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Council of Europe at a glance
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Human Rights
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European Directorate for the Quality of Medicines & HealthCare

European Directorate for the Quality of Medicines & HealthCare

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  • EDQM
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      • Vision, mission & values
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  • Medicines
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    • European Pharmacopoeia (Ph. Eur.)
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      • Newsroom European Pharmacopoeia
      • The European Pharmacopoeia
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        • European Pharmacopoeia - Background and Mission
        • European Pharmacopoeia – New online-only 12th Edition
        • European Pharmacopoeia (Ph. Eur.) 11th Edition
        • The European Pharmacopoeia - Membership & Observership
        • The European Pharmacopoeia Commission
        • Groups of Experts and Working Parties
      • Focus
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        • Biotherapeutics
        • Alternatives to animal testing
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          • Report from the ad hoc meeting on the 3Rs
          • BSP programme for 3RS
          • Replacement, Reduction and Refinement of animal testing (3Rs): latest achievements
      • The Ph. Eur. work programme
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        • Where to find: The Knowledge database
        • Elaboration & Revision
        • The Ph. Eur. Work Programme
      • Pharmacopoeial Harmonisation
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        • Harmonisation status for Excipient monographs (PDG)
        • Harmonisation status for General Texts (PDG)
      • Find information on
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        • Ph. Eur. Technical Guides
        • Databases
        • FAQ - HelpDesk Ph. Eur. texts
      • CombiStats
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        • CombiStats: What's new in the web application?
        • Have a question about CombiStats?
      • Standard Terms Database
      • How to participate in the work of the Ph. Eur.
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        • Join the Network!
        • Submitting drafts and requests for revision
        • Comment on drafts (Pharmeuropa)
        • Pharmeuropa, Pharmeuropa Bio & Scientific Notes
    • Biological Standardisation Programme (BSP)
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      • The BSP Steering Committee
      • BSP Work Programme
      • BSP programme for 3Rs
      • Reference Standards from the BSP programme adopted in 2023
    • Reference Standards (RS)
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      • Ph. Eur. Reference Standards
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        • Ph. Eur. Reference Standards: Purpose and use
        • Ph. Eur. Reference Standards: Orders and Catalogue
      • WHO RS
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        • WHO International Standards for Antibiotics (ISA) : Purpose & Use
        • WHO ISA Orders & Catalogue
        • WHO International Chemical Reference Substances (ICRS) : Purposes & Use
        • WHO ICRS Orders & Catalogue
      • FAQ & HelpDesk Reference Standards (RS)
      • Safety Information for Reference Standards: Safety Data Sheets (SDS) & Biohazard Statements
    • Certification of Suitability (CEP)
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      • Newsroom Certification of suitability
      • About the Procedure
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        • Certification - Background & Legal Framework
        • Mission and organisation
        • What is the CEP 2.0?
        • The Inspection Programme
        • EDQM and real-time remote GMP inspections of API manufacturers during the COVID-19 pandemic: innovation overcoming adversity
      • How to apply
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        • New Applications
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          • Submit A New Application
          • Content of the Dossier
          • Quality Overall Summary (QOS) for CEP applications
        • Notifications, Revisions, Renewals and Sister Files
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          • Classification of changes
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            • Submission of Nitrosamine impurity risk assessment
          • Submit changes
          • Sister files
        • Technical advice & one-to-one meetings
        • Submission format and electronic submission
      • Find information on
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        • Certification Policy Documents & Guidelines
        • Actions on CEPs
        • CERTIFICATION Database
        • KNOWLEDGE Database
        • Fees for Certificates of Suitability (CEP)
        • FAQ & Helpdesk Certification and CEPs
      • Consultation space
    • OMCL Network
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      • Newsroom OMCL
      • General Activities
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        • OMCL - Background and mission
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          • Discover how Official Medicines Control Laboratories contribute to protect your health in Europe and beyond
        • Market Surveillance Studies (MSS)
        • Quality Management (QM) Programme
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          • Quality Management (QM) Documents
        • Physico-chemical and Biological PTS
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          • List of Proficiency Testing Scheme (PTS) Studies planned for 2025
          • Physico-chemical & Biological PTS Fees
      • Programmes EU/EEA Network
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        • Human Biologicals (OCABR)
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          • Questions and answers on OCABR
          • Batch Release for Human Biologicals: vaccines, blood and plasma derivatives
        • Veterinary Biologicals (OCABR/OBPR)
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          • Guidelines for EU OCABR for IVMPs
        • MRP/DCP Post Marketing Surveillance Scheme
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          • MRP/DCP Product Testing Database
        • CAP Sampling & Testing Programme
      • Working group activities
