Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
90 days
regulation
Legal time limit
-
Not published
Steps
5
4 requirements
Application fee
€854
2023 onward
When a medicine is already authorized in one EU member state, other states recognize that authorization. If Spain holds the first authorization and acts as reference state, the agency prepares or updates its assessment report within 90 days. If another state leads, Spain is a concerned state and has 90 days to agree. National decisions follow within 30 days. A medicine authorized in Spain that the holder wants in other member states, or a medicine authorized in another member state that the holder wants in Spain.
The official review target is 90 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The reservation of a slot for spain as reference member state is €854 for 2023 onward.
1. Update the dossier (Spain as reference); 2. Ask the reference state to start; 3. Assessment report by the reference state (90 days); 4. Review by the concerned states (90 days); 5. National decisions (30 days).
Yes. It relies on approvals from European Union (recognition).
Outcome: National authorizations that match the reference state's assessment.
Legal basis: Real Decreto 1345/2007, articles 71, 72 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 210 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. Assessment report from the reference state. This is an official time limit, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Reservation of a slot for Spain as reference member stateOther · 2023 onward · Deducted from the total paid when the procedure 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, Decentralized procedure with Spain as reference member state, 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.