Radiopharmaceuticals - Scientific guideline | European Medicines Agency (EMA)

Radiopharmaceuticals - Scientific guideline

HumanScientific guidelines

This document describes the specific additional information that needs to be submitted in relation to radiopharmaceuticals, in the context of applications for marketing authorisations or variations to authorised medicinal products.

Keywords: Radiopharmaceuticals, pharmaceutical and chemical documentation, development, manufacture, quality control, stability

Current effective version - Currently under revision see concept paper below

Guideline on radiopharmaceuticals - Revision 1

AdoptedReference Number: EMEA/CHMP/QWP/306970/2007Legal effective date:

English (EN) (113.03 KB - PDF)

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Revision 2

Concept paper on the revision of the 'Guideline on Radiopharmaceuticals - Revision 1'

Draft: consultation closedConsultation dates: to Reference Number: EMA/CHMP/QWP/298182/2023

English (EN) (201.49 KB - PDF)

First published:
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Revsion 1

Guideline on radiopharmaceuticals - Revision 1

AdoptedReference Number: EMEA/CHMP/QWP/306970/2007Legal effective date:

English (EN) (113.03 KB - PDF)

First published: Last updated:
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Overview of comments received on draft guideline on radiopharmaceuticals

Reference Number: EMEA/CHMP/CVMP/QWP/567962/2008

English (EN) (182.47 KB - PDF)

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Draft guideline on radiopharmaceuticals

Draft: consultation closedReference Number: EMEA/CHMP/QWP/306970/2007

English (EN) (140.91 KB - PDF)

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Concept paper on the revision of the note for guidance on radiopharmaceuticals

Reference Number: EMEA/CHMP/92877/2005

English (EN) (125.61 KB - PDF)

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First version

Radiopharmaceuticals

AdoptedReference Number: 3AQ20ALegal effective date:

English (EN) (44.57 KB - PDF)

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