The Certification of Suitability (CEP) is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP). CEP should consist of an explicit description of the chemical composition of the substances. The manufacturer should provide an evidence that the quality of the substance is controlled by the monographs of the EP and is granted by Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). The CEP also helps to bridge the gap between health authorities and industries, providing an added advantage for API manufacturers to enter the EU market.

The CEP is necessary for all the manufacturers and suppliers who are seeking market authorizations for:

  • Checking the use of active substances to control the purity and quality of their product
  • Reducing the risk of TSE risk products in accordance with the general monograph
  • Checking the suitability of the monograph for herbal products based on control of herbal drugs and herbal drugs preparations

Sister CEP submissions

Any CEP holder who wishes to file for second CEP for the same API can file a new application known as 'Sister CEP submissions' or 'Sister File'. This application is valid for all the files except sterile, TSE or herbal applications. This can be due to various reasons such as differences in API specifications with an alternate process or to cover alternate grade of material. A sister CEP is, ideally, approved on a fast track basis compared to the timelines of the original CEP applications. A set of pre-defined conditions are set by EDQM that must be fulfilled in order to file a Sister CEP. Reaching out to an expert with information on sister CEP will help in quick approvals of the application. 

Requirements for Sister CEP submissions

  • The manufacturer should be the same for both CEP and Sister CEP application
  • The holder is same for both applications
  • The substance should be same as in the original document
  • The differences in the sister file and the original file should be classified properly

Freyr has an experienced team of Regulatory experts with hand on expertise in compilation, review, and submission of CEP to EDQM in line with EDQM guidelines. To know more about CEP and sister CEP submissions, contact our Regulatory Affairs experts at