REGULATORY ASPECTS INVOLVED IN MARKETING AUTHORIZATION OF MEDICAL DEVICES -OVERVIEW
*Mohammed Sayeed and Dr. B. Vasudha
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.
[Full Text Article]