3.1.5 Ranitidine

3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR

3.1 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #29, March 2020)

Final decision in relation to ranitidine

Final decision

Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision not to amend the current Poisons Standard in relation to ranitidine.

Materials considered

In making this final decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to ranitidine;
• The four public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Advisory Committee on Medicines Scheduling (ACMS #29);
• The two public submissions received in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
• Section 52E of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
• The Scheduling handbook: Guidance for amending the Poisons Standard.

Reasons for the final decision (including findings on material questions of fact)

I have made a final decision to confirm my interim decision not to amend the current Poisons Standard with respect to ranitidine. My view is that the current scheduling of ranitidine is appropriate. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submission received before the second closing date in response to the call for further submissions published on 10 June 2020 under regulation 42ZCZP of the Regulations. The public submission proposes to an alternate scheduling of ranitidine to increase the pack size availability of Schedule 3 ranitidine, which in my view, is a matter for a separate scheduling application. Hence, I have not relied on the material in public submission in making my final decision to retain the current scheduling of ranitidine.

Date of effect of the decision

24 August 2020