EMA issues revised guideline on acceptability of names for human medicines

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

The revised guideline introduces a substantial change with regard to the name submission rules: up to two proposed (invented) names per marketing-authorization 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.

No retrospective impact