Reflections on Decisions Made on the Well-Established Use of Medicinal Products by EU Regulators and the ECJ

Background: In the European Union (EU), a medicinal product needs a marketing authorization (MA) to be placed on the market. The EU’s medicinal products’ legislative framework allows for a reduced application for medicines outside their data exclusivity. One such type of application is the well-esta...

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Detalles Bibliográficos
Autores principales: Borg, John Joseph, Laslop, Andrea, Pani, Luca, Maciulaitis, Romaldas, Melchiorri, Daniela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Scientia Pharmaceutica 2014
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318218/
https://www.ncbi.nlm.nih.gov/pubmed/25853067
http://dx.doi.org/10.3797/scipharm.1402-14

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318218/
https://www.ncbi.nlm.nih.gov/pubmed/25853067
http://dx.doi.org/10.3797/scipharm.1402-14

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