Generic radiopharmaceuticals [Regulatives / Guidelines]

posted by Peregrin – Russia, 2018-03-02 12:05  – Posting: # 18493
Views: 754

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

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