Spain · Spanish Agency of Medicines and Medical Devices · Biosimilars
Review target
-
Not published
Legal time limit
210 days
regulation
Steps
9
11 requirements
Application fee
€8,736
2023 onward
A biological medicine similar to a reference biological cannot use the generic route because of differences in raw materials or manufacturing. The applicant supplies suitable preclinical and clinical data in the Common Technical Document format, following EU biosimilar guidelines. The national procedure and its 210-day limit apply when the EU centralized procedure is not required. A biosimilar for the Spanish market only, where the centralized procedure is not mandatory.
The authorization and registration, abridged dossier (biosimilar) is €8,736 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 9
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.
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
| 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, abridged dossier (biosimilar)Application · 2023 onward | €8,736 |
Other routes in Spain: National scientific and regulatory advice, National marketing authorization (full application), 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, Official batch release of vaccines and plasma-derived medicines, Authorization of a pharmaceutical manufacturer or importer. 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 (32 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.