Spain, through the European Union route · European Medicines Agency · New drugs
Review target
90 days
regulation
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
-
A sponsor can ask for orphan designation for a medicine for a life-threatening or chronically debilitating condition that affects no more than 5 in 10,000 people in the EU, or where sales are unlikely to cover the investment. The Committee for Orphan Medicinal Products gives an opinion within 90 days, and the Commission decides within 30 days. Incentives include protocol assistance, fee reductions and ten years of market exclusivity. During development, before the marketing authorisation application.
The official review target is 90 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Application for designation; 2. Orphan committee opinion (90 days); 3. Commission decision (30 days); 4. Annual development report.
Outcome: Entry in the EU register of orphan medicinal products. Designated orphan medicines must use the centralised procedure for authorisation.
Legal basis: Regulation (EC) No 141/2000
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 120 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
| Decisionregulation. Time limit for the Commission decision after the opinion. | 30 days |
| Review targetregulation. Time limit for the orphan committee opinion. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 90 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, Authorisation under exceptional circumstances, PRIME (priority medicines), 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.