
3. Interim decisions on a proposed amendment referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (ACCS/ACMS #21, March 2019)
   • 3.1 Interim decision in relation to paracetamol