Spain · Spanish Agency of Medicines and Medical Devices · Vaccines
Review target
-
Not published
Legal time limit
60 working days
regulation
Steps
4
3 requirements
Application fee
€4,238
2023 onward
Every finished batch of a vaccine or plasma-derived medicine needs the agency's prior approval before it can be sold in Spain. If another EU authority has already certified the batch, no new testing is done. Without testing, the batch counts as approved if the agency raises no issue within five days (two days for seasonal flu vaccine). With testing, the agency decides within 60 days (30 for seasonal flu vaccine). Each batch of a vaccine or a medicine derived from human plasma placed on the Spanish market.
The recognition of batch certificates and national release, more than 160 releases a year is €4,238 for 2023 onward.
1. Electronic batch release request; 2. Document review without testing (5 days); 3. Laboratory testing (if needed) (60 days); 4. Batch release.
Outcome: Batch release for the Spanish market.
Legal basis: Real Decreto Legislativo 1/2015, article 45.3; Real Decreto 1345/2007, articles 41 to 43
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 60 days end to end with the official step targets. 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
| Legal time limitregulation. Maximum time when lab testing is needed, 30 days for seasonal flu vaccine. Days are working days under the general rule. This is an official time limit, not an actual review time. | 60 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Recognition of batch certificates and national release, more than 160 releases a yearOther · 2023 onward | €4,238 |
| European or national batch release certificate (vaccine or plasma product)Other · 2023 onward | €1,336 |
| Recognition of a batch certificate and national release, lowest band (separate higher bands apply from 6 releases a year)Other · 2023 onward | €85 |
Other routes in Spain: National scientific and regulatory advice, National marketing authorization (full application), National authorization of a biosimilar, 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 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.