AEs collected from market research should still be forwarded to the marketing authorisation holder (MAH) within one business day of first awareness

Some members may be aware that the EMA’s 2014 revisions to the Guideline on good pharmacovigilance practices include a redefinition of how day zero should be calculated for the purposes of reporting adverse events (AEs) to the regulator. 

We are pleased to be able to reassure members that following discussion with the ABPI’s Pharmacovigilance Expert Network no changes are required to the BHBIA/ABPI’s AE reporting guidelines.  AEs collected from market research should still be forwarded to the marketing authorisation holder (MAH) within one business day of first awareness of the AE.  

The MAH’s PV department will have the rest of the 15-day period allowed for expedited reporting, to forward AEs to the regulator. 

View the BHBIA/ABPI’s Guidance notes on the collection of adverse events and product complaints from market research programmes.