Current effective version

PDF iconRevision 1 - Adopted guideline

Reference number CHMP/QWP/306970/2007 Rev. 1
Published 26/11/2008
Effective from 01/05/2009
Keywords Radiopharmaceuticals, pharmaceutical and chemical documentation, development, manufacture, quality control, stability
Description 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.

Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/05/2009–present


Published: 26/11/2008


Published: 05/10/2007


Published: 30/03/2006

First version PDF iconAdopted guideline In operation: 01/06/1991–30/04/2009

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