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Commercialisation Resources

Market access for ATMPs

Marketing authorization pathway  

Standard approval process: centralized procedure 

Marketing Authorisation Application file

Expediting access pathways

Conditional MA

MA under exceptional circumstances   

Accelerated Assessment 

Biosimilars

EMA regulatory support schemes

PRIME 

Adaptive pathways  

    Distribution

    Good Distribution Practices

     

    Advertising

    This section is in development.

     

    Pharmacovigilance (medicines/ATMP)  

    Good Pharmacovigilance Practices

     

    Pricing & reimbursement

     

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