Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
210 days
regulation
Steps
9
11 requirements
Application fee
€17,073
2023 onward
If the active substance has had a well-established medical use in the EU for at least ten years, with recognized efficacy and acceptable safety, published scientific literature can replace the applicant's own preclinical and clinical studies. The national procedure and its 210-day limit apply. An active substance with at least ten years of well-established medical use in the EU. Not for generics, hybrids or biosimilars.
The authorization and registration, full dossier (bibliographic) is €17,073 for 2023 onward.
1. Send the application and fee; 2. Admission check (10 days); 3. Correct defects (if asked) (10 days); 4. Assessment (210 days); 5. Answer questions (clock stop) (91 days); 6. Committee opinion (optional); 7. Hearing on a negative assessment (if any) (15 days); 8. Decision and entry in the register; 9. Post-authorization duties.
Outcome: A national authorization, or a reasoned refusal. Valid for 5 years.
Legal basis: Real Decreto 1345/2007, article 10
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 311 days end to end with the official step targets, of which up to 116 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| Validationregulation. Admission check of the application. | 10 days |
| Longest clock stopregulation. Three months to answer questions, which can be extended to six months in exceptional cases. | 183 days |
| Legal time limitregulation. Maximum time to notify the decision, counted from the day after a valid application. Clock stops for questions are not counted. This is an official time limit, not an actual review time. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Authorization and registration, full dossier (bibliographic)Application · 2023 onward | €17,073 |
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), 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, Authorization of a pharmaceutical manufacturer or importer. 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 (32 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet