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

This consultation closed on 5 March 2020

This web publication constitutes a notice for the purposes of regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (the 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 November 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 5 March 2020.

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 address provided below:

• 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 sub-regulation 42ZCZQ(4) of the Regulations, the Secretary must publish all relevant submissions received, unless the Secretary considers the information to be confidential information.

Contents

1. Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #28, November 2019)
   • 1.1. Interim decision in relation to sumatriptan
   • 1.2. Interim decision in relation to zolmitriptan
   • 1.3. Interim decision in relation to calcifediol
   • 1.4. Interim decision in relation to paracetamol (liquid formulations)
   • 1.5. Interim decision in relation to Paracetamol + ibuprofen
   • 1.6. Interim decision in relation to hyoscine butylbromide
   • 1.7. Interim decision in relation to Lidocaine
2. Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #26, November 2019)
   • 2.1. Interim decision in relation to carbon monoxide
   • 2.2. Interim decision in relation to momfluorothrin
   • 2.3. Interim decision in relation to tetraniliprole
   • 2.4. Interim decision in relation to methiozolin
   • 2.5. Interim decision in relation to lambda-cyhalothrin
3. Interim decision on proposed amendment referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACCS/ACMS #23, November 2019)
   • 3.1. Interim decision in relation to caffeine
   • 3.2. Interim decision in relation to N-methyl-2-pyrrolidone (NMP)