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        • Testing of Active Pharmaceutical Ingredients (APIs)
        • Quality Monitoring of Stockpiled Medicines
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          • Stockpiling of Medicines: Position Paper
          • Stockpiling of Medicines: Technical Guideline
        • OMCL Gene Therapy Working Group
        • Testing of falsified / illegal medicines
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          • Previous Technical OMCL Falsified Medicines Training Sessions
          • Previous press releases
        • Nitrosamine testing activities of the OMCL Network
      • FAQ & HelpDesk - OMCL network
    • N-nitrosamine contamination in brief
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      • Newsroom Nitrosamine contamination
    • Anti-falsification activities
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      • Newsroom - Anti-falsification activities
      • Background and mission - Anti-falsification activities
      • Work programme CD-P-PH/CMED
      • The MEDICRIME Convention
      • Publications on falsified medical products and related crimes
      • Single Points of Contact (SPOC) Network
    • Classification of medicines
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      • Newsroom Classification of medicines
      • CD-P-PH/PHO - Classification of Medicines as Regards their Supply
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        • Work programme CD-P-PH/PHO
        • CD-P-PH/PHO - Database and publications
        • Resolution CM/Res(2018)1 on the classification of medicines as regards their supply
      • FAQ & HelpDesk - Pharmaceuticals
    • Pharmaceutical Care
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      • Newsroom Pharmaceutical care
      • CD-P-PH/PC - Pharmaceutical Practices and Pharmaceutical Care
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        • Work programme: setting quality and safety standards in pharmaceutical practices and pharmaceutical care
        • Activities and projects - CD-P-PH/PC
        • Guidance documents and publications - CD-P-PH/PC
        • Resolutions in the field of pharmaceutical practices and pharmaceutical care
      • European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH)
      • HelpDesk - Pharmaceutical Care
    • European Paediatric Formulary
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      • Background & Mission - Paediatric Formulary
      • FAQ & HelpDesk - Paediatric Formulary
    • EDQM initiatives on medicine shortages
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      • Technical recommendations of the European drug Shortages Formulary Working Party
    • EDQM activities on borderline products
  • Substances of human origin
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    • Blood Transfusion
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      • Newsroom Blood Transfusion
      • Background & Mission
      • Organisation & Work programme
      • Areas of work – Blood
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        • Plasma Supply Continuity
        • Optimal use of blood components and plasma-derived medicinal products
        • Blood Quality Management Programme
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          • Blood Quality Management programme (B-QM)
          • Blood Proficiency Testing Scheme (B-PTS)
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            • List of Blood Proficiency Testing Scheme (B-PTS) for 2025
          • Ordering information for Blood Proficiency Testing Scheme (B-PTS) studies
        • Blood Supply Contingency and Emergency Plan (B-SCEP)
      • Legal framework – Blood
      • Publications - Blood
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        • Guide to the preparation, use and quality assurance of blood components
        • Reports
      • FAQ & HelpDesk
    • Organs, tissues and cells
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      • Newsroom - Organs, tissues and cells
      • Organs, tissues and cells - Background & Mission
      • Organisation & Work Programme
      • Areas of work - Transplantation
      • Legal Framework
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        • Signatures and ratifications of Treaty 216
      • Organs, tissues and cells - Publications
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        • Position Papers & Reports
        • Newsletter Transplant
        • Guide to the quality and safety of tissues and cells for human application
        • Guide to the quality and safety of organs for transplantation
        • Organ, Tissues and Cells of human origin: Council of Europe resolutions, recommendations and reports – 3rd Edition (2017)
        • Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (2018)
        • Booklets
        • Publication - Other Languages - Organs, tissues and cells
      • FAQ & HelpDesk - Organs, tissues and cells
  • Consumer health
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    • Cosmetics & tattoos
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      • Newsroom Cosmetics & tattoos
      • Tattoos and permanent make-up - Focus and activities
      • Cosmetics and consumer health
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        • About Cosmetics and consumer health
        • European legal framework for cosmetic products
      • Publications on cosmetic products and tattoo inks
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        • Cosmetics for children under the age of three
        • Guidance on essential oils in cosmetic products
      • FAQ & HelpDesk - Cosmetics and Tattoos
    • Official Cosmetics Control Laboratories (OCCL)
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      • The Network of Official Cosmetics Control Laboratories (OCCLs)
      • Discover the OCCLs and their achievements
      • Members of the Network of Official Cosmetics Control Laboratories (OCCLs)
      • Activities of the OCCL Network : coordinating surveillance and enhancing testing capacity
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        • OCCLs: analytical methods
        • Market surveillance studies in cosmetics (COS MSS)
        • Proficiency testing scheme studies in cosmetics
      • OCCLs in practice, their work and experience
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        • Special focus on children’s safety: make-up and cosmetics
        • Cutting edge expertise for testing cosmetics
        • Detecting cannabinoids (THC, CBD & CBN) in cosmetic products
        • Are tattoo inks and products safe?
