Article 9U.K.
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.