9/16/2023 0 Comments Dossier meaning of![]() ![]() Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.Īctive Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”). Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records. Pharmaceutical care means the provision of drug therapy and Pharmaceutical means a drug intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or animals. The other parts of the ICH CTD or ACTD may be submitted online via PRISM or in a CD/DVD.Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh). Each application must be accompanied by a completed checklist, which is to be attached in PRISM.Īll administrative documents under Module 1 (ICH CTD) or Part I (ACTD) must be submitted in soft copy in PRISM. Use the checklists below to guide you on compiling a complete application dossier. Any subsequent variation applications for the product should follow the same format. Note: The CTD format cannot be changed once the application is submitted. DocumentsĬommon technical document overview and summaries The table below summaries the organisation of each dossier format. These formats use the modular framework described by the ICH Topic M4 and the ASEAN guidelines on the Common Technical Document for Registration of Pharmaceuticals for Human use: Organisation of the Dossier, respectively. Your application dossier submitted to us must be organised in either the International Council for Harmonisation Common Technical Document (ICH CTD) or the ASEAN CTD format. ![]() They should be submitted within two working days of the PRISM application submission for the NDA or GDA. Application dossiers are technical documents accompanying a new drug application (NDA) or generic drug application (GDA). ![]()
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