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Pharma-Consulting - Coggle Diagram

- - - - person
      - product
      - renewals
      - data update
  - - - market reports
      - DIS 13
      - REG 13
      - monitoring of sunset clause
      - communication with authority
      - national phase
      - PoA/LoA
      - educational/marketing materials
      - Hard copy submissions
      - VPOIS
    - - RA payments
        
        per procedure
        
        annual fees
      - preparation of M1
        
        eAF/national AF
        
        cover letter
        
        package information
      - artworks
        
        check
        
        submission to SÚKL
      - monitoring of reference product
      - CESP/PSUR submission
      - monitoring of safety variations (PRAC, PSUSA, CMDh, Refferals)
    - - eCTD dossier
    - - dossier audit
      - DCP slot request
    - - classification of variations
      - Type of the procedure
      - consultation with autority
      - proposed timelines
    - - variations
      - MAA
      - Renewals
  - - - heathly claims
      - nutrition claims
      - composition
    - - Safety certificate
    - - MZE