Navigation
Skip to Content
WWW.COE.INT
Human Rights
Democracy
Rule of Law
About us
Council of Europe at a glance
The Council of Europe: key facts
Achievements and History
Jobs and Traineeships
Home
Human Rights
Democracy
Rule of Law
Administrative entities
Secretary General
Deputy Secretary General
Chairmanship
Committee of Ministers
Parliamentary Assembly
Congress of Local and Regional Authorities
European Court of Human Rights
Commissioner for Human Rights
Conference of INGOs
Monitoring bodies
Private Office
Treaty Office
46 Member States
Theme files
Newsroom
Events
Bookshop
Online resources
Contact
Intranet
English
Choose language
Français
English
Connect
Search
Council of Europe at a glance
The Council of Europe: key facts
Achievements and History
Jobs and Traineeships
Home
Human Rights
Democracy
Rule of Law
Administrative entities
Secretary General
Deputy Secretary General
Chairmanship
Committee of Ministers
Parliamentary Assembly
Congress of Local and Regional Authorities
European Court of Human Rights
Commissioner for Human Rights
Conference of INGOs
Monitoring bodies
Private Office
Treaty Office
46 Member States
Theme files
Newsroom
Events
Bookshop
Online resources
Contact
Intranet
Avenue de l'Europe
F-67075 Strasbourg Cedex
Tel. +33 (0)3 88 41 20 00
www.coe.int
European Directorate for the Quality of Medicines & HealthCare
Home
EDQM
Back
About us
Back
Newsroom
Back
All EDQM press releases
Vision, mission & values
History
Structure
Memoranda of Understanding and Agreements
Management Systems
Back
Quality Management
Newsletter
Careers
Back
Jobs and careers at EDQM
Medicines
Back
European Pharmacopoeia (Ph. Eur.)
Back
Newsroom European Pharmacopoeia
Focus
Back
Biotherapeutics
Alternatives to animal testing
Back
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
Back
Where to find: The Knowledge database
Elaboration & Revision
The Ph. Eur. Work Programme
Pharmacopoeial Harmonisation
Back
Harmonisation status for Excipient monographs (PDG)
Harmonisation status for General Texts (PDG)
Find information on
Back
Ph. Eur. Technical Guides
Databases
FAQ - HelpDesk Ph. Eur. texts
CombiStats
Back
CombiStats: What's new in the web application?
Have a question about CombiStats?
The European Pharmacopoeia
Back
European Pharmacopoeia - Background and Mission
The European Pharmacopoeia - Membership & Observership
The 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.
Back
Join the Network!
Submitting drafts and requests for revision
Comment on drafts (Pharmeuropa)
Pharmeuropa, Pharmeuropa Bio & Scientific Notes
Biological Standardisation Programme (BSP)
Back
The BSP Steering Committee
BSP Work Programme
BSP programme for 3Rs
Reference Standards from the BSP programme adopted in 2023
Reference Standards (RS)
Back
Ph. Eur. Reference Standards
Back
Ph. Eur. Reference Standards: Purpose and use
Ph. Eur. Reference Standards: Orders and Catalogue
WHO RS
Back
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)
Back
Newsroom Certification of suitability
About the Procedure
Back
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
Back
New Applications
Back
Submit A New Application
Content of the Dossier
Quality Overall Summary (QOS) for CEP applications
Notifications, Revisions, Renewals and Sister Files
Back
Classification of changes
Back
Submission of Nitrosamine impurity risk assessment
Submit changes
Sister files
Technical advice & one-to-one meetings
Submission format and electronic submission
Find information on
Back
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
Back
Newsroom OMCL
General Activities
Back
OMCL - Background and mission
Back
Discover how Official Medicines Control Laboratories contribute to protect your health in Europe and beyond
Market Surveillance Studies (MSS)
Quality Management (QM) Programme
Back
Quality Management (QM) Documents
Physico-chemical and Biological PTS
Back
List of Proficiency Testing Scheme (PTS) Studies planned for 2025
Physico-chemical & Biological PTS Fees
Programmes EU/EEA Network
Back
Human Biologicals (OCABR)
Back
Questions and answers on OCABR
Batch Release for Human Biologicals: vaccines, blood and plasma derivatives
