CRED Practical Document Writing and Management

RMS Day 70 Preliminary Assessment report

RECOMMENDATION

Based on the review of the data on quality, safety and efficacy, the RMS considers that the application for xxxxx in the treatment of yyy, is not approvable since "major objections" have been identified, which preclude a recommendation for marketing authorisation at the present time. The details of these major objections are provided in the preliminary list of questions (Section V).