Pharmacovigilance in Spain
How is it with the drug safety system in this state on the Iberian Peninsula? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Spanish pharmacovigilance services:
LCPPV / EU QPPV in Spain
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Spain?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The Spanish Agency of Medicines and Medical Devices (AEMPS) acts as the national competent authority and plays a crucial role in monitoring and ensuring drug safety across Spain, besides other things.
It is regulatory and autonomous agency of the Government of Spain based in Madrid. AEMPS operates 17 regional pharmacovigilance centers (established in different healthcare institutions) that report directly to the national regulatory authority.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English version, but it offers very limited content, mainly the menu is translated with only some information available in English, most of the website stays still in Spanish.
So, if you’re having trouble finding what you need, we recommend visiting the website in its original Spanish version and using a translator. This approach could significantly increase your chances of locating the information you’re after.
Interesting website sections related to pharmacovigilance
AEMPS BULLETINS
This page contains all bulletins published by AEMPS, the most important ones for you probably are Pharmacovigilance bulletins and Medicine for human use (both are published irregularly and are accessible only in Spanish)
MEDICINE DATABASE
Here you can all the information about the medicinal product that you’re seeking. You can search by name or national code etc., at the bottom part of the page you’ll find quick message selection section such as Latest medicine authorized or Supply problems and more. This page has fully functional English version.
PHARMACOVIGILANCE
This is a huge signpost that can direct you to any way regarding pharmacovigilance, whether you’re looking for some general information, drug safety, legislation on pharmacovigilance, …
LEGISLATION
If you’re looking for Spanish legislation on medicine for human use, this is the page for you. Here you’ll find the legislation sorted into individual categories, such as Pharmacovigilance of medicines for human use, Marketing of medicines, etc. Each of these categories lists the individual decrees that can be viewed.
FREQUENTLY ASKED QUESTIONS
On this page you’ll find most often asked question sorted into individual categories, such as Medicine for human use, Industry, etc. Each category has subcategories and that’s where you find true Q&A, these are mostly drop-down lists.
MARKETING OD MEDICINES
General information for marketers regarding marketing of medicines, all occupation are explaind in video (which is quite long approximately 2,5 hours; Spanish only) on the linked page. Below the video there are some user manuals and guides and more.
Other important institutions & industry groups
MINISTRY OF HEALTH
Ministerio de Sanidad is responsible for health policy formulation and implementation in Spain. It oversees the national health budget and coordinates with regional governments to ensure cohesive healthcare delivery across the country
For starters there are many Plans & Strategies of the Ministry accesible here, such as Digital Health Strategy or Strategic Plan for Health and the Environment. If you like quick statistical overview, that visit “Healthcare at glance”, which a comprehensive summary of the latest and most important data from the Health Information System. Other statistics, including interactive ones that you can build yourself, can be found here.
Ministry’s website: https://www.sanidad.gob.es/
CARLOS III HEALTH INSTITUTE (ISCIII)
A public research institution that focuses on biomedical research and public health. It plays a vital role in health research, training professionals, and providing scientific support for health policies in Spain
The webpage does not consist of much relevant content, is rather informative, you will find here more about Health Research Institutes or a description of Public Health Surveillance and others. So the most interesting section is probably that with articles, though there are not many of them. If you’re interested with ther annual or strategic plans head for this section.
ISCIII’s website: https://www.isciii.es/
FARMAINDUSTRIA
National Trade Association for the pharmaceutical industry in Spain, It plays a crucial role in promoting ethical practices and ensuring compliance with regulations in the pharmaceutical sector.
Through their website you can subscribe to their newsletter, that covers the news in the field (also a great deal of articels that you can read in news section seems to be delivered to you via this newsletter). Then there is section called “Code of Practice”, which for example includes a PDF brochure, Farmaindustria adopted the European Code of Good Practice for the Promotion of Medicines and revised it.
Farmaindustria’s website: https://www.farmaindustria.es/web/
SEFIG
The Spanish Society of Pharmaceutics and Pharmaceutical Technology (SEFIG) is a national organization that includes pharmacists and other professionals involved in pharmaceutical technology. It focuses on advancing pharmaceutical sciences and improving drug formulation and delivery.
Their website does not offer much of a interesting content, basically the only thing that you can read there is their history and their mission, since any publication section is missing.
SEFIG’s website: https://sefig.org/en/
Some of the most important laws
Basic legislation
This decree regulates pharmacovigilance of medicinal products for human use (unofficial English translation revised by the Spanish Agency for Medicines and Medical Devices).
This decree establishes the procedures for the monitoring, evaluation, and prevention of adverse drug reactions.
Royal Legislative Decree 1/2015:
This decree revises the Law on Guarantees and Rational Use of Medicines and Medical Devices, which regulates medicinal products and medical devices in detail.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Guidelines for advertising medicines for human use aimed at the public
Essential EU Legislation and EMA Guidlines
Since Spain is a member of the EU, every Marketing Authorization Holder with a product on the Spanish market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Agency).
