Arrow Left Regulatory Service Desk

Marketing authorisation

Guidance, documents, and network 

  1. Evaluation of medicines in general, NL and EU - from lab to patient: journey of a medicine 
  2. MEB Application compass (CBG Aanvraagwijzer)
    1. Prior to marketing authorisation application
    2. Marketing authorisation procedures
    3. Types of marketing authorisation
    4. Submitting a dossier
    5. Product information requirements
    6. Availability and shortages
    7. Pharmacovigilance
    8. MEB policy
  3. EMA Marketing authorisation
  4. EMA
    1. EMA working groups
    2. EMA regulatory Science Strategy
    3. EMA Regulatory Science Research Needs
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