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Peregrin ☆ Russia, 2018-03-02 13:05 (2626 d 08:33 ago) Posting: # 18493 Views: 1,788 |
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Dear all, Does anybody know whether additional non-clinical/clinical or BE requirements (e.g. in terms of radiation comparability) are applied to generic radiopharmaceuticals? Articles 6 and 9 of Directive 2001/83/EC and Part III.2 of Annex I to the same Directive do not specify any additional requirements to generic radiopharmaceuticals (apart quality aspects of radionuclide generators). These products are usually presented as true solutions. All the best |
Ing. Helmut Schütz