Search Results For : SmPC

CMDh Best Practice Guide for the translation of the SmPC, PIL and Labelling

Professional translation providers specializing in medical translation and pharmaceutical translation are largely reliant on the best practice standards set out by the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human). In what follows, we will briefly summarise the criteria defined for the SmPC, PIL and Labelling translation review and the process that must be followed in order to ensure high quality, consistency, readability, coherence, and eventually successful and timely national submissions.