Pharmacovigilance in Luxembourg
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 Luxembourgian pharmacovigilance services:
LCPPV / EU QPPV in Luxembourgh
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Luxembourg?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance is the Division de la Pharmacie et des Médicaments (DPM), headquartered in Strassen. This division is responsible for monitoring and evaluating adverse effects of medicinal products
The DPM collaborates with the Centre Régional de Pharmacovigilance (CRPV) located in Nancy, France.
Useful insights about the authority website
NOTICE
Division de la Pharmacie et des Médicaments (DPM) do not have it’s own website as such, there is official website of ministry of health or health portal published by ministry of health, which we recommend to use.
LIMITED CONTENT IN ENGLISH
Ministry of Health’s website has English, French, German and Luxembourish version but, the section regarding pharmacovigilance seems to miss.
Health portal’s website provide more information in field of pharmacovigilance, though website does not have an English version, only French one.
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.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE SECTION
Instead of general information about pharmacovigilance, you will find a signpost that will guide you further into more advanced areas, for example to information for MAHs or to information regarding reporting ADRs.
FORMS TO DOWNLOAD
List of the most important forms regarding medicines and health professionals, such as Fees in relation to marketing authorizations in Luxembourg or Procedures for marketing authorization applications in Luxembourg.
RISK MANAGEMENT PLANS & aRMM
Dive into the essential world of Risk Management Plans (RMPs) & Additional Risk Minimization Measures (aRMM) and discover how they play a crucial role.
INFORMATION FOR MAHs
Here you’ll find basic information about the person responsible for pharmacovigilance, additional risk minimisation activities (aRMM) and direct communications to healthcare professionals.
Other important institutions & industry groups
MINISTRY OF HEALTH AND SOCIAL SECURITY
The Ministry of Health in Luxembourg is responsible for overseeing public health and the organization of the healthcare system. Additionally, the ministry plays a crucial role in pharmacovigilance through its Division of Pharmacy and Medicines (DPM).
You can browse general information about ministry, on this linked page there are also links for other important public institutions in the field of health. Ministry website seems not to provide special section dedicated to pharmacovigilance.
Ministry website: https://m3s.gouvernement.lu/en.html
BELGIAN PHARMACEUTICAL INDUSTRY ASSOCIATION (IML)
This association represents the innovative pharmaceutical industry in Luxembourg, advocating for access to innovative medicines and promoting therapeutic innovation.
You can visit their pharmacovigilance section or their legislation section, where you can find PDF on distribution, marketing, taxes, advertising medicines and much more.
IML website: https://www.iml.lu/en
EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES AND ASSOCIATIONS (EFPIA)
Although not exclusive to Luxembourg, this federation is representing the interests of the pharmaceutical industry at a broader European level.
EFPIA is trying to increase patient access to medicines across Europe, here you can read how exactly. If you’re interested in pharma industry in figures, for example with with a focus on total spending on healthcare, visit their publication section.
EFPIA website: https://www.efpia.eu/#/
Some of the most important laws
Basic legislation
Grand-ducal regulation of December 15, 1992
placing medicinal products on the market, marketing of medicinal products
Grand-ducal regulation of May 30, 2005
application of good clinical practices in the conduct of clinical trials of medicinal products for human use
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 Luxembourg is a member of the EU, every MAH with a product on the Luxembourgian 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
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Luxembourg, 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.
DPM (Division de la Pharmacie et des Médicaments)
→ Main authority on pharmacovigilance in Luxembourg.
CRPV (Centre Régional de Pharmacovigilance)
→ DPM collaborates with CRPV in order to handle pharmacovigilance even better.
PGR (Plan de gestion des risques)
→ RPM / Risk Management Plan
AMM (d’Autorisation de Mise sur le Marché)
→ MA / Marketing Authorisation
RCP (Caractéristiques du Produit)
→ SPC / Summary of Product Characteristics
aRMM (Activités additionnelles de minimisation des risques)
→ aRMM / additional risk minimisation activities
Is LCPPV needed or is EU QPPV enough?
Yes, the Local Contact Person for Pharmacovigilance (LCPPV) is required in Luxembourg, requirements for this role are stated in Grand-Ducal Regulation, as amended, of December 15, 1992.
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 Luxembourg?
In order to report an ADRs, please contact the Nancy Regional Pharmacovigilance Centre or the Pharmacy and Medicines Division of the Health Department, contact information can be found here.
In case of any further questions regarding reporting ADRs in Luxembourg, please go through this Q&A document.
Local medical journals to screen
Here are few examples of Luxembourgian local literature that medical authorization holders should monitor:
LUXEMBOURG INSTITUTE OF HEALTH (LIH)
Although not strictly a journal, the LIH, a leading biomedical research institution, publishes numerous research papers in various international medical journals.
EUROPEAN JOURNAL OF PUBLIC HEALTH
A leading international journal that focuses on public health issues in Europe.
It publishes original research, reviews, and commentaries on a wide range of topics, including disease prevention, health promotion, health policy, and social determinants of health.
ISSN: 1464-360X
UNIVERSITY OF LUXEMBOURG
The University of Luxembourg, particularly the Faculty of Science and Medicine, supports research in various medical fields. Faculty members often publish their findings in international journals.
You can visit their website to see some of their publication or search in their bibliography.
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
Luxembourg: 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 and health
National antibiotics plan: first monitoring report in Luxembourg
A comprehensive report detailing the monitoring of antibiotic consumption, resistance, and residues in the environment. This document compiles the latest national data across human health, animal health, and environmental factors, highlighting the urgent need for a coordinated “One Health” approach to combat antibiotic resistance, a critical global health threat.
Adverse Drug Reaction Reporting by Patients in 12 European Countries
This article explores the vital role that patients play in reporting suspected adverse drug reactions (ADRs) and how their contributions strengthen pharmacovigilance systems across Europe.
Survey of healthcare professionals on pharmacovigilance
La Division de la Pharmacie et des Médicaments de la Direction de la santé (DPM-DISA) is announcing a new survey aimed at understanding how healthcare professionals in Luxembourg perceive pharmacovigilance.
Survey is now open online and in the future it might be interesting to see the outcome.
Uppsala reports
Article about PV system in Luxembourg
News platform of the Uppsala Monitoring Centre, designed for anyone interested in the latest developments in medicine safety, you can subscribe their newsletter.
Do you need some help with putting the Luxembourgian PV System together? We’re here for you.
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