How medicines and medical devices get approved in Spain

One application to the European Medicines Agency leads to one marketing authorisation valid in every EU country. The agency's committee for human medicines gives an opinion within 210 active days. The European Commission then takes the binding decision.

Full application, new active substance · target 210 days · verified October 3, 2026

A full application through the European Medicines Agency for a product whose active substance is already known in the EU. New fixed combinations of known substances also use this type of application, with new data on the combination. The review steps and the 210-day opinion limit are the same as for new active substances.

Full or mixed application, known active substance · target 210 days · verified October 3, 2026

An application based mainly on published scientific literature for an active substance with at least ten years of well-established medicinal use in the EU. When it goes through the European Medicines Agency, the standard centralised steps and the 210-day opinion limit apply.

Well-established use · target 210 days · verified October 3, 2026

For medicines of major public health interest, in particular therapeutic innovation, the committee for human medicines can shorten its review from 210 to 150 days. The applicant asks for it before submitting the application.

Priority or accelerated review · target 150 days · verified October 3, 2026

The EU can authorise a medicine for a seriously debilitating or life-threatening disease before comprehensive clinical data are available, if the benefit of immediate availability outweighs the risk. The holder must complete studies to confirm the benefit. The authorisation lasts one year and is renewed each year.

Conditional or accelerated approval · target 210 days · verified October 3, 2026

The EU can authorise a medicine when comprehensive data on efficacy and safety can never be collected, for example because the disease is very rare. The authorisation carries conditions that are reassessed every year. It normally does not become a standard authorisation.

Approval under exceptional circumstances · target 210 days · verified October 3, 2026

PRIME is a European Medicines Agency scheme that gives early and enhanced support to developers of medicines that target an unmet medical need. Support includes early appointment of a rapporteur, iterative scientific advice and a submission readiness meeting. Products in PRIME can expect to be eligible for accelerated assessment.

Intensive development support designation · verified October 3, 2026

A sponsor can ask for orphan designation for a medicine for a life-threatening or chronically debilitating condition that affects no more than 5 in 10,000 people in the EU, or where sales are unlikely to cover the investment. The Committee for Orphan Medicinal Products gives an opinion within 90 days, and the Commission decides within 30 days. Incentives include protocol assistance, fee reductions and ten years of market exclusivity.

Orphan or rare disease designation · target 90 days · verified October 3, 2026

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.

Pediatric plan or incentive · target 60 days · verified October 3, 2026

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.

Work-sharing or joint review · target 210 days · verified October 3, 2026

Used when a medicine already has a national marketing authorisation in one EU country and the holder wants it in other countries. The other countries recognise the existing authorisation based on the reference country's assessment report. Approval takes up to 90 days, then 30 days for national decisions.

Reliance route, recognition or verification · target 90 days · verified October 3, 2026

A medicine outside the mandatory centralised scope can be authorised in a single EU country by its national agency. EU law sets a maximum of 210 days after a valid application. If the same medicine is under review or authorised in another EU country, the decentralised or mutual recognition procedure must be used instead. National fees and details are set by each country.

Other route · verified October 3, 2026

The agency gives non-binding advice on the development of a medicine, on regulatory, quality, preclinical, clinical or pharmacovigilance questions. After a 10-day validation, a written report comes within 90 calendar days, or the advice is given in a meeting. Fees depend on whether the advice covers one question, several questions, a generic, or a follow-up.

Other route · target 90 days · verified October 3, 2026

The national route for a medicine that will be sold only in Spain. The Spanish medicines agency (AEMPS) checks the file, assesses quality, safety and efficacy, and must notify its decision within 210 calendar days of a valid application, not counting time the applicant takes to answer questions.

Full application, new active substance · verified October 3, 2026

For a product close to a reference medicine that does not meet the generic definition. Examples are a change in strength, dosage form, route or indication, or when bioequivalence cannot be shown with bioavailability studies. The applicant adds suitable preclinical or clinical data. The national procedure and its 210-day limit apply.

Full or mixed application, known active substance · verified October 3, 2026

If the active substance has had a well-established medical use in the EU for at least ten years, with recognized efficacy and acceptable safety, published scientific literature can replace the applicant's own preclinical and clinical studies. The national procedure and its 210-day limit apply.

Well-established use · verified October 3, 2026

For a medicine not yet authorized in any EU member state, the applicant can ask Spain to lead an EU decentralized procedure. The applicant first books a slot with the agency. Spain then prepares the draft assessment report and product information within 120 days, the other states have 90 days to agree, and each state issues its national decision within 30 days. Spanish fees are 25 percent higher when Spain leads.

