![]() ![]() the organisation of the dossier across 5 modules.A submission is a collection of one or more applications that are grouped together for fee purposes, and is specific to a particular active ingredient and applicant.any other data to support the application that is lodged following initial lodgement of the application (for example, section 31 responses, further safety data).any dossiers provided to the TGA previously that are referenced by the application.the dossier lodged in the first instance.A dossier contains and/or references the necessary data to demonstrate the quality, safety and efficacy of a prescription medicine.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. Register for the Daily Good Word E-Mail! - You can get our daily Good Word sent directly to you via e-mail in either HTML or Text format.The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. (If we kept a dossier on George Kovac, it would be thick with excellent Good Word suggestions like today's.) No other Indo-European language shows any evidence of it. Dorsum underlies dorsalis "of/on the back", the origin of English dorsal. ![]() The word was based on dos "back", the residual of Vulgar Latin dossum, a variant of Latin dorsum "back". Word History: Today's Good Word was plain out swiped from French dossier "bundle of papers labeled on the back". Drinks.'" Other times they are so well organized they could be published: "Rhoda Book's first novel was more or less a dossier about herself." In Play: Sometimes dossiers contain so little information as to require little organization: "Bulldog Drummond's dossier contained the following rather sketchy note: 'Good speaker clever unscrupulous. ![]() This word has not spawned any derivational offspring, except a plural: dossiers. Dossier implies an ordered, perhaps secret, file. Since dossiers are usually filed, it is often replaced by file. This word preserves the French spelling but not the accent on the final syllable. Notes: Look out for the spelling of today's Good Word. Meaning: A file containing documents about a particular person, event, or subject. ![]()
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