Dossier for marketing authorization in the European union
Keywords:marketing authorization, application dossier, domestic laws
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 legislation in Federation of Bosnia and Herzegovina has also taken more steps towards those European directions.
The presentation and content of the dossier in the European Union has been redefined. The “old” EU format will be replaced with the Common Technical Document (EU CTD format) agreed in 2000, within the International Conference on Harmonization framework. These two formats are intended to coexist during the transition period until July 2003. The CTD is an internationally agreed upon format for the preparation of a well structured presentation for applications to be submitted to regulatory authorities in the three ICH regions of Europe, US and Japan.