SCIENTIFIC DISCUSSION Invented name of the medicinal product: Zyprexa Marketing Authorisation Holder:
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Reflections on Decisions Made on the Well-Established Use of Medicinal Products by EU Regulators and the ECJ
BACKGROUND In the European Union (EU), a medicinal product needs a marketing authorization (MA) to be placed on the market. The EU's medicinal products' legislative framework allows for a reduced application for medicines outside their data exclusivity. One such type of application is the well-established use (WEU) medicinal product application (i.e. bibliographic applications). Recently, these...
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The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is an international tripartite cooperation programme that brings together regulatory authorities and industry representatives from the European Union, Japan and the United States, with Australia, New Zealand and Canada as observers. VICH aims to improve international...
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تاریخ انتشار 2004