EDQM FAQs
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Answer:
Electronic signature
Wet signature
Numbering
2-block alphanumerical code
CEP 20XX-XXX-Rev 00
3-block alphanumerical code
R0-CEP 20XX-XXX-Rev 00
Information on companies
| CEP 2.0 | Hybrid CEP | Old CEP |
Format
Electronic document
Paper document
CEP granted from 01/09/2023 electronic documents signed electronically
| Old paper CEP signed manually granted till 31/08/2023. | |
Their numbering is a 2-block alphanumerical code | ||
Name and address of the holder and production sites completed by SPOR OMS LOC &ORG ID.  
| Their numbering is a 3-block alphanumerical code R0 CEP 2010-123-Rev 00 Name and address of the holder and production sites | |
Technical information (CHEM AND HERBAL)
Inclusion of the approved specification inclusion of description of additional methods required to control the substance
Limits for additional impurities and inclusion of additional tests used in addition to the Ph. Eur. monograph tests, required to control the substance.
Expiry date
No
No reference to a validity date of 5 years (renewal is due date, on public data base)
Yes
Box of Acces- Letter of Access
Letter of Access (seperate document)
Template available on EDQM website
Box of access
On the CEP
Some tips:
...
only. | ||
No expiry date. Information on renewal date is available in the public database
| Expiry date, if any, mentioned on CEP | |
The approved site(s) of production, substance specification (section 3.2.S.4.1) and any necessary supplementary test procedure(s)(from 3.2.S.4.2) are an integral part of the certificate.
| Any supplementary tests deemed necessary are mentioned on the certificate with associated limits. Approved site(s) of production, and any supplementary test procedure(s) are included as annexes of the certificate.
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Separate letter of access | Box of access on the CEP | |
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