![]() ![]() Application type relates to the fees associated with an application and is identified by a letter, for example, A, B or C application types.Application category is identified by a number, for example, category 1 and category 2 applications, and refers to the overall legislated time-frames for decisions about applications.an application for the registration of a new medicine.It is the specific set of information on the product submitted for review.Application refers to the regulatory activity required in respect of a product (a specific set of formulations, strengths and presentations) as requested by the applicant of the product.On this page: Terminology | Overview | Module 1: Administrative information and prescribing information for Australia | Module 2: Common technical document summaries | Module 3: Quality | Module 4: Safety (nonclinical study reports) | Module 5: Efficacy (clinical study reports) | Summary of requirements: Dossier documents matrix Terminology Application The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic Goods Administration (TGA) in 2004. In practice, this RAE prescription is not always followed.The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. Spanish Alternative forms Īccording to Royal Spanish Academy (RAE) prescriptions, unadapted foreign words should be written in italics in a text printed in roman type, and vice versa, and in quotation marks in a manuscript text or when italics are not available. dossier in Wielki słownik języka polskiego, Instytut Języka Polskiego PAN.dossier ( collection of documents related to a person or situation ) Synonyms: akta, dokumentacja.Unadapted borrowing from French dossier, from Middle French dossier. dossier (collection of papers, especially legal).“ dossier”, in Trésor de la langue française informatisé, 2012.Symbole associé à un dossier informatique. an organizer to keep papers in, to be stored as a single unit in a filing cabinet, see folder.back of furniture, to rest the sitter's back on.By surface analysis, dos ( “ back(side) ” ) + -ier. file, physical collection of documentation.Spanish: dosier m, expediente (es), archivo (es)ĭossier n ( plural dossiers, diminutive dossiertje n).Portuguese: dossiê (pt) m, pasta (pt) f.Polish: akta (pl) nvir, dokumentacja (pl) f, dossier (pl) n.Finnish: kansio (fi) asiakirjat (fi) pl, paperit (fi) pl. ![]() Dutch: dossier (nl) n, map (nl) f, folder (nl) m.Czech: spis (cs) m, fascikl m, akta (cs) pl. ![]()
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