Radiopharmaceuticals - Scientific guideline

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: 01/05/2009

Revision 2

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

Draft: consultation closedConsultation dates: 21/07/2023 to 31/10/2023Reference Number: EMA/CHMP/QWP/298182/2023

Revsion 1

Guideline on radiopharmaceuticals - Revision 1

AdoptedReference Number: EMEA/CHMP/QWP/306970/2007Legal effective date: 01/05/2009

Overview of comments received on draft guideline on radiopharmaceuticals

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

Draft guideline on radiopharmaceuticals

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

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

Reference Number: EMEA/CHMP/92877/2005

First version

Radiopharmaceuticals

AdoptedReference Number: 3AQ20ALegal effective date: 01/06/1991