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Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021
6Form of information
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6 Form of information
For the purposes of subparagraph 23B(2)(d)(ii) of the Act, the information in an application dossier, that accompanies an application for the registration of a medicine mentioned in Schedule 1, must be in: (a) the eCTD format; or (b) if exceptional circumstances exist—another format with the prior written agreement of the Therapeutic Goods Administration.