Spain, through the European Union route · National competent authorities of the EU member states · New drugs
Review target
-
Not published
Legal time limit
210 days
law
Steps
2
7 requirements
Application fee
-
A medicine outside the mandatory centralised scope can be authorised in a single EU country by its national agency. EU law sets a maximum of 210 days after a valid application. If the same medicine is under review or authorised in another EU country, the decentralised or mutual recognition procedure must be used instead. National fees and details are set by each country. Medicines for one EU country only, outside the mandatory centralised scope.
1. Application to the national agency; 2. National assessment and decision (210 days).
Outcome: A national marketing authorisation valid in that country. It is valid for five years and can then be renewed. Valid for 5 years.
Legal basis: Directive 2001/83/EC, Articles 6, 8 and 17
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 210 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 limitlaw. Maximum time for a national procedure under EU law, after a valid application. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Spain: Centralised marketing authorisation, new active substance, Centralised marketing authorisation, known active substance or new fixed combination, Centralised generic application, Centralised hybrid application, Centralised well-established use application, Accelerated assessment, Conditional marketing authorisation, Authorisation under exceptional circumstances, PRIME (priority medicines), Orphan designation, Paediatric investigation plan, Integral drug-device combination authorised as a medicine, Decentralised procedure. 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.