Radiopharmaceuticals

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/QWP/306970/2007 Rev. 1
Published26/11/2008
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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