Pharmacovigilance in Portugal
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 Portuguese pharmacovigilance services:
LCPPV / EU QPPV in Portugal
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Portugal?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The Portuguese National Pharmacovigilance System (NPS) is coordinated by INFARMED (Instituto Nacional de Farmácia e do Medicamento), a government agency accountable to the Health Ministry, plays a crucial role in maintaining public health standards.
It is responsible for oversight and regulatory compliance within the healthcare sector. Furthermore, it manages the National System for the Surveillance of Medical Devices (SNVDM), ensuring the safety and performance of medical devices in the market.
REGIONAL PHARMACOVIGILANCE UNITS
NPS counts 8 regional pharmacovigilance units (RPUs). RPUs cover the entire mainland and archipelagos of the Azores and Madeira islands.
These units are responsible for collecting and assessing adverse drug reactions (ADRs), identifying and assessing risks associated with medicines, implementing risk minimization measures, and communicating with healthcare professionals and the public.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English version, but the content seems to be quite limited, thus you may get only some information in English.
If you’re having difficulty finding the information you need, we suggest trying the Portuguese version of the website and use online translation tools like Google Translate; this could help you locate the details you’re seeking.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE SECTION
This page is basically a signpost, that can direct you into the exact area that you’re looking for. It contains Q&A section, Legislation, Educational materials and more.
PHARMACOVIGILANCE BULLETIN
This publication provides valuable insights into the adverse effects of authorized medicines, offering information at both the national and European levels.
These bulletins are translated to English, though those newly published appear firstly only in Portuguese and then after some time in the English section.
CIRCULARS
Those are official communications that provide important updates, guidelines, and regulatory information regarding medicines and health products.
In most cases they are only in Portuguese, you can sort the list by the parameters on the left.
HUMAN MEDICINES
This is another signpost that can direct you further, whether you’re looking for information regarding Marketing authorisation (Submission of Marketing Authorisation Applications), Availability of medicines or Pharmacovigilance (Instructions to Applicants etc.), this the page.
MEDICINE DATABASE
All medicinal products that are eligible to be placed on the market can be found here but, the database is visually user friendly. You can search simply by name or use advanced search.
Other important institutions & industry groups
MINISTRY OF HEALTH & DIRECTORATE-GENERAL OF HEALTH (DGS)
The ministry plays a crucial role in overseeing the country’s health system, focusing on the regulation, monitoring, and financing of healthcare services while developing national health policies.
The Directorate-General of Health (DGS) is a central body under the Ministry of Health. It plays a crucial role in public health management and the implementation of health policies.
It’s not entirely clear whether the ministry has its own website or purely has this section on the government website, information about the ministry can also be found here.
On DGS’s website we can recommend the publication section, where some interesting articles and studies can be found, such as NATIONAL REPORT OF PORTUGAL: Universal Health and Preparedness Review. There are aslo some statistics, though they are a bit hide due to some ministrial regulation as it seems, so we provide you with a link that directs you to statistics sorted by years. DGS ahs also its own neswletter.
Ministry’s website: https://www.portugal.gov.pt/pt/gc24/area-de-governo/saude
DGS’ website: https://www.dgs.pt/
PORTUGUESE SOCIETY OF PHARMACOVIGILANCE
This Society is dedicated to enhancing medication safety by promoting the importance of monitoring and reporting adverse drug reactions. They offer resources and training for healthcare professionals, fostering a collaborative environment that improves patient safety and ensures effective risk management in the use of medicines.
However, their website basically do not offer any interesting content worth mentioning, since their publication section is empty and other sections do not posses any important information regarding pharmacovigilance.
Society’s website: https://spfarmacologia.pt/pt/
PORTUGUESE PHARMACEUTICAL INDUSTRY ASSOCIATION (APIFARMA)
It represents over 100 companies involved in the production and import of medicines, vaccines, and diagnostics. Their key activities include promoting innovation in healthcare, ensuring efficient drug authorization processes, and supporting access to medications for all citizens.
Once again we can recommend their publications section containing interesting studies or statistics such as Pharmaceutical Industry in Numbers 2022. They also publish Economic Bulletins, which summarizes key indicators of the pharmaceutical market, detailing the National Health Service’s spending on medicines and the broader macroeconomic landscape. If you like listening to podcasts you try theirs, its called “Pela Sua Saúde” and it offers discussions about current topics in health, science, and society.
Association’s website: https://apifarma.pt/
Some of the most important laws
Basic legislation
Decree-Law No. 176/2006: Establishes the legal system of the medicinal products for human use and is usually referred as Medicinal Products Statute.
Decree-Law No. 128/2013: Further aligns Portuguese law with EU pharmacovigilance regulations.
