AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

Who regulates medicines in Spain?

In one sentence

The AEMPS is Spain's regulator of medicines, medical devices, cosmetics and biocides, a state agency attached to the Ministry of Health.

It coordinates the Spanish pharmacovigilance system: regional centres collect suspected reactions into one national database, FEDRA (Farmacovigilancia Española, Datos de Reacciones Adversas), and the agency forwards them to the European Union (EU).

Where it sits

MinistryMinisterio de Sanidad
State agencyAgencia Española de Medicamentos y Productos Sanitarios
NetworkSistema Español de Farmacovigilancia de medicamentos de uso humano (SEFV-H)
Database and portalFEDRA and NotificaRAMSuspected reactions land here

Think of it like this

Think of a neighbourhood watch with one switchboard. Every district has its own lookout, every call is logged in one place, and the serious ones are passed on to the whole city within days.

Key insights

Older than the agencyMany front doors, one databaseReporting is a legal dutyEurope’s trial capital

Spain’s pharmacovigilance system dates from 1984; the agency that coordinates it opened in 1999. In 2024 the system took in 37,944 suspected reaction reports. Chapter 1 tells the story.

Each region runs its own pharmacovigilance centre. Every report, from a doctor, a pharmacist or a patient, is registered in one national database, FEDRA, which the AEMPS runs and feeds into EudraVigilance.

In Spain a health professional does not choose whether to report a suspected reaction: the medicines law makes it an obligation, and the 2013 decree says as fast as possible, to the regional centre. Chapter 2 sets the clocks.

In 2024 the AEMPS authorised 930 clinical trials, more than any other regulator in the EU, and 1,253 human medicines, 30 percent more than the year before.

Jump to: 1 Three moments 2 Your report, their clock 3 What Spain adds to the EU rules 4 Test yourself

Chapter 1

Which three moments made the AEMPS what it is?

Pick a year. Each changed who reports, to whom, and how fast.

1984A yellow card, region by region1999An agency of its own2013Anyone can report

A yellow card, region by region

From 1984 the Ministry of Health ran the Spanish pharmacovigilance system on one basic programme: structured reporting of suspected adverse effects by health professionals, on a yellow card. The regions joined one by one through agreements, each with its own centre; Valencia in 1986.

The name stuck. The 2013 decree that governs the system today still tells a professional to note a medication error “en la tarjeta amarilla”.

What it left behind: a system run by the regions and coordinated from Madrid, fifteen years older than the agency itself.

An agency of its own

A 1997 law created the Agencia Española del Medicamento as an autonomous body attached to the Ministry of Health and handed it the ministry’s powers over medicines: granting marketing authorisations and taking part in the EU’s own evaluations. It opened in 1999 with barely 100 people.

In 2011 it became a state agency with its own statute, legal personality and budget. A governing council chaired by the Secretary of State for Health appoints its Director; by then it also covered medical devices, cosmetics and biocides.

What it left behind: a regulator that can act on EU decisions at once, and that marked its 25th anniversary in 2024.

Anyone can report

Real Decreto 577/2013 rewrote the rules for the EU’s 2012 pharmacovigilance package. For the first time a patient could report a suspected reaction directly, through a web form named on every leaflet: NotificaRAM. Professionals keep their duty to report as fast as possible to their regional centre.

The decree also fixed the plumbing: one national database, FEDRA, administered by the AEMPS, and the agency’s own clock to pass serious reports on to EudraVigilance within 15 days, non-serious ones within 90.

What it left behind: 86 safety signals opened between June 2014 and the end of 2024, most of them from cases sent through NotificaRAM.

Chapter 2

Your report, their clock

A case has reached your company. Real Decreto 577/2013 sets the deadline for a suspected adverse drug reaction (ADR) with two questions: is it serious, and was it in the EU? Pick a cell.

