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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use article 9 CELEX: 02001L0083-20250101 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. |