News image

The latest ABPI/BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations (Adverse Events [AEs]) during market research was published in August 2018.

The main change concerns when AEs are collected directly from patients or consumers where market research is conducted in the UK. Market researchers now need if possible to collect the patient/consumer’s contact details and forward these details to the Marketing Authorisation Holder’s (MAH) pharmacovigilance (PV) team to follow up where needed. This change was implemented to allow PV to meet their European Medicines Agency (EMA) obligations. Please refer to the BHBIA website for details of the Guidance notes.
EphMRA recommends that this process should be followed for healthcare market research conducted in the UK with patients/consumers. EphMRA is assessing the implications of the changes in UK AE reporting for other EU countries and will update members in due course.