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days issues for the applicant to clarify. The clock can stop at this stage for the applicant to submit comments in writing. The Notice to Applicants draft suggests 6 months is the maximum to reply, and if longer is needed, liaison with the Agency is essential to decide how to progress. After the rapporteur prepares the conclusions from the written comments, the CPMP will conclude the evaluation and adopt the opinion within 210 days. At this meeting of the CPMP the applicant can give an oral explanation. Useful guidance on oral explanations are given in the Notice to Applicants. At the time of issuing the opinion, it is necessary to have the SmPC and patient insert available in all 12 community languages. |
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In the event of an unfavorable opinion, the applicant has 15 days to decide if they will appeal and a further 45 days to send in the written grounds for appeal. An unfavorable opinion includes the cases where the SmPC should be |
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