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European Directorate for the Quality of Medicines & HealthCare

European Directorate for the Quality of Medicines & HealthCare

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      • How to apply
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          • Content of the Dossier
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          • Classification of changes
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            • Submission of Nitrosamine impurity risk assessment
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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)
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          • List of Proficiency Testing Scheme (PTS) Studies planned for 2025
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        • Human Biologicals (OCABR)
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        • Testing of Active Pharmaceutical Ingredients (APIs)
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        • Work programme CD-P-PH/PHO
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      • Newsroom Pharmaceutical care
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        • Work programme: setting quality and safety standards in pharmaceutical practices and pharmaceutical care
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      • European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH)
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      • Technical recommendations of the European drug Shortages Formulary Working Party
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  • Substances of human origin
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      • Background & Mission
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      • 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
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        • Guide to the preparation, use and quality assurance of blood components
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    • Organs, tissues and cells
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      • Newsroom - Organs, tissues and cells
      • Organs, tissues and cells - Background & Mission
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      • Areas of work - Transplantation
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        • 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
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      • FAQ & HelpDesk - Organs, tissues and cells
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      • Newsroom Cosmetics & tattoos
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      • 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
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      • 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
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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
        • Cork materials and articles for contact with food
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      • How to place an order for EDQM Publications
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      • European Pharmacopoeia – New online-only 12th Edition
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      • Pharmeuropa
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      • How to place an order for EDQM RS
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      • FAQ & HelpDesk Reference Standards (RS)
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  • Events & training
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    • Upcoming events
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      • 2025 EDQM virtual training programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
      • Joint EDQM-EPAA Symposium: Pyrogen testing 2.0: Ethical, Evolving and Eco-friendly Implementing safe, rapid, state-of-the-art and sustainable non-animal approaches worldwide
    • Past events, training and campaigns
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      • European Donation Day 2025
      • Conference: Certified for success: using the CEP Procedure to elevate quality and drive trust
      • 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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    • FAQ & HelpDesk - Events and visits
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      • European Donation Day – Media Kit
    • Contact the EDQM
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  1. European Directorate for the Quality of Medicines & HealthCare
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test

 

Abbreviations and Acronyms

Cases of borderline products in jurisdiction

Classification

Role of Customs / Interaction with Customs

Definitions

Detections

General Consideration / Problem Statement

International Aspects

National Cooperation

Prevention

Response

Risk Assessment

 

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