Posting: # 18493
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