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New Applications
Submit A New Application
To obtain a Certificate of Suitability to the monographs of the European Pharmacopoia (CEP), applicants must send the following documentation to the Certification of Substances Division (DCEP) of the EDQM:
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a completed application form which includes your invoicing details
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a single copy of a dossier in CTD format in one of the two official languages of the Council of Europe (preferably in English)
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a single copy of the Quality Overall Summary (QOS).
Upon receipt, the application is validated and listed for assessment. After assessment, the EDQM may send queries to the applicant. When they are resolved, the EDQM sends the applicant a CEP, which is valid for 5 years from the date of first issue and valid indefinitely following the 5-year renewal.
To optimise the process for evaluating applications and to ensure the official timelines are met, the EDQM applies strictly the procedure described in the Resolution AP CSP (07) 1. The evaluation of new applications is handled in two phases:
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the evaluation of the original application, and,
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if necessary, the evaluation of additional information upon request from the EDQM.
Applications lacking sufficient information after evaluation of the applicant's response to the deficiency letter are definitively closed. A second request for additional information is issued in exceptional cases only.
Content of the Dossier
Detailed information on what an application should contain is described in the documents below. Refer to the document relevant to your application.
Content of the Dossier for Chemical Purity and Microbiological Quality (PA/PH/CEP 04 1 4R)
Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2)
Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation
Certificates of Suitability for Sterile Active Substances (PA/PH/Exp. CEP/T (06) 13, 1R)
You should also read the:
Submission Format (Paper or Electronic)
Applicants are encouraged to submit electronic versions of their applications. Additionally, there are new requirements for paper submissions. This allows us to manage the applications more efficiently. Please read the:
And
CEP holders are obliged to inform all their customers for each CEP revision, suspension, withdrawal or negative outcome of an EDQM inspection.
News
Note concerning the assessment of stability data within the Certification procedure
Packaging information within the Certification procedure
Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk
GPS/DUNS information to be mentioned in the application forms
Refusal of information from third parties in reply to EDQM's request for information
Update of monographs regarding limit for unspecified impurities
Changes to Submitted Documentation No Longer Accepted During the Assessment Phase
Change in Contact Details: Notify the EDQM
Products & Services
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).
For more information about fees:
- Registration Fees
- Products & Services
Samples
Applicants commit to provide samples of substance and/or impurities when requested by the EDQM.
Additional Information & Documentation
New Procedure for the Assessment of Sister Files, PA/PH/CEP (09) 141
Note for the Applicants: Procedure for Validation of New Applications, PA/PH/Exp. CEP/T (08) 37
The EDQM's Position on CEP Applications for Biological Substances
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