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

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Download document Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure
Reference number CPMP/328/98, Revision 6
Status draft: consultation open
First published 07/06/2013
Last updated 07/06/2013
Consultation start date 07/06/2013
Consultation end date 30/08/2013
Email address for submissions nrg@ema.europa.eu

Summary

The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the centralised procedure. Specific aspects of the criteria applied to address safety and public-health concerns, international-non-proprietary-name issues, product-specific concerns and the procedure for submission of proposed (invented) names requests are further clarified.