What is Certificate of Suitability (CEP) ?
Certificate of Suitability (CEP/COS) is a certificate issued by EDQM (European Directorate for the Quality of Medicines & HealthCare). This certificate stands for compliance of Active pharma ingredient or excipient with monograph of European Pharmacopeia.
In CEP the manufacturer of the substance has to be provide documentary evidence that the quality of a substance corresponds to the quality defined in the Ph. Eur. monograph.
What are the different types of CEPs ?
– Certificate for chemical purity and microbiological quality (“Chemical CEP”)
– Certificate for herbal drugs and herbal drug preparations (“Herbal CEP”)
– TSE Certificate (“TSE CEP”) certifies that the substance complies with monograph
1483 of the Ph. Eur. “Products with risk of transmitting agents of animal spongiform
encephalopathies” current edition including supplements
Where is CEP Accepted?
CEPs are accepted in all European Member states and some other countries also like Albania, Algeria, Australia, Azerbaijan, Canada, Georgia, Ghana Israel, Kyrgyzstan, Malaysia, Moldova, Morocco, New Zealand, Saudi Arabia, Singapore, South Africa, Tunisia, and Uzbekistan these countries may or may not have additional conditions for use of CEPs
What is CEP Procedure?
CEP has to be drafted in CTD Section and applied in eCTD Format to EDQM. Submission in Paper or NEES format are no more accepted.
Fees for CEP Application is as below
- Simple chemical certificate – EURO 5000
- Simple TSE or herbal certificate – EURO 3000
How long does it take to obtain a certificate of suitability?
On A average a CEP Is granted anywhere between 9 month to 18 months, this cover the time taken by EDQM and application for responding. ( Approx time based on procedure)
How can FDApals help?
We at FDApals can assist you to fulfil your CEP Certification requirements with ease. Having over 30 years of experience in the field of regulatory filings we can help you
- Draft Complete CEP/COS Application
- Gap Audit your existing DMF/ Documents
- eCTD Conversion and Submission to EDQM
- Identify Testing requirements
- Renewal of CEP
- Filing Minor & Major Changes for CEP