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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Scientia Pharmaceutica
2014
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| Materias: | |
| 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 |