Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
90 days
official guidance
Legal time limit
-
Not published
Steps
6
2 requirements
Application fee
€6,739
2023 onward
The agency gives non-binding advice on the development of a medicine, on regulatory, quality, preclinical, clinical or pharmacovigilance questions. After a 10-day validation, a written report comes within 90 calendar days, or the advice is given in a meeting. Fees depend on whether the advice covers one question, several questions, a generic, or a follow-up. Before a national, decentralized, mutual recognition or centralized application, when no reference state or rapporteur has been named yet.
The official review target is 90 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The complex national advice (several questions) is €6,739 for 2023 onward.
1. Request with questions; 2. Validation and acceptance (10 days); 3. Send briefing documents and fee proof (30 days); 4. Written advice (90 days); 5. Advice meeting (alternative); 6. Minutes and final report (15 days).
Outcome: A final advice report. It does not bind later decisions.
Legal basis: Real Decreto Legislativo 1/2015, article 123 (fee group IV)
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 130 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. Written advice, from validation of the request. This is an official time limit, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Complex national advice (several questions)Scientific advice · 2023 onward | €6,739 |
| National advice for generic medicinesScientific advice · 2023 onward | €3,369 |
| Follow-up advice in the same yearScientific advice · 2023 onward | €2,022 |
| Simple national advice (one specific question)Scientific advice · 2023 onward · Advice not intended for profit-making activities is exempt. | €1,348 |
Other routes in Spain: 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, 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, Hospital exemption for advanced therapy medicines, Official batch release of vaccines and plasma-derived medicines. 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.