Sister File Procedure, Certification of Suitability, CEP Submission, Renewal

Freyr Regulatory team helps API manufacturers in sister CEP filing, compilation, review and submission to EDQM for all types of APIs/drug substances as per EDQM guidelines and requirements.

A certification of Suitability (CEP) holder, who wishes to possess a second CEP for the same Active Pharmaceutical Ingredient (API)/drug substance, can file a new application referred as a “Sister file”. It can be due to differences in API specification obtained with alternate process or to cover alternate grade of material. This is valid for all files except sterile, TSE or herbal applications.

A Sister CEP to the approved CEP filed with European Directorate for the Quality of Medicines and Health Care (EDQM), must be approved on a fast track basis compared to the approval timelines of original CEP applications.  There are pre-defined conditions set by the EDQM that must be fulfilled in order to file the sister CEP. Hence, expertise is required to file the sister CEP with the EDQM for quick approvals.

Know more at Freyr Page - Sister Certification of Suitability (CEP) Submissions

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