In the EUOutside the EUSeriousSerious, in the EUSerious, outside the EUNot seriousNot serious, in the EUNot serious, outside the EU

Or you are not a company at all: a doctor or pharmacist in Spain or a patient in Spain

Every serious suspected reaction, in the EU or a third country, within 15 calendar days of the day you learned of it; a Spanish case also names the reporter’s region. Real Decreto 577/2013, article 9

A non-serious suspected reaction in the EU within 90 calendar days of the day you learned of it. Real Decreto 577/2013, article 9

A non-serious reaction outside the EU is not on the article 9 list. It stays in your pharmacovigilance system, which the decree requires you to run and summarise in your application. Real Decreto 577/2013, articles 8 and 9

Reporting is an obligation, not a choice: as fast as possible, to your regional pharmacovigilance centre, with priority for serious or unexpected reactions and for medicines under additional monitoring. Real Decreto 577/2013, article 6; Real Decreto Legislativo 1/2015, article 53

You may report directly on NotificaRAM, the web form named on your leaflet, or through a professional. The agency then passes a serious case to EudraVigilance within 15 days, a non-serious one within 90. Real Decreto 577/2013, articles 4 and 7

Los profesionales sanitarios tienen la obligación de comunicar con celeridad a los órganos competentes en materia de farmacovigilancia de cada Comunidad Autónoma las sospechas de reacciones adversas.
Real Decreto Legislativo 1/2015, article 53: professionals must report suspected reactions promptly to their regional pharmacovigilance body

In 2024 the system recorded 37,944 notifications, 38 for every 100,000 inhabitants, back at pre-pandemic levels. Half came straight from professionals and the public; the rest mostly through industry.

Chapter 3

What does Spain add to the EU rules?

The EU directive sets the floor and the European Medicines Agency (EMA) runs the shared database. Five places where Spain built its own layer on top.

	The EU rule	Spain’s own layer
Reports from the public	Member States encourage patients and professionals to report	Professionals are legally obliged to report; regional centres register each case in FEDRA within 10 days if serious, 80 if not
The company’s people	A qualified person for pharmacovigilance, permanently and continuously	Plus a pharmacovigilance contact person based in Spain, permanently and continuously
Each case	Sent to EudraVigilance, the EU database run by the EMA	Must also name the Spanish region of the reporting professional or patient
Who inspects you	The national competent authority, in cooperation with the EMA	The AEMPS and the regional health authorities, master file included
Who approves nationally	The European Commission, on the EMA’s opinion, for centralised medicines	The AEMPS grants national authorisations and sits in the EU’s evaluations

Show the legal references

Reports: Directive 2001/83/EC, Article 102(a); Real Decreto Legislativo 1/2015, article 53.2; Real Decreto 577/2013, articles 5.5 and 6.1.
People: Directive 2001/83/EC, Article 104(3)(a); Real Decreto 577/2013, article 14.1.
Cases: Regulation (EC) No 726/2004, Article 24(1); Real Decreto 577/2013, article 9.
Inspections: Directive 2001/83/EC, Article 111(1); Real Decreto 577/2013, article 23.1.
Approval: Regulation (EC) No 726/2004, Article 10(1); Ley 66/1997, article 90.

Same Europe, more doors: in Spain a case has a region, a company an extra named person, and a professional a legal duty.

The facts, in one place

What it is	A state agency with its own legal personality and budget, attached to the Ministry of Health; statute by Real Decreto 1275/2011.
Since	Created by law in 1997 as the Agencia Española del Medicamento, open since 1999 with barely 100 people; a state agency under its present name since 2011.
Who decides	A Director, appointed by the governing council on the proposal of its President, the Secretary of State for Health.
Seat	Calle Campezo 1, Madrid.
2024 in numbers	1,253 human medicines authorised, 930 clinical trials authorised, 410 inspections of pharmaceutical laboratories, 37,944 suspected reaction notifications.
Safety system	The Sistema Español de Farmacovigilancia: regional centres, the AEMPS, professionals and the public; FEDRA is the national database, NotificaRAM the public portal.
Member of	The Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 1998; the International Coalition of Medicines Regulatory Authorities (ICMRA), as an associate; the Heads of Medicines Agencies (HMA), whose management group the AEMPS director chaired from October 2024.

Don’t confuse it with: the regional pharmacovigilance centre

AEMPS

The national coordinator

Runs: FEDRA, the one database for all suspected reactions in Spain
Forwards: serious cases to EudraVigilance in 15 days, non-serious in 90
Example: opens a signal and changes the product information

Centro Autonómico de Farmacovigilancia

The regional front door

Receives: the reports from professionals and patients in its region
Registers: each case in FEDRA within 10 days if serious, 80 if not, and follows it up
Example: asks the doctor for the missing lab result

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“A doctor in Spain may decide for themselves whether a suspected reaction is worth reporting.”

MythTruth

MythYou got it.Not quite.

The medicines Act makes reporting an obligation, and the 2013 decree says as fast as possible, to the regional centre, with priority for serious or unexpected reactions.

“A patient in Spain can send a suspected reaction straight to the system, without going through a doctor.”