Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Use of authorized medicines outside their authorized conditions

Spain · Spanish Agency of Medicines and Medical Devices · New drugs

Other routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

2 requirements

Application fee

What is the Use of authorized medicines outside their authorized conditions in Spain?

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. A patient for whom no authorized alternative exists.

What are the steps of the Use of authorized medicines outside their authorized conditions?

1. Doctor justifies and informs; 2. Agency use recommendations (if issued).

Outcome: Treatment under the doctor's responsibility, following any agency recommendations and hospital protocols.

Legal basis: Real Decreto Legislativo 1/2015, article 24.3; Real Decreto 1015/2009, chapter III

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).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Approvals per year, other route 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. Doctor justifies and informsThe doctor records the reason in the clinical record, informs the patient of benefits and risks and gets consent.
2. Agency use recommendations (if issued)only in some casesThe agency can issue recommendations, for example for restricted-prescription medicines or when the use has a relevant impact on care.

Requirements

What the applicant must provide or meet

Clinical data

Justification and consentThe doctor justifies the need in the clinical record, informs the patient and obtains consent.

After approval

No promotion by the holderThe authorization holder must not promote the medicine for uses outside its authorized conditions.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.