Spain, through the European Union route · European Medicines Agency · New drugs
Review target
210 days
regulation
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
-
The EU can authorise a medicine for a seriously debilitating or life-threatening disease before comprehensive clinical data are available, if the benefit of immediate availability outweighs the risk. The holder must complete studies to confirm the benefit. The authorisation lasts one year and is renewed each year. Medicines for seriously debilitating or life-threatening diseases, medicines for public health emergencies, and designated orphan medicines, when they meet an unmet medical need.
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 with less complete clinical data; 2. Assessment and opinion (210 days); 3. Commission decision with specific obligations (67 days); 4. Annual review and renewal; 5. Conversion to a standard authorisation.
Outcome: A one-year renewable authorisation with specific obligations. It can become a standard authorisation once the obligations are met. Valid for 1 years.
Legal basis: Regulation (EC) No 726/2004, Article 14-a; Regulation (EC) No 507/2006
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, 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.