Work-sharing or joint review · target 120 days · verified October 3, 2026

When a medicine is already authorized in one EU member state, other states recognize that authorization. If Spain holds the first authorization and acts as reference state, the agency prepares or updates its assessment report within 90 days. If another state leads, Spain is a concerned state and has 90 days to agree. National decisions follow within 30 days.

Reliance route, recognition or verification · target 90 days · relies on EU · verified October 3, 2026

In exceptional cases the agency can authorize a medicine whose preclinical or clinical data are incomplete, when the applicant shows objective and verifiable reasons. Examples are a very rare indication, the current state of science, or medical ethics. The authorization carries conditions and is reviewed every year.

Approval under exceptional circumstances · verified October 3, 2026

Patients with a chronic, seriously debilitating or life-threatening disease who cannot be treated well with authorized medicines can receive a medicine that is in clinical trials or under a marketing application. A hospital asks the agency for individual access, or the agency issues a temporary authorization of use that covers a group of patients.

Early or compassionate access · verified October 3, 2026

The agency can exceptionally allow the import and use of a medicine that is legally marketed in another country but not authorized in Spain, or authorized but not marketed. There must be no medicine with the same composition in Spain and no suitable authorized alternative. Access is per patient, or through a use protocol for a group.

Early or compassionate access · verified October 3, 2026

Using an authorized medicine outside the conditions in its product information is exceptional. It is limited to patients without authorized alternatives. The doctor must justify the use in the clinical record and inform the patient. The agency can issue use recommendations.

Other route · verified October 3, 2026

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.

Other route · verified October 3, 2026

A biosimilar is a biological medicine highly similar to a reference biological medicine already approved in the EU. The applicant shows similarity through comparability studies and adds the non-clinical and clinical data needed for the differences. The European Medicines Agency reviews it under the same 210-day opinion limit.

Biosimilar application · target 210 days · verified October 3, 2026

A biological medicine similar to a reference biological cannot use the generic route because of differences in raw materials or manufacturing. The applicant supplies suitable preclinical and clinical data in the Common Technical Document format, following EU biosimilar guidelines. The national procedure and its 210-day limit apply when the EU centralized procedure is not required.

Biosimilar application · verified October 3, 2026

A generic application relies on the data of a reference medicine and shows bioequivalence. The European Medicines Agency assesses it when the reference medicine was centrally authorised or the generic brings a significant advantage. Most other generics are authorised nationally.

Generic application · target 210 days · verified October 3, 2026

A hybrid application relies partly on the data of a reference medicine and partly on new studies. It is used when a product is close to a reference medicine but differs, for example in strength, route of administration or indication. Through the European Medicines Agency, the same 210-day opinion limit applies.

Full or mixed application, known active substance · target 210 days · verified October 3, 2026

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.

Generic application · verified October 3, 2026

Every marketing authorisation states whether the medicine needs a prescription. A medicine can be classified as not subject to prescription when it does not meet the prescription criteria. When a switch is approved on the basis of significant new tests or trials, those data are protected for one year against other applicants seeking the same switch. Most non-prescription medicines are authorised at national level.

Non-prescription application · verified October 3, 2026

Spain has no separate OTC application. The agency sets the prescription status inside the marketing authorization. It can classify a medicine as non-prescription when it treats conditions that do not need a precise diagnosis and its safety data and route do not require a prescription. Such medicines are dispensed in pharmacies by a pharmacist.

Non-prescription application · verified October 3, 2026

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 or herbal registration · verified October 3, 2026

Every finished batch of a vaccine or plasma-derived medicine needs the agency's prior approval before it can be sold in Spain. If another EU authority has already certified the batch, no new testing is done. Without testing, the batch counts as approved if the agency raises no issue within five days (two days for seasonal flu vaccine). With testing, the agency decides within 60 days (30 for seasonal flu vaccine).

Other route · verified October 3, 2026

Gene therapies, somatic cell therapies and tissue engineered products must use the centralised procedure. The Committee for Advanced Therapies prepares the draft opinion, and the committee for human medicines adopts the final opinion. The European Commission decides.

Full application, new active substance · target 210 days · verified October 3, 2026

Gene therapy, somatic cell therapy and tissue engineered products that a hospital prepares occasionally, under specific quality rules, to fill an individual prescription for one patient need an authorization of use from the agency. The decision limit is 210 calendar days. The authorization covers only that hospital, lasts three years and can be renewed for five-year periods.

