Medicinal products

• Clinical trials
  • Clinical Trials Information System - CTIS
  • Compassionate Use
  • GCP Inspections Unit
• Licensing
  • Types of Marketing Authorisation
    • Licensing of Biosimilars
    • Interchangeability of biosimilars
    • Bibliographical Application
    • Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)
  • Licensing Procedures
    • Centralised Procedures
    • National Licensing Procedures
    • Decentralised Procedure (DCP) - Mutual Recognition Procedure (MRP)
    • Parallel import of medicinal products
  • Follow-up Procedures
    • Renewals
    • Written renouncement
    • Variations
      • Variations
      • National Variations
    • Sunset Clause
    • Publication of clinical trials results acc. Section 42b AMG
  • Issues Relevant for Licensing
    • Information on WHO Certificates
    • eSubmission
    • Brexit
    • Pharmacopoeia
      • Pharmacopoeia Commissions
    • Demarcation/Borderline questions
      • Joint Commission of Experts on the Classification of Substances
  • Medicines for children
    • EU-regulation on medicinal products for children
    • Paediatric Worksharing
  • Medicines for rare diseases
• GCP Inspections Unit
• Pharmacovigilance
  • Reporting risks
  • Risk information
    • Rote-Hand-Briefe and Information Letters
    • Other risk information
    • Risk Assessment Procedures
    • List of medicines under additional monitoring
    • Educational material
    • European Database on Adverse Drug Reaction Reports
    • Risk Management Plans (RMP)
    • Risk information on medicinal products
  • Periodic Safety Update Reports (PSURs)
    • PSUR Repository
  • Graduated plan officer
  • Boards and Committees
    • Pharmacovigilance Risk Assessment Committee (PRAC)
    • Prescription-only issues
    • Pharmacy-only issues
    • Routine sessions
• Medicinal products information
  • Rapid Alert System
  • Supply shortages
    • Advisory Board on shortages
    • ALBVVG
    • Joint Action CHESSMEN
    • Mitigation measures
    • Reporting obligations
    • SPOC on shortages
    • ICU Taskforce
  • Falsified Medicines Directive
  • Reference Pricing
  • Online medicine retailers
    • EU Security Logo
    • Registered Online Medicine Retailers
  • Research medicinal products
    • Medicinal Product Information System AMIce
      • Database description for AMIce Batch Release
      • Database description for AMIce Substances
      • Database description for AMIce Terms of Substances
      • Database description for AMIce Medicinal Products
  • PharmNet.Bund

Medical devices

• Regulatory framework
  • Basic information
    • Conformity assessment
  • Laws and regulations
  • Competent authorities and ethics committees
    • Competent Authorities
    • Ethics Committees
    • Notified Bodies
  • Europe and EUDAMED
    • EUDAMED
• Tasks of the BfArM
  • Clinical investigations and performance studies
    • Clinical investigations according to MDR / MPDG
      • Request for authorisation
      • Notification of a Post-Market Clinical Follow-up investigation
      • Notification of other clinical investigations
      • Substantial modifications
      • Halt, Termination or End of a Clinical Investigation
      • Guidance for the application procedure
    • Performance studies of in vitro diagnostic medical devices
      • Halt, Termination or End of a Performance Study
      • Request for waiving the authorisation
      • Authorisation
      • Notification of a Post-Market Performance Study
      • Substantial modifications
      • Notifications of performance studies with CDx left-over samples
    • Application for decision on requirement to approve MD / IVD
  • Risk assessment
    • Reporting risks
    • Field corrective actions
    • BfArM recommendations
  • Differentiation and classification
  • DiGA and DiPA
    • Digital nursing applications (DiPA)
      • Interesting facts
    • Digital Health Applications (DiGA)
      • Interesting facts
  • DMIDS
    • Clinical investigations and performance studies
    • Notification of Medical Devices and In vitro Diagnostics
    • Public databases
      • Database Information Medical Devices Notification
      • Database Information In Vitro Diagnostic Medical Devices Notifications
      • Database Information Medical Devices Addresses
    • Operating the system
      • System requirements
  • Further tasks
    • Corona Pandemic
    • Companion diagnostics (CDx)
  • FAQ and contact persons
• Contact persons
• Reports and Corrective Actions
  • Incident report
  • SAE and DD report
    • SAE and DD reporting for performance studies
    • SAE and DD reporting for clinical investigations
  • Recall report
  • Notification interruptions or discontinuations of the supply of a medical device
  • Overview reporting channels
  • Field corrective actions
• Portals
  • DiGA- and DiPA-Portal
  • DMIDS

