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      • Kenneth Casler – Living with Myeloma
      • Karin Hoogendoorn – Decentralized Cell Therapy Manufacturing
  • About
    • ATMP Swedens
      • The ATMP Sweden Association
        • Meet the Board
        • Members List
      • History
      • Newsletter
      • Membership
        • Member Package
        • Discounts
      • Contact
    • ATMPs
      • What are ATMPs?
      • Vad är ATMPs?
    • Swedish ATMP
      • ATMP Map
      • ATMP Companies
      • Immunotherapies
      • Related Organisations
  • Initiatives
    • Working Groups
  • Job Board
  • News
  • ATMP Development
    • Resources
      • Commercial aspects
      • Dictionary
      • Logistics Cookbook
        • What is GDP?
        • Regulators expect
        • FAQ
        • References
      • Patent/IP Support
      • Reports
      • Training Opportunities
    • Process Map
      • Clinical Process Map
      • Commercial Process Map
      • Manufacture Process Map
      • Regulatory Process Map
      • Product Developer Process Map
    • ATMP Regulatory Guide
      • How to use this guide
      • Definition and idea
      • Risk assessment and early documentation
      • Advanced Therapy Medicinal Products (ATMPs)
      • Clinical Trials
      • Hospital Exemption
      • The ATMP Classes
        • Combined ATMPs (cATMP)
        • Gene Therapy Medicinal Products (GTMPs)
        • Somatic Cell Therapy Medical Products (sCTMPs)
        • Tissue Engineered Products (TEPs)
      • Guides and Documents
      • Abbreviations
      • Links
  • Events
    • Annual Conferences
      • ATMP Sweden 2025 Conference
        • Host an ATMP Exchange Roundtable
        • Conference Program & Agenda
        • Sponsorships & Exhibition
          • Sponsorship Opportunities at a glance
        • Venue, Travel & Accomodation
        • Contact & Collaboration
    • ATMP Sweden Webinars
      • Kenneth Casler – Living with Myeloma
      • Karin Hoogendoorn – Decentralized Cell Therapy Manufacturing
Become a member
ATMP Sweden ATMP development Resources Logistics Cookbook References
Resources
  • Commercial aspects
  • Reports
  • Patent/IP support
  • Training opportunities
  • Logistics Cookbook
    • What is GDP?
    • Regulators expect
    • FAQ
    • References

References

Resources
  • Commercial aspects
  • Reports
  • Patent/IP support
  • Training opportunities
  • Logistics Cookbook
    • What is GDP?
    • Regulators expect
    • FAQ
    • References

References

For more information:

  • EU Guidelines on Good Distribution Practice (GDP) of medicinal products for human use
  • REGULATION (EU) 2021/1280 GDP for active substances used as starting materials in veterinary medicinal products
  • (EU) 2021/1248 GDP for veterinary medicinal products in accordance with Regulation (EU) 2019/6
  • EC Q&A GDP FOR MEDICINAL PRODUCTS FOR HUMAN USE
  • Annex 7 WHO Good storage and distribution practices for medical products
  • Annex 5 WHO GDP  for pharmaceutical products
  • Annex 6 WHO Guidelines for inspection of drug distribution channels
  • WHO technical supplement – Temperature mapping of storage areas PIC/S GUIDE TO GDP FOR MEDICINAL PRODUCTS
  • European GDP Association website

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ATMP CONTACTS

Comms & Project Lead

Henrik Simonsson

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