Certification Policy Documents & Guidelines
Explore the EDQM’s Certification Policy Documents and Guidelines to access essential resources for the Certification of Suitability (CEP) procedure. This section provides up-to-date regulatory guidance, technical advice, and operational documents to support pharmaceutical ingredients manufacturers and stakeholders in preparing their CEP applications.
Operational documents
These documents are related to the practical aspects of the Certification procedure (management of documents, fees, maintenance of CEP, administrative information)
- User guide for Certification On-Line database (PA/PH/CEP (23) 56, May 2024)
- Letter of access template
- Management of CEP guidelines and operational documents for the CEP procedure (PA/PH/CEP (22) 44, November 2022)
- Fees and inspection costs (FORM/001 rev09, January 2022)
- Change in Contact Details: Notify the EDQM (PA/PH/CEP (10) 86 2R, February 2022)
- Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure (PA/PH/CEP (13) 110, 3 R, November 2021)
- Complaints procedure (PA/PH/CEP (15) 19 1R, February 2017)
- Guideline 'How to read a CEP' (PA/PH/CEP (15) 31, May 2025)
- Guidance on Applications for “Sister Files” (PA/PH/CEP (09) 141 2R, November 2018)
- Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2 7R corr, September 2018)
- Electronic signature features (PA/PH/CEP (23) 50, September 2023)
- Technical Advice to Applicants and Holders of Certificates of Suitability (CEP), PA/PH/Exp. CEP/T (04) 27, 5R, April 2009)
- Unique identification of manufacturing sites linked to CEP applications using SPOR OMS and GPS coordinates PA/PH/CEP (10) 118, 4R, March 2024
- Inspection fees and travel costs charged to companies inspected by EDQM (PA/PH/CEP (12) 28, 1R, January 2015)
Governance documents
These documents describe the background and the legal framework of the Certification Procedure. They clarify its mission and organisation.
- Guide for declassification of documents pertaining to the CEP procedure (PA/PH/CEP (23) 29, January 2024)
- CEP holders responsibilities towards their customers (PA/PH/CEP (21) 57, January 2022)
- Resolution AP-CSP (07) 1 on the 'Certification of Suitability to the Monographs of the European Pharmacopoeia (Revised Version, adopted on February 2007)'
- Rules of Procedure of the European Pharmacopoeia containing in Annex 1 the Terms of Reference of the Certification of suitability procedure PA/PH/Exp. ROP/T (24) 2
- Rules of Procedure CEP PA/PH/CEP (24) 42 (December 2024)
- EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability' (PA/PH/CEP (08) 17, R5, June 2024)
- Code of Practice for the Certification Procedure (PA/PH/CEP (02) 04 4 R, June 2025)
How to build a good CEP application
These documents (including applications forms) are available for CEP holders and applicants to assist them in preparing a high-quality dossier and addressing guidance to be followed for specific technical points.
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
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