Pharmacovigilance in Belgium
How is it with drug safety system in European country? Follow our guide and you will be in the picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Belgian pharmacovigilance services:
LCPPV / EU QPPV in Belgium
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Belgium?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Belgium is the Belgian Centre for Pharmacovigilance (BCPH), headquartered in Sain-Gilles, which operates under the Federal Agency for Medicines and Health Products (FAMHP).
It is responsible for coordinating various tasks related to pharmacovigilance, including a evaluating ADRs.
BCPH does not have its own website, only a page dedicated to describe its main tasks.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English, French and Dutch version and practicaly all pages containing the most important information are translated but.
Though if you cannot find what you’re looking for, we suggest you to try different version of the websit and use translator, this way you have potentially much bigger chance to find what you’re looking for.
NOTICE
While the website has different language versions, the name of the website differs in each language. In English it’s “FAMHP”, in French “AFMPS” and in Dutch “FAGG”.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE SECTION
Dive deeper into specifics of PV system in Belgium, here you’ll find specific obligations for Marketing authorisation holders (MAs) or how to report ADRs.
MEDICINAL DATABASE
Find out how is it with availability of medicinal products, which medicinal products are newly authorised or medicinal products for which the authorisation has been suspended. All in nicely organized tables.
FORMS TO DOWNLOAD
Here you can find some important forms, including application and authorisation form, both forms are only in French or Dutch.
ANNUAL REPORTS
Archive of annual reports dates back to 2007, each of these reports can be displayed either as PDF document or on special website. Annual reports are accessible in English, French, Dutch and German.
Other important institutions & industry groups
FEDERAL PUBLIC SERVICE HEALTH (FPS Health)
It is a broader governmental body responsible for public health, food safety, and environmental protection. It also oversees scientific institutions such as Sciensano and the Superior Health Council.
We recommend to browse general information about public health or to subscribe to their newsletter in Dutch or French, their website seems not to provide special section dedicated to pharmacovigilance.
FPS Health website: https://www.health.belgium.be/en
BELGIAN PHARMACEUTICAL INDUSTRY ASSOCIATION
It represents over 130 innovative pharmaceutical companies operating in Belgium. Main role is advocating for the interests of the pharmaceutical industry.
Visit their publication section to stay up to date on health and research in Belgium or subscribe to their newsletter. Website is accessible in French or Dutch.
PHARMA website: https://pharma.be/fr
Some of the most important laws
Basic legislation
Law of 25 March 1964 on Medicinal Products
This foundational law regulates the authorization, distribution, and surveillance of medicinal products in Belgium.
Royal Decree of 14 December 2006
It outlines the regulations concerning medicines for human use, including pharmacovigilance requirements.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Various circulars issued by the Federal Agency for Medicines and Health Products (FAMHP) provide additional guidance, such as for MAHs in circulars 635 & 637. We recommend to use the website in French, while not all circulars are translated to English.
Essential EU Legislation and EMA Guidlines
Since Belgium is a member of the EU, every MAH with a product on the Belgian market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Organization).
To navigate through the European regulations, its is useful to know following:
EMA Pharmacovigilance System Manual
Directive 2001/83/EC and Regulation (EC) 726/2004
Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Is LCPPV needed or is EU QPPV enough?
Yes, the Local Contact Person for Pharmacovigilance (LCPPV) is required in Belgium. This requirement is based on Article 66 of the Royal Decree of 14 December 2006.
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 Belgium?
You can report ADRs directly to the Belgian Centre for Pharmacovigilance, here you’ll find different forms regarding whether you are patient or healthcare professional.
If you have any questions about reporting ADRs, visit their Q&A section.
Local medical journals to screen
Here are few examples of Belgian local literature that medical authorization holders should monitor:
ACTA CLINICA BELGICA
This journal publishes articles across various medical specialties, including clinical research, case reports, and reviews.
It aims to promote high-quality clinical research and improve patient care.
ISSN: 2295-3337
REVUE MÉDICALE DE LIÉGE
This medical journal is published by the University of Liège and covers a wide range of medical topics.
It aims to disseminate knowledge among healthcare professionals in Belgium.
ISSN: 0370-629X
BELGIAN JOURNAL OF MEDICAL ONCOLOGY (BJMO)
The BJMO is the official journal of the Belgian Society of Medical Oncology and the Belgian Association for Cancer Research.
It provides insights into the latest developments in medical oncology, focusing on practical information for specialists in the field.
ISSN: 1784-7141
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
Belgium: Country Health Profile
The 2023 editions provide 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.
Scientific publications regarding pharmacovigilance
Belgian community pharmacists’ pharmacovigilance perspective and practice
This article examines the impact of pharmacovigilance legislation introduced in 2012, focusing on new concepts like inverted black triangles and risk minimization activities in Belgian community pharmacies. It aims to assess how these changes have influenced everyday dispensing practices, highlighting a significant increase in the number of dispensed medicines subject to additional monitoring since 2014.
Pharmacovigilance in pharmaceutical companies: An overview
This article discusses the evolution of pharmacovigilance legislation in the EU, particularly focusing on the responsibilities of marketing authorization holders to monitor medicine safety and report adverse reactions.
Do you need some help with putting the Belgian PV System together? We’re here for you.
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