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OTC new medicine N1 applicationsVersion 1.0, November 2015Therapeutic Goods AdministrationCopyright Commonwealth of Australia 2015 This work is copyright. You may reproduce the whole or part of this
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OTC New Medicine N1 is a regulatory submission form used for the approval of new over-the-counter medications. It includes information about the product's formulation, safety, efficacy, and labeling.
Manufacturers or distributors of over-the-counter medications who wish to introduce a new product to the market are required to file OTC New Medicine N1.
To fill out OTC New Medicine N1, applicants must provide detailed information regarding the product's formulation, intended use, proposed labeling, safety data, and clinical efficacy data, as well as other required documentation.
The purpose of OTC New Medicine N1 is to ensure that new over-the-counter medicines meet safety, efficacy, and labeling standards before they can be marketed to consumers.
Reported information includes product formulation, dosing instructions, indications for use, labeling information, safety data, and evidence of efficacy.
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