        • Austrian agency for health and food safety, AGES
    • Food contact materials and articles
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      • Newsroom Food contact materials and articles
      • Food contact materials and articles
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        • Resolutions & Policy statements
      • Publications on food contact materials and articles
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        • Multi-analyte methods for the determination of substances migrating from printing inks to dry food or food simulants
        • Paper and board used in food contact materials and articles
        • Metals and alloys used in food contact materials and articles
        • Documentation supporting the compliance and safety of food contact materials and articles
      • FAQ & HelpDesk Food contact materials and articles
  • Products & services
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    • Newsroom Products and services
    • Ordering Reference Standards & Publications
    • Sales information
    • CombiStats
    • EDQM publications
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      • How to place an order for EDQM Publications
      • How to register your subscription key (en anglais)
      • European Pharmacopoeia 11th Edition
      • Pharmeuropa
      • Technical guides Ph. Eur.
      • Blood guide
      • Organs guide
      • Tissues and cells technical guide
      • Cosmetics & Tattooing
      • Food contact materials and articles guide
      • Overview of pharmacopoeia related products and services
      • Online access for Freepub publications
    • EDQM reference standards
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      • How to place an order for EDQM RS
      • Ph. Eur. RS Orders & catalogue
      • WHO ISA Orders & catalogue
      • WHO ICRS Orders & Catalogue
      • Safety Data Sheets
    • FAQ & HelpDesk - EDQM all activities
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      • FAQ & HelpDesk Reference Standards (RS)
      • FAQ & HelpDesk - Publications
      • FAQ & HelpDesk Electronic Publications - Technical Support
  • Events & training
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    • Upcoming events
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      • Medication reviews in Europe and their role in optimising the use of medicines by patients
      • 35th Regional ISBT Congress
      • Sterile substance CEP webinar
      • CPhI China 2025
      • Certified for success: using the CEP Procedure to elevate quality and drive trust
    • Past events, training and campaigns
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      • European Donation Day (EDD)
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        • Institutions for organ donation and transplantation in our member states
        • European Donation Day 2024
      • EDQM Open Day – A day for all to enjoy!
      • Celebrating 60 years of excellence in public health protection
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        • Celebrating 60 years of excellence in public health protection - Communication kit
        • Celebrating 60 years of excellence in public health protection - Speaker profiles
        • Questions and answers from the "Tomorrow" session
      • European Pharmacopoeia 11th Edition Conference highlights
      • EDQM Blood Conference
      • EDQM Stakeholder Event - Plasma Supply Continuity
    • Latest e-learning resources
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      • e-Learning catalogue
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        • 2024 EDQM Virtual Training Programme: independent modules on Ph. Eur., Reference Standards and CEP Procedure
    • FAQ & HelpDesk - Events and visits
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      • Information for Event Participants
      • Webinar System Requirements
  • Contact
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    • Helpdesk
    • Contact the Webmaster
    • Media enquiries
    • Contact the EDQM
    • Stay connected with the EDQM
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  1. European Directorate for the Quality of Medicines & HealthCare
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