Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
120 days
regulation
Legal time limit
-
Not published
Steps
7
6 requirements
Application fee
€17,073
2023 onward
For a medicine not yet authorized in any EU member state, the applicant can ask Spain to lead an EU decentralized procedure. The applicant first books a slot with the agency. Spain then prepares the draft assessment report and product information within 120 days, the other states have 90 days to agree, and each state issues its national decision within 30 days. Spanish fees are 25 percent higher when Spain leads. Medicines intended for several EU member states that have no authorization in any of them and do not need the centralized procedure.
The official review target is 120 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The full dossier base fee; increased by 25 percent when spain is the reference member state is €17,073 for 2023 onward.
1. Book a slot with the agency (21 days); 2. Pre-submission meeting (optional); 3. Send the identical dossier to all states; 4. Draft assessment report by Spain (120 days); 5. Review by the concerned states (90 days); 6. Coordination group (if states disagree) (60 days); 7. National decisions (30 days).
Outcome: Agreement among the member states and national authorizations in each of them.
Legal basis: Real Decreto 1345/2007, articles 71, 73 and 74; Real Decreto Legislativo 1/2015, article 123
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 321 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionregulation. National decisions after the agreement. | 30 days |
| Review targetregulation. Draft assessment report and product information from Spain. This is an official time limit, not an actual review time. | 120 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Full dossier base fee; increased by 25 percent when Spain is the reference member stateApplication · 2023 onward | €17,073 |
| Abridged dossier base fee (generic, hybrid, biosimilar); increased by 25 percent when Spain is the reference member stateApplication · 2023 onward | €8,736 |
| Reservation of a slot for Spain as reference member stateOther · 2023 onward · The slot fee is deducted from the total paid when the application is filed. | €854 |
Other routes in Spain: National scientific and regulatory advice, National marketing authorization (full application), National authorization of a generic medicine, National hybrid application (known active substance with extra data), National authorization of a biosimilar, National authorization based on well-established use, Non-prescription (OTC) status and switches, Simplified registration of traditional herbal medicines, Mutual recognition procedure involving Spain, National authorization in exceptional circumstances, Compassionate use of investigational medicines, Access to medicines not authorized in Spain (foreign medicines), Use of authorized medicines outside their authorized conditions, Official batch release of vaccines and plasma-derived medicines, Authorization of a pharmaceutical manufacturer or importer. See all routes on the Spain page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (25 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.