Spain, through the European Union route · European Medicines Agency · New drugs
Review target
210 days
regulation
Legal time limit
-
Not published
Steps
4
2 requirements
Application fee
-
The EU can authorise a medicine when comprehensive data on efficacy and safety can never be collected, for example because the disease is very rare. The authorisation carries conditions that are reassessed every year. It normally does not become a standard authorisation. When the applicant cannot provide comprehensive efficacy and safety data under normal conditions of use, for objective and verifiable reasons.
The official review target is 210 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Centralised application without comprehensive data; 2. Assessment and opinion (210 days); 3. Commission decision with conditions (67 days); 4. Annual reassessment.
Outcome: An authorisation with specific conditions, linked to an annual reassessment.
Legal basis: Regulation (EC) No 726/2004, Article 14(8); Directive 2001/83/EC, Annex I
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 277 days end to end with the official step targets. 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
| Review targetregulation. Standard centralised time limit for the committee opinion. 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 authorisation of advanced therapy medicinal products, Centralised marketing authorisation, known active substance or new fixed combination, Centralised hybrid application, Centralised biosimilar application, Centralised well-established use application, Accelerated assessment, Conditional marketing authorisation, 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.