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  • EDQM FAQs in English
    • EDQM MISSION AND ROLE
    • QUALITY
    • SAFETY
    • HEALTHCARE
    • EUROPEAN PHARMACOPOEIA & INTERNATIONAL HARMONISATION
    • BIOLOGICAL STANDARDISATION PROGRAMME
    • CONTROL OF MEDICINES (OFFICIAL MEDICINES CONTROL LABORATORIES, OMCLs)
    • CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE
      • CEP 2.0
      • General information on Substances for pharmaceutical use
        • General and scope
          • What does ‘CEP’ mean?
          • How to use a CEP?
          • Is CEP mandatory for marketing a substance in EU countries?
          • How should the certificate coding be interpreted?
          • How do I know if I have the latest valid version of a CEP?
          • Can I get a copy of a certificate from the EDQM?
          • Does the Certification procedure apply to herbal drugs and herbal drug preparations?
          • How long does it take to obtain a certificate of suitability?
          • Which countries accept certificates of suitability?
          • Is a certificate of suitability equivalent to a GMP certificate?
          • Is it possible to apply for a CEP for biological substances?
          • How can I withdraw my CEP?
          • What does “P0X” or “PXX” mean as an extension to the CEP number on EDQM CEP communication letters (Re: CEP 202X-XXX-P0X or PXX / Substance name)?
        • Quality Overall Summary (QOS)
        • Application dossier
        • Sterile substances
        • TSE
        • E-submission
        • Fees
      • Revisions/ Renewals
      • Inspections
      • General matters related to certification
    • PRODUCTS AND SERVICES (Publications, Reference standards, CombiStats)
    • EDQM ELECTRONIC PUBLICATIONS - TECHNICAL SUPPORT
    • COMMUNICATIONS & EVENTS
    • EDQM HelpDesk User Manual
  • FAQ de l’EDQM en français
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  1. Pages
  2. …
  3. EDQM FAQs
  4. EDQM FAQs in English
  5. CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE
  6. General information on Substances for pharmaceutical use
  • Jira links

General and scope

  • Created by ZHATKIN Yurii, last modified on Jul 15, 2019

  • What does ‘CEP’ mean?
  • How to use a CEP?
  • Is CEP mandatory for marketing a substance in EU countries?
  • How should the certificate coding be interpreted?
  • How do I know if I have the latest valid version of a CEP?
  • Can I get a copy of a certificate from the EDQM?
  • Does the Certification procedure apply to herbal drugs and herbal drug preparations?
  • How long does it take to obtain a certificate of suitability?
  • Which countries accept certificates of suitability?
  • Is a certificate of suitability equivalent to a GMP certificate?
  • Is it possible to apply for a CEP for biological substances?
  • How can I withdraw my CEP?
  • What does “P0X” or “PXX” mean as an extension to the CEP number on EDQM CEP communication letters (Re: CEP 202X-XXX-P0X or PXX / Substance name)?

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EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71
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