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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 ...
There are two types of evaluation: dossier evaluation and substance evaluation: Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are avoided, and to check the compliance of registration dossier with the registration requirements.
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
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]
Banaras Hindu University does not have an active political student union, but an administrative student council called the Banaras Hindu University Students Council to represent and safeguard the interests of the students. [330] [331] Despite no elections, student wings of major political parties have an active presence on the campus. [332] [333]
Thus, in case C-392/97, [3] the European Court of Justice held that: "where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and ...