Spain, through the European Union route · National competent authorities of the EU member states · New drugs
Review target
210 days
law
Legal time limit
-
Not published
Steps
8
8 requirements
Application fee
-
Used to get the same national marketing authorisation in several EU countries at once for a medicine not yet authorised in any of them. One reference member state leads the assessment and the other countries comment and approve. The procedure lasts up to 210 days plus clock stop, followed by 30 days for national decisions. Medicines outside the mandatory centralised scope, not yet authorised in any EU country, for which the applicant wants authorisations in two or more countries. Most generics and non-prescription medicines use national, decentralised or mutual recognition routes.
The official review target is 210 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Submission to the reference and concerned member states; 2. Preliminary assessment report (day 70) (70 days); 3. Comments and list of questions (day 105) (35 days); 4. Clock stop: applicant answers; 5. Draft assessment report (day 120) (15 days); 6. Assessment step II (day 120 to day 210) (90 days); 7. Coordination group referral (if no agreement) (60 days); 8. National decisions (30 days).
Outcome: Separate national marketing authorisations with harmonised product information in each country concerned.
Legal basis: Directive 2001/83/EC, Articles 28 and 29
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 483 days end to end with the official step targets, of which up to 183 days are clock stops (time the applicant uses to answer). 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
| Decisionlaw. Time for national decisions after agreement. | 30 days |
| Longest clock stopofficial guidance. About 3 months, which can be extended by a further 3 months (about 6 months in total). | 183 days |
| Review targetlaw. Days from the start of the procedure to closure, excluding the clock stop: 120 days for the draft report plus 90 days for approval by the other countries. 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, Mutual recognition procedure, National procedure under EU rules, Non-prescription status and switch (EU rules). See all routes on the Spain page or explore them in the Regulatory section.
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 (27 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.