Note: If there is insufficient room, include further details in an attached document. CTD Applicant module checklist 1.8.1 Meetings Has written pre-submission advice been sought from TGA? Y N Has a pre-submission meeting been held with the TGA regarding this Y N application? Note: A meeting includes meetings conducted in any format (i.e. face to face, teleconference or videoconference). ** If yes, attach relevant documents (for example, copies of Y correspondence, meeting minutes, action items) and, where relevant, how/when any issues will be addressed. 1.10.1 Overseas regulatory status Has there been, or is there an intention to make similar applications for Y N market approval in any of the following regions or countries? If yes, indicate which countries. Note: If insufficient room, include further details in an attached document. Country/region Date submitted or If approved intend to submit Approval date Approved indications European Union (indicate if centralised procedure mutual recognition, decentralised, or national) United States of America Canada New Zealand Singapore Switzerland
Note: If there is insufficient room, include further details in an attached document. CTD module Applicant checklist 1.8.1 Meetings Has written pre-submission advice been sought from TGA? Y N Has a pre-submission meeting been held with the TGA regarding this application? Note: A meeting includes meetings conducted in any format (i.e. face to face, teleconference or videoconference). Y N ** If yes, attach relevant documents (for example, copies of correspondence, meeting minutes, action items) and, where relevant, how/when any issues will be addressed. Y 1.10.1 Overseas regulatory status Has there been, or is there an intention to make similar applications for market approval in any of the following regions or countries? Y N If yes, indicate which countries. Note: If insufficient room, include further details in an attached document. Country/region Date submitted or intend to submit If approved Approval date Approved indications European Union (indicate if centralised procedure mutual recognition, decentralised, or national) United States of America Canada New Zealand Singapore Switzerland