Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMA/CHMP/671361/2015 Rev. 1
Published07/03/2016
KeywordsAccelerated Assessment
DescriptionBased on the experience gathered by reviewing the approach taken to the assessment of past applications since the last version of the guideline in July 2006, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the justifications provided by the applicant that the medicinal product falls within the scope of the accelerated assessment.

Document history

Revision 1
Current version

PDF iconAdopted guideline

PDF iconDraft guideline

In operation: 01/01/2015-present

Published: 24/01/2008

First version PDF iconAdopted guideline Published: 17/07/2006

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