Decree-Law no. 102/2007 of 2 April: Establishes the principles and detailed guidelines for good clinical practice.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Essential EU Legislation and EMA Guidlines
Since Portugal is a member of the EU, every Marketing Authorization Holder with a product on the Portuguese 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 Portugal, following terms will be helpful for you to get familiar with:
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
INFARMED (Instituto Nacional de Farmácia e do Medicamento)
→ Main authority on pharmacovigilance.
SNVDM (Sistema Nacional de Vigilância de Dispositivos Médicos)
→ National Medical Device Surveillance System / It aims to monitor incidents related to medical devices.
Portal RAM (Portal de notificação de suspeitas de reações adversas a medicamentos)
→ RAM Portal / Portal for reporting suspected adverse drug reactions
Is LCPPV needed or is EU QPPV enough?
LCPPV must be appointed by the marketing authorization holder (MAH) for the medicinal product. The LCPPV must be located in Portugal and perform their pharmacovigilance functions in a permanent and continuous way as stated in Decree-Law n.º 176/2006, in the present actualization, article n.º 170, number 5, more legal requirements are mentioned in this circular.
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 Portugal?
Reports can be submitted electronically through the RAM Portal, which is coordinated by INFARMED.
After clicking on the link, you’ll encourage to select whether the origin of the adverse reaction is COVID-19 vaccine or other vaccine and medicine and also whether you are a Healthcare professional or Public, more information here.
Local medical journals to screen
Here are few examples of Portuguese local literature sources that medical authorization holders should monitor:
REVISTA PORTUGUESA DE FARMACOTERAPIA
Covering latest advancements in pharmacotherapy, offering valuable insights into drug efficacy and safety, which is essential for healthcare professionals looking to enhance patient treatment strategies.
Its vast field of research articles and clinical case studies makes it a vital resource for anyone interested in improving pharmaceutical care in Portugal.
ISSN: 2183-7341
PORTUGUESE JOURNAL OF PUBLIC HEALTH
It serves as a platform for discussing public health issues and policies, featuring research that addresses the social determinants of health
This journal is particularly valuable for public health practitioners and researchers seeking to understand and improve health outcomes within the Portuguese context.
ISSN: 2504-3145
ACTA MÉDICA PORTUGUESA
It publishes original research, reviews, and clinical guidelines across a broad spectrum of medical disciplines, making it a comprehensive resource for healthcare professionals.
Its emphasis on evidence-based medicine and clinical practice ensures that readers stay informed about the latest developments in medical science relevant to Portugal.
ISSN: 1646-0758
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
Portugal: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Portugal” 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.
Publications by INFARMED
As it seems the INFARMED’s annual reports have its own section on the website, but if the link stopped working we recommend to search it manually, when searching use “Relatório anual”. Here is Annual activity report 2023, only in Portuguese.
Analysis of the consumption of non-prescription medicines outside pharmacies
Infographics covering covering the prescription in Portugal since 2006, there is a PDF with statistics under each year, in Portuguese only.
Here you’ll actually find just one statistic despite the title and that is Medicines and Health Products Statistics, which is published annualy and it is accesible in both Portuguese and English.
Report: National Pharmacovigilance System 2023
By the end of 2023, the ADR Reporting Portal had documented around 155,497 reports of suspected adverse drug reactions (ADRs), with healthcare professionals being the primary contributors. This publication highlights trends in ADR reporting, emphasizing the need for increased awareness about the importance of documenting these reactions to enhance patient safety and improve healthcare outcomes.
The link for the report itself is on the linked page at the end fo the paragraph, accessible only in Portuguese.
Studies related to pharmacovigilance in Portugal
In this pharmacovigilance study, researchers investigate the incidence of spontaneously reported suspected adverse drug reactions (ADRs) associated with oral anticoagulants. By shedding light on the safety profiles of widely used medications, the study aims to enhance understanding of their risks and benefits.
In this comprehensive study, researchers analyzed 3,692 spontaneous reports of ADRs among individuals aged 65 and older, revealing that the most commonly reported ADRs fell into categories related to general disorders and skin conditions. This review sheds light on the critical need for vigilance in monitoring these drugs, making it a must-read.
This study highlights how the implementation of a newly developed active pharmacovigilance model for oral antineoplastic agents has significantly improved toxicity management and clinical outcomes for patients, fostering a supportive environment where patients feel empowered to report adverse events.
Quality of Spontaneous Reports of Adverse Drug Reactions Sent to a Regional Pharmacovigilance Unit
This study uncovers critical gaps in the documentation of adverse drug reactions (ADRs), revealing that serious ADRs are often reported incompletely, which complicates accurate causality assessments and effective risk management. Readers will find compelling evidence that highlights the urgent need for improved training on ADR reporting.
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