- User guide for Certification On-Line database (PA/PH/CEP (23) 56, mai 2024) (en anglais uniquement)
- Letter of access template
- Guide for declassification of documents pertaining to the CEP procedure (PA/PH/CEP (23) 29, janvier 2024) (en anglais uniquement)
- New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations according to the CEP 2.0 (PA/PH/CEP (23) 21 1R)
CEP Page Test
The following list contains access to:
- Content of the dossier
- Specific guidance
- Application forms
How to build a good CEP application
Content of a dossier
- Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 7R, March 2024
- NEW Content of the dossier for sterile substances, PA/PH/CEP (23) 54, November 2024
- Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2 1R, January 2018)
- Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation (PA/PH/CEP (02) 6 1R, February 2013)
Specific guidance
- The use of carrier oils for antioxidants in Omega-3 Type Substances (PA/PH/CEP (16) 30, June 2016)
- New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations according to the CEP 2.0 (PA/PH/CEP (23) 21 1R)
- Requirements for the content of the CEP dossier according to the CEP 2.0
- ...
test
EDQM
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