• Home
• EDQM
  • About us
    • Newsroom
      • All EDQM press releases
    • Vision, mission & values
    • History
      • History of the EDQM from 1997 to 2009
      • History of the EDQM from 1964 to 1997
    • Structure
    • Memoranda of Understanding and Agreements
    • Management Systems
      • Quality Management
        • ISO 9001 Certificate
        • ISO 17025
      • Safety Management System
    • Fact sheets
    • Calls for tenders
    • FAQ & HelpDesk
    • Newsletter
    • RS newsletter
  • Careers
    • Why join the EDQM?
    • What we look for in you
    • Jobs and careers at EDQM
      • Vacancies
• COVID-19
  • COVID-19: EDQM business continuity plan to safeguard core activities
  • EDQM initiatives in the context of COVID-19 vaccines and therapies
  • Newsroom COVID-19
• Medicines
  • European Pharmacopoeia (Ph. Eur.)
    • Newsroom European Pharmacopoeia
    • Focus
      • Biotherapeutics
      • Alternatives to animal testing
        • 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
      • Where to find: The Knowledge database
      • Elaboration & Revision
      • The Ph. Eur. Work Programme
    • Pharmacopoeial Harmonisation
      • Harmonisation status for Excipient monographs (PDG)
      • Harmonisation status for General Texts (PDG)
    • Find information on
      • Ph. Eur. Technical Guides
      • Databases
      • FAQ - HelpDesk Ph. Eur. texts
    • CombiStats
      • CombiStats: What's new in the web application?
      • Have a question about CombiStats?
    • The European Pharmacopoeia
      • European Pharmacopoeia - Background and Mission
      • The European Pharmacopoeia - Membership & Observership
      • The European Pharmacopoeia Commission
        • Newsroom European Pharmacopoeia Commission
      • Groups of Experts and Working Parties
      • European Pharmacopoeia (Ph. Eur.) 11th Edition
    • Standard Terms Database
    • How to participate in the work of the Ph. Eur.
      • Join the Network!
      • Submitting drafts and requests for revision
      • Comment on drafts (Pharmeuropa)
      • Pharmeuropa, Pharmeuropa Bio & Scientific Notes
  • Biological Standardisation Programme (BSP)
    • Newsroom Biological standardisation programme
    • The BSP Steering Committee
    • Biological Standardisation Programme (BSP) - Background & Mission
    • BSP Work Programme
    • BSP programme for 3Rs
    • Participate in a BSP Study
    • Reference Standards from the BSP programme adopted in 2023
    • RS newsletter
  • Reference Standards (RS)
    • Reference standards - Newsroom
    • Ph. Eur. Reference Standards
      • Ph. Eur. Reference Standards: Purpose and use
      • Ph. Eur. Reference Standards: Orders and Catalogue
      • Get Involved in the Establishment of Ph. Eur. Chemical Reference Substances (CRS)
    • WHO RS
      • 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 data sheets
      • Terms and conditions for EDQM SDS and their use
  • Certification of Suitability (CEP)
    • Newsroom Certification of suitability
    • About the Procedure
      • 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
      • New Applications
        • Submit A New Application
        • Content of the Dossier
        • Quality Overall Summary (QOS) for CEP applications
      • Notifications, Revisions, Renewals and Sister Files
        • Classification of changes
          • Submission of Nitrosamine impurity risk assessment
        • Submit changes
        • Sister files
      • Technical advice & one-to-one meetings
      • Submission format and electronic submission
    • Find information on
      • 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
    • Newsroom OMCL
    • General Activities
      • OMCL - Background and mission
        • Discover how Official Medicines Control Laboratories contribute to protect your health in Europe and beyond
      • Market Surveillance Studies (MSS)
      • Quality Management (QM) Programme
        • Quality Management (QM) Documents
      • Physico-chemical and Biological PTS
        • List of Proficiency Testing Scheme (PTS) Studies planned for 2025
        • Physico-chemical & Biological PTS Fees
    • Programmes EU/EEA Network
      • Human Biologicals (OCABR)
        • Human OCABR Guidelines
        • Questions and answers on OCABR
        • Batch Release for Human Biologicals: vaccines, blood and plasma derivatives
      • Veterinary Biologicals (OCABR/OBPR)
        • Guidelines for EU OCABR for IVMPs
      • MRP/DCP Post Marketing Surveillance Scheme
        • MRP/DCP Product Testing Database
      • CAP Sampling & Testing Programme
    • Working group activities
      • Testing of Active Pharmaceutical Ingredients (APIs)
      • Quality Monitoring of Stockpiled Medicines
        • Stockpiling of Medicines: Position Paper
        • Stockpiling of Medicines: Technical Guideline
      • OMCL Gene Therapy Working Group
      • Testing of falsified / illegal medicines
        • 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
    • Newsroom Nitrosamine contamination
  • Anti-falsification activities
    • 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
    • Know-X
  • Classification of medicines
    • Newsroom Classification of medicines
    • CD-P-PH/PHO - Classification of Medicines as Regards their Supply
      • 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
      • MELCLASS Database
    • European Committee on Pharmaceuticals and Pharmaceutical Care - CD-P-PH
    • FAQ & HelpDesk - Pharmaceuticals
  • Pharmaceutical Care
