Certification Policy Documents & Guidelines
General documents
- User guide for Certification On-Line database (PA/PH/CEP (23) 56, May 2024)
- Letter of access template
- Guide for declassification of documents pertaining to the CEP procedure (PA/PH/CEP (23) 29, January 2024)
- 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)
- Communication on the implementation of the CEP 2.0 (PA/PH/CEP (23) 06, March 2023)
- Management of CEP guidelines and operational documents for the CEP procedure (PA/PH/CEP (22) 44, November 2022)
- CEP holders responsibilities towards their customers (PA/PH/CEP (21) 57, January 2022)
- EDQM DCEP Sharing Tool - How to manage your account PA/PH/CEP (21) 62 2R, June 2024)
- 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)
- Code of Practice for the Certification Procedure (PA/PH/CEP (02) 04 3 R, June 2019)
- Fees and inspection costs (FORM/001 rev09, January 2022)
- Change in Contact Details: Notify the EDQM (PA/PH/CEP (10) 86 2R, February 2022)
- Change of contact details for CEP applications (FORM/577 rev03, April 2022)
- Changes to Submitted Documentation No Longer Accepted During the Assessment Phase (PA/PH/CEP (10) 85, August 2010)
- EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability' (PA/PH/CEP (08) 17, R5, June 2024)
- Refusal of information from third parties in reply to EDQM's request for information (PA/PH/CEP (11) 18, March 2011)
- Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk (PA/PH/CEP (11) 29, April 2011)
- 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)
- The use of carrier oils for antioxidants in Omega-3 Type Substances (PA/PH/CEP (16) 30, June 2016)
- Guideline 'How to read a CEP' (PA/PH/CEP (15) 31, April 2018)
Scope
Technical
- NEW Top Ten Deficiencies in New Applications for Certificates of Suitability for Chemical Purity PA/PH/CEP (24) 10
- Use of a CEP to describe a material used in an application for another CEP (PA/PH/CEP (14) 06 1R, September 2016)
- Implementation of policy on elemental impurities in the Certification Procedure PA/PH/CEP (16) 23, 2R April 2021
Submission format
New Applications
- Application form “Request for new Certificate of Suitability”
- Requirements for the content of the CEP dossier according to the CEP 2.0
- Template for Quality Overall Summary to be submitted for Certification applications (PA/PH/CEP (15) 26 1R, January 2024)
- Guidance on Applications for “Sister Files” (PA/PH/CEP (09) 141 2R, November 2018)
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)
Revisions & Renewals
- Application form request for sister file
- Application form "Request for Revision or renewal of Certificate of Suitability"
- Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2 7R corr, September 2018)
Technical Advice & One-to-one Meetings
The Inspection Programme
- Terms of reference for the programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers (PA/PH/CEP (12) 30, February 2012)
- Cases of falsification of data in the context of the CEP procedure (PA/PH/CEP (12) 11, March 2012)
- 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)
- EDQM inspections and trends of deficiencies: Overview 2006 to 2018 (PA/PH/CEP(18) 56 April 2019)