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CEPs: What Applicants and Authorisation Holders should know!
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Due to the current situation in Europe, many applicants and marketing authorisation holders (MAHs) are increasingly asking how and to what extent "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) are currently being processed and issued.
In this regard, the EDQM (European Directorate for the Quality of Medicines & HealthCare) website provides the most up-to-date information. On the one hand, the topics are mentioned that are currently being prioritized in the CEPs area. On the other hand, it comprises explanations for which measures were taken and which processes were changed or newly established as a result of the corona pandemic.
Clear priority at this stage is given to issues relating to the evaluation of CEP applications and the granting of a new or amended CEP. As examples for the changed processes in relation to CEPs it may be mentioned that currently inspections cannot be carried out on site - and that at this time sending paper-based documentation may take a little longer.
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