Guideline on the acceptability of names for human medicinal products processed through the centralised procedure

Current effective version

PDF iconRevision 6 - Adopted guideline

Reference numberEMA/CHMP/287710/2014 – Rev. 6
Published3 June 2014
KeywordsEMA, CHMP, NRG, invented name
DescriptionBased on the experience gathered by the Name Review Group (NRG) since the last revision of the
guideline in December 2007, it became apparent that some areas of the guideline would benefit from
further clarifications, in particular with regards to the requirements for acceptability and submission of
proposed (invented) names of medicinal products processed through the centralised procedure.
This 6th update of the guideline further clarifies specific aspects of the criteria applied to address
safety and public health concerns, international non-proprietary names issues and product-specific
concerns in proposed (invented) names. Also, the procedure for submission of proposed (invented)
names requests is streamlined and further clarified.

Document history

Revision 6
Current version

PDF iconAdopted guideline

PDF iconDraft guideline

In operation: 01/01/2015-present

Published: 24/01/2008

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