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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/QWP/306970/2007 Rev. 1
Effective from01/05/2009
KeywordsRadiopharmaceuticals, pharmaceutical and chemical documentation, development, manufacture, quality control, stability
DescriptionThis 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

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/05/2009–present

Published: 26/11/2008

Published: 05/10/2007

Published: 30/03/2006

First versionAdopted guidelineIn operation: 01/06/1991–30/04/2009

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