The FAMHP has created an online form for healthcare professionals to notify any adverse effects of medicinal products for human use. This new format incorporates the patient notification form for that has been online since March 2019. From now on, anybody can notify adverse effects of medicinal products using simplified online forms available at a single address: www.notifieruneffetindesirable.be or www.eenbijwerkingmelden.be.
For patients and healthcare professionals
In March 2019, the FAMHP began modernising the forms for notifying any adverse effects of medicinal products for human use, by making an online notification form available to patients. The FAMHP has now further improved this form for patients and revised the notification form for healthcare professionals. The “yellow cards” (www.fichejaune.be), are now a thing of the past. There is one go-to address for notifying adverse effects of medicines: www.notifieruneffetindesirable.be - www.eenbijwerkingmelden.be. Users are given a choice of options to click to be redirected to the appropriate form to use to notify the FAMHP and provide as much useful information as possible on the suspected adverse effect.
More practical and user friendly
The new versions of the notification forms are intuitive to use and more user friendly thanks to new functions that facilitate the notification of adverse effects.
- Compatibility with mobile devices (tablets, GSM, etc.).
- Compatibility with a number of web browsers (Chrome, FireFox, Edge, Safari, etc.).
- Simplified access rights (optional login and removal of DocCheck for professionals).
- Simplified coding thanks to various drop-down menus and explanatory pop-ups.
- Rregistration of a rough-draft notification that can be completed later on;.
- Acknowledgement of receipt by e-mail.
- Summary of the notification available (pdf);
- Improved visual presentation.
Even safer medicinal products thanks to the notification
The purpose of simplifying these notification forms is to increase the number of notifications of adverse effects of medicinal products and consequently improve knowledge of the safety profile of medicinal products.
Xavier De Cuyper, General Administrator of the FAMHP: “Under-reporting of the adverse effects of medicinal products continues to be of primary concern to the FAMHP. The agency hopes that these new tools will encourage healthcare professionals and patients to submit more notifications of adverse effects of medicinal products. The more information on adverse effects our experts receive, the more they are able to improve the safety of medicinal products on the Belgian and European markets.”
We would like to remind you that all adverse effect reports notified to the FAMHP are internally evaluated by its scientific experts. The notifications will also be registered in the European Medicines Agency (EMA) EudraVigilance database and in the World Health Organization (WHO) VigiBase database. After analysing the cases submitted to these databases, new adverse effects may be identified and listed in the summary of product characteristics and patient information leaflets of medicinal products and/or new precautions for use, interactions or contraindications may also be added. These measures are generally taken following consultation at European level within the EMA.
You can find additional information on notifying adverse effects associated with medicinal products on the FAMHP website.
Comments and/or suggestions are always welcome at ADR@afmps.be.
The medicinal product adverse effect notification forms can also be accessed by logging in to www.masante.belgique.be.