S.L. 458.34 Art. 6Application for radionuclide generator.

In the case of an application for a marketing authorisation for a radionuclide generator, in addition to the requirements set out in regulations 5 and 7(1), the application shall also contain:

(a) 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; and

(b) qualitative and quantitative particulars of the eluate or the sublimate.