BfArM - Federal Institute for Drugs and Medical Devices

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If the BfArM's Fee Ordinance is not applicable for new variations on purely national licences, how can I calculate the relevant fees or rather how will the invoices be prepared?

For processing purely national variations there will first be a conditional fee, i.e. the BfArM explicitly reserves the right to request fees after an amendment of the AMG Fees Ordinance. The exact amount of the fees will be determined by the legislator. It will be adapted to personnel and material expenditures and will therefore probably be somewhere between the costs for variations with Germany as RMS and those for variations with Germany as CMS. The invoices will be circulated after the amended AMG Fees Ordinance has come into force.