Spain · Spanish Agency of Medicines and Medical Devices · Over-the-counter
Review target
-
Not published
Legal time limit
183 days
regulation
Steps
4
7 requirements
Application fee
€1,132
2023 onward
A simplified registration for herbal medicines meant for use without a doctor, for oral or external use or by inhalation, with at least 30 years of traditional use, 15 of them in the EU. Literature on traditional use and safety replaces clinical trials. The agency must decide within six months, and silence means refusal. Traditional herbal medicines that meet the conditions of use, route and tradition.
The authorization and registration, simplified dossier is €1,132 for 2023 onward.
1. Send the application; 2. Assessment (183 days); 3. EU herbal committee opinion (if needed); 4. Registration or refusal.
Outcome: Entry in the register of traditional herbal medicines, or refusal.
Legal basis: Real Decreto 1345/2007, articles 50 to 54
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 183 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
| Legal time limitregulation. About six months from a valid application. Without a decision the application is treated as refused. This is an official time limit, not an actual review time. | 183 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Authorization and registration, simplified dossierApplication · 2023 onward | €1,132 |
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 based on well-established use, Non-prescription (OTC) status and switches, 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), Use of authorized medicines outside their authorized conditions, Authorization of a pharmaceutical manufacturer or importer. 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.