Agencies

This page provides an overview of European agencies. Weblinks to the authority homepages, information about implementation of EC 1234/2008, annual fees, payment requirements and links to fee source documents are listed.

All information is subject to change. We reserve the right not to be responsible for the topicality, correctness, completeness or quality of the information provided.

Country Agency Implementation 1234 Feedocs Payment Annual Fee Comment
Austria AGES invoice 1.528,00 EUR
annual fee if AT is RMS: 2,953 EUR; if CMS: 1,528 EUR; for national: 1,272 EUR
Belgium FAMHP advance - 0,00 EUR
Bulgaria BDA advance 250,00 BGN
Annual fee for each Marketing Authorisation: 250,00 BGN. Annualf fee for each Registration Certificate: 100,00 BGN
Cyprus MOH advance - 0,00 EUR
Czech Republic SUKL advance 19.500,00 CZK
If CZ is RMS: 39.100,00 CZK. For micro companies: 5.000,00 CZK; 19.500 CZK in all other cases
Denmark DHMA invoice 13.575,00 DKK
Estonia SAM admin advance / assessment as invoice - 0,00 EUR
Finland FIMEA invoice 1.400,00 EUR
France ANSM advance - 0,00 EUR
Germany BfArM invoice - 0,00 EUR
Greece EOF advance - 0,00 EUR
Hungary OGYI advance 270.000,00 HUF
Iceland IMCA invoice 30.000,00 ISK
Annual fee for each marketing authorisation number; if RMS: 33.000,00 ISK
Ireland HPRA advance 812,00 EUR
First 10 Marketing Authorisations: 650,00 EUR annual fee
Italy AIFA upon submission 1.091,00 EUR
818,00€ reduced fee for micro, small and medium sized companies and for public companies
Latvia ZVA advance 498,01 EUR
Liechtenstein LLV advance - 0,00 EUR
Lithuania VVKT advance - 0,00 EUR
Luxembourg MS upon submission 100,00 EUR
Please note, the payment form is the case for specific application only – for variations no payment is made in advance
Malta MA advance 800,00 EUR
Applies for Malta being RMS. 250,00 EUR for other MA.
Netherlands CBG-MEB invoice 1.120,00 EUR
With the exception of MA where NL is RMS. If NL is RMS: 1.420,00 EUR.
Norway NoMA invoice - 0,00 NOK
Poland URPL advance - 0,00 PLN
Annual fee: No fee is charged before first renewal; from the date of first renewal 1/5 of the renewal fee per year has to be paid.
Portugal INFARMED advance - 0,00 EUR
Romania ANM advance - 0,00 EUR
filled-in payment form in advance, payment invoice
Slovakia SIDC advance - 0,00 EUR
Slovenia JAZMP advance 80,00 EUR
Spain AEMPS advance 377,44 EUR
Sweden MPA invoice 51.000,00 SEK
additional strength or pharmaceutical form: 25.000,00 SEK
United Kingdom MHRA invoice 9.710,00 GBP
For new active substance. Other derivatives: 6.554,00 GBP
European Economic Area EMA invoice 100.000,00 EUR
101,200 EUR for each MA of a medicinal product.; biosimilar: 50,600 EUR. abridged: 25,200 EUR; all: covering all presentations of one product
Croatia HALMED advance 3.000,00 HRK