Code systems

• Classifications
  • ICD
    • ICD-10-GM
      • Alphabetical index
      • Application
      • Code-Search
      • History and outlook
      • Proposal procedure
      • Tabular list
      • Versions and formats
    • ICD-11
    • ICD-10-WHO
      • Alphabetical index
      • Application
      • Causes of death statistics
      • Code-Search
      • History and outlook
      • Instruction manual
      • Tabular list
    • ICD-O-3
      • Code-Search
  • OPS, ICHI
    • OPS
      • Alphabetical index
      • Application
      • Code-Search
      • History and outlook
      • Proposal procedure
      • Tabular list
      • Versions and formats
    • ICHI
  • ATC
  • IVD EDMA
  • ICF
• Terminologies
  • SNOMED CT
    • Application for a SNOMED CT affiliate licence
    • Submit change requests for SNOMED CT
    • Request German translations of SNOMED CT concepts
    • Information about SNOMED CT
    • Working Group AG SNOMED
    • National Release Center (NRC)
    • Training courses and events
    • Why SNOMED CT?
    • National Edition / National Extension
    • Promotion by the EU Commission
  • LOINC
    • Change Requests
    • German translations of LOINC terms
    • KKG AG LOINC
    • LOINC at BfArM
    • Further Information
  • UCUM
  • Alpha-ID-SE
    • National project rare diseases coding
  • UMDNS, EMDN
    • UMDNS
• Collaboration and projects
  • KKG
  • WHO Collaborating Centre
  • EU projects
    • RD-Code
    • RD-Action
  • Orphanet
  • Iris Institute
    • Iris News
      • Iris News - subscribe and unsubscribe
    • Downloads
    • Iris software
    • Iris users
    • Iris support
    • Events and trainings
    • Iris and ICD-11
  • Pilot of a nationwide electronic death certificate
  • Further collaboration
• Services
  • Downloads
  • Terminology server
    • Commentary
    • Semantic strategy
    • Stages
    • Terminology server for healthcare
  • Code-Search online versions
  • OID registry
    • OID-Application
  • FAQ/Contact

Federal Opium Agency

• Narcotic drugs
  • Licences
  • Notifications
  • Records
  • Import and Export
  • Travelling with narcotic drugs
• Precursors
  • Import and Export
  • Licence and Registration
  • Announcements
• T-prescriptions
• Substitution Register
• Contact persons

About us

• Organisation
  • Head
  • Library
• Tasks
  • Medical Research Act
  • Research
    • Biostatistics
    • Special Indications
    • Research and Projects on Medical Device Safety
    • Pharmacogenomics
    • Pharmacoepidemiology
    • Neuropsychopharmacology
    • Drug allergies
    • Publications
  • Advice procedures
    • Kick-off Meeting through the Innovation Office at the BfArM
    • Scientific Advice and Pre-submission Meeting
    • Joint Advice BfArM and G-BA
  • Model project genome sequencing
    • News
      • Events
  • Data Access and Coordination Office
    • Application process
    • Responsibilities
    • EU Integration
    • Metadata catalog
    • Secure Processing Environments
    • Newsletter
  • DRKS - German Clinical Trials Register
    • Further Information
    • FAQ and Glossary
    • Search studies
    • Study Submission and User Account
    • Networking
    • About Us
    • Statistics
• Contact persons
• EU and International
  • CHMP
  • ERON European Regulatory Oncology News
  • Pharmacovigilance Risk Assessment Committee (PRAC)
  • EU Projects
    • EU4Health Programme
      • IncreaseNET
      • HDP4Germany
    • CSA-STARS
      • About STARS
      • STARS Common Strategy
      • STARS Curricula
      • STARS Pilots and Training Materials
      • STARS Publications
  • International Collaborations
    • GHPP
      • PharmTrain2
        • All reports
        • eLearning
        • Guidelines
        • Manuals
        • Capacity Development
        • Harmonisation
        • Structure Development
        • Publications
      • LabTrain
        • All reports
    • ICH - The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
  • GHPP
    • PharmTrain2
      • All reports
      • eLearning
      • Guidelines
      • Manuals
      • Capacity Development
      • Harmonisation
      • Structure Development
      • Publications
    • LabTrain
      • All reports

News

• News from the divisions
  • New information in the topic code systems
  • All news at a glance
  • New information in the topic Pharmacovigilance
  • New information in the topic clinical trials
  • New information in the topic medicinal products
  • New information in the topic medical devices
  • New information in the topic licensing
• Press
  • Photos
• Blog
• Publications
  • Impulse report / Annual report
• Statistics
  • Applications for Authorisation and Registration
  • Marketable Medicinal Products
  • CAM and TMP
  • Advice procedures
• Events
  • WGCP Face-to-Face-Meeting 2025
    • Hotels in Bonn
    • Registration form
      • Confirmation of your registration
• Antibiotic resistances
• 30 years BfArM