Directive 2001/83/EC of the European Parliament and of the… Article 9

Article 9

In addition to the requirements set out in Articles 8 and 10(1), an application for authorization to market a radionuclide generator shall also contain the following information and particulars: - a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation, - qualitative and quantitative particulars of the eluate or the sublimate.

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Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 9 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

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