Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
6 requirements
Application fee
-
Patients with a chronic, seriously debilitating or life-threatening disease who cannot be treated well with authorized medicines can receive a medicine that is in clinical trials or under a marketing application. A hospital asks the agency for individual access, or the agency issues a temporary authorization of use that covers a group of patients. A patient outside a clinical trial who has no satisfactory authorized alternative, when the company agrees to supply the investigational medicine.
1. Hospital request; 2. Correct defects (if asked) (10 days); 3. Arguments before a refusal (if any) (10 days); 4. Individual authorization; 5. Temporary authorization of use (group route).
Outcome: An individual access authorization, or a temporary authorization of use that sets conditions for a group of patients.
Legal basis: Real Decreto Legislativo 1/2015, article 24.3; Real Decreto 1015/2009, chapter II
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 10 days end to end with the official step targets, of which up to 20 days are clock stops (time the applicant uses to answer). 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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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, Mutual recognition procedure involving Spain, National authorization in exceptional circumstances, Access to medicines not authorized in Spain (foreign medicines), Use of authorized medicines outside their authorized conditions. See all routes on the or explore them in the .
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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.