To facilitate some procedures in force between the Marketing Authorisation Holder (MAH) and the FAMHP, some guidelines are drawn up concerning:
· Transmission by the FAMHP to the MAH of the notifications of adverse drug reactions by health care professionals (“paper” yellow cards) :ENG - FR - NL.
· Obtaining “follow-up” information on yellow cards: ENG - FR - NL.
· Admission of the MAHs or sponsors of clinical trials to electronic reporting : ENG - FR - NL.
· Electronic sending of ICSRs reported in Belgium since 01/01/1995 in the Eudravigilance system (“Retrospective population”): ENG - FR - NL.
· Electronic transmission of the yellow cards by FAMHP to the MAHs: ENG - FR - NL.
Comments on sending mails to adversedrugreactions@fagg-afmps.be
If you wish to send an e-mail on the following subjects, please include the information listed below in the subject line:
| Transmission of notifications of adverse drug reactions by healthcare professionals (yellow cards) to MAHs | Company name: transmission of yellow cards to MAHs |
| Obtaining follow-up information on yellow cards | Company name: requesting follow-up information concerning a yellow card (mentioning the reference number of the FAMHP, i.e. DHH2009N…) |
| Admission of the MAHs or sponsors of clinical trials to electronic reporting | Company name: electronic reporting to FAMHP |
| “Retrospective population” in the system EudraVigilance with the reports reported in Belgium since 01/01/1995 | Company name: retrospective population of EudraVigilance |
| Electronic transmission of yellow cards to a MAH | Company name: electronic transmission of the yellow cards by FAMHP to MAHs |