Spain · Spanish Agency of Medicines and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
90 working days
regulation
Steps
5
3 requirements
Application fee
€9,418
2023 onward
Companies that make medicines in Spain, including for export only, and importers that test medicines from outside the EU need the agency's prior authorization. The agency checks the file, inspects the site and must notify its decision within 90 days of receiving the application. Manufacturing, packaging or importing and testing medicines or investigational medicines in Spain.
The authorization to open a pharmaceutical laboratory is €9,418 for 2023 onward.
1. Electronic application; 2. Admission check (10 days); 3. Extra information (if asked) (30 days); 4. Site inspection; 5. Decision (90 days).
Outcome: An authorization that lists the sites, activities, dosage forms and technical directors.
Legal basis: Real Decreto 824/2010, articles 5 to 10
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 100 days end to end with the official step targets, of which up to 30 days are clock stops (time the applicant uses to answer). 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
| Legal time limitregulation. Counted from receipt of the application. Working days under the general rule. This is an official time limit, not an actual review time. | 90 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Authorization to open a pharmaceutical laboratoryEstablishment · 2023 onward | €9,418 |
Other routes in Spain: National scientific and regulatory advice, National marketing authorization (full application), National authorization of a generic medicine, National hybrid application (known active substance with extra data), National authorization of a biosimilar, National authorization based on well-established use, Non-prescription (OTC) status and switches, Simplified registration of traditional herbal medicines, Decentralized procedure with Spain as reference member state, Mutual recognition procedure involving Spain, National authorization in exceptional circumstances, Compassionate use of investigational medicines, Access to medicines not authorized in Spain (foreign medicines). 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.