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RegisterGeneric radiopharmaceuticals [Regulatives / Guidelines]
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
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
Complete thread:
- Generic radiopharmaceuticalsPeregrin 2018-03-02 12:05
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Ing. Helmut Schütz