Spain · Spanish Agency of Medicines and Medical Devices · Generics
Generic applicationHigh confidenceLast verified October 3, 2026
Review target
-
Not published
Legal time limit
210 days
regulation
Steps
9
13 requirements
Application fee
€8,736
2023 onward
What is the National authorization of a generic medicine in Spain?
A generic can rely on the reference medicine's preclinical and clinical data once the reference has been authorized for at least eight years in the EU. It can be marketed only ten years after the reference was first authorized, or eleven years if a significant new indication was added. The national procedure and its 210-day limit apply. A generic of a reference medicine that is or was authorized in Spain or the EU on a full dossier, for the Spanish market only.
How much does the National authorization of a generic medicine cost?
The authorization and registration, abridged dossier (generic) is €8,736 for 2023 onward.
What are the steps of the National authorization of a generic medicine?
1. Send the application and fee; 2. Admission check (10 days); 3. Correct defects (if asked) (10 days); 4. Assessment (210 days); 5. Answer questions (clock stop) (91 days); 6. Committee opinion (optional); 7. Hearing on a negative assessment (if any) (15 days); 8. Decision and entry in the register; 9. Post-authorization duties.
Outcome: A national authorization. The product name is followed by the letters EFG. Valid for 5 years.
Legal basis: Real Decreto 1345/2007, article 7; Real Decreto Legislativo 1/2015
How the pathway works
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 311 days end to end with the official step targets, of which up to 116 days are clock stops (time the applicant uses to answer). Targets, not actual times.
Approvals per year, generic application in Spain
From the official approvals data of this market, all products of this pathway type and segment
Steps
In order, with the official target for each step
1. Send the application and feeApplication to the agency on its form, with proof of fee payment.
2. Admission check10 daysThe agency checks within 10 calendar days that the application is complete and tells the applicant the procedure and deadline.
3. Correct defects (if asked)10 days, clock stopped, only in some casesIf the file is incomplete, the applicant has 10 calendar days to correct it, or the file is closed.
4. Assessment210 daysThe agency assesses quality and bioequivalence with the reference medicine. The decision must be notified within 210 calendar days of a valid application.
5. Answer questions (clock stop)91 days, clock stopped, only in some casesThe agency can ask for more data. The applicant has three months, in exceptional cases six. The 210-day clock stops meanwhile.
6. Committee opinion (optional)only in some casesThe agency may ask its human medicines committee for an opinion. The opinion is not binding.
7. Hearing on a negative assessment (if any)15 working days, clock stopped, only in some casesIf the assessment is unfavorable, the applicant has 15 working days to respond.
8. Decision and entry in the registerA reasoned resolution. The authorization includes the conditions, the product information, the labeling and the leaflet.
9. Post-authorization dutiesMarketing notices, annual declarations, safety reporting and renewal.
Requirements
What the applicant must provide or meet
Clinical data
BioequivalenceBioavailability studies, unless the applicant shows that the generic meets the criteria in the relevant guidelines for an exemption.
Reference approval
Reference medicineIf the reference is not authorized in Spain, the applicant names the member state where it is or was authorized. The agency asks that state for confirmation within one month.
Quality and manufacturing
Same active substanceDifferent salts, esters or other derivatives count as the same active substance unless their safety or efficacy differs a lot, in which case extra data are needed.
Labeling
Name and EFG lettersThe name uses the Spanish official name of the active substance, or a brand that cannot be confused with it, followed by EFG.
Labeling and leaflet in SpanishLabel and leaflet texts are filed at least in Spanish. Other languages may be added if they carry the same information.
Local presence
Official time targets
Targets, not actual review times
Validationregulation. Admission check of the application.
10 days
Longest clock stopregulation. Three months to answer questions, which can be extended to six months in exceptional cases.
183 days
Legal time limitregulation. Maximum time to notify the decision, counted from the day after a valid application. Clock stops for questions are not counted. This is an official time limit, not an actual review time.
210 days
Fees
Official amounts in the local currency
Fee
Amount
Authorization and registration, abridged dossier (generic)Application · 2023 onward
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 (34 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
National authorization of a generic medicine in Spain: Steps, Timeline and Fees | DataPorium
Applicant established in the EU
The applicant must be established in the European Union. It may name a legal representative for the procedure.
Pharmacovigilance contact person in SpainThe authorization holder keeps a permanent pharmacovigilance contact person in Spain and gives the agency the contact details.
Language
Documents in SpanishThe documentation is filed at least in Spanish. The agency may accept some scientific parts in another language.
Other
Dossier format: Common Technical DocumentThe file follows the Common Technical Document with five modules.
After approval
Adverse reaction reportingSerious suspected adverse reactions are sent to the EU database within 15 calendar days. Non-serious ones from the EU within 90 calendar days.
Marketing noticesThe holder tells the agency the date of first marketing at least 15 days before, and makes a yearly declaration in October about continued marketing.
Sunset ruleThe authorization lapses if the product is not actually marketed within three years, or is off the market for three years in a row, unless health reasons justify keeping it.
Renewal after five yearsThe authorization is valid for five years. The renewal file is sent at least nine months before expiry. After renewal it is normally valid without limit.
