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CERTIFICATE OF SUITABILITY

 

 

LEGAL

 

 

RESOLUTION AP-CSP (07) 1 TERMS OF REFERENCE
   
Registration Fees Products & Services Catalogue 2011 (English/French)
   

NEW SUBMISSION AND GUIDELINES

   

NEW SUBMISSION - APPLICATION FORM

QUALITY OVERALL SUMMARY TEMPLATE

Guidelines

Content of the Dossier for Chemical Purity and Microbiological Quality (PA/PH/CEP 04 1 4R) Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2)
   
Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation

Certificates of Suitability for Sterile Active Substances (PA/PH/Exp. CEP/T (06) 13, 1R)

   
Clarification on the Acceptability of CEP Applications for Sterile Grade Material (PA/PH/CEP (08) 60, November 2008) Explanatory note: Updated EDQM procedures related to Paper and Electronic Submissions for CEP applications (PA/PH/CEP (09) 109, 1R
   
Guidance for Submission of Electronic Documentation for Applications for Certificates of Suitability (CEPs): Revised Procedures (PA/PH/CEP (09) 108 Top Deficiencies Found During First Assessment of New Applications From October to December 2009, PA/PH/CEP (10) 65
New Procedure for the Assessment of Sister Files, PA/PH/CEP (09) 141 Note for the Applicants: Procedure for Validation of New Applications, PA/PH/Exp. CEP/T (08) 37
   
The EDQM's Position on CEPApplications for Biological Substances  
   
   

REVISON AND RENEWALS GUIDELINES

   

REVISION APPLICATION FORM

RENEWALS APPLICATION FORM

   

Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs, PA/PH/CEP (04) 2 4R

 

Explanatory Note: Updated EDQM Procedures related to Paper and Electronic Submissions for CEP Applications PA/PH/CEP (09) 109, 1R
Guidance for Submission of Electronic Documentation for Applications for Certificates of Suitability (CEPs): Revised Procedures PA/PH/CEP (09) 108, 1R Procedures for Management of Revisions/Renewals of Certificates of Suitability to the European Pharmacopoeia Monograph, PA/PH/Exp CEP/T (04) 18 2R

 

 

NEWS

 

 

Note concerning the assessment of stability data within the Certification procedure Packaging information within the Certification procedure
Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk GPS/DUNS information to be mentioned in the application forms
Refusal of information from third parties in reply to EDQM's request for information

Update of monographs regarding limit for unspecified impurities            

- List of monographs

Changes to Submitted Documentation No Longer Accepted During the Assessment Phase

Change in Contact Details: Notify the EDQM
EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability' PA/PH/CEP (08) 17, R2 The report on the international APIinspection pilot programme