Friday , 3 December 2021

Study Process of Drug Approval Process in European Union via Centralized Procedure (From 2015-2018)

Rajkiran Kolakota*, I. Uma
Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP.

A B S T R A C T
The current scenario of this article mainly highlights about the medicinal products that are highly synchronized in European Union. Medicinal products undergo an elaborate system of approvals that governs how, when, where, and in what form such products will be authorized to be sold within European Union. The current marketing authorization procedures that are applicable to European Economic Area include 28 European member states and 3 European Free Trade Association states. This article mainly emphasizes on centralized marketing procedure, decentralized procedure, mutual recognition procedure, and national procedure in European Union.
Keywords: Centralized marketing procedure, decentralized procedure, mutual recognition procedure, and national procedure, medicinal products

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