Spain, through the European Union route · European Medicines Agency · New drugs
Review target
60 days
regulation
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
-
Applications for new medicines must include results of an agreed paediatric investigation plan, or a waiver or deferral. The Paediatric Committee gives its opinion on a proposed plan within 60 days. Completing an agreed plan can earn a six-month extension of the supplementary protection certificate, or two extra years of market exclusivity for orphan medicines. Early in development, usually no later than the end of human pharmacokinetic studies in adults.
The official review target is 60 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Submit plan or waiver request; 2. Paediatric Committee opinion (60 days); 3. Agency decision; 4. Results in the marketing authorisation application.
Outcome: An agency decision agreeing the plan, a waiver or a deferral. Rewards follow when the results are included in the authorisation.
Legal basis: Regulation (EC) No 1901/2006
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 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
| Review targetregulation. Time limit for the Paediatric Committee opinion on a valid plan. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 60 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), Orphan designation, 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.