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 effect that may have been caused by a medicine that they are aware of. Other health professionals and patients can also report these adverse side effects.
This system shall be used to collect useful information on the risks of medicinal products as regards patients' and public health in general. It helps to ensure the safe and appropriate use of medicines, to better inform patients and health professionals, and to ensure 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 Pharmacovigilance Centre of Nancy / Lorraine, France.
Pharmaceutical companies being the holders of marketing authorisations for medicinal products are required to implement a system of pharmacovigilance.
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.