You are here:

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


  • No labels