CRIMINALITATEA AFACERILOR ÎN DOMENIUL FARMACEUTIC
BUSINESS CRIME IN THE PHARMACEUTICAL FIELD
Author(s): Marius Pantea, Carmen PurdelSubject(s): Law, Constitution, Jurisprudence, Civil Law
Published by: Universul Juridic
Keywords: regulatory affairs; medicinal products for human use; marketing authorization procedures; European Medicine Agency;
Summary/Abstract: Taking into account that all marketed medicinal products are subject to european or national regulations in order to be authorized, it is obvous that a good legislativ regulation in the field of authorization is vital. This article provides an integrated overview on the submision steps involed in the authorization process, focusing on the differences between european procedures.
Journal: Revista de Investigare a Criminalitatii
- Issue Year: 2014
- Issue No: 01
- Page Range: 14-22
- Page Count: 9
- Language: Romanian
- Content File-PDF