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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...
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| Publicado no: | Sci Pharm |
|---|---|
| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Scientia Pharmaceutica
2014
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4318218/ https://ncbi.nlm.nih.gov/pubmed/25853067 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3797/scipharm.1402-14 |
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