TOPICS : 07- CERTIFICATION OF PHARMACEUTICAL SUBSTANCES / 01- GENERAL INFORMATION  / 01. General and scope / 07. How long does it take to obtain a certificate of suitability? 


The time needed to grant a certificate of suitability is the combination of the time needed for the assessment together with the time necessary for the applicant to respond to questions raised during assessment.

The target time for initial assessment of a CEP application is 5 months. In most cases, the need for additional data is identified during this initial assessment. Consequently a request for additional information is sent to the applicant, who has to respond within 6 months. The target time for assessment of the response is 4 months, totalling the target processing time to 15 months.

At this point in time, the average time to obtain a new CEP for chemical purity is 18 months. We are constantly striving to improve the processing times to meet the target date.


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