Veterinary Biologicals (OCABR/OBPR)
Back
Guidelines for EU OCABR for IVMPs
MRP/DCP Post Marketing Surveillance Scheme
Back
MRP/DCP Product Testing Database
CAP Sampling & Testing Programme
Working group activities
Back
Testing of Active Pharmaceutical Ingredients (APIs)
Quality Monitoring of Stockpiled Medicines
Back
Stockpiling of Medicines: Position Paper
Stockpiling of Medicines: Technical Guideline
OMCL Gene Therapy Working Group
Testing of falsified / illegal medicines
Back
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
Back
Newsroom Nitrosamine contamination
Anti-falsification activities
Back
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
Back
Newsroom Classification of medicines
CD-P-PH/PHO - Classification of Medicines as Regards their Supply
Back
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
Back
Newsroom Pharmaceutical care
CD-P-PH/PC - Pharmaceutical Practices and Pharmaceutical Care
Back
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
Back
Background & Mission - Paediatric Formulary
FAQ & HelpDesk - Paediatric Formulary
EDQM initiatives on medicine shortages
Back
Technical recommendations of the European drug Shortages Formulary Working Party
EDQM activities on borderline products
Substances of human origin
Back
Blood Transfusion
Back
Newsroom Blood Transfusion
Background & Mission
Organisation & Work programme
Areas of work – Blood
Back
Plasma Supply Continuity
Optimal use of blood components and plasma-derived medicinal products
Blood Quality Management Programme
Back
Blood Quality Management programme (B-QM)
Blood Proficiency Testing Scheme (B-PTS)
Back
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
Back
Guide to the preparation, use and quality assurance of blood components
Reports
FAQ & HelpDesk
Organs, tissues and cells
Back
Newsroom - Organs, tissues and cells
Organs, tissues and cells - Background & Mission
Organisation & Work Programme
Areas of work - Transplantation
Legal Framework
Back
Signatures and ratifications of Treaty 216
Organs, tissues and cells - Publications
Back
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
Back
Cosmetics & tattoos
Back
Newsroom Cosmetics & tattoos
Tattoos and permanent make-up - Focus and activities
Cosmetics and consumer health
Back
About Cosmetics and consumer health
European legal framework for cosmetic products
Publications on cosmetic products and tattoo inks
Back
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)
Back
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
Back
OCCLs: analytical methods
Market surveillance studies in cosmetics (COS MSS)
Proficiency testing scheme studies in cosmetics
OCCLs in practice, their work and experience
Back
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
Back
Newsroom Food contact materials and articles
Food contact materials and articles
Back
Resolutions & Policy statements
Publications on food contact materials and articles
Back
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
Back
Newsroom Products and services
Ordering Reference Standards & Publications
Sales information
CombiStats
EDQM publications
Back
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
Back
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
Back
FAQ & HelpDesk Reference Standards (RS)
FAQ & HelpDesk - Publications
FAQ & HelpDesk Electronic Publications - Technical Support
Events & training
Back
Upcoming events
Back
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
Back
European Donation Day (EDD)
Back
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
Back
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
Back
e-Learning catalogue
Back
2024 EDQM Virtual Training Programme: independent modules on Ph. Eur., Reference Standards and CEP Procedure
FAQ & HelpDesk - Events and visits
Back
Information for Event Participants
Webinar System Requirements
Contact
Back
Helpdesk
Contact the Webmaster
Media enquiries
Contact the EDQM
Stay connected with the EDQM
You are here:
European Directorate for the Quality of Medicines & HealthCare
Document display page
Élaboration/Révision d’une monographie (Procédure 1)
Download document
Hidden
Avenue de l'Europe
Avenue de l'Europe