Notification of adverse effects of medicinal products (pharmacovigilance)
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All activities aimed at monitoring, assessment, understanding and prevention of adverse effects (AEs) resulting from the use of medicines in humans fall under pharmacovigilance.
This continuous monitoring is carried out in collaboration with health professionals and patients. In particular, physicians, dentists, pharmacists and midwives are required to report any adverse effects that they are aware of and that may have been caused by a medicine. Other health professionals and patients can also report these adverse side effects.
This system is used to collect useful information on the risks of medicinal products with regard to the patients' and the public health in general. It helps to ensure the safe and appropriate use of medicines, to better inform patients and health professionals, and to guarantee a positive benefit-risk balance for patients.
This information concerns in particular the adverse reaction occurring in humans in case of:
- the use of a medicine in accordance with the terms of its marketing authorisation;
- any use that is not in accordance with the terms of the marketing authorisation;
- occupational exposure.
They also concern 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, among others, prevent or reduce the risks of drug use.
Who is concerned?
Physicians, dentists, pharmacists and midwives are required to report any suspected adverse effects of medicinal products.
Other health professionals and patients can make a declaration without being obliged to do so.
The Division of Pharmacy and Medicines of the National Health Directorate acts as the competent authority in Luxembourg for pharmacovigilance, and works in collaboration with the Nancy Pharmacovigilance Centre / Lorraine, France.
Pharmaceutical companies, as holders of marketing authorisations for medicinal products, are required to implement a pharmacovigilance system.
How to proceed
Submitting the declaration
In order to notify cases of suspected adverse effects of a medicinal product, an adverse effect notification form is available for all health professionals. This form can also be used by patients.
It can be sent by email, mail or fax to the Regional Pharmacovigilance Centre of Lorraine and/or to the National Health Directorate.
Health professionals and patients may report suspected adverse reactions by any other means by contacting the Regional Pharmacovigilance Centre of Lorraine or the Division of Pharmacy and Medicines of the National Health Directorate.
They may also contact the pharmacovigilance department of the pharmaceutical company responsible for marketing the medicinal product(s) concerned.
Data protection
The information note on data protection which explains how personal data is processed in the context of pharmacovigilance reports can be consulted here in French (French, Pdf, 462 Kb).
Online services and forms
Downloadable forms
Note: view tips for using PDF forms.
For the PDF document below, right-click the button instead of clicking with the left mouse button. In the menu that opens, select the "Save link as..." command. The "Save as” dialogue box will open and you can save the document to your computer. Then launch the Acrobat Reader program and use it to open the file (the dynamic PDF form) saved on your computer.
If you have problems downloading the dynamic PDF form, you can also fill in the Word form for health professionals.
The information note on data protection which explains how personal data is processed in the context of the forms below can be consulted here in French (French, Pdf, 462 Kb).
Who to contact
Division of Pharmacy and Medicines
-
Ministry of Health and Social Security Division of Pharmacy and Medicines
- Address:
- 2a, rue Thomas Edison L-1445 Strassen Luxembourg
- Phone:
- (+352) 247-85592
- Email address:
- pharmacovigilance@ms.etat.lu
Regional Pharmacovigilance Centre Nancy
-
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
Links
Further information
sur Sante.lu
Legal references
- Code de la santé
-
Règlement grand-ducal modifié du 15 décembre 1992
relatif à la mise sur le marché des médicaments
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