The FAMHP wants to inform its current and future partners (authorisation holders, sponsors of clinical trials…) in the framework of the electronic reporting of adverse reactions of medicinal products for human use, of the new procedure for electronic reporting. This will be applied from 22 April 2011.
The FAMHP wants to inform its current and future partners (authorisation holders, sponsors of clinical trials…) in the framework of the electronic reporting of adverse reactions of medicinal products for human use, of the new procedure for electronic reporting. This will be applied from 22 April 2011.
The FAMHP wants to inform of its new procedure all the partners who need to report electronically (E2B format) adverse reactions with medicinal products to the FAMHP according to the current national and European legislation. This will be applied from 22 April 2011.
This new procedure is aimed at providing a solution to the problems the FAMHP is facing with its local EudraVigilance system. A communication about this issue has already been published on 24 December 2010.
This new procedure will imply a simplification of electronic reporting namely:
| The SUSARs from interventional clinical trials* must be sent to the EVCTMPROD** module.
The other reports* must be sent to the EVHUMAN** module. |
* which need to be sent according to the legal framework mentioned in the official Communication
* from the EudraVigilance system of the European Medicines Agency (EMA).
Via the following links you will find the official Communication, signed by the CEO of the FAMHP and destined to every partner who must report electronically to the FAMHP: NL, FR, ENG.
You can find additional information concerning this official Communication in:
- Document history: For which reason FAMHP has taken this decision regarding a new procedure for electronic reporting?
- Technical requirements enabling the partners to follow the new procedure for electronic reporting / info for new partners
- Q&A about the official Communication related to EudraVigilance
If, for example for inspection reasons, you want to receive the official Communication personally addressed to your organisation (as authorisation holder or as sponsor of a clinical trial), you can request this via icsr@fagg-afmps.be.
For questions concerning this Communication, you can also contact icsr@fagg-afmps.be.