REGULATORY ASPECTS INVOLVED IN MARKETING AUTHORIZATION OF MEDICAL DEVICES -OVERVIEW
*Mohammed Sayeed and Dr. B. Vasudha
ABSTRACT
This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure, Mutual recognition procedure, Decentralised procedure.
Keywords: MAA, EU, Rapporteur, Co-Rapporteur, EMA.
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