How to Pay Fees and Charges Levied by EMA: Guidance to Marketing Authorization Holders and Applicants

The European Medicines Agency (EMA) has released detailed guidance for marketing authorization holders and applicants regarding the payment of fees and charges.

Key Points of the Guidance:

• Customer Account Numbers:
  • Each customer is assigned a unique account number.
  • Numbers starting with 5 are for Parallel Distributors, while those starting with 6 are for other entities.
• Invoices:
  • Invoices are sent in PDF format via email or can be downloaded from the EMA Invoicing Portal.
  • Invoice numbers are generated based on the fee type.
• Payment Process:
  • Payments should be made only after receiving the invoice.
  • The payment deadline is 30 calendar days from the invoice date.
  • A pre-reminder is sent 10 days before the due date to ensure timely payment.
• Credit Balances and Refunds:
  • Discrepancies or questions about invoices should be raised through the EMA Invoicing Portal.
  • Corrections will be either refunded or offset against future invoices.
• Contact Information:
  • For queries not addressed in the guidance, the EMA’s accounting team can be reached at accountsreceivable@ema.europa.eu.

This guidance aims to streamline the invoicing and payment process, ensuring clarity and efficiency for all stakeholders.”

Region: EU Harmonized (27 Markets)

Source: https://www.ema.europa.eu/en/documents/other/how-pay-fees-charges-levied-ema-guidance-marketing-authorisation-holders-applicants_en.pdf