Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
4
4 requirements
Application fee
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The agency can exceptionally allow the import and use of a medicine that is legally marketed in another country but not authorized in Spain, or authorized but not marketed. There must be no medicine with the same composition in Spain and no suitable authorized alternative. Access is per patient, or through a use protocol for a group. A patient needs a medicine marketed abroad and there is no suitable authorized alternative in Spain, or there is a shortage of the Spanish product.
1. Request via the regional health service or hospital; 2. Correct defects (if asked) (10 days); 3. Individual access and import authorization; 4. Use protocol for a patient group (alternative).
Outcome: Individual access or a use protocol, and an import authorization.
Legal basis: Real Decreto Legislativo 1/2015, article 24.4; Real Decreto 1015/2009, chapter 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 10 days end to end with the official step targets, of which up to 10 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, Compassionate use of investigational 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.