Introduction
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. The aim is to put in place, in a collaborative manner, the necessary public health measures to make the use of the various substances of human origin, whether reproductive or not, safer and more effective.
Like the existing forms, the BioVigilance application takes account the new Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin (SoHO) intended for human application and ensures that the FAMHP complies with European annual reporting requirements.
In this respect, we would like to remind stakeholders of the legal provisions relating to notifications in the context of biovigilance.
In accordance with the Royal Decree of 28 September 2009, establishing the arrangements for the notification of serious adverse reactions and serious adverse events relating to human body material and the traceability requirements to be met by the hospital with regard to human body material which is applied to or intended for human beings, as specified in paragraphs 1 and 2 of article 3, the chief physician of the hospital or the human body material manager of the establishment must immediately notify the FAMHP as soon as a serious adverse event or reaction is suspected in the donor, the recipient or the donor-conceived child.
In addition, in accordance with article 3, paragraph 3 of the same Royal Decree, all data on serious adverse events and serious adverse reactions must be kept in a legible form by the FAMHP, establishments and hospitals for a minimum of 30 years and a maximum of 50 years.
The 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.
Please note: the BioVigilance application must be used as soon as it is put into service. Notification forms will still be available in the event of problems with the application.
Access to the BioVigilance app.
Back-up forms
When the BioVigilance application is temporarily unavailable, biovigilance contact persons can use Word forms.
- Form for SAEs of the reproductive system (FR/NL)
- Form for SARs of the reproductive system (FR/NL)
- Form for SAEs of the non-reproductive system (FR/NL)
- Form for SARs of the non-reproductive system (FR/NL)
Further information
User guide (FR/NL)
Connection guide (FR/NL)
Privacy Statement (FR/NL)
Contact details
biovigil@fagg-afmps.be