To navigate through the European regulations, its is useful to know following:
– EMA Pharmacovigilance System Manual
– Directive 2001/83/EC
– Regulation (EC) 726/2004
– Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Spain, following terms will be helpful for you to get familiar with:
(more abbreviations can be found here)
EMA (European Medicine Organization)
→ Key part of the EU, dedicated to ensuring the safety and effectiveness of medicines.
EVPM (EudraVigilance post-authorization module)
→ Dedicated to the collection of ICSRs related to all medicinal products authorised in the EEA.
PRAC (Pharmacovigilance Risk Assessment Committee)
→ Committee responsible for assessing and monitoring the safety of human medicines
AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)
→ Spanish Agency of Medicines and Medical Products / Main authority on pharmacovigilance.
SEFV-H (Sistema Español de Farmacovigilancia de medicamentos de uso Humano)
→ Spanish Pharmacovigilance System for Medicines for Human Use
CIMA (Centro de información de medicamentos)
→ Spanish Medical Database
FEDRA (Farmacovigilancia Española, Datos de Reacciones Adversas)
→ Spanish Pharmacovigilance, Adverse Reaction Data / database containing reports of suspected adverse reactions to medicines (ADRs) for human use
RAM (reacciones adversas a medicamentos)
→ ADR / adverse drug reaction
Is LCPPV needed or is EU QPPV enough?
It is obligatory to appoint a Spanish local contact person (LCPPV), who must be always continuously available for pharmacovigilance, according to Royal Decree 577/2013, Article 14. Contact details must be provided via elecetronic system for such purpose and these details will be maintained by the Spanish Medicines Agency.
If you need a translation of those instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.
How can be adverse events reported in Spain?
Healthcare professionals and MAHs must report serious adverse reactions occurring in Spain to the regional pharmacovigilance centers.
Reports can be submitted electronically through the FEDRA’s web form Notificación de Sospechas de Reacciones Adversas a Medicamentos that allows healthcare professionals and patients to report suspected adverse reactions directly to the SEFV-H.
Local medical journals to screen
Here are few examples of Spanish local literature sources that medical authorization holders should monitor:
REVISTA CLÍNICA ESPAÑOLA
Established in 1940, this journal serves as the official publication of the Spanish Society of Internal Medicine (SEMI). It focuses on updating knowledge in internal medicine and publishes original articles, reviews, and consensus documents that are rigorously peer-reviewed.
The journal emphasizes practical applications of internal medicine, making it a valuable resource for clinicians seeking to stay current with best practices.
ISSN: 1578-1860
REVISTA ESPAÑOLA DE MEDICINA LEGAL
Spanish Journal of Legal Magazine focuses on legal and forensic medicine and is the official journal of the National Association of Forensic Physicians. It provides a platform for scientific articles.
Its focus on the overlap between medicine and law makes it a must-read for professionals in forensic medicine and the legal field.
ISSN: 2445-4249
GACETA SANITARIA
A public health journal that publishes research articles, reviews, and opinion pieces related to various aspects of public health. It aims to disseminate knowledge that contributes to improving health policies and practices.
The journal is known for its focus on public health issues specific to Spain, making it a critical resource for policymakers and health professionals.
ISSN: 1578-1283
MEDICINA CLÍNICA
It publishes clinical research articles across various medical specialties and aims to provide a forum for scientific exchange among healthcare professionals.
The journal is particularly noted for its rapid publication process, allowing timely dissemination of critical clinical findings.
ISSN: 1578-8989
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
Country Public Health / Health System Assessments
Spain: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Spain” provides a comprehensive look at the health landscape in the country, exploring key topics such as overall health status, important health determinants and risk factors, and how the health system is organized and funded.
Studies related to pharmacovigilance in Spain
Reporting of suspected adverse drug reactions by nursing in Spain
This study shines a light on the crucial yet often overlooked role of nurses in reporting adverse drug reactions in Spain, revealing that many cases go unreported, particularly in vaccine administration. Discover the key insights and recommendations that could empower nurses to enhance pharmacovigilance practices and improve patient safety in healthcare settings.
This material explores the evolving role of clinical pharmacology in Spain, emphasizing the need to shift from traditional drug assessments to a broader focus on how medications impact individuals and society as a whole. Dive into the discussion on how real-world data and ongoing evaluations can reshape our understanding of drug effectiveness and safety, ultimately leading to smarter healthcare decisions that benefit everyon
Uncovering important safety signals related to drug-induced hyponatraemia, particularly highlighting its serious impact on older women taking multiple medications. Learn about the specific drugs linked to this condition and why ongoing patient monitoring is crucial, as well as how healthcare professionals can better recognize and report these potentially dangerous reactions.
Do you need some help with putting the Spanish PV System together? We’re here for you.
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