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

For more information on timelines, see Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure (PA/PH/CEP (13) 110).