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The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use ...
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
The Institute of Medical Sciences (IMS-BHU) is one of the Six institutes of Banaras Hindu University in Varanasi, India and comprises three faculties, Faculty of Medicine, Dental Sciences, and Ayurveda. [1] The Institute of Medical Sciences is the medical school of the university. Like other institutions forming BHU, it is residential and co ...
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
www.bhu.ac.in /Site /UnitHomeTemplate /1 _35 _1104 _Main-Site-Institutes-and-Faculties 25°15′30″N 82°59′05″E / 25.2583268°N 82.9848228°E / 25.2583268; 82.9848228 Institute of Agricultural Sciences, Banaras Hindu University (IAS, BHU) is one of India's premier agricultural colleges located in Varanasi in Uttar Pradesh
The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
Institute of Science, Banaras Hindu University (ISc-BHU) is a constituent institute of Banaras Hindu University, Varanasi, India which offers courses in Zoology, Botany, Biochemistry, Computer science, Geography, Mathematics, Physics, Geology, Geophysics, Chemistry, Statistics. [1] [2]
The Banaras Hindu University (pronunciation ⓘ) (BHU), is a collegiate, central, and research university located in Varanasi, Uttar Pradesh, India, and founded in 1916.The university incorporated the Central Hindu College, which had been founded by theosophist and future Indian Home Rule leader Annie Besant in 1898.