An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe

PURPOSE: The aim of this study is to provide a comprehensive overview of the outcomes of marketing authorisation applications via the mutual recognition and decentralised procedures (MRP/DCP) and assess determinants of licensing failure during CMDh referral procedures. METHODS: All MRP/DCP procedure...

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Detalhes bibliográficos
Publicado no:Eur J Clin Pharmacol
Main Authors: Ebbers, Hans C., Langedijk, Joris, Bouvy, Jacoline C., Hoekman, Jarno, Boon, Wouter P. C., de Jong, Jean Philippe, De Bruin, Marie L.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer Berlin Heidelberg 2015
Assuntos:
Pharmacoepidemiology and Prescription
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4564446/
https://ncbi.nlm.nih.gov/pubmed/26204969
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s00228-015-1904-1
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