The FAMHP launches BioVigilance, a new online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin (SoHO) intended for human application.
Biovigilance is the systematic monitoring (reporting, management and prevention) of serious adverse events and reactions from the selection of the donor to the follow-up of the recipient, including any child born from a donation.
In accordance with the Royal Decree of 28 September 2009, the hospital’s chief medical officer or the human body material manager of the establishment must immediately notify the FAMHP of any suspected serious adverse event (SAE) or serious adverse reaction (SAR) in the donor, the recipient or child born from a donation, with an impact on the quality and safety of substances of human origin (SoHO). From now on, they can notify the FAMHP quickly and easily via the new application.
The application takes into account the new Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application and ensures that the FAMHP complies with European annual reporting requirements.
This application supports the FAMHP's mission to ensure public health and is part of its efforts to further modernise and optimise the notification process, with particular attention paid to user-friendliness, data security and transparency.
Further information
Webportal FAMHP
Application user guide (FR - NL)
Biovigilance web page
Excerpt from the official page. The original is authoritative.