Notification of adverse effects of medicinal products (pharmacovigilance)

Last update

This page contains information on how to report suspected adverse effects relating to the use of medicines. There are 2 procedures: one for healthcare professionals and one for patients.

Summary:

In the event of adverse effects suspected to be related to the use of medicines, depending on your status (healthcare professional or patient), you must or may report this case to the Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments - DPM) of the Health Directorate or to the Regional Pharmacovigilance Centre (Centre régional de pharmacovigilance - CRPV) in Nancy (France).

Professionnels de santé : Notification d’effet(s) indésirable(s) suspecté(s) d’être lié(s) à un/des médicament(s) à usage humain
Patients : Notification d’effet(s) indésirable(s) suspecté(s) d’être lié(s) à un/des médicament(s) à usage humain
Go to online services and forms

Pharmacovigilance covers all activities aimed at monitoring, assessing, understanding and preventing adverse effects (AEs) resulting from the use of medicines in humans.

This continuous monitoring is carried out in collaboration with healthcare professionals and patients.

The reason for reporting suspected adverse effects relating to the use of medicines or vaccines is to gather useful information about the potential risks of medicines to patient health and public health in general. It ensures:

  • the safe use and proper administration of medicines;
  • a continuous positive risk-benefit ratio for patients.

This information concerns in particular the adverse effects occurring in humans in the event of:

  • use of a medicine in accordance with authorised indications;
  • use that does not comply with the authorised indications.

It also concerns specific situations with or without associated adverse effects such as medication errors, abuse, misuse, overdose, unauthorised use, accidental exposure or exposure during pregnancy or breastfeeding.

This information is subject to a scientific assessment in order to prevent and/or reduce the risks associated with the consumption of medicines.

Who is concerned

Physicians, dentists, pharmacists and midwives are required to report any adverse effects resulting from the use of medicines.

Other healthcare professionals and patients can make a declaration without being obliged to do so.

The Division of Pharmacy and Medicines (DPM) of the Health Directorate:

  • is the competent authority in Luxembourg for pharmacovigilance; and
  • works in cooperation with the Regional Pharmacovigilance Centre (CRPV) in Nancy (France).

Costs

The declaration is free of charge.

How to proceed

Submitting the declaration

You can report any suspected adverse effects of medicines online via MyGuichet.lu.

This procedure can be carried out:

  • with authentication using:
    • a LuxTrust product; or
    • an electronic identity (eID) card; or
    • an eIDAS means of identification from another Member State of the European Union (EU) or the European Economic Area (EEA); or
  • without authentication.

If MyGuichet.lu is unavailable, you can:

  • use the adverse effect notification form available for download below and send it:
  • contact the CRPV in Nancy directly by phone: (+33) 3 83 65 60 85.

Data protection

The data protection information notice, which explains how personal data is processed in the context of pharmacovigilance reports, can be consulted here in English (Pdf, 49 Kb).

Online services and forms

Data protection information notice (Pdf, 49 Kb)

Online services

Professionnels de santé : Notification d’effet(s) indésirable(s) suspecté(s) d’être lié(s) à un/des médicament(s) à usage humain

Patients : Notification d’effet(s) indésirable(s) suspecté(s) d’être lié(s) à un/des médicament(s) à usage humain

Downloadable forms

Note: view tips for using PDF forms.

Healthcare professionals

Notification of adverse effect(s) suspected to be associated with one or more medicinal product(s) for human use - Form for healthcare professionals

Last update 14.11.2024

PDF749 Kb

Other language(s)

Notification of adverse effect(s) suspected to be associated with one or more medicinal product(s) for human use - Form for healthcare professionals

Last update 14.11.2024

WORD50 Kb

Other language(s)

Patients

Notification of side effect(s) suspected to be associated with one or more medicinal product(s) or vaccine(s) for human use - Form for patients

Last update 14.11.2024

PDF732 Kb

Other language(s)

Notification of side effect(s) suspected to be associated with one or more medicinal product(s) or vaccine(s) for human use - Form for patients

Last update 14.11.2024

WORD53 Kb

Other language(s)

Who to contact

Ministry of Health and Social Security Division of Pharmacy and Medicines

Address:
2, rue Thomas Edison L-1445 Strassen
Phone:
(+352) 247 85 592
Email address:
pharmacovigilance@ms.etat.lu
Website:
https://santesecu.public.lu/fr/espace-professionnel/domaines/pharmacies-et-medicaments.html/

Regional Pharmacovigilance Centre Nancy

Address:
CHRU de Nancy - Hôpitaux de Brabois (Bâtiment BBB), rue du Morvan F-54511 Vandoeuvre les Nancy CEDEX France
Phone:
(+33) 3 83 65 60 85
Fax:
(+33) 3 83 65 61 33
Email address:
crpv@chru-nancy.fr

Related procedures and links

Procedures

Mandatory reporting of infectious diseases

Links

Further information

Pharmacovigilance

sur SanteSecu.lu

Legal references

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