MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET
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.
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References
2. Authorisation Procedures for medicinal products [Internet] European Commission; 2015 [updated 2015 March 16; Cited on 2014 Dec 27]. Available from:
http://ec.europa.eu/health/authorisation-procedures_en.htm.
3. EU: MAA Regulatory submissions [Internet] EDQM, France; 2015 [Cited on 2014 Dec 28]. Available from:
https://www.edqm.eu/en/Certification-Policy-documents-Guidelines-1658.html.
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