Other route · verified October 3, 2026

When a device includes a substance that would be a medicine on its own and supports the device's action, the device is class III. The notified body must ask a medicines authority, or the European Medicines Agency, for a scientific opinion on the substance. The authority gives its opinion within 210 days of receiving all documents.

Device: conformity assessment by a certification body · verified October 3, 2026

When a device and a medicine form a single integral product meant only for use in that combination and not reusable, such as a prefilled syringe, the whole product is authorised under medicines law. The device part must meet the general safety and performance requirements of the medical devices regulation. If the device alone would need a notified body, the dossier includes a notified body opinion on the device part.

Other route · target 210 days · verified October 3, 2026

Makers of class I medical devices declare conformity themselves after preparing the technical documentation. No notified body is involved, except for sterile, measuring and reusable surgical class I devices. The device is registered in the EU database before it is placed on the market.

Device: exempt or self-declared · verified October 3, 2026

Class I devices that are sterile, have a measuring function or are reusable surgical instruments need limited notified body involvement. The notified body checks only sterility, metrology or reuse aspects, under Annex IX Chapters I and III or Annex XI Part A.

Device: conformity assessment by a certification body · verified October 3, 2026

Class IIa devices need a notified body. The usual route is a quality management system audit with assessment of the technical documentation for at least one representative device per category. An alternative route combines technical documentation with product conformity verification.

Device: conformity assessment by a certification body · verified October 3, 2026

Class IIb devices need a notified body audit of the quality management system and assessment of technical documentation. For most class IIb implantable devices, the technical documentation of every device is assessed. Class IIb active devices that administer or remove medicines go through an extra expert panel consultation.

Device: conformity assessment by a certification body · verified October 3, 2026

Class III devices need a full notified body assessment, with the technical documentation of each device reviewed. Clinical investigations are generally required for class III and implantable devices. For class III implantable devices, the notified body consults an expert panel on its clinical evaluation assessment.

Device: conformity assessment by a certification body · verified October 3, 2026

On top of the EU rules, every economic operator that markets medical devices or in vitro diagnostics in Spain, other than custom-made devices, must first join the agency's marketing register and report each product with its UDI-DI, its Spanish labeling and instructions, and the start date. The entries are updated every year, or they are removed.

Device: premarket notification · verified October 3, 2026

On top of EU device rules, Spain requires a prior operating licence from the agency for anyone who makes, imports, groups or sterilizes medical devices, and for those who make, import or sterilize in vitro diagnostics. The agency must decide within three months. The licence lasts up to five years and can be renewed.

Other route · verified October 3, 2026

Makers of custom-made devices, such as orthopedic or dental products, need an operating licence from the health authority of their region, not from the national agency. Makers that place custom-made devices on the market, and authorized representatives in Spain, also register with the agency's register of persons responsible.

Device: registration or licence with the regulator · verified October 3, 2026

Spain limits the EU in-house exemption. Only hospitals may make medical devices for their own use, and not class IIb, class III or implantable devices. Health centers may make in-house in vitro diagnostics if their laboratories are accredited to ISO 15189. In both cases the center notifies the agency before it starts, may not subcontract the manufacturing, and may not sell or pass the products to others.

Device: premarket notification · verified October 3, 2026

Makers of class A in vitro diagnostic devices declare conformity themselves after preparing the technical documentation. Class A devices sold sterile need a notified body for the sterility aspects.

Device: exempt or self-declared · verified October 3, 2026

Class B in vitro diagnostic devices need a notified body audit of the quality management system and assessment of technical documentation for at least one representative device per category of devices. Self-tests and near-patient tests also get a technical documentation assessment.

Device: conformity assessment by a certification body · verified October 3, 2026

Class C in vitro diagnostic devices need a notified body audit of the quality management system and assessment of technical documentation for at least one representative device per generic device group. Self-tests and near-patient tests also get a technical documentation assessment. Companion diagnostics also need a medicines authority opinion.

Device: conformity assessment by a certification body · verified October 3, 2026

Class D in vitro diagnostic devices get the strictest assessment. The notified body reviews the quality system and technical documentation. Where an EU reference laboratory is designated, it verifies the claimed performance by laboratory testing and gives a scientific opinion within 60 days. For a first certification without common specifications, expert panels review the performance evaluation.

Device: conformity assessment by a certification body · verified October 3, 2026

Software is a medical device when the maker intends it for a medical purpose. It follows the same rules as other devices or IVDs. Rule 11 places software that informs diagnosis or treatment decisions in class IIa, IIb or III by the possible impact on health, and other software in class I. The class then decides the conformity assessment route.

Device: conformity assessment by a certification body · verified October 3, 2026