Dossier for marketing authorization in the European union
Extensive and complete documentation must be presented for marketing authorization of a medicinal product in the EU. Presented documentation should prove quality, safety and efficacy of the medicinal product. It is ensured that the applicant supplies the authorities with complete information. The l...
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| Format: | Article |
| Language: | English |
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Association of Basic Medical Sciences of Federation of Bosnia and Herzegovina
2003-02-01
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| Series: | Bosnian Journal of Basic Medical Sciences |
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| Online Access: | http://www.bjbms.org/ojs/index.php/bjbms/article/view/3572 |