Agreements concerning the individual reports of adverse drug reactions
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 (PDF, 120.26 Kb) - FR (PDF, 120.76 Kb) - NL (PDF, 119.9 Kb).
· Obtaining “follow-up” information on yellow cards: ENG (PDF, 98.36 Kb) - FR (PDF, 98.64 Kb) - NL (PDF, 98.1 Kb).
· Admission of the MAHs or sponsors of clinical trials to electronic reporting : ENG (PDF, 125.5 Kb) - FR (PDF, 121.72 Kb) - NL (PDF, 120.31 Kb).
· Electronic sending of ICSRs reported in Belgium since 01/01/1995 in the Eudravigilance system (“Retrospective population”): ENG (PDF, 142.46 Kb) - FR (PDF, 109.88 Kb) - NL (PDF, 109.65 Kb).
· Electronic transmission of the yellow cards by FAMHP to the MAHs: ENG (PDF, 82.44 Kb) - FR (PDF, 83.87 Kb) - NL (PDF, 82.72 Kb).
Comments on sending mails to adrs-mah@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 |