    • Newsroom Pharmaceutical care
    • CD-P-PH/PC - Pharmaceutical Practices and Pharmaceutical Care
      • 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
    • Newsroom European Paediatric Formulary
    • Background & Mission - Paediatric Formulary
    • FAQ & HelpDesk - Paediatric Formulary
  • EDQM initiatives on medicine shortages
• Substances of human origin
  • Blood Transfusion
    • Newsroom Blood Transfusion
    • Background & Mission
    • Blood - Organisation & Work Programme
    • Recommendations and resolutions
    • Plasma Supply Management
    • Optimal use of blood components and plasma-derived medicinal products
    • Reports
    • Guide to the preparation, use and quality assurance of blood components
    • Blood Quality Management Programme
      • Blood Quality Management programme (B-QM)
      • Blood Proficiency Testing Scheme (B-PTS)
        • List of Blood Proficiency Testing Scheme (B-PTS) for 2024
      • Ordering information for Blood Proficiency Testing Scheme (B-PTS) studies
    • Blood Supply Contingency and Emergency Plan (B-SCEP)
    • FAQ & HelpDesk - Blood transfusion
    • FAQ & Helpdesk: Blood Proficiency Testing Scheme (B-PTS)
  • Organs, tissues and cells
    • Newsroom - Organs, tissues and cells
    • Organs, tissues and cells - Background & Mission
    • Organisation & Work Programme
    • Areas of work - Transplantation
    • Legal Framework
      • Signatures and ratifications of Treaty 216
    • Organs, tissues and cells - Publications
      • 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
    • Registry of International Travel for Transplantation Activity-RITTA (Restricted)
    • FAQ & HelpDesk - Organ, tissue and cell transplantation
• Consumer health
  • Cosmetics & tattoos
    • Newsroom Cosmetics & tattoos
    • Tattoos and permanent make-up - Focus and activities
    • Cosmetics and consumer health
      • About Cosmetics and consumer health
      • European legal framework for cosmetic products
    • Publications on cosmetic products and tattoo inks
      • 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)
    • 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
      • OCCLs: analytical methods
      • Market surveillance studies in cosmetics (COS MSS)
      • Proficiency testing scheme studies in cosmetics
    • OCCLs in practice, their work and experience
      • 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
    • Newsroom Food contact materials and articles
    • Food contact materials and articles
      • Resolutions & Policy statements
    • Publications on Food contact materials and articles
      • New 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
    • FAQ & HelpDesk Food contact materials and articles
• Products & services
  • Newsroom Products and services
  • Ordering Reference Standards & Publications
  • Sales information
  • CombiStats
  • Dedicated Customer Support at your service
  • EDQM publications
    • 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
    • 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
    • FAQ & HelpDesk Reference Standards (RS)
    • FAQ & HelpDesk - Publications
    • FAQ & HelpDesk Electronic Publications - Technical Support
• Events & training
  • Upcoming events
    • CombiStats Online - Training
      • CombiStats Online - Training (modules)
    • Everything you've always wanted to know about the certification (CEP) procedure
    • 2024 EDQM virtual training programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
      • 2024 EDQM virtual training programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure - Modules
    • Advancements in gene therapy: the European Pharmacopoeia’s new approach
      • Advancements in gene therapy: the European Pharmacopoeia’s new approach - Question form
    • EDQM Blood Conference
      • About
        • Scope
      • Practical information
        • Blood conference - Programme
      • Scientific committee
      • Speakers
      • Registration
      • Contact us
      • Call for abstracts
    • Upcoming event 23 (Food contact materials and articles) [hidden]
  • Upcoming events & training (Calendar)
  • Past events, training and campaigns
    • European Donation Day (EDD)
      • 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
      • Celebrating 60 years of excellence in public health protection - Communication kit
      • Celebrating 60 years of excellence in public health protection - Speaker profiles
        • Fiona Adshead
        • Petra DOERR
        • Alexandre MEJAT
        • David Novillo-Ortiz
        • Scott Mark SKYLAR-SCOTT
        • Eric Sutherland
        • Kirsty Reid
      • Questions and answers from the "Tomorrow" session
    • European Pharmacopoeia 11th Edition Conference highlights
  • Latest e-learning resources
    • e-Learning catalogue
      • 2024 EDQM Virtual Training Programme: 4 independent modules on European Pharmacopoeia texts related to Biologicals and on Microbiology chapters
      • 2023 EDQM Virtual Training Programme: independent modules on Ph. Eur., Reference Standards and CEP Procedure
      • All EDQM presentations
    • Online training
  • FAQ & HelpDesk - Events and visits
    • Information for Event Participants
    • Webinar System Requirements
• Contact
  • Helpdesk
  • Contact the Webmaster
  • Media enquiries
    • EDQM media kit
  • Contact the EDQM
  • Visit the EDQM
  • EDQM Holidays
  • Stay connected with the EDQM
  • RSS News Feeds
• Search
• Newsroom
• Sitemap
• Access denied / Page inaccessible