Certification Policy Documents & Guidelines
General documents
- Letter of access template
- 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)
- 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 1R, September 2022)
- Resolution AP-CSP (07) 1 on the 'Certification of Suitability to the Monographs of the European Pharmacopoeia (Revised Version, adopted on February 2007)'
- Certification of Suitability to the Monographs to the European Pharmacopoeia Terms of Reference and Rules of Procedure (PA/PH/CEP (01) 1, 13R, September 2022)
- 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, R4, June 2014)
- 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)
- Impact on CEPs following implementation of Ph. Eur monograph title changes regarding hydration (PA/PH/CEP (16) 20, April 2016)
- 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
- Certificates of Suitability for Sterile Active Substances (PA/PH/Exp. CEP/T (06) 13, 1R, July 2006)
- Clarification on the Acceptability of CEP Applications for Sterile Grade Material (PA/PH/CEP (08) 60, 1R, July 2016)
- API-Mix (or mixtures) and CEPs (PA/PH/CEP (16) 70, December 2016)
Technical
- 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
- Top ten deficiencies (2015-2016) – CEPs for chemical purity (PA/PH/CEP (16) 58, December 2016)
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, September 2015)
- 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, 6R, December 2018
- 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)
- Data on location of manufacturing sites (GPS coordinates) linked to CEP applications (PA/PH/CEP (10) 118 12, February 2022)
- 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)