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 -  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

 

Last updated on 25/10/2016