Luxembourg
Since January 2025, the payment system for variation fees in Luxembourg has changed.
In the past, variation fees were paid bi-annual and based on the number of products and variations included in the submission.
As from January 2025, variations need to be paid in advance, and the proof of payment needs to be included in the initial eCTD sequence of the variation (12form/lu).
In the transaction’s description, the name of the product as well as the procedure number must be clearly indicated.
The amount of fee that needs to be paid has changed to 1 fee per submitted dossier (even if more than one medicine, strength, or pharmaceutical form are concerned, or if more than one variation is included in one same dossier).
Please note that for 2025 a transition period is foreseen: if required, variation fees can still be paid twice a year or annually during 2025.
For more information, please see: FEES FOR MARKETING AUTHORIZATION APPLICATIONS IN LUXEMBOURG
Source: Procédures au Luxembourg – Portail Santé – Luxembourg