Are you a Belgian tissue establishment or hospital? From now on, you should report all serious adverse events (SAEs) and serious adverse reactions (SARs) to the FAMHP Biovigilance Entity using the new forms.
Every year, Belgian tissue establishments and hospitals must report all serious adverse events (SAEs) and reactions (SARs) that have occurred when processing and using tissues and cells, to the FAMHP Biovigilance Entity.
Four forms
For this purpose, the FAMHP is making four new forms available to you:
- a form for SAEs of the reproductive system;
- a form for SARs of the reproductive system;
- a form for SAEs of the non-reproductive system;
- a form for SARs of the non-reproductive system.
These forms facilitate compulsory notification by SoHO establishments and hospitals and allow for a better transition to notification through an electronic system that is currently under development.
The new biovigilance forms also take into account the new Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin (SoHO) intended for human application.
Last but not least, the forms ensure compliance with European requirements for annual reporting by the FAMHP. All these improvements will further ensure the quality and safety of the various substances of human origin (SoHO).