HMA - Heads of Medicines Agencies
  • RSS
  • Sitemap
  • Login (HMA-DMS)
  • Contact
  • About HMA
  • Human Medicines
  • Veterinary Medicines
  • You are here:
  • Home
  • >Human Medicines
  • >CMDh
  • >Templates
  • >Assessment Reports
  • >ASMF
  • CMDh
    • About CMDh
    • Statistics
    • Agendas and Minutes
    • Press Releases
    • COVID-19
    • BREXIT
    • Procedural Guidance
    • CMDh-Referrals
    • Product Information
    • Advice from CMDh
    • Templates
      • Applications for MA
      • QRD
      • Assessment Reports
        • DCP (AR/Comments)
        • MRP
        • Renewals
        • Variations
        • Art 61.3 Procedure
        • Public AR
        • Paediatric Data
        • ASMF
      • Art.29 Referrals
      • PSUR
      • Variations
      • Renewals
      • RMP
      • RUP
    • CMD Working Parties / Working Groups
    • Paediatric Regulation
    • Pharmacovigilance
    • Falsified Medicines
    • Questions & Answers
    • Contact Points
    • Recently Published history
  • MRI Product Index
  • Pharmacovigilance
  • Availability of Medicines
  • Publications and reports
  • National Contacts

 

Templates for ASMF Procedures

  • Template for Active Substance Master File (ASMF) Type IB Variation Assessment Report (July 2019)
  • Template for Active Substance Master File (ASMF) Assessment Report (Applicant's Part) (July 2019)
  • Template for Active Substance Master File (ASMF) Assessment Report (Resctricted Part) (July 2019)

 

The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. HMA and CMDh/v are in the process of making appropriate changes to this website. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. In case you notice information that should be updated, please report this website link using the contact form.

  • Useful Links
  • Privacy Policy
  • Credits & Disclaimer
  • Contact
© Heads of Medicines Agencies - https://www.hma.eu/human-medicines/cmdh/templates/assessment-reports/asmf.html