| Regulatory pathways in the European Union. | |
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MedLine Citation:
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PMID: 21487236 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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In principle, there are three defined procedures to obtain approval for a medicinal product in the European Union. As discussed in this overview of the procedures, the decision on which regulatory pathway to use will depend on the nature of the active substance, the target indication(s), the history of product and/or the marketing strategy. |
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Authors:
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Manuela Kohler |
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Publication Detail:
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Type: Journal Article Date: 2011-05-01 |
Journal Detail:
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Title: mAbs Volume: 3 ISSN: 1942-0870 ISO Abbreviation: MAbs Publication Date: 2011 May-Jun |
Date Detail:
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Created Date: 2011-07-07 Completed Date: 2011-12-27 Revised Date: 2012-03-14 |
Medline Journal Info:
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Nlm Unique ID: 101479829 Medline TA: MAbs Country: United States |
Other Details:
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Languages: eng Pagination: 241-2 Citation Subset: IM |
Affiliation:
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Pharmatching GmbH, Freiburg, Germany. manuela.kohler@pharmatching.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Drug Approval
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legislation & jurisprudence*,
methods*,
organization & administration European Union Humans Legislation, Drug / organization & administration, standards* Pharmaceutical Preparations / standards* Product Surveillance, Postmarketing / standards |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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