EU Group Probes Incorrect Use of National Procedures for Marketing Applications

Executive Summary The EU's regulatory coordination group, the CMDh, is concerned that some companies are submitting parallel marketing authorization applications under national procedures, creating more workload for EU national competent authorities. It is investigating why these submissions are not being routed through the mutual...

Executive Summary

The EU's regulatory coordination group, the CMDh, is concerned that some companies are submitting parallel marketing authorization applications under national procedures, creating more workload for EU national competent authorities. It is investigating why these submissions are not being routed through the mutual recognition/decentralized procedures, which are best suited for such applications.

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There Can Be Potential Obstacles To Using Correct The Procedures
Source: pink.pharmaintelligence.informa.com