Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
In exceptional cases the agency can authorize a medicine whose preclinical or clinical data are incomplete, when the applicant shows objective and verifiable reasons. Examples are a very rare indication, the current state of science, or medical ethics. The authorization carries conditions and is reviewed every year. When complete efficacy and safety data cannot be supplied because the indication is very rare, science does not allow it, or ethics forbid collecting the data.
1. Application with justification; 2. Assessment under the national procedure; 3. Authorization with conditions; 4. Annual review.
Outcome: An authorization with specific obligations, reviewed annually.
Legal basis: Real Decreto Legislativo 1/2015, article 24.1; Real Decreto 1345/2007, article 26
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).
Official step durations
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, Compassionate use of investigational medicines, 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.