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EU: EMA Regulatory information – Revised guideline on acceptability of names for human medicines is published


(Source: EMA 2014-6-04)

The European Medicines Agency has published a revised guideline on the acceptability of names for human medicines processed through the centralised procedure.

The revised guideline introduces a substantial change with regard to the name submission rules: up to two proposed (invented) names per marketing-authorisation application can be accepted by the Agency’s Name Review Group(NRG) and a maximum of two (invented) names per name review request can be proposed for consideration at each NRG meeting. Sponsors can currently propose up to four names.

This reduction in the number of proposed names allowed has no retroactive effect. Therefore, all (invented) names accepted prior to the implementation of the revisedguideline will be retained. The final NRG meeting where four proposed names can be accepted will be held on 26 November 2014. All subsequent name review requests should adhere to the new rules.

The updated guideline will come into effect on 1 January 2015. The overview of comments received during the public consultation on this revisedguideline will be made available by the beginning of July.

More Information on EMA and Guideline on the Acceptability of Names for Human Medicinal Products Processed Through the Centralised Procedure