Name Review Group form

This form should be read in conjunction with the 'Guideline on the Acceptability of Names for Human Medicinal Products Processed through the Centralised Procedure' (CHMP/287710/2014)

Current effective version

Name Review Group form

Reference Number: Version 1.0.4

Related content

Deadlines for submission of Proposed Names and dates of NRG discussion - see question 'What are the dates for submission of (invented) name requests?' on the pre-authorisation guidance page

Related documents

Name Review Group form - questions and answers

Reference Number: EMA/741768/2012Summary:

The NRG Form is an electronic version of the Word (.doc) based forms ‘Proposed (invented) name(s) request form for human medicinal products’ and the ‘Proposed (invented) name(s) justification form for human medicinal products’ that have been used as part of the Medicinal Product naming process here at the EMA since 2004.

NRG position paper re-use of invented names of medicinal products

Reference Number: EMA/648795/2009Summary:

The invented name of a medicinal product should, as a matter of principle, not create any public-health

concern or potential safety risk. The NRG is reviewing the acceptability of a proposed name based on

criteria set out in the respective guideline (CPMP/328/98, Revision 5). An essential element of such

review is to ensure that an invented name of a medicinal product is not causing confusion with the

name of another medicinal product, since such confusion could lead to safety issues with respect to the

use of these products.

Announcement for the NRG position paper re-use of invented names of medicinal products

Reference Number: EMA/51157/2011Summary:

Since 1995 to date, the NRG/CHMP has reviewed more than 3100 invented names that are currently held in the NRG database.