Know your submission fees before you commit
Set your procedure, markets and product details. Get a country-by-country breakdown with sources and payment guidance, then refine it for free.
Route, markets and product.
- 6Process typesFrom new MAA and extension to MAH transfer
- 4Procedure routesNational, DCP, MRP, centralised
- 30EU and EEA marketsThe EU 27, Iceland, Liechtenstein and Norway, plus EMA
Different rules in. One clear estimate out.
Base fees, extra strengths, local currencies, payment terms. Each agency adds another set of details to reconcile. Regunaut brings them together around the submission you’re planning.
Compare the fees. Understand the rules. Know how to pay.
Six steps to a fee estimate
Each step asks only what the fee depends on.
- 01
Choose the process
It decides which questions come next.
New MAAExtensionVariationRenewalAnnual feeMAH transfer - 02
Pick the route and markets
The procedure, then its countries from 30 EU and EEA markets.
- National
- One or more markets
- DCP / MRP
- RMS and CMS
- Centralised
- EMA
- 03
Add the dossier details
Only what your markets price by.
- Legal basis
- GenericHybridBiosimilarFull dossier+6 more
- Product
- ClassSME statusSubstancesForms and strengths
- Variations
- Type IA / IBType IIMAs covered
- 04
Review, then calculate
Every answer on one screen before you run it.
- Flags any missing input
- Jump back to change any step
- 05
Read the result
A total in EUR, then each market on its own.
- Local currency and EUR
- Fee codes and sources
- Payment steps
- 06
Answer what was assumed
See what another answer would change.
- Change per answer
- Free repricing
- Rule changes flagged
More than a number at the bottom.
Start with the total. Follow it through to the calculation and the payment details your team needs next.
RMS
CMS
The detail stays connected to the estimate.
We maintain the fee schedules for every market. Each fee line cites the fee law it comes from, and a saved calculation is flagged when the rules behind it change.
Agency schedules
Fees, pricing rules and payment instructions.
Your submission
Procedure, markets, legal basis and product.
A reviewable result
Totals, fee lines, sources and assumptions.
What decides the fee for a pharmaceutical submission
The calculator covers 30 EU and EEA markets and EMA, six process types and four procedure routes. These are the rules it applies.
Fees follow the procedure
A national application is priced by one agency. In the decentralised and mutual recognition procedures the reference member state charges an assessment fee and every concerned member state charges its own, so the total is the sum of the markets you pick. Centralised applications are priced by EMA instead of per market.
The process type sets the schedule
Each agency keeps separate fee lines for a new marketing authorisation, a line extension, a variation, a renewal, an annual maintenance fee and a transfer of the marketing authorisation. Picking the process first is what narrows the calculator to the questions that change the amount.
Legal basis changes the amount
A generic application under Article 10(1) of Directive 2001/83/EC is usually priced below a full dossier under Article 8(3), and some agencies charge more for a new active substance than for a known one. Hybrid, biosimilar, fixed combination, well-established use, herbal and homeopathic applications have their own lines in many schedules.
Forms and strengths multiply it
Most national schedules charge a base fee for the first pharmaceutical form or strength and a supplement for each additional one. Germany, for example, charges 33,100 EUR for the first strength of a generic as DCP reference state and 15,000 EUR for each further one, while Ireland covers further strengths with the first-strength fee.
Each market has conditions of its own
EMA, Czechia, Hungary, Italy and Malta reduce fees for SMEs. Germany adds 7,100 EUR to a DCP reference state fee when the Umweltbundesamt assesses environmental risk. The calculator shows what it assumed and what another answer would change.
Variations are priced per change and per market
Type IA, Type IB and Type II variations carry different fees, and grouped variations or worksharing procedures are priced on their own terms. For a product authorised in many markets, one Type II change means one fee per market, so the count of marketing authorisations matters as much as the variation type.
Currencies and payment terms differ
Fees are set in local currency in Poland, Denmark, Sweden, Czechia, Hungary and others, and in euro elsewhere. Agencies also differ on when payment is due, which reference to quote and what proof of payment they expect with the submission. The calculator shows amounts in local currency and euro and keeps each agency's payment instructions with its line.
Fee schedules change, often at the start of a calendar year. Regunaut maintains them and flags a saved calculation when its rules change. Alerts flags fee changes from the agencies you watch. For the procedures themselves, see the glossary entries on the decentralised procedure and the mutual recognition procedure.
Filing beyond the EU and EEA?
Tell us which markets to price next.
Related on Regunaut
- Fee estimates feed straight into regulatory lifecycle planning for renewals and variations.
- Pricing a multi-country filing starts with the procedure: the decentralised procedure (DCP) is the usual route for a new generic in several markets at once.
- Extending an existing national authorisation to new markets runs through the mutual recognition procedure (MRP).
- Choosing markets first? Market expansion research compares routes and coverage before you price them.
Price your next submission
Choose your procedure and markets to see the country-by-country breakdown.