EDQM FAQs
| Info | ||
|---|---|---|
| ||
|
Answer:
CEP 2.0 | Hybrid CEP | Old CEP | |
Format | Electronic document | Paper document | |
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 | Name and address of the holder and production sites completed by SPOR OMS LOC &ORG ID | Name and address of 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:
- Old CEPs remain valid as they are. Their issue date is before 1st September 2023.
- Layout, legal sentences, heading (namely numbering) are modified for hybrid CEP and CEP 2.0.
- The validity of a CEP can be checked on EDQM public database. In case of doubt contact EDQM
- Hybrid and new CEP will have issue dates after 1st September 2023